Eli Lilly and Company has received a not approvable letter from the U.S. Food and Drug Administration for Zyprexa(R) long-acting injection (olanzapine LAI) for the treatment and maintenance treatment of schizophrenia in adults, the company announced today. Zyprexa LAI is an investigational formulation that combines the atypical antipsychotic medication Zyprexa (olanzapine) with a pamoate salt, resulting in an extended delivery of up to four weeks.
In its letter, the FDA said it needs more information to better understand the risk and underlying cause of excessive sedation events that have been observed in about 1 percent of patients in clinical trials. These events were discussed during the FDA's Feb. 6 Psychopharmacologic Drugs Advisory Committee hearing. At the conclusion of that meeting, the committee voted that there were circumstances under which Zyprexa LAI would be acceptably safe and effective for the treatment of acutely exacerbated schizophrenia and maintenance treatment of schizophrenia in adults.
In its letter, however, the FDA cited a new excessive sedation event that occurred shortly before the Feb. 6 hearing. Lilly alerted the agency and the advisory committee about the existence of a possible new case on Feb. 6, noting that Lilly was investigating the details of the event including conflicting information about the time of onset. After collecting additional information, Lilly was able to confirm after the advisory committee hearing that this was a case of excessive sedation and that it began between 3 to 5 hours after injection. All previous excessive sedation events had begun within three hours of injection. As with all previous patients with excessive sedation, this patient fully recovered.
"We are disappointed by the FDA's decision and we are committed to ongoing discussions to better understand the agency's perspective regarding this recent case of excessive sedation and to define the path forward and the associated timeline," said Dr. Jennifer Stotka, Vice President of U.S. Regulatory Affairs, Eli Lilly and Company. "Given the chronic and severe nature of schizophrenia, persistent challenges with adherence, and the limited number of approved depot formulations, we continue to believe that, if approved, Zyprexa LAI would provide a valuable treatment option for patients suffering from schizophrenia."
Independent regulatory reviews of Zyprexa LAI applications are ongoing in the European Union and other countries including Canada and Australia.
Friday, February 29, 2008
Dyax Corp. Announces First Market Approval from Licensing and Funded Research Program
Feb 28, 2008 - Dyax Corp. (NASDAQ: DYAX) announced today that Wyeth Pharmaceuticals, a division of Wyeth (NYSE: WYE), recently received market approval from the U.S. Food and Drug Administration for XYNTHA(TM) (Antihemophilic Factor (Recombinant), Plasma/Albumin-Free), a recombinant factor VIII product, for patients with hemophilia A for both the control and prevention of bleeding episodes and surgical prophylaxis. The peptide ligand, used in the purification process during the manufacture of XYNTHA, was discovered utilizing Dyax's proprietary phage display library and is part of the Company's Licensing and Funded Research Program (LFRP). XYNTHA is now distinguished as the only recombinant factor VIII treatment to utilize an entirely synthetic purification process.
Under the terms of the license agreement with Wyeth, Dyax is entitled to a milestone payment triggered by the first commercial sale of XYNTHA followed by royalties based on certain pre-determined sales levels.
"This announcement marks a significant milestone for our maturing Licensing and Funded Research Program and further validates the strengths of our proprietary phage display technology. Currently there are several clinical candidates in late Phase 2 trials in this program," commented Henry E. Blair, Chairman, President and Chief Executive Officer of Dyax. "The LFRP has the potential to generate substantial revenue as licensees and collaborators, like Wyeth, advance product candidates to commercialization."
Under the terms of the license agreement with Wyeth, Dyax is entitled to a milestone payment triggered by the first commercial sale of XYNTHA followed by royalties based on certain pre-determined sales levels.
"This announcement marks a significant milestone for our maturing Licensing and Funded Research Program and further validates the strengths of our proprietary phage display technology. Currently there are several clinical candidates in late Phase 2 trials in this program," commented Henry E. Blair, Chairman, President and Chief Executive Officer of Dyax. "The LFRP has the potential to generate substantial revenue as licensees and collaborators, like Wyeth, advance product candidates to commercialization."
FDA Approves Nexium for Use in Children Ages 1-11 Years
Feb. 28, 2008--The U.S. Food and Drug Administration approved Nexium (esomeprazole magnesium) for short-term use in children ages 1-11 years for the treatment of gastroesophageal reflux disease (GERD). The agency approved Nexium in two forms, a delayed-release capsule and liquid form. Nexium is approved in 10 milligrams (mg) or 20 mg daily for children 1-11 years old compared to 20 mg or 40 mg recommended for pediatric patients 12 to 17 years of age.
"This approval provides important information for appropriate dosing for children ages 1-11 years with GERD," said Julie Beitz, M.D., director of the FDA's Office of Drug Evaluation III in the Center for Drug Evaluation and Research. "Children prescribed this drug should be monitored by their physicians for any adverse drug reactions."
Nexium is part of a class of drugs known as proton pump inhibitors (PPIs). PPIs decrease the amount of acid produced in the stomach and help heal erosions in the lining of the esophagus known as erosive esophagitis.
FDA approved the use of Nexium in patients 1 to 11 years for short-term treatment of GERD based upon the extrapolation of data from previous study results in adults to the pediatric population, as well as safety and pharmacokinetic studies performed in pediatric patients. In one study, 109 patients 1-11 in age, diagnosed with GERD, were treated with Nexium once-a-day for up to eight weeks to evaluate its safety and tolerability. Most of these patients demonstrated healing of their esophageal erosions after eight weeks of treatment.
The most common adverse reactions in children treated with Nexium were headache, diarrhea, abdominal pain, nausea, gas, constipation, dry mouth and sleepiness. The safety and efficacy of Nexium has not been established in children less than one year of age.
Nexium is manufactured by AstraZeneca of Wilmington, DE.
"This approval provides important information for appropriate dosing for children ages 1-11 years with GERD," said Julie Beitz, M.D., director of the FDA's Office of Drug Evaluation III in the Center for Drug Evaluation and Research. "Children prescribed this drug should be monitored by their physicians for any adverse drug reactions."
Nexium is part of a class of drugs known as proton pump inhibitors (PPIs). PPIs decrease the amount of acid produced in the stomach and help heal erosions in the lining of the esophagus known as erosive esophagitis.
FDA approved the use of Nexium in patients 1 to 11 years for short-term treatment of GERD based upon the extrapolation of data from previous study results in adults to the pediatric population, as well as safety and pharmacokinetic studies performed in pediatric patients. In one study, 109 patients 1-11 in age, diagnosed with GERD, were treated with Nexium once-a-day for up to eight weeks to evaluate its safety and tolerability. Most of these patients demonstrated healing of their esophageal erosions after eight weeks of treatment.
The most common adverse reactions in children treated with Nexium were headache, diarrhea, abdominal pain, nausea, gas, constipation, dry mouth and sleepiness. The safety and efficacy of Nexium has not been established in children less than one year of age.
Nexium is manufactured by AstraZeneca of Wilmington, DE.
Government Concludes Vaccines Caused Autism
February 28, 2008 /PRNewswire-USNewswire/ -- It was announced that the U.S. Court of Federal Claims and the National Vaccine Injury Compensation Program ruled in favor of a child who regressed into autism as a result of vaccinations, several of which contained the mercury-based preservative thimerosal.
Case documents state that the vaccines administered to the claimant significantly aggravated an underlying condition that ultimately led to regressive encephalopathy and symptoms of autism.
According to official court documents, the child was developing normally until given the vaccines, and shortly after the shots, regressed into full autism. The child was diagnosed by nationally recognized autism medical specialists.
For more than a decade, thousands of parents have come forward with reports of sharp regression in their children following immunizations. The cases of autism have dramatically spiked in the past 15 years to as many as 1 in 150 children, making it the leading childhood developmental disorder today.
The National Autism Association (NAA) sees the ruling as confirmation of what so many parents have been saying for years. "This case echoes the stories of thousands of children across the country. With almost 5,000 similar cases pending in vaccine court, we are confident that this is just the first of many that will confirm what we have believed for so long, vaccines can and do cause children to regress into autism," says Wendy Fournier, parent and president of NAA. "We call on the Centers for Disease Control (CDC) to acknowledge that the current vaccine schedule is not safe for every child and as with the administration of any medicine, individual risks and susceptibilities must be considered for each patient."
While thimerosal has been phased out of many pediatric vaccines, it is still used in flu shots recommended for pregnant women and children. At a meeting of the Advisory Committee for Immunization Practices held yesterday at the CDC, the committee voted to recommend annual flu shots for all children up to the age of 18, and to date has refused to state a preference for mercury-free vaccines.
Case documents state that the vaccines administered to the claimant significantly aggravated an underlying condition that ultimately led to regressive encephalopathy and symptoms of autism.
According to official court documents, the child was developing normally until given the vaccines, and shortly after the shots, regressed into full autism. The child was diagnosed by nationally recognized autism medical specialists.
For more than a decade, thousands of parents have come forward with reports of sharp regression in their children following immunizations. The cases of autism have dramatically spiked in the past 15 years to as many as 1 in 150 children, making it the leading childhood developmental disorder today.
The National Autism Association (NAA) sees the ruling as confirmation of what so many parents have been saying for years. "This case echoes the stories of thousands of children across the country. With almost 5,000 similar cases pending in vaccine court, we are confident that this is just the first of many that will confirm what we have believed for so long, vaccines can and do cause children to regress into autism," says Wendy Fournier, parent and president of NAA. "We call on the Centers for Disease Control (CDC) to acknowledge that the current vaccine schedule is not safe for every child and as with the administration of any medicine, individual risks and susceptibilities must be considered for each patient."
While thimerosal has been phased out of many pediatric vaccines, it is still used in flu shots recommended for pregnant women and children. At a meeting of the Advisory Committee for Immunization Practices held yesterday at the CDC, the committee voted to recommend annual flu shots for all children up to the age of 18, and to date has refused to state a preference for mercury-free vaccines.
Hospira Launches Generic Irinotecan Injection
Hospira, Inc. , the world leader in generic injectable pharmaceuticals, today announced the launch of irinotecan hydrochloride injection in the United States. The medication is a generic version of Pfizer's Camptosar(R), which posted 2007 U.S. sales of more than $545 million. Irinotecan hydrochloride injection is used for patients with colon or rectal cancer whose disease has recurred or progressed following therapy with other treatments.
"We are continuing to grow our leading portfolio of generic medications used to treat patients with cancer," said Robert Felicelli, vice president and general manager, Specialty Pharmaceuticals, Hospira. "By providing irinotecan and other high-quality, lower-cost alternatives to proprietary medications, Hospira is meeting patient needs in this fast-growing therapeutic area."
Hospira's irinotecan product portfolio extends beyond the formulations available from the innovator. In addition to offering the medication in 40 mg and 100 mg single-dose vials, Hospira is also marketing a 500 mg single-dose vial, for additional convenience when preparing and delivering larger doses. The company packages irinotecan in its proprietary Onco-Tain(TM) vials for safe handling.
Hospira offers the broadest generic injectable product portfolio in the world, with more than 190 generic injectable products in more than 900 dosages and formulations. Product areas include cardiovascular, anesthesia, anti-infectives, oncology, analgesics, emergency and other therapeutic segments. A host of proprietary non-biologic drugs are facing patent expiration globally over the coming years, and many of these compounds are in Hospira's robust product pipeline. To help reduce medication errors, Hospira labels all of its injectable products with unit-of-use bar codes.
"We are continuing to grow our leading portfolio of generic medications used to treat patients with cancer," said Robert Felicelli, vice president and general manager, Specialty Pharmaceuticals, Hospira. "By providing irinotecan and other high-quality, lower-cost alternatives to proprietary medications, Hospira is meeting patient needs in this fast-growing therapeutic area."
Hospira's irinotecan product portfolio extends beyond the formulations available from the innovator. In addition to offering the medication in 40 mg and 100 mg single-dose vials, Hospira is also marketing a 500 mg single-dose vial, for additional convenience when preparing and delivering larger doses. The company packages irinotecan in its proprietary Onco-Tain(TM) vials for safe handling.
Hospira offers the broadest generic injectable product portfolio in the world, with more than 190 generic injectable products in more than 900 dosages and formulations. Product areas include cardiovascular, anesthesia, anti-infectives, oncology, analgesics, emergency and other therapeutic segments. A host of proprietary non-biologic drugs are facing patent expiration globally over the coming years, and many of these compounds are in Hospira's robust product pipeline. To help reduce medication errors, Hospira labels all of its injectable products with unit-of-use bar codes.
APP Pharmaceuticals Receives Final Approval for Irinotecan Hydrochloride Injection
Feb. 27, 2008 - APP Pharmaceuticals, Inc. (Nasdaq:APPX), a leading manufacturer of multi-source and branded injectable pharmaceutical products, today announced that it has received approval from the U.S. Food and Drug Administration (FDA) of its Abbreviated New Drug Application (ANDA) for Irinotecan Hydrochloride Injection, 40 mg/2mL and 100mg/5mL, the generic equivalent of Camptosar(R) Injection manufactured by Pfizer Inc. APP has immediately commenced marketing and shipping the product. APP's irinotecan is AP-rated, bar-coded and latex-free. According to IMS data, sales of Camptosar(R) in the United States were approximately $556 million in 2007.
Pfizer's Camptosar(R) Injection is a chemotherapy drug used to treat advanced cancer of the large intestine and rectum. It is indicated as a component of first-line therapy in combination with 5-fluorouracil and leucovorin for patients with metastatic colorectal cancer. The drug is also indicated for patients with metastatic colorectal cancer whose disease has recurred or progressed following initial fluorouracil-based therapy.
"Irinotecan is a large market opportunity," said Tom Silberg, President of APP. "Since receiving tentative approval for this product in October 2007, we have worked to secure a number of contracts and are pleased to be one of the first pharmaceutical companies to market and ship irinotecan in the U.S. Irinotecan represents the fourth ANDA approval APP has received thus far in 2008."
Pfizer's Camptosar(R) Injection is a chemotherapy drug used to treat advanced cancer of the large intestine and rectum. It is indicated as a component of first-line therapy in combination with 5-fluorouracil and leucovorin for patients with metastatic colorectal cancer. The drug is also indicated for patients with metastatic colorectal cancer whose disease has recurred or progressed following initial fluorouracil-based therapy.
"Irinotecan is a large market opportunity," said Tom Silberg, President of APP. "Since receiving tentative approval for this product in October 2007, we have worked to secure a number of contracts and are pleased to be one of the first pharmaceutical companies to market and ship irinotecan in the U.S. Irinotecan represents the fourth ANDA approval APP has received thus far in 2008."
Boca Pharmacal Receives FDA Approval for Carbinoxamine Oral Solution
February 27, 2008 /PRNewswire/ -- Boca Pharmacal, Inc. announced today that the U.S. Food and Drug Administration has granted final approval for the Company's Abbreviated New Drug Application (ANDA) to market its generic version of Pamlab's Palgic(R) Oral Solution (Carbinoxamine Maleate Oral Solution) 4 mg/5mL. The Company plans to launch its product immediately.
Carbinoxamine Maleate Oral Solution 4mg/5mL is indicated to treat seasonal and perennial allergic rhinitis.
"This approval is another example of our commitment to providing affordable drug products to customers and consistent innovation in the pharmaceutical industry," commented Robert J. Edwards Jr., CEO. "At Boca Pharmacal we pride ourselves on our ability to offer lower volume items that may have been overlooked by some of the larger generic companies. Carbinoxamine Maleate Oral Solution is the first of many approvals we expect in 2008. Having filed multiple ANDA applications coupled with our multinational partnerships we expect 2008 to be a very big year."
Carbinoxamine Maleate Oral Solution 4mg/5mL is indicated to treat seasonal and perennial allergic rhinitis.
"This approval is another example of our commitment to providing affordable drug products to customers and consistent innovation in the pharmaceutical industry," commented Robert J. Edwards Jr., CEO. "At Boca Pharmacal we pride ourselves on our ability to offer lower volume items that may have been overlooked by some of the larger generic companies. Carbinoxamine Maleate Oral Solution is the first of many approvals we expect in 2008. Having filed multiple ANDA applications coupled with our multinational partnerships we expect 2008 to be a very big year."
Pfizer to Seek to Appeal Lipitor Enantiomer Patent Ruling in the Netherlands, Company Notes That Ruling Has No Commercial Impact
Feb 28, 2008 - Pfizer Inc said today that it will seek to appeal a ruling of the Court of Appeal of The Hague in the Netherlands that Pfizer's atorvastatin enantiomer patent is invalid. The patent (EP 409,281) had been challenged by generics manufacturer Ranbaxy and expires in July 2010.
The decision has no commercial impact because Pfizer's basic patent covering Lipitor (EP 247,633) remains in force and expires in November 2011. Last week, the same court ruled that the basic patent would be infringed by Ranbaxy's proposed generic atorvastatin product. That decision, which is also subject to possible appeal, prevents Ranbaxy from launching a competitor drug before November 2011.
The company pointed out that today's ruling does not affect patent litigation involving Lipitor in other jurisdictions, including the United States. Pfizer said it will continue to vigorously defend its patents against infringement.
The decision has no commercial impact because Pfizer's basic patent covering Lipitor (EP 247,633) remains in force and expires in November 2011. Last week, the same court ruled that the basic patent would be infringed by Ranbaxy's proposed generic atorvastatin product. That decision, which is also subject to possible appeal, prevents Ranbaxy from launching a competitor drug before November 2011.
The company pointed out that today's ruling does not affect patent litigation involving Lipitor in other jurisdictions, including the United States. Pfizer said it will continue to vigorously defend its patents against infringement.
Teva Announces Approval of Generic Camptosar
Feb 28, 2008 - Teva Pharmaceutical Industries Ltd. (Nasdaq: TEVA) announced today that the U.S. Food and Drug Administration has granted final approval for the Company's Abbreviated New Drug Application (ANDA) to market its generic version of Pfizer's chemotherapy agent, Camptosar(R) (Irinotecan Hydrochloride) Injection, 20 mg/mL. Shipment of this product, available in 40 mg/2 mL and 100 mg/5 mL single dose vials, will begin immediately.
The brand product had annual sales of approximately $556 million in the United States for the twelve months that ended December 31, 2007, based on IMS sales data.
The brand product had annual sales of approximately $556 million in the United States for the twelve months that ended December 31, 2007, based on IMS sales data.
Wednesday, February 27, 2008
Shasun enters technology licensing agreement with Merck
Shasun Chemicals & Drugs Ltd has announced that the company has entered into a non-exclusive licensing agreement with Merck & Co., Inc.
Under the terms of the agreement Shasun grants Merck the use of its proprietary cross-coupling copper technology (also known as Buchwald technology) to manufacture and commercialize API's (Active Pharmaceutical Ingredients). The Buchwald cross-coupling technology is one of the most popular technologies in the pharmaceutical area allowing increasingly complex new drugs to be manufactured in an efficient and economical way, a company release stated.
Commenting on this development, Dr. Michel Spagnol (Chief Technology Officer) said, "I am very excited to have finalized this agreement with Merck. This is an important milestone for Shasun in making this technology widely accessible and paving the way for further collaborations".
Govindarajan (CEO and managing director of Shasun) added "This is yet another example that demonstrates Shasun's commitment to developing and commercializing its expanding portfolio of cutting edge technologies".
Under the terms of the agreement Shasun grants Merck the use of its proprietary cross-coupling copper technology (also known as Buchwald technology) to manufacture and commercialize API's (Active Pharmaceutical Ingredients). The Buchwald cross-coupling technology is one of the most popular technologies in the pharmaceutical area allowing increasingly complex new drugs to be manufactured in an efficient and economical way, a company release stated.
Commenting on this development, Dr. Michel Spagnol (Chief Technology Officer) said, "I am very excited to have finalized this agreement with Merck. This is an important milestone for Shasun in making this technology widely accessible and paving the way for further collaborations".
Govindarajan (CEO and managing director of Shasun) added "This is yet another example that demonstrates Shasun's commitment to developing and commercializing its expanding portfolio of cutting edge technologies".
FDA MedWatch - Tysabri (natalizumab) - Reports Of Clinically Significant Liver Injury
Feb. 27, 2008-Biogen Idec, Elan and FDA notified healthcare professionals of reports of clinically significant liver injury, including markedly elevated serum hepatic enzymes and elevated total bilirubin, occurred as early as six days after the first dose of Tysabri. The combination of transaminase elevations and elevated bilirubin without evidence of obstruction is recognized as an important predictor of severe liver injury that may lead to death or the need for a liver transplant in some patients. Tysabri should be discontinued in patients with jaundice or other evidence of significant liver injury. Physicians should inform patients that Tysabri may cause liver injury.
Tysabri_dhcp_letter.pdf
Tysabri_PI.pdf
Tysabri_dhcp_letter.pdf
Tysabri_PI.pdf
Sirion Therapeutics Receives NDA Acceptance and Priority Review From the FDA for Durezol in the Treatment of Postoperative Ocular Inflammation
Sirion Therapeutics, Inc., a privately held ophthalmic-focused biopharmaceutical company, today announced that its New Drug Application (NDA) for Durezol(TM) has been accepted by the U.S. Food and Drug Administration (FDA) and granted priority review. Sirion Therapeutics is seeking approval from the FDA for its investigational compound Durezol(TM) (difluprednate ophthalmic emulsion) 0.05%, a twice-daily steroid, as a treatment for postoperative ocular inflammation.
Priority review is granted by the FDA to those drugs that have the potential to provide a significant improvement compared to marketed products. This designation results in a review period of six months from the date of receipt of the NDA. The FDA has issued an action date of June 26, 2008 under the Prescription Drug User Fee Act (PDUFA).
Data from two Phase 3 clinical studies in post-operative inflammation will be presented at the American Society of Cataract and Refractive Surgery 2008 Symposium and Congress on Tuesday, April 8, 2008 at 8:32 am in room 176B at McCormick Place West in Chicago, IL.
Durezol(TM) is the trademark of Sirion Therapeutics Inc. and is currently under review by the U.S. Food and Drug Administration and has not yet been cleared as the trade name for commercial use.
Priority review is granted by the FDA to those drugs that have the potential to provide a significant improvement compared to marketed products. This designation results in a review period of six months from the date of receipt of the NDA. The FDA has issued an action date of June 26, 2008 under the Prescription Drug User Fee Act (PDUFA).
Data from two Phase 3 clinical studies in post-operative inflammation will be presented at the American Society of Cataract and Refractive Surgery 2008 Symposium and Congress on Tuesday, April 8, 2008 at 8:32 am in room 176B at McCormick Place West in Chicago, IL.
Durezol(TM) is the trademark of Sirion Therapeutics Inc. and is currently under review by the U.S. Food and Drug Administration and has not yet been cleared as the trade name for commercial use.
FDA Accepts for Review OVATION's Two NDA Submissions for Sabril
Feb 27, 2008 - OVATION Pharmaceuticals, Inc. announced today that the U.S. Food and Drug Administration (FDA) has accepted the company's new drug applications (NDA) for Sabril(R) (vigabatrin) in two types of epilepsies. The FDA assigned a priority NDA review for Sabril for the treatment of Infantile Spasms (IS), and will review the submission for refractory complex partial seizures (CPS) in the same time frame. Sabril is currently under review by the FDA for use as a monotherapy for patients with IS and as an adjunctive treatment for adults with refractory CPS. A priority review designation is given to drugs that provide treatment where no adequate therapy exists, or that offer major advances in treatment.
"The FDA's acceptance of our Sabril NDA filings is a significant milestone for the company and for this development program as we continue to advance our late-stage central nervous system pipeline," said Jeffrey S. Aronin, OVATION President and Chief Executive Officer. "The Sabril program, along with other epilepsy compounds we have in development, reflect our commitment to exploring new treatment options for patients suffering from severe and catastrophic epilepsies, particularly where current treatment needs are not fully addressed."
To date, there are no medications approved by the FDA for the treatment of Infantile Spasms, a devastating form of epilepsy which usually strikes infants in the first year of life. In the United States, Infantile Spasms constitute about two percent of childhood epilepsies, and 25 percent of epilepsies with onset in the first year of life. Infants with IS suffer spasms that typically last for one to five seconds and occur in clusters of up to 100 spasms at a time.
Complex Partial Seizures are epileptic attacks that cause impaired consciousness and originate from a single region of the brain. About one-third of patients with CPS are unresponsive, or refractory, to treatment with many first- or second-line anti-epileptic drugs (AEDs). In patients with refractory CPS, these treatments may only reduce the frequency and severity of the seizures, rather than providing complete seizure control.
"The FDA's acceptance of our Sabril NDA filings is a significant milestone for the company and for this development program as we continue to advance our late-stage central nervous system pipeline," said Jeffrey S. Aronin, OVATION President and Chief Executive Officer. "The Sabril program, along with other epilepsy compounds we have in development, reflect our commitment to exploring new treatment options for patients suffering from severe and catastrophic epilepsies, particularly where current treatment needs are not fully addressed."
To date, there are no medications approved by the FDA for the treatment of Infantile Spasms, a devastating form of epilepsy which usually strikes infants in the first year of life. In the United States, Infantile Spasms constitute about two percent of childhood epilepsies, and 25 percent of epilepsies with onset in the first year of life. Infants with IS suffer spasms that typically last for one to five seconds and occur in clusters of up to 100 spasms at a time.
Complex Partial Seizures are epileptic attacks that cause impaired consciousness and originate from a single region of the brain. About one-third of patients with CPS are unresponsive, or refractory, to treatment with many first- or second-line anti-epileptic drugs (AEDs). In patients with refractory CPS, these treatments may only reduce the frequency and severity of the seizures, rather than providing complete seizure control.
ZARS Pharma Announces Marketing Authorization of Rapydan in Europe
February 27, 2008 ZARS Pharma, Inc. announced today that Rapydan(R) (70 mg lidocaine/70 mg tetracaine medicated plaster) has now received marketing authorization in Sweden, the United Kingdom, the Netherlands, France, Spain, Austria, the Czech Republic, Greece, Ireland, Norway and Portugal following the completion of the European Mutual Recognition Procedure. ZARS Pharma has licensed the European sales and marketing rights of Rapydan to EUSA Pharma, Inc. Rapydan received marketing authorization in Sweden in January 2007 and was launched in May 2007. EUSA Pharma began launching Rapydan in other European Union countries in early 2008.
Rapydan is a topical local anesthetic patch approved for use on normal and intact skin to provide surface anesthesia of the skin in connection with needle punctures, in children from 3 years and above, and needle punctures and superficial surgical procedures in adults. Rapydan resembles a small adhesive bandage in appearance and is similar in its ease of application. The patch is applied to the skin for 30 minutes before painful medical procedures. Rapydan is the first product approved in Europe using the patented Controlled Heat-Assisted Drug Delivery or CHADD(R) technology developed by ZARS Pharma.
Rapydan is marketed as Synera(R) (lidocaine 70 mg and tetracaine 70 mg) in the United States and was approved by the U.S. Food and Drug Administration in 2005.
Rapydan is a topical local anesthetic patch approved for use on normal and intact skin to provide surface anesthesia of the skin in connection with needle punctures, in children from 3 years and above, and needle punctures and superficial surgical procedures in adults. Rapydan resembles a small adhesive bandage in appearance and is similar in its ease of application. The patch is applied to the skin for 30 minutes before painful medical procedures. Rapydan is the first product approved in Europe using the patented Controlled Heat-Assisted Drug Delivery or CHADD(R) technology developed by ZARS Pharma.
Rapydan is marketed as Synera(R) (lidocaine 70 mg and tetracaine 70 mg) in the United States and was approved by the U.S. Food and Drug Administration in 2005.
Actavis Extends Portfolio With Four New Products in the U.S.
Actavis Group, the international generic pharmaceuticals company, has received approval on four new products from the U.S. Food & Drug Administration.
The four products include:
Phendimetrazine tartrate tablets, 35mg: the generic equivalent of Bontril(R) tablets by Valeant Pharmaceuticals, are indicated in the adjunct management of weight loss. Annual sales of Phendimetrazine tartrate tablets had annual sales of US$3.1 million for the 12 months ending December 2007 according to IMS Health data.
Buspirone tablets, 30mg: the generic equivalent of Bristol Myers Squibb's Buspar(R). Buspirone tablets, used in the treatment of anxiety disorders, had annual sales of US$15.4 million for the 12 months ending December 2007 according to IMS Health data.
Baclofen tablets: the generic equivalent of Lioresal(R) tablets by Novartis, will be available in 10mg and 20mg strengths. Baclofen tablets are used to relax muscles and relieve pain and discomfort associated with certain nerve disorders.
Benztropine Mesylate Tablets, 0.5mg, 1mg, 2mg: are the generic equivalent to Cogentin(R). Benztropine mesylate is an antidrykinetic, which reduces the symptoms of Parkinson's disease by improving muscle control and reducing stiffness. Annual sales of Benztropine mesylate were US$12.8 million for the 12 months ending December 2007 according to IMS Health data.
"These approvals signify our commitment to provide our customers with a broad and expanding pipeline. We launched 19 products in the United States in 2007 and plan to increase that number in 2008. Actavis currently has over 70 pending applications at the FDA, including a growing list of first-to-file generic products. This momentum in our development pipeline will ensure that we continue to be on the forefront of bringing new generic products to market."
The four products include:
Phendimetrazine tartrate tablets, 35mg: the generic equivalent of Bontril(R) tablets by Valeant Pharmaceuticals, are indicated in the adjunct management of weight loss. Annual sales of Phendimetrazine tartrate tablets had annual sales of US$3.1 million for the 12 months ending December 2007 according to IMS Health data.
Buspirone tablets, 30mg: the generic equivalent of Bristol Myers Squibb's Buspar(R). Buspirone tablets, used in the treatment of anxiety disorders, had annual sales of US$15.4 million for the 12 months ending December 2007 according to IMS Health data.
Baclofen tablets: the generic equivalent of Lioresal(R) tablets by Novartis, will be available in 10mg and 20mg strengths. Baclofen tablets are used to relax muscles and relieve pain and discomfort associated with certain nerve disorders.
Benztropine Mesylate Tablets, 0.5mg, 1mg, 2mg: are the generic equivalent to Cogentin(R). Benztropine mesylate is an antidrykinetic, which reduces the symptoms of Parkinson's disease by improving muscle control and reducing stiffness. Annual sales of Benztropine mesylate were US$12.8 million for the 12 months ending December 2007 according to IMS Health data.
"These approvals signify our commitment to provide our customers with a broad and expanding pipeline. We launched 19 products in the United States in 2007 and plan to increase that number in 2008. Actavis currently has over 70 pending applications at the FDA, including a growing list of first-to-file generic products. This momentum in our development pipeline will ensure that we continue to be on the forefront of bringing new generic products to market."
Sun Pharma Gets FDA Approval to Market Generic Demadex Tablets
Feb. 27, 2008: Sun Pharmaceutical Industries Ltd. announced that USFDA has granted final approval for the Company’s Abbreviated New Drug Application (ANDA) to market its generic version of Hoffman la Roche’s Demadex®, torsemide tablets.
These generic torsemide tablets are therapeutic equivalents of Hoffman la Roche’s Demadex® Tablets and include four strengths: 5 mg, 10 mg, 20 mg and 100 mg. These strengths of torsemide tablets have annual sales of approximately USD 35 million in the US.
Torsemide is a diuretic, indicated for the treatment of edema associated with congestive heart failure, renal disease, or hepatic disease. Use of torsemide has been found to be effective for the treatment of edema associated with chronic renal failure. Torsemide is also indicated for the treatment of hypertension alone or in combination with other antihypertensive agents.
The Company expects to reach the market shortly with these products.
Demadex® is a registered trademark of Roche Therapeutics, Inc.
These generic torsemide tablets are therapeutic equivalents of Hoffman la Roche’s Demadex® Tablets and include four strengths: 5 mg, 10 mg, 20 mg and 100 mg. These strengths of torsemide tablets have annual sales of approximately USD 35 million in the US.
Torsemide is a diuretic, indicated for the treatment of edema associated with congestive heart failure, renal disease, or hepatic disease. Use of torsemide has been found to be effective for the treatment of edema associated with chronic renal failure. Torsemide is also indicated for the treatment of hypertension alone or in combination with other antihypertensive agents.
The Company expects to reach the market shortly with these products.
Demadex® is a registered trademark of Roche Therapeutics, Inc.
Apotex Settles Generic Neurontin Suit With Pfizer
NEW YORK -(Dow Jones)- Apotex Corp. has settled all outstanding patent infringement and antitrust litigation with Pfizer Inc. (PFE) regarding that company's former blockbuster anticonvulsant Neurontin.
Though terms of the settlement are confidential, Apotex said that it is free to market and sell the generic version as it has done since April 2005.
The agreement ends almost a decade of litigation between the two companies.
Pfizer added Neurontin to its drug stable when it purchased Warner-Lambert in February 2000. The drug had received approval from the U.S. Food and Drug Administration in January 1994.
In 2005, the federal district court in New Jersey ruled that Pfizer was unable to prove infringement of its Neurontin patents by generic drug makers including Alpharma Inc. (ALO), Apotex, Teva Pharmaceutical Industries Inc. (TEVA) and Eon Labs, which is part of Novartis AG (NVS).
In September, an appeals court overturned portions of the 2005 decision and sent the case to a new trial after ruling that the district court erred in granting summary judgment of non-infringement.
Afterward, Pfizer said it planned to pursue full damages due to the so-called at-risk launch of generic versions of Neurontin, the patent for which doesn't expire until 2017.
Such a move is called an at-risk launch because, under U.S. law, the generic maker can be liable for triple the damages incurred by the branded-drug company if it ends up losing the patent case.
Pfizer says sales of Neurontin were more than $2 billion a year, prior to the generic versions' launching.
Pfizer offers a generic version of Neurontin through its unit Greenstone Ltd.
Though terms of the settlement are confidential, Apotex said that it is free to market and sell the generic version as it has done since April 2005.
The agreement ends almost a decade of litigation between the two companies.
Pfizer added Neurontin to its drug stable when it purchased Warner-Lambert in February 2000. The drug had received approval from the U.S. Food and Drug Administration in January 1994.
In 2005, the federal district court in New Jersey ruled that Pfizer was unable to prove infringement of its Neurontin patents by generic drug makers including Alpharma Inc. (ALO), Apotex, Teva Pharmaceutical Industries Inc. (TEVA) and Eon Labs, which is part of Novartis AG (NVS).
In September, an appeals court overturned portions of the 2005 decision and sent the case to a new trial after ruling that the district court erred in granting summary judgment of non-infringement.
Afterward, Pfizer said it planned to pursue full damages due to the so-called at-risk launch of generic versions of Neurontin, the patent for which doesn't expire until 2017.
Such a move is called an at-risk launch because, under U.S. law, the generic maker can be liable for triple the damages incurred by the branded-drug company if it ends up losing the patent case.
Pfizer says sales of Neurontin were more than $2 billion a year, prior to the generic versions' launching.
Pfizer offers a generic version of Neurontin through its unit Greenstone Ltd.
Tuesday, February 26, 2008
Natco plea for export permission of two patented drugs may trigger several patent battles
(Article published in Pharmabiz http://www.pharmabiz.com/article/detnews.asp?articleid=43173§ionid)
As the Patent Control office here is scheduled to take up on February 28 for preliminary hearing the case of Hyderabad-based Natco Pharma seeking permission to manufacture and export two patented drugs to Nepal, a fresh series of patent battles on compulsory licensing is on cards.
Coming up as a test case after the amended Patent Act of 2005 came into effect, the favourable stand of Government on granting permission for patented drugs to be manufactured for exporting may trigger a slew of applications from other companies and possible legal cases from the multinationals that are going to be hit badly. However, the government may get more time to take a stand as it is just the first hearing on the case.
Armed with an import licence from the Nepal Government, Natco in September filed application for exporting anti-cancer Erlotinib, patented by Swiss manufacturers Roche last year in the country under brand name Tarceva and Sunitinib, patented by Pfizer under the brand name Sutent.
A spokesman of Natco said they have also filed an interlocutory petition questioning the sanctity of calling the patent holders for forwarding their representation on the case as the Government had the jurisdiction to allow the compulsory licence. ``At the first hearing, nothing decisive is going to happen as we are going to sit and work out on the terms and conditions of the case. It is pure discretion of the government to grant permission and there is no time limit fixed to take a decision also,'' company secretary Adinarayanan told Pharmabiz.
However, the case has already attracted a lot of attention from across the globe as it is the first of its kind in the country and if sanctioned, second of the sort in the world after Canada allowing to export an anti-AIDS drug TriAvir, patented by GlaxoSmithKline, to Rwanda. The so-called compulsory licence is a recognised legal instrument contained within the World Trade Organization Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS). TRIPS does not stipulate exactly when countries might need to use such a provision and it is a flexibility built into the agreement that leaves it up to governments. Under Section 92A of Indian patent law, companies can apply for a licence to export copies of patented drugs to a country that requests it.
Natco, which intends to produce 30,000 tablets of erlotinib and 15,000 of sunitinib, has offered the patent holders a five per cent royalty, in line with the WTO requirement to provide remuneration.
As the Patent Control office here is scheduled to take up on February 28 for preliminary hearing the case of Hyderabad-based Natco Pharma seeking permission to manufacture and export two patented drugs to Nepal, a fresh series of patent battles on compulsory licensing is on cards.
Coming up as a test case after the amended Patent Act of 2005 came into effect, the favourable stand of Government on granting permission for patented drugs to be manufactured for exporting may trigger a slew of applications from other companies and possible legal cases from the multinationals that are going to be hit badly. However, the government may get more time to take a stand as it is just the first hearing on the case.
Armed with an import licence from the Nepal Government, Natco in September filed application for exporting anti-cancer Erlotinib, patented by Swiss manufacturers Roche last year in the country under brand name Tarceva and Sunitinib, patented by Pfizer under the brand name Sutent.
A spokesman of Natco said they have also filed an interlocutory petition questioning the sanctity of calling the patent holders for forwarding their representation on the case as the Government had the jurisdiction to allow the compulsory licence. ``At the first hearing, nothing decisive is going to happen as we are going to sit and work out on the terms and conditions of the case. It is pure discretion of the government to grant permission and there is no time limit fixed to take a decision also,'' company secretary Adinarayanan told Pharmabiz.
However, the case has already attracted a lot of attention from across the globe as it is the first of its kind in the country and if sanctioned, second of the sort in the world after Canada allowing to export an anti-AIDS drug TriAvir, patented by GlaxoSmithKline, to Rwanda. The so-called compulsory licence is a recognised legal instrument contained within the World Trade Organization Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS). TRIPS does not stipulate exactly when countries might need to use such a provision and it is a flexibility built into the agreement that leaves it up to governments. Under Section 92A of Indian patent law, companies can apply for a licence to export copies of patented drugs to a country that requests it.
Natco, which intends to produce 30,000 tablets of erlotinib and 15,000 of sunitinib, has offered the patent holders a five per cent royalty, in line with the WTO requirement to provide remuneration.
Pfizer launches smoking cessation drug Champix in India
Pfizer Limited has launched the non-nicotine smoking cessation prescription drug Champix in India. The varenicline tartrate product christened as Chantix in US will be marketed through 600 smoking cessation clinics set up by the company in partnership with physicians across 17 cities in India.
The company will initiate a 12-week Champix prescription course and will provide support to the customers through the Champs Club support programme that together will help smokers to overcome their addiction. Champix is the first non-nicotine based prescription drug for smoking cessation getting approved by US FDA in the last 10 years.
The distribution of the product, which has dual mechanism of action on nicotine receptors to reduce nicotine craving and to suppress the sense of pleasure from smoking, is restricted to 17 cities for better results, informed Kewal Handa, MD, Pfizer India in a press conference.
"We are planning to work a model offering 12-week smoking cessation course at a cost of Rs 9652.50 for an individual. This not a big amount for the product, considering that the smoking related disease burden in India is estimated to be over Rs 24,000 crore," said Handa.
Research on the product shows that the odds of quitting smoking on Champix is twice than that of buproprion, product manufactured by GlaxoSmithKline Pharma in the name of Zyban, and four times that of placebo, said Dr Anjan Chattergee, medical director, global product team, Pfizer Inc. He also said that the allegation on the increased psychiatric problems related to the drug is not correct, as these withdrawal symptoms are regular in any type of smoking cessation.
The company, which received US FDA approval for the product in May 2006, has added stronger warnings to the drug in January 2008, stressing that a direct link between Chantix and the reported psychiatric problems has not been established, but could not be ruled out. However, the product which has already been prescribed to around 5.75 million people worldwide is poised to be a revenue builder for Pfizer, according to reports.
The company will initiate a 12-week Champix prescription course and will provide support to the customers through the Champs Club support programme that together will help smokers to overcome their addiction. Champix is the first non-nicotine based prescription drug for smoking cessation getting approved by US FDA in the last 10 years.
The distribution of the product, which has dual mechanism of action on nicotine receptors to reduce nicotine craving and to suppress the sense of pleasure from smoking, is restricted to 17 cities for better results, informed Kewal Handa, MD, Pfizer India in a press conference.
"We are planning to work a model offering 12-week smoking cessation course at a cost of Rs 9652.50 for an individual. This not a big amount for the product, considering that the smoking related disease burden in India is estimated to be over Rs 24,000 crore," said Handa.
Research on the product shows that the odds of quitting smoking on Champix is twice than that of buproprion, product manufactured by GlaxoSmithKline Pharma in the name of Zyban, and four times that of placebo, said Dr Anjan Chattergee, medical director, global product team, Pfizer Inc. He also said that the allegation on the increased psychiatric problems related to the drug is not correct, as these withdrawal symptoms are regular in any type of smoking cessation.
The company, which received US FDA approval for the product in May 2006, has added stronger warnings to the drug in January 2008, stressing that a direct link between Chantix and the reported psychiatric problems has not been established, but could not be ruled out. However, the product which has already been prescribed to around 5.75 million people worldwide is poised to be a revenue builder for Pfizer, according to reports.
Provectus Pharmaceuticals Receives Patent Allowances in Europe and China
Feb 26, 2008 - Provectus Pharmaceuticals, Inc. (OTCBB: PVCT, http://www.pvct.com), a development-stage oncology and dermatology biopharmaceutical company, has received allowance of its patent applications in Europe and China covering diagnostic use of PV-10 and a number of related agents in CT and MRI imaging. The pending patents cover products for diagnosis of cancer and other serious diseases.
"These cases augment our international portfolio of twenty-six issued patents and four pending patents, along with our U.S. patent portfolio of sixteen issued and five pending patents," said Craig Dees, PhD, CEO of Provectus Pharmaceuticals. "As important milestones, they demonstrate the scope of our patent activity that spans markets ranging from the developed world to the rapidly developing world."
"These cases augment our international portfolio of twenty-six issued patents and four pending patents, along with our U.S. patent portfolio of sixteen issued and five pending patents," said Craig Dees, PhD, CEO of Provectus Pharmaceuticals. "As important milestones, they demonstrate the scope of our patent activity that spans markets ranging from the developed world to the rapidly developing world."
Caliper and AntiCancer Announce Cross-Licensing of Intellectual Property and Settlement of Litigation
February 26, 2008 /PRNewswire-FirstCall/-- Caliper Life Sciences and AntiCancer, Inc. today announced that they have entered into an agreement to establish a cross-licensing relationship and end all outstanding patent litigation between the two companies. Under the new cross-licensing arrangement, Caliper acquires the right to sublicense AntiCancer's fluorescent protein optical imaging patents to third-parties, alongside Caliper's own portfolio of in vivo fluorescent and bioluminescent optical imaging patents; AntiCancer acquires the right to sublicense Caliper's optical imaging patents, in the field of fluorescent protein imaging, to a specified annual number of third parties throughout the life of the agreement, alongside AntiCancer's own fluorescent protein optical imaging patents. In addition, each company receives a royalty free license from the other for internal and contract research operations.
The agreement further strengthens Caliper's intellectual property estate specifically extending the range of fluorescent protein optical imaging rights available to customers. Focused on delivering a range of optical imaging technologies to meet the needs of the pharmaceutical and biotech industries, Caliper continues to strive to enable unsurpassed research flexibility specifically in the areas of cancer research and other critical therapeutic areas.
Under the cross-license arrangement, Caliper and AntiCancer will share in any revenues generated by the licensing of their proprietary imaging technologies in the field of fluorescent protein imaging. No other payments will be made for either the settlement or cross-licensing agreements. Further financial details of the cross-licensing arrangement were not disclosed.
The companies also expect to enter into an OEM distribution agreement under which Caliper will market and sell certain mouse and cell lines developed by AntiCancer for use in fluorescent protein-based optical imaging experiments.
"This settlement and the resulting alignment between Caliper and AntiCancer represent a major step forward for the in vivo molecular imaging community," said Kevin Hrusovsky, President and CEO of Caliper. "In addition to our unique position in bioluminescent and fluorescent conjugate imaging, the cross-licensing arrangement enables Caliper to provide our existing and prospective license customers with a broader suite of intellectual property rights for optical imaging with fluorescent proteins. This should greatly enhance the clarity and breadth of protection associated with these patents. We also look forward to the opportunity to expand our reagents business by marketing and selling fluorescent protein cell lines developed by AntiCancer."
"We are very pleased with the opportunity to work collaboratively with Caliper, the clear leader in terms of the number of pre-clinical optical imaging instruments placed in the market," said Robert Hoffman, Ph.D., President and CEO of AntiCancer. "AntiCancer is very pleased to have an outstanding partner such as Caliper to greatly enhance this pioneering fluorescent imaging technology. AntiCancer's mission has always been the development of technologies for the treatment and cure of cancer, and we look forward to furthering this mission through the combined innovative power of AntiCancer and Caliper."
The agreement further strengthens Caliper's intellectual property estate specifically extending the range of fluorescent protein optical imaging rights available to customers. Focused on delivering a range of optical imaging technologies to meet the needs of the pharmaceutical and biotech industries, Caliper continues to strive to enable unsurpassed research flexibility specifically in the areas of cancer research and other critical therapeutic areas.
Under the cross-license arrangement, Caliper and AntiCancer will share in any revenues generated by the licensing of their proprietary imaging technologies in the field of fluorescent protein imaging. No other payments will be made for either the settlement or cross-licensing agreements. Further financial details of the cross-licensing arrangement were not disclosed.
The companies also expect to enter into an OEM distribution agreement under which Caliper will market and sell certain mouse and cell lines developed by AntiCancer for use in fluorescent protein-based optical imaging experiments.
"This settlement and the resulting alignment between Caliper and AntiCancer represent a major step forward for the in vivo molecular imaging community," said Kevin Hrusovsky, President and CEO of Caliper. "In addition to our unique position in bioluminescent and fluorescent conjugate imaging, the cross-licensing arrangement enables Caliper to provide our existing and prospective license customers with a broader suite of intellectual property rights for optical imaging with fluorescent proteins. This should greatly enhance the clarity and breadth of protection associated with these patents. We also look forward to the opportunity to expand our reagents business by marketing and selling fluorescent protein cell lines developed by AntiCancer."
"We are very pleased with the opportunity to work collaboratively with Caliper, the clear leader in terms of the number of pre-clinical optical imaging instruments placed in the market," said Robert Hoffman, Ph.D., President and CEO of AntiCancer. "AntiCancer is very pleased to have an outstanding partner such as Caliper to greatly enhance this pioneering fluorescent imaging technology. AntiCancer's mission has always been the development of technologies for the treatment and cure of cancer, and we look forward to furthering this mission through the combined innovative power of AntiCancer and Caliper."
Barr Confirms Patent Challenge of Avodart Soft Gelatin Capsules, 0.5mg
Barr Pharmaceuticals, Inc. today confirmed that its subsidiary, Barr Laboratories, Inc., has initiated a challenge of the patents listed by GlaxoSmithKline in connection with its Avodart(R) (dutasteride) soft gelatin capsules, 0.5mg. The Company believes that it is the first to file an Abbreviated New Drug Application (ANDA) containing a paragraph IV certification for Avodart.
Barr filed its ANDA containing a paragraph IV certification for a generic Avodart product with the U.S. Food & Drug Administration (FDA) in October 2007, and received notification of the application's acceptance for filing in January 2008. Following receipt of the notice from the FDA that Barr's ANDA had been accepted for filing, Barr notified the New Drug Application (NDA) and patent holder.
On February 25, 2008, GlaxoSmithKline filed suit in the U.S. District Court for the District of Delaware to prevent Barr from proceeding with the commercialization of its product. This action formally initiates the patent challenge process under the Hatch-Waxman Act.
Avodart (dutasteride) had annual sales of approximately $362 million in the U.S., based on IMS sales data for the twelve-month period ending December 2007.
Barr filed its ANDA containing a paragraph IV certification for a generic Avodart product with the U.S. Food & Drug Administration (FDA) in October 2007, and received notification of the application's acceptance for filing in January 2008. Following receipt of the notice from the FDA that Barr's ANDA had been accepted for filing, Barr notified the New Drug Application (NDA) and patent holder.
On February 25, 2008, GlaxoSmithKline filed suit in the U.S. District Court for the District of Delaware to prevent Barr from proceeding with the commercialization of its product. This action formally initiates the patent challenge process under the Hatch-Waxman Act.
Avodart (dutasteride) had annual sales of approximately $362 million in the U.S., based on IMS sales data for the twelve-month period ending December 2007.
Monday, February 25, 2008
Jubilant bags US$ 92 million worth CRAMS contracts for 2008 calendar
Jubilant Organosys Ltd., an integrated pharmaceutical industry player and India's largest Custom Research and Manufacturing Services (CRAMS) company, has bagged new contracts worth US $92 million for its proprietary products and exclusive synthesis segment under CRAMS business for 2008.
Given Jubilant's geographical focus on the regulated markets, a large percentage of these contracts are realisable from the US, Europe and Japan. Outside the regulated markets, China is a major market for the company.
Its order book for the calendar year 2008 stands further augmented with the addition of these contracts by over 50 per cent. In addition to the annual contracts, the company also executes half yearly, quarterly and monthly contracts and spot sales. The new contracts have been signed with leading international pharma and other lifesciences companies, some of whom have been doing business with Jubilant for the past many years.
Given its experience in servicing global customers and the domain knowledge that it has built in key product areas, Jubilant has rapidly established itself as a world-class product and service provider in the CRAMS space. It has a healthy pipeline of products which are in phase III, stage of development at the customers end; and to support this it has made timely investments to expand key capacities. These contracts represent a huge opportunity for volume growth going forward for the exclusive synthesis and contract manufacturing segments under CRAMS.
Commenting on the development, Shyam S Bhartia, chairman and managing director and Hari S Bhartia, Co-chairman and managing director of Jubilant Organosys stated the substantial increment in order size that the company proves its record in delivering quality and cost-efficient outsourcing solutions to demanding, global life sciences players. Given our integrated business model we have been able to meet requirements across the value-chain for our customers. The signing of the recent agreements is expected to translate into considerable improved performance in the key Pharma and Life Sciences Products segment for 2008.
Given Jubilant's geographical focus on the regulated markets, a large percentage of these contracts are realisable from the US, Europe and Japan. Outside the regulated markets, China is a major market for the company.
Its order book for the calendar year 2008 stands further augmented with the addition of these contracts by over 50 per cent. In addition to the annual contracts, the company also executes half yearly, quarterly and monthly contracts and spot sales. The new contracts have been signed with leading international pharma and other lifesciences companies, some of whom have been doing business with Jubilant for the past many years.
Given its experience in servicing global customers and the domain knowledge that it has built in key product areas, Jubilant has rapidly established itself as a world-class product and service provider in the CRAMS space. It has a healthy pipeline of products which are in phase III, stage of development at the customers end; and to support this it has made timely investments to expand key capacities. These contracts represent a huge opportunity for volume growth going forward for the exclusive synthesis and contract manufacturing segments under CRAMS.
Commenting on the development, Shyam S Bhartia, chairman and managing director and Hari S Bhartia, Co-chairman and managing director of Jubilant Organosys stated the substantial increment in order size that the company proves its record in delivering quality and cost-efficient outsourcing solutions to demanding, global life sciences players. Given our integrated business model we have been able to meet requirements across the value-chain for our customers. The signing of the recent agreements is expected to translate into considerable improved performance in the key Pharma and Life Sciences Products segment for 2008.
Adherex Receives Orphan Drug Designation for ADH-1 in Melanoma
Adherex Technologies Inc. (TSX:AHX)(AMEX:ADH), a biopharmaceutical company with a broad portfolio of oncology products under development, today announced that it has received orphan drug designation for ADH-1 from the U.S. Food and Drug Administration (FDA). The designation was granted for the use of ADH-1 in conjunction with melphalan for the treatment of Stage IIB/C, III, and IV malignant melanoma. Adherex is currently conducting a Phase IIb expansion trial in melanoma using systemic ADH-1 in combination with regional melphalan. "FDA orphan drug designation for ADH-1 is an important asset in Adherex's development of this drug," said Dr. William P. Peters, CEO and Chairman of Adherex. "Orphan drug designation provides multiple incentives for Adherex to continue its accelerated development of ADH-1 for this significant clinical problem. Melanoma is a disease with an extremely poor prognosis and one in which the molecular target for ADH-1, N-cadherin, is frequently and often intensively expressed. N-cadherin is also intimately involved in the invasion and metastasis of melanoma. Our experience to date combining ADH-1 and melphalan for the treatment of in-transit melanoma has been very encouraging. To continue with the rapid development of this combination, two additional centers, Lehigh Valley and H. Lee Moffitt, have joined our Phase IIb trial which is ongoing at Duke and the MD Anderson. All four participating institutions are first-class medical centers with experienced investigators, and we are very pleased to have them involved in this development program."
The FDA orphan drug designation, administered by the Office of Orphan Products Development, provides potential incentives such as funding for clinical studies, study design assistance, waiver of FDA user fees, tax credits and, importantly, up to seven years of market exclusivity upon marketing approval.
Adherex is currently evaluating the synergy of systemic ADH-1 in combination with regionally-infused melphalan for the treatment of melanoma in a Phase I/IIb trial. The Lehigh Valley Hospital in Pennsylvania and the H. Lee Moffitt Cancer Center in Florida are being added as additional clinical trial sites to provide further multi-institutional experience. The Phase IIb portion of this trial is anticipated to complete patient accrual by approximately mid-2008, with data to be released at an appropriate scientific venue.
Another Phase I trial is also nearing completion at US Oncology in which systemic ADH-1 is being evaluated in combination with three different systemic chemotherapies: ADH-1 + docetaxel (Taxotere(R)), ADH-1 + carboplatin, and ADH-1 + capecitabine (Xeloda(R)). Subsequent Phase II and potential randomized, prospective trials of ADH-1 in combination with chemotherapy will be planned and based upon the results of the combination studies currently ongoing.
The FDA orphan drug designation, administered by the Office of Orphan Products Development, provides potential incentives such as funding for clinical studies, study design assistance, waiver of FDA user fees, tax credits and, importantly, up to seven years of market exclusivity upon marketing approval.
Adherex is currently evaluating the synergy of systemic ADH-1 in combination with regionally-infused melphalan for the treatment of melanoma in a Phase I/IIb trial. The Lehigh Valley Hospital in Pennsylvania and the H. Lee Moffitt Cancer Center in Florida are being added as additional clinical trial sites to provide further multi-institutional experience. The Phase IIb portion of this trial is anticipated to complete patient accrual by approximately mid-2008, with data to be released at an appropriate scientific venue.
Another Phase I trial is also nearing completion at US Oncology in which systemic ADH-1 is being evaluated in combination with three different systemic chemotherapies: ADH-1 + docetaxel (Taxotere(R)), ADH-1 + carboplatin, and ADH-1 + capecitabine (Xeloda(R)). Subsequent Phase II and potential randomized, prospective trials of ADH-1 in combination with chemotherapy will be planned and based upon the results of the combination studies currently ongoing.
Duramed's Lo Seasonique NDA Accepted for Filing by FDA
Barr Pharmaceuticals, Inc. today announced that its subsidiary, Duramed Pharmaceuticals, Inc., has received notification that the U.S. Food and Drug Administration (FDA) has accepted for review its New Drug Application (NDA) for Lo SEASONIQUE(R) (levonorgestrel/ethinyl estradiol tablets 0.10 mg/0.02 mg and ethinyl estradiol tablets 0.01 mg) extended-cycle oral contraceptive. The Company is seeking approval to manufacture and market the Lo SEASONIQUE, the first lower dose, extended-cycle oral contraceptive for the prevention of pregnancy. The Prescription Drug User Fee Action (PDUFA) date for the Lo SEASONIQUE NDA is October 24, 2008.
The clinical data supporting the Lo SEASONIQUE NDA resulted from one large pivotal multi-centered, open label clinical trial which concluded in June 2007. The clinical trial involved over 2,200 female subjects between the ages of 18 and 40 at 56 sites throughout the United States. Subjects were enrolled in the clinical trial for a duration of 12 months.
Under the Lo SEASONIQUE extended-cycle regimen, women take active tablets of 0.10 mg levonorgestrel/0.02 mg of ethinyl estradiol for 84 consecutive days, followed by seven days of 0.01 mg of ethinyl estradiol. The regimen is designed to reduce the number of withdrawal bleeding periods from 13 to four per year. By contrast, the majority of oral contraceptive products currently available in the United States are based on a regimen of 21 treatment days, followed by seven days of placebo.
The clinical data supporting the Lo SEASONIQUE NDA resulted from one large pivotal multi-centered, open label clinical trial which concluded in June 2007. The clinical trial involved over 2,200 female subjects between the ages of 18 and 40 at 56 sites throughout the United States. Subjects were enrolled in the clinical trial for a duration of 12 months.
Under the Lo SEASONIQUE extended-cycle regimen, women take active tablets of 0.10 mg levonorgestrel/0.02 mg of ethinyl estradiol for 84 consecutive days, followed by seven days of 0.01 mg of ethinyl estradiol. The regimen is designed to reduce the number of withdrawal bleeding periods from 13 to four per year. By contrast, the majority of oral contraceptive products currently available in the United States are based on a regimen of 21 treatment days, followed by seven days of placebo.
Actelion Withdraws Its Application for an Extension of Indication for Zavesca
LONDON, Feb. 25, 2008-The European Medicines Agency (EMEA) has been formally notified by Actelion of its decision to withdraw its application for an extension of indication for the centrally authorised medicine Zavesca (miglustat).Zavesca was expected to be used for the treatment of neurological manifestations in patients with Niemann Pick type C disease, a rare inherited neurodegenerative disease of childhood and adolescence. Zavesca is an orphan medicinal product.Zavesca was first authorised in the European Union on 20 November 2002. It is currently indicated for the oral treatment of mild to moderate type 1 Gaucher disease. Zavesca may be used only in the treatment of patients for whom enzyme replacement therapy is unsuitable.The application for the extension of indication for Zavesca was submitted to the EMEA on 16 October 2006. The Agency’s Committee for Medicinal Products for Human Use (CHMP) had given a negative opinion recommending the refusal of the type II variation to extend the indication on 18 October 2007. The company had requested a re-examination of the negative opinion. The re-examination had not yet finished when the company withdrew.In its official letter, the company is saying that the withdrawal of the application was based on its discussions with the CHMP regarding the need for additional data to be provided from patients treated with miglustat in the clinical setting. These data could be provided in order to support a resubmission in this indication in the near future.More information about Zavesca and the state of the scientific assessment at the time of withdrawal will be made available in a question-and-answer document. This document, together with the withdrawal letter from the company, will be published on the EMEA website in due course.
Artisan Pharma's Lead Product, ART-123, Approved in Japan
Feb 22, 2008 - Artisan Pharma, Inc. today announced that the Japanese Pharmaceutical and Medical Device Agency approved Artisan's lead drug, ART-123 (human, soluble, recombinant thrombomodulin), on January 25, 2008 for the treatment of disseminated intravascular coagulation ("DIC") in Japan.
The approval of ART-123, which was received by Artisan's partner and licensor of ART-123, Asahi Kasei Pharma Corporation ("AKP"), further establishes AKP as a leader in biologic pharmaceutical product development.
About ART-123
ART-123 is a novel, recombinant, soluble thrombomodulin for the treatment of DIC (disseminated intravascular coagulation) in sepsis. ART-123 uniquely targets both anti-coagulant and systemic anti-inflammatory pathways, and holds great promise as a self-regulating treatment of DIC in sepsis. Artisan licensed ART-123 from Asahi Kasei Pharma Corporation and holds all development and commercial rights for ART-123 outside of Japan, China, Taiwan and Korea.
The approval of ART-123, which was received by Artisan's partner and licensor of ART-123, Asahi Kasei Pharma Corporation ("AKP"), further establishes AKP as a leader in biologic pharmaceutical product development.
About ART-123
ART-123 is a novel, recombinant, soluble thrombomodulin for the treatment of DIC (disseminated intravascular coagulation) in sepsis. ART-123 uniquely targets both anti-coagulant and systemic anti-inflammatory pathways, and holds great promise as a self-regulating treatment of DIC in sepsis. Artisan licensed ART-123 from Asahi Kasei Pharma Corporation and holds all development and commercial rights for ART-123 outside of Japan, China, Taiwan and Korea.
FDA Grants Accelerated Approval of Avastin in Combination With Paclitaxel Chemotherapy for First-Line Treatment of Advanced HER2- -ve Breast Cance
(As per the article published on Pharmalive.com)
Feb 22, 2008 - Genentech, Inc. (NYSE:DNA) today announced that the U.S. Food and Drug Administration (FDA) granted accelerated approval for Avastin(R) (bevacizumab), in combination with paclitaxel chemotherapy, for the treatment of patients who have not received chemotherapy for their metastatic HER2-negative breast cancer. The approval is based on a Phase III study (E2100) that showed that Avastin in combination with paclitaxel chemotherapy resulted in a 52 percent reduction in the risk of disease progression or death compared to those treated with paclitaxel alone and a doubling in progression-free survival (PFS) (based on a hazard ratio of 0.48; p less than 0.0001). The safety profile of Avastin was consistent with our previous experience and no new safety signals were observed.
Avastin was approved in advanced breast cancer under the FDA's accelerated approval program, which allows the FDA to approve products for cancer or other life-threatening diseases based on initial positive clinical data. Genentech has shared with the FDA a summary of the results from a second positive Phase III trial (AVADO), and is expecting results from a third Phase III trial (RIBBON I) in first-line metastatic breast cancer in late 2008. A full review of both the AVADO and RIBBON I data by the FDA will be required for the accelerated approval to be converted into a full approval. As a part of our commitment to fully evaluate Avastin in breast cancer, Genentech will also submit data to the FDA from three additional randomized trials that are either ongoing or planned.
"There is no cure for metastatic breast cancer so it is important to control the disease as early and for as long as possible," said Kathy Miller, M.D., Associate Professor of Medical Oncology, Indiana University School of Medicine and lead investigator on the E2100 trial. "Now with Avastin plus paclitaxel, we can increase the time a woman's cancer is kept under control, and offer a biologic option to women who previously were limited to chemotherapies alone."
"As an oncologist who has treated women with metastatic breast cancer, I know how important the first course of therapy can be," said Susan Desmond-Hellmann, M.D., M.P.H., president, Product Development, Genentech. "New treatments are needed, and this approval provides women who have not yet received chemotherapy for their metastatic breast cancer a new option to consider with their physician and families."
Breast cancer is the second most common form of cancer and the second leading cancer killer among American women. According to the American Cancer Society, an estimated 178,000 women were diagnosed with breast cancer and approximately 40,000 died from the disease in the U.S. in 2007. Genentech estimates that 75 percent of women with newly diagnosed metastatic breast cancer are HER2-negative.
Feb 22, 2008 - Genentech, Inc. (NYSE:DNA) today announced that the U.S. Food and Drug Administration (FDA) granted accelerated approval for Avastin(R) (bevacizumab), in combination with paclitaxel chemotherapy, for the treatment of patients who have not received chemotherapy for their metastatic HER2-negative breast cancer. The approval is based on a Phase III study (E2100) that showed that Avastin in combination with paclitaxel chemotherapy resulted in a 52 percent reduction in the risk of disease progression or death compared to those treated with paclitaxel alone and a doubling in progression-free survival (PFS) (based on a hazard ratio of 0.48; p less than 0.0001). The safety profile of Avastin was consistent with our previous experience and no new safety signals were observed.
Avastin was approved in advanced breast cancer under the FDA's accelerated approval program, which allows the FDA to approve products for cancer or other life-threatening diseases based on initial positive clinical data. Genentech has shared with the FDA a summary of the results from a second positive Phase III trial (AVADO), and is expecting results from a third Phase III trial (RIBBON I) in first-line metastatic breast cancer in late 2008. A full review of both the AVADO and RIBBON I data by the FDA will be required for the accelerated approval to be converted into a full approval. As a part of our commitment to fully evaluate Avastin in breast cancer, Genentech will also submit data to the FDA from three additional randomized trials that are either ongoing or planned.
"There is no cure for metastatic breast cancer so it is important to control the disease as early and for as long as possible," said Kathy Miller, M.D., Associate Professor of Medical Oncology, Indiana University School of Medicine and lead investigator on the E2100 trial. "Now with Avastin plus paclitaxel, we can increase the time a woman's cancer is kept under control, and offer a biologic option to women who previously were limited to chemotherapies alone."
"As an oncologist who has treated women with metastatic breast cancer, I know how important the first course of therapy can be," said Susan Desmond-Hellmann, M.D., M.P.H., president, Product Development, Genentech. "New treatments are needed, and this approval provides women who have not yet received chemotherapy for their metastatic breast cancer a new option to consider with their physician and families."
Breast cancer is the second most common form of cancer and the second leading cancer killer among American women. According to the American Cancer Society, an estimated 178,000 women were diagnosed with breast cancer and approximately 40,000 died from the disease in the U.S. in 2007. Genentech estimates that 75 percent of women with newly diagnosed metastatic breast cancer are HER2-negative.
Alvine Pharmaceuticals Obtains Patents for Celiac Disease Therapies
Feb 21, 2008 - Alvine Pharmaceuticals, Inc., a biopharmaceutical company focused on the treatment of autoimmune and gastrointestinal diseases, today announced that the United States Patent and Trademark Office has issued two key patents, 7,320,788 and 7,303,871, covering gluten detoxification with proline specific prolyl endopeptidases (PEPs) and with mixtures of a PEP and a glutamine specific protease. Alvine has an exclusive worldwide license to these patents under an agreement with Stanford University. Both patents provide important protection for ALV003, Alvine's lead product currently in clinical development for use in the treatment of celiac disease.
"Alvine is delighted that these two patents have issued," said Dr. Abhay Joshi, Alvine's President and Chief Executive Officer. "Alvine and others have shown PEPs to be efficient at degrading gluten. With these patents and our recently announced initiation of clinical trials of ALV003 (a combination of a PEP and a glutamine specific protease), we believe Alvine is well positioned to capitalize on the potential use of proteases as therapeutic agents to treat celiac disease. ALV003 is more efficient at degrading gluten than either a PEP or a glutamine specific protease alone."
About ALV003
ALV003 is an orally administered combination of two proteases engineered to digest gluten. It targets the glutamine and proline residues that are common in gluten. ALV003 consists of a glutamine specific cysteine protease (EP-B2) and a proline specific prolyl endopeptidase (PEP). The proposed mechanism of action of ALV003 is to digest gluten into non-immunotoxic fragments.
"Alvine is delighted that these two patents have issued," said Dr. Abhay Joshi, Alvine's President and Chief Executive Officer. "Alvine and others have shown PEPs to be efficient at degrading gluten. With these patents and our recently announced initiation of clinical trials of ALV003 (a combination of a PEP and a glutamine specific protease), we believe Alvine is well positioned to capitalize on the potential use of proteases as therapeutic agents to treat celiac disease. ALV003 is more efficient at degrading gluten than either a PEP or a glutamine specific protease alone."
About ALV003
ALV003 is an orally administered combination of two proteases engineered to digest gluten. It targets the glutamine and proline residues that are common in gluten. ALV003 consists of a glutamine specific cysteine protease (EP-B2) and a proline specific prolyl endopeptidase (PEP). The proposed mechanism of action of ALV003 is to digest gluten into non-immunotoxic fragments.
China Pharma Holdings, Inc. Receives $5.6 Million in Purchase Orders for Pusen OK (Generic Aleve-D(TM) Product)
China Pharma Holdings, Inc. ("China Pharma") which develops, manufactures, and markets generic and branded bio-pharmaceutical products in China, today announced it received new purchase orders from one of its main distributors for its Pusen OK, a generic version of Aleve-D(TM). The orders total approximately $5.6 million, are expected to be recognized during 2008 and carry associated gross margins higher than 55 percent, which is approximately 10 percent higher than the Company's average gross margins during the past year.
Separately, the Company announced preliminary revenues for 2007 of at least $33 million, representing an over 50 percent growth compared to 2006. Pusen OK contributed approximately $4.1 million in revenues during 2007.
Since mid January, several of the worst snowstorms in decades struck most of central and southern China. As a result of this and other factors related to the colder weather and lower temperatures in China, the incidence of flu and cardiovascular diseases surged dramatically, and has increased the demand for China Pharma's cold medicine Pusen OK, the only generic version of Aleve-D(TM) brand with an antihistamine in China. Compared to other cold medicines in China's market, Pusen OK is among the most effective with 12-hour relief and does not cause sleepiness as a side effect.
Ms. Zhilin Li, president and CEO of China Pharma said: "I am very pleased to announce this new order for our Pusen OK product as our focused sales and marketing efforts have successfully created awareness among many of our major pharmaceutical distributors. The Company recently initiated production to fulfill these orders and anticipate initial contributions during the first quarter. Further, we expect Pusen OK will be a significant contributor to our growth during 2008, and will be supported by increased sales from our existing product portfolio in addition to the launch of two new products during the first half of 2008."
Separately, the Company announced preliminary revenues for 2007 of at least $33 million, representing an over 50 percent growth compared to 2006. Pusen OK contributed approximately $4.1 million in revenues during 2007.
Since mid January, several of the worst snowstorms in decades struck most of central and southern China. As a result of this and other factors related to the colder weather and lower temperatures in China, the incidence of flu and cardiovascular diseases surged dramatically, and has increased the demand for China Pharma's cold medicine Pusen OK, the only generic version of Aleve-D(TM) brand with an antihistamine in China. Compared to other cold medicines in China's market, Pusen OK is among the most effective with 12-hour relief and does not cause sleepiness as a side effect.
Ms. Zhilin Li, president and CEO of China Pharma said: "I am very pleased to announce this new order for our Pusen OK product as our focused sales and marketing efforts have successfully created awareness among many of our major pharmaceutical distributors. The Company recently initiated production to fulfill these orders and anticipate initial contributions during the first quarter. Further, we expect Pusen OK will be a significant contributor to our growth during 2008, and will be supported by increased sales from our existing product portfolio in addition to the launch of two new products during the first half of 2008."
Teva Announces Two Court Decisions to Revoke MSD's European Patent on Generic Fosamax
Feb 25, 2008 - Teva Pharmaceutical Industries Ltd. (Ticker: TEVA) announced the following decisions by two European courts:
On February 13, 2008, the Hague District Court in the Netherlands, decided to revoke the Dutch part of Merck Sharp & Dohme's ("MSD") European Patent no. 1,175,904, due to lack of inventive step, which relates to Fosamax(R) Once Weekly (Alendronate 70mg Once Weekly). This decision is the first European court decision on the merits of this patent, which is currently being litigated by Teva in Belgium, France, Italy, Sweden and Spain as well as in the European Patent Office.
On February 15, the Tribunal de Grande Instance de Paris, decided that MSD Somerset's supplementary protection certificate SPC 96C0032 covering the use of Alendronate for the treatment of Urolithiase and Bone Resorption was invalid for lack of inventive step.
Both decisions may be appealed.
Teva's Alendronate products are a subject to multiple European litigations between MSD, Teva and other parties, relating to both Alendronate 10mg and Alendronate 70mg.
Teva is already marketing Alendronate 10mg and 70mg in various European countries.
On February 13, 2008, the Hague District Court in the Netherlands, decided to revoke the Dutch part of Merck Sharp & Dohme's ("MSD") European Patent no. 1,175,904, due to lack of inventive step, which relates to Fosamax(R) Once Weekly (Alendronate 70mg Once Weekly). This decision is the first European court decision on the merits of this patent, which is currently being litigated by Teva in Belgium, France, Italy, Sweden and Spain as well as in the European Patent Office.
On February 15, the Tribunal de Grande Instance de Paris, decided that MSD Somerset's supplementary protection certificate SPC 96C0032 covering the use of Alendronate for the treatment of Urolithiase and Bone Resorption was invalid for lack of inventive step.
Both decisions may be appealed.
Teva's Alendronate products are a subject to multiple European litigations between MSD, Teva and other parties, relating to both Alendronate 10mg and Alendronate 70mg.
Teva is already marketing Alendronate 10mg and 70mg in various European countries.
Teva Introduces Oxcarbazepine Tablets
February 21, 2008 – Teva Pharmaceuticals is pleased to announce the introduction and availability of Oxcarbazepine Tablets. This product is AB rated and bioequivalent to Trileptal®* Tablets. Oxcarbazepine Tablets are available in 150 mg, 300 mg, and 600 mg strengths, in bottle sizes of 100.“Generic pharmaceuticals are playing an increasingly important role in healthcare costcontainment,” states John Denman, V.P. Sales and Marketing.
“Teva Pharmaceuticals continues tolead the way with timely new product launches.”Teva Pharmaceuticals, located in North Wales, Pennsylvania, is the leading pharmaceutical manufacturer for both new and total prescriptions.‡ The company has an aggressive Research andDevelopment effort and one of the best overall ANDA approval records in the industry
“Teva Pharmaceuticals continues tolead the way with timely new product launches.”Teva Pharmaceuticals, located in North Wales, Pennsylvania, is the leading pharmaceutical manufacturer for both new and total prescriptions.‡ The company has an aggressive Research andDevelopment effort and one of the best overall ANDA approval records in the industry
Saturday, February 23, 2008
FDA Grants Priority Review for Daiichi Sankyo, Lilly Drug, Prasugrel
Daiichi Sankyo Company, Limited and Eli Lilly and Company today announced that the U.S. Food and Drug Administration (FDA) accepted and designated Priority Review for the New Drug Application for prasugrel, for patients with acute coronary syndrome being managed with percutaneous coronary intervention (PCI). The NDA for prasugrel was submitted to the agency on Dec. 26, 2007.
A priority designation by the FDA sets the PDUFA (Prescription Drug User Fee Act) goal date. The PDUFA goal for priority applications is to have an action provided for 90 percent of applications within six months. FDA can take three different actions - approved, approvable with further discussion, or not approved.
"We are greatly pleased to learn that the FDA has determined the application meets its criteria for such a review, and we look forward to working with the agency as it continues its review process," said Dr. J. Anthony Ware, Lilly vice president for cardiovascular/acute care.
"If approved, prasugrel will provide physicians and acute coronary syndrome patients an alternative medicine that may further help reduce the risk of heart attacks," said John Alexander, M.D., M.P.H., global head of research and development, Daiichi Sankyo Company, Ltd.
A priority designation by the FDA sets the PDUFA (Prescription Drug User Fee Act) goal date. The PDUFA goal for priority applications is to have an action provided for 90 percent of applications within six months. FDA can take three different actions - approved, approvable with further discussion, or not approved.
"We are greatly pleased to learn that the FDA has determined the application meets its criteria for such a review, and we look forward to working with the agency as it continues its review process," said Dr. J. Anthony Ware, Lilly vice president for cardiovascular/acute care.
"If approved, prasugrel will provide physicians and acute coronary syndrome patients an alternative medicine that may further help reduce the risk of heart attacks," said John Alexander, M.D., M.P.H., global head of research and development, Daiichi Sankyo Company, Ltd.
Orexigen Therapeutics Announces Notice of Allowance for U.S. Patent Strengthening Exclusivity for Empatic for Obesity
Orexigen(TM) Therapeutics, Inc. (Nasdaq: OREX), a biopharmaceutical company focused on the treatment of central nervous system disorders, including obesity, today announced that a Notice of Allowance has been issued by the United States Patent and Trademark Office (USPTO) for a patent application providing broad coverage of the use of zonisamide either alone or in combination with other drugs in the treatment of obesity. Zonisamide is an active constituent of Empatic(TM), a novel formulation of zonisamide sustained release (SR) paired with bupropion SR, for the treatment of obesity. The combination of these two drugs is designed to provide more clinically meaningful weight loss for patients by both initiating weight loss and sustaining it over a longer period of time. The Phase IIb clinical trial for Empatic was completed last year, and the Company plans to initiate another Phase IIb clinical trial for Empatic this year.
This patent, when issued, would complement an issued U.S. patent (7,109,198) that Orexigen has exclusively licensed from Duke University protecting the use of zonisamide to promote weight-loss in combination with bupropion. Both patents would expire in 2023.
Empatic is one of two Orexigen compounds in late stage clinical development for obesity. In January, the Company presented 48 week Empatic Phase IIb clinical trial results which demonstrated weight loss ranging from approximately 12% to 15% in patients who completed the trial under double blind treatment. Results depended on the dose of the constituent drugs used, with the highest dose achieving the greatest weight loss. Results of this trial also indicated that Empatic was safe and generally well tolerated.
This patent, when issued, would complement an issued U.S. patent (7,109,198) that Orexigen has exclusively licensed from Duke University protecting the use of zonisamide to promote weight-loss in combination with bupropion. Both patents would expire in 2023.
Empatic is one of two Orexigen compounds in late stage clinical development for obesity. In January, the Company presented 48 week Empatic Phase IIb clinical trial results which demonstrated weight loss ranging from approximately 12% to 15% in patients who completed the trial under double blind treatment. Results depended on the dose of the constituent drugs used, with the highest dose achieving the greatest weight loss. Results of this trial also indicated that Empatic was safe and generally well tolerated.
Brain Tumour Gene Link Found
LONDON, Feb. 21, 2008--CANCER Research UK funded Scientists have discovered a mutation in a DNA repair gene which may increase the risk of developing meningioma, a rare type of brain tumour, according to new research published in the latest edition of the Journal of the National Cancer Institute.
The researchers, based at The Institute of Cancer Research, explored 136 DNA repair genes before they homed in on a mutation in the gene BRIP1 – a gene also associated with increased breast cancer risk. This mutation may account for 16 per cent of meningiomas.
More than 7,500 people are diagnosed with malignant or benign brain tumours in the UK each year. Meninigiomas account for over 30 per cent of these, yet little is known about the cause of the disease which tends to affect older people, and women.
The vast majority of meningiomas are benign. They grow slowly in the tissues of the brain or spinal cord and as a result do not respond well to chemotherapy and cannot always be safely removed by surgery.
The new study examined genetic differences in the brains of 1,268 people from four European countries. Data from 631 patients with meningiomas was compared with 637 healthy individuals. Previous US research had analysed a small sample of just 200 people, making this is the largest study of gene involvement in meningioma risk.
Lead researcher, Professor Richard Houlston, based at The Institute of Cancer Research, said: "Using a large sample, we have identified a new region associated with meningioma risk. However, further investigation into the functions of BRIP1, could shed more light on the relationship between the gene and brain tumour growth.
Currently, the only sure way to diagnose many brain tumours is by biopsy. Research like ours, which examines gene changes may offer the hope of non-invasive ways to diagnose the disease and new tailored treatments for brain cancer patients."
Dr Lesley Walker, Cancer Research UK’s director of cancer information, said: "Although meningioma is a rare condition, we welcome any insight that helps us to understand it further. This study has shown some very interesting results. However, further studies are needed to explain how additional changes in the BRIP1 gene may also contribute to the growth of these tumours."
The researchers, based at The Institute of Cancer Research, explored 136 DNA repair genes before they homed in on a mutation in the gene BRIP1 – a gene also associated with increased breast cancer risk. This mutation may account for 16 per cent of meningiomas.
More than 7,500 people are diagnosed with malignant or benign brain tumours in the UK each year. Meninigiomas account for over 30 per cent of these, yet little is known about the cause of the disease which tends to affect older people, and women.
The vast majority of meningiomas are benign. They grow slowly in the tissues of the brain or spinal cord and as a result do not respond well to chemotherapy and cannot always be safely removed by surgery.
The new study examined genetic differences in the brains of 1,268 people from four European countries. Data from 631 patients with meningiomas was compared with 637 healthy individuals. Previous US research had analysed a small sample of just 200 people, making this is the largest study of gene involvement in meningioma risk.
Lead researcher, Professor Richard Houlston, based at The Institute of Cancer Research, said: "Using a large sample, we have identified a new region associated with meningioma risk. However, further investigation into the functions of BRIP1, could shed more light on the relationship between the gene and brain tumour growth.
Currently, the only sure way to diagnose many brain tumours is by biopsy. Research like ours, which examines gene changes may offer the hope of non-invasive ways to diagnose the disease and new tailored treatments for brain cancer patients."
Dr Lesley Walker, Cancer Research UK’s director of cancer information, said: "Although meningioma is a rare condition, we welcome any insight that helps us to understand it further. This study has shown some very interesting results. However, further studies are needed to explain how additional changes in the BRIP1 gene may also contribute to the growth of these tumours."
Wyeth's Xyntha Approved by FDA for Treatment of Hemophilia A
Wyeth Pharmaceuticals, a division of Wyeth , announced today that it has received approval from the U.S. Food and Drug Administration for XYNTHA(TM) (Antihemophilic Factor [Recombinant], Plasma/Albumin-Free), a recombinant factor VIII product, for patients with hemophilia A for both the control and prevention of bleeding episodes and surgical prophylaxis. XYNTHA (pronounced "ZIN-tha") is manufactured using a completely albumin-free process and state- of-the-art nanofiltration purification technology. In addition, XYNTHA is the only recombinant factor VIII product to utilize an entirely synthetic (non- human and non-animal based) purification process in its manufacture.
Until now, the purification process for all recombinant factor VIII products used monoclonal antibodies derived from mouse cell lines. In the manufacture of XYNTHA, the mouse monoclonal antibody is replaced with a synthetic peptide ligand, which was invented by Wyeth scientists.
"XYNTHA is important for hemophilia A patients because it establishes a new standard in recombinant factor VIII product purification technology," says Robert R. Ruffolo, Jr., Ph.D., President, Wyeth Research, and Senior Vice President, Wyeth. "This is another example of Wyeth's continued commitment to the advancement of science in the treatment of hemophilia."
The safety and efficacy of XYNTHA in the prevention and control of bleeding episodes and for surgical prophylaxis for patients with hemophilia A has been demonstrated in pivotal clinical trials.
Until now, the purification process for all recombinant factor VIII products used monoclonal antibodies derived from mouse cell lines. In the manufacture of XYNTHA, the mouse monoclonal antibody is replaced with a synthetic peptide ligand, which was invented by Wyeth scientists.
"XYNTHA is important for hemophilia A patients because it establishes a new standard in recombinant factor VIII product purification technology," says Robert R. Ruffolo, Jr., Ph.D., President, Wyeth Research, and Senior Vice President, Wyeth. "This is another example of Wyeth's continued commitment to the advancement of science in the treatment of hemophilia."
The safety and efficacy of XYNTHA in the prevention and control of bleeding episodes and for surgical prophylaxis for patients with hemophilia A has been demonstrated in pivotal clinical trials.
Abbott Receives FDA Approval for Humira (Adalimumab) for Polyarticular Juvenile Idiopathic Arthritis
Abbott announced today it has received U.S. Food and Drug Administration (FDA) approval to market HUMIRA(R) (adalimumab) as a treatment to reduce signs and symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis (JIA) in patients four years of age and older. In the U.S., JIA is commonly referred to as juvenile rheumatoid arthritis (JRA). The approval is based on safety and efficacy results from a clinical study of JIA patients four to 17 years of age. HUMIRA is the first biologic treatment to receive FDA approval for this condition since 1999, and the first to be administered by injection in these patients once every two weeks.
"The pain and inflammation caused by JIA can be debilitating for some children, making it hard for them to run, jump, play or participate in other activities with children their age," said Daniel J. Lovell, M.D., M.P.H., associate director, Division of Rheumatology, Cincinnati Children's Hospital Medical Center, Cincinnati. "HUMIRA is an important new treatment that gives physicians and families another option that can ease the symptoms of polyarticular JIA."
JIA is the most common chronic rheumatic disease in children with onset before age 16. Typical symptoms include stiffness when awakening, limping, and joint swelling. Any joint can be affected and inflammation may limit the mobility of the affected joints. While it was once believed that most children eventually outgrow JIA, it is now known that between 25 and 70 percent of children with JIA will still have active disease into adulthood.
"The symptoms of JIA can make it difficult for children to experience many of the simple joys of childhood," said John Hardin, M.D., chief scientific officer, Arthritis Foundation. "The Arthritis Foundation welcomes the approval of new therapies that expand effective treatment options for doctors and families, helping children and adolescents to keep their symptoms under control."
JIA is the sixth disease indication for which HUMIRA has received approval since 2002.
"The pain and inflammation caused by JIA can be debilitating for some children, making it hard for them to run, jump, play or participate in other activities with children their age," said Daniel J. Lovell, M.D., M.P.H., associate director, Division of Rheumatology, Cincinnati Children's Hospital Medical Center, Cincinnati. "HUMIRA is an important new treatment that gives physicians and families another option that can ease the symptoms of polyarticular JIA."
JIA is the most common chronic rheumatic disease in children with onset before age 16. Typical symptoms include stiffness when awakening, limping, and joint swelling. Any joint can be affected and inflammation may limit the mobility of the affected joints. While it was once believed that most children eventually outgrow JIA, it is now known that between 25 and 70 percent of children with JIA will still have active disease into adulthood.
"The symptoms of JIA can make it difficult for children to experience many of the simple joys of childhood," said John Hardin, M.D., chief scientific officer, Arthritis Foundation. "The Arthritis Foundation welcomes the approval of new therapies that expand effective treatment options for doctors and families, helping children and adolescents to keep their symptoms under control."
JIA is the sixth disease indication for which HUMIRA has received approval since 2002.
Thursday, February 21, 2008
FDA Licenses New Hemophilia Treatment
Feb. 21, 2008--The U.S. Food and Drug Administration today licensed a treatment for hemophilia A, a rare, hereditary blood-clotting disorder that affects approximately 15,000 individuals, almost exclusively males, in the United States.
The new treatment, called Xyntha Antihemophilic Factor (Recombinant) Plasma/Albumin Free, is a genetically engineered version of factor VIII, a protein essential for the clotting of blood. Factor VIII, known as an anti-hemophilic factor, is missing or decreased in patients with hemophilia A.
Xyntha is licensed for the control and prevention of bleeding, which can occur spontaneously or after an accident or injury in patients diagnosed with hemophilia A. Xyntha is also licensed to help prevent surgical bleeding in this patient population.
Xyntha is manufactured using recombinant DNA techniques that enable scientists to create new DNA strands with specific traits, such as the capacity to produce a specific protein.
To make Xyntha, genes from Chinese Hamster Ovary cells (CHO) are modified to produce factor VIII. These CHO cells are free from known infectious agents, and Xyntha undergoes an additional process of viral inactivation. Also, the culture in which the cells are grown is free of any human or animal material.
"This product provides an additional treatment option for hemophilia A patients. This recombinant Factor VIII is produced without additives from human or animal material, which further minimizes any risk of infection from the product," said Jesse Goodman, M.D., M.P.H., director of FDA’s Center for Biologics Evaluation and Research.
In clinical trials, Xyntha was shown to be effective at preventing or controlling bleeding, including preventing bleeding in surgery, for hemophilia A patients. Generally, the most frequently reported adverse reaction was headache. For those receiving Xyntha to prevent bleeding in surgery, the most frequently reported adverse reaction was fever. Most adverse reactions reported in either study were considered mild or moderate in severity.
In addition, two of 89 individuals who received 50 days of treatment with Xyntha, developed factor VIII inhibitors, which are antibodies that counteract treatment with factor VIII.
Xyntha is manufactured by Wyeth Pharmaceuticals Inc., located in Philadelphia.
The new treatment, called Xyntha Antihemophilic Factor (Recombinant) Plasma/Albumin Free, is a genetically engineered version of factor VIII, a protein essential for the clotting of blood. Factor VIII, known as an anti-hemophilic factor, is missing or decreased in patients with hemophilia A.
Xyntha is licensed for the control and prevention of bleeding, which can occur spontaneously or after an accident or injury in patients diagnosed with hemophilia A. Xyntha is also licensed to help prevent surgical bleeding in this patient population.
Xyntha is manufactured using recombinant DNA techniques that enable scientists to create new DNA strands with specific traits, such as the capacity to produce a specific protein.
To make Xyntha, genes from Chinese Hamster Ovary cells (CHO) are modified to produce factor VIII. These CHO cells are free from known infectious agents, and Xyntha undergoes an additional process of viral inactivation. Also, the culture in which the cells are grown is free of any human or animal material.
"This product provides an additional treatment option for hemophilia A patients. This recombinant Factor VIII is produced without additives from human or animal material, which further minimizes any risk of infection from the product," said Jesse Goodman, M.D., M.P.H., director of FDA’s Center for Biologics Evaluation and Research.
In clinical trials, Xyntha was shown to be effective at preventing or controlling bleeding, including preventing bleeding in surgery, for hemophilia A patients. Generally, the most frequently reported adverse reaction was headache. For those receiving Xyntha to prevent bleeding in surgery, the most frequently reported adverse reaction was fever. Most adverse reactions reported in either study were considered mild or moderate in severity.
In addition, two of 89 individuals who received 50 days of treatment with Xyntha, developed factor VIII inhibitors, which are antibodies that counteract treatment with factor VIII.
Xyntha is manufactured by Wyeth Pharmaceuticals Inc., located in Philadelphia.
Debiopharm Signs Canadian Partner for Sanvar
Debiopharm Group (Debiopharm), a global independent biopharmaceutical development specialist in oncology and serious medical conditions, announces the signature of a License and Supply Agreement with Medical Futures Inc., a Canadian based Gastroenterology focused speciality pharmaceutical company, for the Canadian distribution rights to SANVAR(R) IR (SANVAR(R)), an immediate release formulation. The product, developed by Debiopharm for the treatment of acute esophageal variceal bleeding (EVB), is currently under review for approval by the Canadian Health Authorities. In addition to purchasing the product directly from Debiopharm, Medical Futures Inc. is responsible for upfront and milestone payments.
"Medical Futures Inc. is excited about partnering with Debiopharm for SANVAR(R)," says Dr. Par Nijhawan, Chief Medical Officer of Medical Futures Inc., who believes that SANVAR(R) will help improve the options available for life threatening variceal bleeds. "Medical Futures has created a therapeutic focus and a strong product offering for the gastroenterology market in Canada," says Dr. Loic Maurel, President and Chief Executive Officer of Debiovision Inc., the Debiopharm Affiliate in Canada. "With SANVAR(R) in their capable hands, we are confident of its success in an important market for us." Debiopharm has already signed various sales and marketing agreements for SANVAR(R), namely with Salix pharmaceuticals in the US; Ranbaxy Laboratories Ltd in the Indian territories; EMS Sigma Farma in Brazil; Tzamal Bio-Pharma Ltd in Israel; and LG Life Sciences in Korea.
"Medical Futures Inc. is excited about partnering with Debiopharm for SANVAR(R)," says Dr. Par Nijhawan, Chief Medical Officer of Medical Futures Inc., who believes that SANVAR(R) will help improve the options available for life threatening variceal bleeds. "Medical Futures has created a therapeutic focus and a strong product offering for the gastroenterology market in Canada," says Dr. Loic Maurel, President and Chief Executive Officer of Debiovision Inc., the Debiopharm Affiliate in Canada. "With SANVAR(R) in their capable hands, we are confident of its success in an important market for us." Debiopharm has already signed various sales and marketing agreements for SANVAR(R), namely with Salix pharmaceuticals in the US; Ranbaxy Laboratories Ltd in the Indian territories; EMS Sigma Farma in Brazil; Tzamal Bio-Pharma Ltd in Israel; and LG Life Sciences in Korea.
Sciele Pharma and LifeCycle Pharma Announce U.S. Market Launch of Fenoglide
Feb 21, 2008 - Sciele Pharma, Inc. (NASDAQ:SCRX) and LifeCycle Pharma A/S (OMX:LCP) today announced that Sciele has launched Fenoglide(TM) in the U.S. Fenoglide, indicated for the treatment of hyperlipidemia and hypertriglyceridemia, utilizes LifeCycle Pharma's Meltdose(R) technology, which is designed to provide enhanced absorption and greater bioavailability. Fenoglide will be available in 120-milligram and 40-milligram doses and will therefore have the lowest dosage strengths of fenofibrate available for patients.
Patrick Fourteau, chief executive officer of Sciele Pharma, Inc., said, "We are excited about the launch of Fenoglide, a product that incorporates LifeCycle Pharma's novel Meltdose technology. This is an important new product that will be marketed in the U.S. by Sciele Pharma's Primary Care Cardiovascular and Diabetes sales forces."
Patrick Fourteau, chief executive officer of Sciele Pharma, Inc., said, "We are excited about the launch of Fenoglide, a product that incorporates LifeCycle Pharma's novel Meltdose technology. This is an important new product that will be marketed in the U.S. by Sciele Pharma's Primary Care Cardiovascular and Diabetes sales forces."
Orexigen Therapeutics Announces Notice of Allowance for U.S. Patent Strengthening Exclusivity for Empatic for Obesity
Feb 21, 2008 - Orexigen(TM) Therapeutics, Inc. (Nasdaq: OREX), a biopharmaceutical company focused on the treatment of central nervous system disorders, including obesity, today announced that a Notice of Allowance has been issued by the United States Patent and Trademark Office (USPTO) for a patent application providing broad coverage of the use of zonisamide either alone or in combination with other drugs in the treatment of obesity. Zonisamide is an active constituent of Empatic(TM), a novel formulation of zonisamide sustained release (SR) paired with bupropion SR, for the treatment of obesity. The combination of these two drugs is designed to provide more clinically meaningful weight loss for patients by both initiating weight loss and sustaining it over a longer period of time. The Phase IIb clinical trial for Empatic was completed last year, and the Company plans to initiate another Phase IIb clinical trial for Empatic this year.
This patent, when issued, would complement an issued U.S. patent (7,109,198) that Orexigen has exclusively licensed from Duke University protecting the use of zonisamide to promote weight-loss in combination with bupropion. Both patents would expire in 2023.
"This notice from the USPTO is an important milestone toward issuance of the patent and would give us an additional layer of protection for our use of zonisamide in treating obesity," said Orexigen President and CEO, Gary Tollefson, M.D., Ph.D. "We believe this strengthens our intellectual property rights with Empatic, and may block attempts to copy our approach to treating obesity with any zonisamide-based compounds."
Empatic is one of two Orexigen compounds in late stage clinical development for obesity. In January, the Company presented 48 week Empatic Phase IIb clinical trial results which demonstrated weight loss ranging from approximately 12% to 15% in patients who completed the trial under double blind treatment. Results depended on the dose of the constituent drugs used, with the highest dose achieving the greatest weight loss. Results of this trial also indicated that Empatic was safe and generally well tolerated.
This patent, when issued, would complement an issued U.S. patent (7,109,198) that Orexigen has exclusively licensed from Duke University protecting the use of zonisamide to promote weight-loss in combination with bupropion. Both patents would expire in 2023.
"This notice from the USPTO is an important milestone toward issuance of the patent and would give us an additional layer of protection for our use of zonisamide in treating obesity," said Orexigen President and CEO, Gary Tollefson, M.D., Ph.D. "We believe this strengthens our intellectual property rights with Empatic, and may block attempts to copy our approach to treating obesity with any zonisamide-based compounds."
Empatic is one of two Orexigen compounds in late stage clinical development for obesity. In January, the Company presented 48 week Empatic Phase IIb clinical trial results which demonstrated weight loss ranging from approximately 12% to 15% in patients who completed the trial under double blind treatment. Results depended on the dose of the constituent drugs used, with the highest dose achieving the greatest weight loss. Results of this trial also indicated that Empatic was safe and generally well tolerated.
Appellate Court in the Netherlands Upholds Basic Lipitor Patent, Prevents Launch of Ranbaxy Product before November 2011
Feb 21, 2008 - Pfizer Inc said today that the Court of Appeal of The Hague in the Netherlands has ruled that the basic patent covering atorvastatin - the active ingredient in Lipitor - would be infringed by a competitor product from generics manufacturer Ranbaxy. The decision prevents Ranbaxy from launching its drug before Lipitor's basic patent (EP 247,633) expires in November 2011.
"Today's decision is another affirmation of the strength of the intellectual property behind Lipitor, one of the most important medical breakthroughs of our era," said Pfizer General Counsel Allen Waxman. "The court's ruling reinforces the fundamental principle that patent laws exist to support and encourage medical innovators, not undermine them."
Ranbaxy can seek to appeal the decision to the Supreme Court of the Netherlands.
"Today's decision is another affirmation of the strength of the intellectual property behind Lipitor, one of the most important medical breakthroughs of our era," said Pfizer General Counsel Allen Waxman. "The court's ruling reinforces the fundamental principle that patent laws exist to support and encourage medical innovators, not undermine them."
Ranbaxy can seek to appeal the decision to the Supreme Court of the Netherlands.
GSK Receives Favorable Recommendation by FDA Advisory Committee for Rotarix (Rotavirus Vaccine, Live, Oral)
GlaxoSmithKline announced today that the U.S. Food and Drug Administration's (FDA) Vaccines and Related Biological Products Advisory Committee (VRBPAC) provided a favorable recommendation for the Company's oral rotavirus candidate vaccine, ROTARIX(R) [rotavirus vaccine, live, oral], to prevent rotavirus gastroenteritis in infants. The Committee voted unanimously (12-0) in favor of GSK's data being adequate to support the efficacy of the candidate vaccine. The Committee voted 11-1 in favor of GSK's data being adequate to support the safety of the candidate vaccine.
If approved by the FDA, GSK's candidate vaccine would allow for completion of the rotavirus vaccination series by four months of age and could be integrated into the current vaccine schedule at the two and four month immunization visits. Severe rotavirus diarrhea and dehydration can occur as young as three months of age. Of children under five years of age in the U.S. hospitalized with rotavirus, approximately one in five are younger than six months of age. Rotavirus infects virtually every child in the U.S. by age five and is the leading cause of severe gastroenteritis in infants and young children worldwide.
The candidate vaccine contains a live, weakened form of human rotavirus derived from the most common human rotavirus strain. "If approved, we believe ROTARIX, which was developed to mimic the protective effects of natural infection, would offer an important option in completing rotavirus vaccination by four months of age," said Barbara Howe, M.D., Vice President and Director, North American Vaccine Development, GlaxoSmithKline. "Studies have shown that naturally occurring human rotavirus infection provides significant protection against subsequent moderate to severe rotavirus gastroenteritis regardless of the infecting serotype."
The committee's favorable recommendation, although not binding, will be considered by the FDA in its review of the Biologics License Application (BLA) for the candidate vaccine, which is currently underway.
Clinical data published on two doses of ROTARIX show that protection was sustained through the first two years of life and was highly efficacious against rotavirus hospitalizations (96%) and severe rotavirus gastroenteritis (90%). In addition, the candidate vaccine was effective against rotavirus gastroenteritis of any severity (79%). Specifically, significant protection was demonstrated against severe rotavirus gastroenteritis during two rotavirus seasons caused by types G1 (96%), G2 (86%), G3 (94%), G4 (95%), and G9 (85%), the most commonly circulating rotavirus types in the U.S.
The CDC Advisory Committee on Immunization Practices (ACIP), the American Academy of Pediatrics (AAP), and the American Academy of Family Physicians (AAFP) recommend that infants receive routine vaccination with the rotavirus vaccine currently licensed by the FDA at two, four, and six months of age in order to prevent rotavirus gastroenteritis.
If approved by the FDA, GSK's candidate vaccine would allow for completion of the rotavirus vaccination series by four months of age and could be integrated into the current vaccine schedule at the two and four month immunization visits. Severe rotavirus diarrhea and dehydration can occur as young as three months of age. Of children under five years of age in the U.S. hospitalized with rotavirus, approximately one in five are younger than six months of age. Rotavirus infects virtually every child in the U.S. by age five and is the leading cause of severe gastroenteritis in infants and young children worldwide.
The candidate vaccine contains a live, weakened form of human rotavirus derived from the most common human rotavirus strain. "If approved, we believe ROTARIX, which was developed to mimic the protective effects of natural infection, would offer an important option in completing rotavirus vaccination by four months of age," said Barbara Howe, M.D., Vice President and Director, North American Vaccine Development, GlaxoSmithKline. "Studies have shown that naturally occurring human rotavirus infection provides significant protection against subsequent moderate to severe rotavirus gastroenteritis regardless of the infecting serotype."
The committee's favorable recommendation, although not binding, will be considered by the FDA in its review of the Biologics License Application (BLA) for the candidate vaccine, which is currently underway.
Clinical data published on two doses of ROTARIX show that protection was sustained through the first two years of life and was highly efficacious against rotavirus hospitalizations (96%) and severe rotavirus gastroenteritis (90%). In addition, the candidate vaccine was effective against rotavirus gastroenteritis of any severity (79%). Specifically, significant protection was demonstrated against severe rotavirus gastroenteritis during two rotavirus seasons caused by types G1 (96%), G2 (86%), G3 (94%), G4 (95%), and G9 (85%), the most commonly circulating rotavirus types in the U.S.
The CDC Advisory Committee on Immunization Practices (ACIP), the American Academy of Pediatrics (AAP), and the American Academy of Family Physicians (AAFP) recommend that infants receive routine vaccination with the rotavirus vaccine currently licensed by the FDA at two, four, and six months of age in order to prevent rotavirus gastroenteritis.
Tuesday, February 19, 2008
FDA Accepts Treanda New Drug Application for the Treatment of Relapsed Indolent Non-Hodgkin's Lymphoma
Cephalon, Inc. today announced that the U.S. Food and Drug Administration (FDA) has accepted the company's new drug application (NDA) for TREANDA(R) (bendamustine HCl) for Injection for the treatment of patients with indolent B-cell non-Hodgkin's lymphoma (NHL) who have progressed during or following treatment with rituximab or a rituximab-containing regimen. According to the National Cancer Institute, an estimated 30,000 people in the United States were expected to be diagnosed in 2007 with indolent NHL, a serious and slow growing cancer of the lymphatic system that is difficult to treat because patients are prone to relapse after treatment. Cephalon submitted the TREANDA application for relapsed indolent NHL in December 2007 and a decision from the FDA is expected by October 31, 2008.
AMAG Pharmaceuticals, Inc. Announces FDA Acceptance for Filing of Ferumoxytol New Drug Application in Chronic Kidney Disease
Feb 19, 2008 - AMAG Pharmaceuticals, Inc. (NASDAQ: AMAG) today announced that the New Drug Application (NDA) for ferumoxytol in chronic kidney disease (CKD) has been accepted for standard review by the U.S. Food and Drug Administration (FDA). The Company is seeking marketing approval for ferumoxytol as an intravenous treatment of iron deficiency anemia in patients with CKD, including dialysis dependent and non-dialysis dependent patients. The Company expects FDA action on the NDA by late October 2008.
The NDA is supported by data from four Phase III studies, which consisted of three open-label, multi-center, randomized efficacy and safety clinical studies and a fourth double-blind, multi-center, randomized, placebo-controlled safety study. The results of each of the three efficacy and safety studies demonstrated a statistically significant achievement of all primary and secondary efficacy endpoints. In total, over 1,700 patients and healthy volunteers were treated with ferumoxytol in the Company's eleven clinical studies.
The NDA is supported by data from four Phase III studies, which consisted of three open-label, multi-center, randomized efficacy and safety clinical studies and a fourth double-blind, multi-center, randomized, placebo-controlled safety study. The results of each of the three efficacy and safety studies demonstrated a statistically significant achievement of all primary and secondary efficacy endpoints. In total, over 1,700 patients and healthy volunteers were treated with ferumoxytol in the Company's eleven clinical studies.
Abbott Receives FDA Approval for Simcor (Niaspan / simvastatin), a Novel Combination Medicine for Comprehensive Cholesterol Management
SIMCOR Is a New Single-Pill Combination of Two Proven Therapies that Significantly Raises HDL "Good" Cholesterol and Lowers LDL "Bad" Cholesterol
Abbott received U.S. Food and Drug Administration (FDA) approval for SIMCOR(R), the first fixed-dose combination of two widely prescribed cholesterol therapies, Niaspan(R) (Abbott's proprietary niacin extended-release) and simvastatin. SIMCOR is approved for use along with diet to lower levels of elevated total cholesterol, LDL "bad" cholesterol and triglycerides, and to raise HDL "good" cholesterol in patients with complex lipid disease when treatment with simvastatin or Niaspan monotherapies are not considered adequate.
Abbott received U.S. Food and Drug Administration (FDA) approval for SIMCOR(R), the first fixed-dose combination of two widely prescribed cholesterol therapies, Niaspan(R) (Abbott's proprietary niacin extended-release) and simvastatin. SIMCOR is approved for use along with diet to lower levels of elevated total cholesterol, LDL "bad" cholesterol and triglycerides, and to raise HDL "good" cholesterol in patients with complex lipid disease when treatment with simvastatin or Niaspan monotherapies are not considered adequate.
FDA Approves Xyzal (levocetirizine dihydrochloride) Oral Solution for the Relief of Seasonal and Year Round Allergies and Chronic Idiopathic Urticaria
February 19, 2008 - UCB and sanofi-aventis announced today that the U.S. Food and Drug Administration (FDA) approved a New Drug Application (NDA) for XYZAL® (levocetirizine dihydrochloride) 0.5 mg/mL oral solution, a prescription antihistamine indicated for the relief of symptoms associated with indoor and outdoor allergies, as well as the treatment of chronic idiopathic urticaria. XYZAL® tablets received FDA approval on May 25, 2007 and both formulations are now approved for use in adults and children 6 years and older.
"The oral solution of XYZAL® provides a welcome alternative for those patients who have difficulty swallowing or who prefer liquid medication," said Michael S. Blaiss, MD, Clinical Professor of Pediatrics and Medicine at the University of Tennessee Health Science Center in Memphis, Tennessee. "Both the oral solution and tablets offer patients powerful and long-lasting allergy relief."
Studies in allergic rhinitis patients demonstrated levocetirizine significantly reduced the symptoms of sneezing, itchy nose, runny nose, and itchy eyes. Studies in chronic idiopathic urticaria patients showed levocetirizine significantly reduced the severity of itching and the number and size of wheals.
In September 2006, UCB and sanofi-aventis entered into an agreement to launch and co-market XYZAL® in the U.S. UCB and sanofi-aventis have a long history in the allergy treatment arena and are committed to advancing treatment for allergy sufferers and helping meet unmet medical needs for patients with chronic allergy symptoms.
"The oral solution of XYZAL® provides a welcome alternative for those patients who have difficulty swallowing or who prefer liquid medication," said Michael S. Blaiss, MD, Clinical Professor of Pediatrics and Medicine at the University of Tennessee Health Science Center in Memphis, Tennessee. "Both the oral solution and tablets offer patients powerful and long-lasting allergy relief."
Studies in allergic rhinitis patients demonstrated levocetirizine significantly reduced the symptoms of sneezing, itchy nose, runny nose, and itchy eyes. Studies in chronic idiopathic urticaria patients showed levocetirizine significantly reduced the severity of itching and the number and size of wheals.
In September 2006, UCB and sanofi-aventis entered into an agreement to launch and co-market XYZAL® in the U.S. UCB and sanofi-aventis have a long history in the allergy treatment arena and are committed to advancing treatment for allergy sufferers and helping meet unmet medical needs for patients with chronic allergy symptoms.
Santarus Announces Launch of Zegerid Products by GlaxoSmithKline in Puerto Rico and U.S. Virgin Islands
Feb 19, 2008 - Santarus, Inc. (NASDAQ:SNTS), a specialty pharmaceutical company, today announced that GlaxoSmithKline plc (GSK) has launched ZEGERID(R) (omeprazole/sodium bicarbonate) Capsules and ZEGERID (omeprazole/sodium bicarbonate) Powder for Oral Suspension in Puerto Rico and the U.S. Virgin Islands. The ZEGERID products were developed by Santarus and are the first and only immediate-release oral proton pump inhibitors (PPIs) commercialized in the U.S. According to the market research firm IMS Health Incorporated, retail sales of prescription PPI products in Puerto Rico and the U.S. Virgin Islands were approximately $124 million for the 12 months ended September 30, 2007 and grew at 24% compared with the prior 12 month period.
We are very pleased that GSK, a highly regarded global pharmaceutical company with well-established commercialization capabilities, is making our ZEGERID products available to patients in Puerto Rico and the U.S. Virgin Islands," said Gerald T. Proehl, president and chief executive officer of Santarus, Inc. "GSK has long demonstrated success in marketing products in the gastrointestinal therapeutic area, and we believe it is the ideal partner to bring physicians in these regions the message about the benefits of ZEGERID products."
Santarus and GSK entered into a distribution agreement in November 2007 under which GSK will distribute, market and sell ZEGERID brand prescription products in Puerto Rico and the U.S. Virgin Islands. At the same time, Santarus licensed rights to GSK to develop, manufacture and commercialize immediate-release omeprazole products in up to 114 countries in GSK's International Region, including in Africa, Asia, the Middle-East, and Central and South America. According to IMS Health, retail sales of PPI products in the covered territories were estimated to be approximately $2 billion for the 12 months ended September 30, 2007 and grew at approximately 22% compared with the prior 12 month period. The license agreement excludes the U.S., Europe, Australia, Japan and Canada.
We are very pleased that GSK, a highly regarded global pharmaceutical company with well-established commercialization capabilities, is making our ZEGERID products available to patients in Puerto Rico and the U.S. Virgin Islands," said Gerald T. Proehl, president and chief executive officer of Santarus, Inc. "GSK has long demonstrated success in marketing products in the gastrointestinal therapeutic area, and we believe it is the ideal partner to bring physicians in these regions the message about the benefits of ZEGERID products."
Santarus and GSK entered into a distribution agreement in November 2007 under which GSK will distribute, market and sell ZEGERID brand prescription products in Puerto Rico and the U.S. Virgin Islands. At the same time, Santarus licensed rights to GSK to develop, manufacture and commercialize immediate-release omeprazole products in up to 114 countries in GSK's International Region, including in Africa, Asia, the Middle-East, and Central and South America. According to IMS Health, retail sales of PPI products in the covered territories were estimated to be approximately $2 billion for the 12 months ended September 30, 2007 and grew at approximately 22% compared with the prior 12 month period. The license agreement excludes the U.S., Europe, Australia, Japan and Canada.
Wyeth Wins Thimerosal-Autism Case in Maryland Court
Wyeth announced today that The Honorable Stuart R. Berger of the Circuit Court for Baltimore City in Baltimore, Maryland, has granted Wyeth's motion for summary judgment in the case of Blackwell, et al. v. Sigma Aldrich, Inc., et al -- an alleged vaccine injury case claiming that Jamarr Blackwell's exposure to thimerosal-containing vaccines caused him to become autistic.
Previously, the Court had granted Wyeth's motion to preclude all five of plaintiffs' expert witnesses from offering testimony at trial following extensive briefing and a 10-day evidentiary hearing held by the Court last August.
In his December 21, 2007 Memorandum and Order pertaining to Wyeth's evidentiary motion, Judge Berger found that "it is generally accepted in the relevant scientific community that thimerosal in vaccines does not cause or contribute to neurodevelopmental disorders such as autism," also noting that "it is generally accepted in the relevant scientific community that autism is genetic in origin except in rare instances of prenatal exposures to certain substances at defined periods during pregnancy."
"This is a significant victory for good science generally," says Daniel J. Thomasch, a partner at Orrick, Herrington & Sutcliffe LLP, who served as lead counsel for Wyeth in this matter. "The Court appropriately found that plaintiffs' attempt to link autism to childhood vaccines is contrary to generally accepted science."
Previously, the Court had granted Wyeth's motion to preclude all five of plaintiffs' expert witnesses from offering testimony at trial following extensive briefing and a 10-day evidentiary hearing held by the Court last August.
In his December 21, 2007 Memorandum and Order pertaining to Wyeth's evidentiary motion, Judge Berger found that "it is generally accepted in the relevant scientific community that thimerosal in vaccines does not cause or contribute to neurodevelopmental disorders such as autism," also noting that "it is generally accepted in the relevant scientific community that autism is genetic in origin except in rare instances of prenatal exposures to certain substances at defined periods during pregnancy."
"This is a significant victory for good science generally," says Daniel J. Thomasch, a partner at Orrick, Herrington & Sutcliffe LLP, who served as lead counsel for Wyeth in this matter. "The Court appropriately found that plaintiffs' attempt to link autism to childhood vaccines is contrary to generally accepted science."
Barr Receives Final Approval for Generic Mirapex Tablets, 0.125mg, 0.25mg, 0.5mg, 1mg & 1.5mg
Barr Pharmaceuticals, Inc. today announced that its subsidiary, Barr Laboratories, Inc., has received final approval from the U.S. Food and Drug Administration (FDA) for its generic version of Boehringer Ingelheim Pharmaceuticals, Inc.'s Mirapex(R) Tablets (Pramipexole Dihydrochloride) 0.125mg, 0.25mg, 0.5mg, 1mg & 1.5mg. The Company believes that it is the first to file an Abbreviated New Drug Application (ANDA) with a paragraph IV certification for Mirapex Tablets, 0.125mg, 0.25mg, 0.5mg, 1mg & 1.5mg.
The Company is currently challenging a patent protecting Mirapex and a trial is scheduled to begin on March 10, 2008 in the District Court in Delaware. Under the terms of a Court Order, Barr has agreed not to launch its Pramipexole Dihydrochloride tablets product until the earliest of the following occurs: 90 days following the conclusion of the presentation of evidence in the District Court trial, the date a favorable judgment for Barr is entered by the District Court, or July 14, 2008.
Barr filed its ANDA for generic Mirapex Tablets, 0.25mg containing a paragraph IV certification with the FDA in May 2005 and in June 2005 amended its application to include the tablet strengths 0.125mg, 0.5mg, 1mg, and 1.5mg. The Company received notification of the application's acceptance for filing in July 2005. Following receipt of the notice from the FDA, Barr notified Boehringer Ingelheim, the New Drug Application (NDA) holder and patent owner. On September 26, 2005, Boehringer Ingelheim filed suit in the U.S. District Court in Delaware to prevent Barr from proceeding with the commercialization of its product, formally initiating the patent challenge process under the Hatch-Waxman Act.
Barr's Pramipexole Dihydrochloride tablets are indicated for the treatment of the signs and symptoms of idiopathic Parkinson's disease.
The Company is currently challenging a patent protecting Mirapex and a trial is scheduled to begin on March 10, 2008 in the District Court in Delaware. Under the terms of a Court Order, Barr has agreed not to launch its Pramipexole Dihydrochloride tablets product until the earliest of the following occurs: 90 days following the conclusion of the presentation of evidence in the District Court trial, the date a favorable judgment for Barr is entered by the District Court, or July 14, 2008.
Barr filed its ANDA for generic Mirapex Tablets, 0.25mg containing a paragraph IV certification with the FDA in May 2005 and in June 2005 amended its application to include the tablet strengths 0.125mg, 0.5mg, 1mg, and 1.5mg. The Company received notification of the application's acceptance for filing in July 2005. Following receipt of the notice from the FDA, Barr notified Boehringer Ingelheim, the New Drug Application (NDA) holder and patent owner. On September 26, 2005, Boehringer Ingelheim filed suit in the U.S. District Court in Delaware to prevent Barr from proceeding with the commercialization of its product, formally initiating the patent challenge process under the Hatch-Waxman Act.
Barr's Pramipexole Dihydrochloride tablets are indicated for the treatment of the signs and symptoms of idiopathic Parkinson's disease.
Endo and Penwest Receive Paragraph IV Certification Notice From Actavis for Opana ER
Endo Pharmaceuticals Holdings Inc. (NASDAQ: ENDP) and Penwest Pharmaceuticals Co. (NASDAQ: PPCO) announced today that on February 14, 2008, they received a notice from Actavis South Atlantic LLC advising of the filing by Actavis of an Abbreviated New Drug Application (ANDA) containing a Paragraph IV certification under 21 U.S.C. Section 355(j) for oxymorphone hydrochloride extended-release tablets CII.
The Actavis Paragraph IV certification notice refers to Penwest's U.S. Patent Nos. 5,128,143, 5,662,933, 5,958,456, and 7,276,250, which cover the formulation of OPANA(R) ER. These patents are listed in the FDA's Orange Book and expire in 2008, 2013, 2013, and 2023, respectively. In addition to these patents, OPANA ER has a new dosage form (NDA) exclusivity that prevents final approval of any ANDA by the FDA until the exclusivity expires on June 22, 2009. Endo and Penwest are currently reviewing the details of this notice from Actavis. Endo and Penwest note that they intend to pursue all available legal and regulatory avenues in defense of OPANA ER, including enforcement of their intellectual property rights and approved labeling.
As previously disclosed, Endo and Penwest also have been notified by IMPAX Laboratories Inc. of its filing of an ANDA containing Paragraph IV certifications for OPANA ER in late 2007. Patent infringement suits against IMPAX are pending in the U.S. District Court for the District of Delaware.
The Actavis Paragraph IV certification notice refers to Penwest's U.S. Patent Nos. 5,128,143, 5,662,933, 5,958,456, and 7,276,250, which cover the formulation of OPANA(R) ER. These patents are listed in the FDA's Orange Book and expire in 2008, 2013, 2013, and 2023, respectively. In addition to these patents, OPANA ER has a new dosage form (NDA) exclusivity that prevents final approval of any ANDA by the FDA until the exclusivity expires on June 22, 2009. Endo and Penwest are currently reviewing the details of this notice from Actavis. Endo and Penwest note that they intend to pursue all available legal and regulatory avenues in defense of OPANA ER, including enforcement of their intellectual property rights and approved labeling.
As previously disclosed, Endo and Penwest also have been notified by IMPAX Laboratories Inc. of its filing of an ANDA containing Paragraph IV certifications for OPANA ER in late 2007. Patent infringement suits against IMPAX are pending in the U.S. District Court for the District of Delaware.
Panacea Biotec net up at Rs 28.93 cr in Q3
Panacea Biotec, the second largest vaccine producer in India, has achieved better performance during the third quarter ended December 2007 despite rupee appreciation and lower other income.
Sanofi Pasteur MSD Applies for European Approval of the First Seasonal Influenza Vaccine Delivered by Intradermal Microinjection
Sanofi Pasteur MSD has applied for the European licensure for the first seasonal influenza vaccine delivered by intradermal (ID) microinjection. The European Medicines Agency (EMEA) has accepted the filing and started its review.
Clinical trials, involving more than 7,000 participants, evaluated the safety and ability to generate an immune response of this novel (ID) seasonal influenza vaccine.[1]
The ID vaccine generated a superior level of seroprotective immune response against all tested influenza strains, compared with standard intramuscular (IM) influenza vaccination, in participants over 60 years of age.[2],[3]
With ageing, the immune system tends to weaken – the elderly become not only more susceptible to infections but also less responsive to classical intramuscular vaccination, a phenomenon known as immunosenescence.[4],[5],[6],[7]
“As a natural consequence of ageing, the immune system of the elderly becomes less able to fight off influenza infection as well as the more serious influenza-related complications. This underscores the strong rationale for a better-performing vaccine in the elderly," explains Dr. Jean-Pierre Michel, professor and chair of rehabilitation and geriatrics at the University of Geneva Medical School in Switzerland.
"The concept of this vaccine is based on the fact that there is a high concentration of specialised immune cells in the intradermal skin layer and their ability to effectively provide an improved immune response," says Patrick Poirot, vice-president for Medical and Scientific Affairs at Sanofi Pasteur MSD.
A proprietary new, pre-filled and ready-to use microinjection system[*] with a very fine and short needle provides accurate and reliable intradermal delivery of the vaccine.[8],[9]
If approved, Sanofi Pasteur MSD will market the vaccine within its territory[†]. Outside this territory, the vaccine will be marketed by sanofi pasteur, one of Sanofi Pasteur MSD's parent companies.
Clinical trials, involving more than 7,000 participants, evaluated the safety and ability to generate an immune response of this novel (ID) seasonal influenza vaccine.[1]
The ID vaccine generated a superior level of seroprotective immune response against all tested influenza strains, compared with standard intramuscular (IM) influenza vaccination, in participants over 60 years of age.[2],[3]
With ageing, the immune system tends to weaken – the elderly become not only more susceptible to infections but also less responsive to classical intramuscular vaccination, a phenomenon known as immunosenescence.[4],[5],[6],[7]
“As a natural consequence of ageing, the immune system of the elderly becomes less able to fight off influenza infection as well as the more serious influenza-related complications. This underscores the strong rationale for a better-performing vaccine in the elderly," explains Dr. Jean-Pierre Michel, professor and chair of rehabilitation and geriatrics at the University of Geneva Medical School in Switzerland.
"The concept of this vaccine is based on the fact that there is a high concentration of specialised immune cells in the intradermal skin layer and their ability to effectively provide an improved immune response," says Patrick Poirot, vice-president for Medical and Scientific Affairs at Sanofi Pasteur MSD.
A proprietary new, pre-filled and ready-to use microinjection system[*] with a very fine and short needle provides accurate and reliable intradermal delivery of the vaccine.[8],[9]
If approved, Sanofi Pasteur MSD will market the vaccine within its territory[†]. Outside this territory, the vaccine will be marketed by sanofi pasteur, one of Sanofi Pasteur MSD's parent companies.
Labopharm's Once-Daily Tramadol Approved in South Korea and Australia
Labopharm Inc. today announced that its once-daily tramadol product has received regulatory approval from the Korea Food and Drug Administration, which allows for the marketing and sale of Labopharm's once-daily tramadol product in South Korea, and from the Australian Department of Health and Aging, which allows for the marketing and sale of Labopharm's once-daily tramadol product in Australia.
"Approval in South Korea and Australia brings the number of countries in which our product has been approved to 27," said James R. Howard-Tripp, President and Chief Executive Officer, Labopharm Inc. "South Korea and Australia are important components of the global commercialization plan for our product. We are now working with our marketing partners in both countries towards the launches of our product later this year."
Labopharm completed licensing and distribution agreements for its once-daily tramadol product for South Korea with WhanIn Pharmaceutical Co., Ltd last year, and for Australia with iNova Pharmaceuticals (Australia) Pty Limited earlier this year. The Company expects its product to be launched in South Korea and Australia later this year.
Marketing Partnership for Once-Daily Tramadol for Turkey
Labopharm also announced today that it has signed a licensing and distribution agreement for its once-daily tramadol product for Turkey with Dr. F. Frik Ilac San. Ve Tic. A. S.
Under terms of the agreement, Dr. F. Frik will have the exclusive right to market and sell Labopharm's once-daily tramadol product in Turkey. Labopharm will supply Dr. F. Frik with finished packaged product and will receive revenue from the sale of such finished packaged product at rates commensurate with those of previous licensing and distribution agreements that Labopharm has entered into for other European markets. Labopharm is also eligible to receive additional payments upon the achievement of certain milestones.
Labopharm has submitted a marketing application for regulatory approval of its once-daily formulation of tramadol to the Ministry of Health in Turkey. The Company expects to receive approval in early 2009.
For the 12-month period ended September 2007, sales of tramadol products in Turkey were 7.1 million standard units, representing a compounded annual growth rate over the previous five 12-month periods of 35%.
"Approval in South Korea and Australia brings the number of countries in which our product has been approved to 27," said James R. Howard-Tripp, President and Chief Executive Officer, Labopharm Inc. "South Korea and Australia are important components of the global commercialization plan for our product. We are now working with our marketing partners in both countries towards the launches of our product later this year."
Labopharm completed licensing and distribution agreements for its once-daily tramadol product for South Korea with WhanIn Pharmaceutical Co., Ltd last year, and for Australia with iNova Pharmaceuticals (Australia) Pty Limited earlier this year. The Company expects its product to be launched in South Korea and Australia later this year.
Marketing Partnership for Once-Daily Tramadol for Turkey
Labopharm also announced today that it has signed a licensing and distribution agreement for its once-daily tramadol product for Turkey with Dr. F. Frik Ilac San. Ve Tic. A. S.
Under terms of the agreement, Dr. F. Frik will have the exclusive right to market and sell Labopharm's once-daily tramadol product in Turkey. Labopharm will supply Dr. F. Frik with finished packaged product and will receive revenue from the sale of such finished packaged product at rates commensurate with those of previous licensing and distribution agreements that Labopharm has entered into for other European markets. Labopharm is also eligible to receive additional payments upon the achievement of certain milestones.
Labopharm has submitted a marketing application for regulatory approval of its once-daily formulation of tramadol to the Ministry of Health in Turkey. The Company expects to receive approval in early 2009.
For the 12-month period ended September 2007, sales of tramadol products in Turkey were 7.1 million standard units, representing a compounded annual growth rate over the previous five 12-month periods of 35%.
Biovail Receives Canadian Approval for Wellbutrin XL for the Prevention of Seasonal Major Depressive Illness
Feb 15, 2008 - Biovail Corporation (NYSE: BVF) (TSX: BVF) today announced that it has received a Notice of Compliance from the Therapeutic Products Directorate (TPD) for its supplemental New Drug Submission (sNDS) for a new indication for Wellbutrin(R) XL in Canada - the prevention of major depressive illness with an autumn-winter seasonal pattern.
The approval of Wellbutrin(R) XL for this indication represents a significant milestone for Biovail and for Canadian healthcare, as it represents the first time in Canada that a medication has received an indication for the prevention of this type of major depressive illness. Many patients with major depressive disorder have a seasonal pattern to their disease. For the first time, their physicians will have the option to prescribe an agent specifically indicated to prevent their seasonal major depressive episodes.
"Seasonal major depressive illness is a serious and often under-diagnosed type of depression," says Scott Smith, Vice-President and General Manager of Biovail Pharmaceuticals Canada (BPC), the Canadian sales and marketing division of the Company, that will introduce this new indication to Canadian health care professionals in 2008. "The approval of Wellbutrin(R) XL as a prevention for this type of depression offers new hope to patients who dread the onset of winter, and the episodes of major depression that often come with it."
"Physicians who already appreciate the unique combination of first-line efficacy with low incidence of sexual dysfunction and weight gain offered by Wellbutrin(R) XL, will have a new reason to choose it for their patients."
The approval of Wellbutrin(R) XL in seasonal major depressive illness represents Biovail's third Notice of Compliance in the past six months.
The efficacy of Wellbutrin(R) XL for the prevention of seasonal major depressive episodes was established in three, double-blind, placebo-controlled trials in adult outpatients with a history of major depressive disorder with an autumn-winter seasonal pattern, as defined by Diagnostic and Statistical Manual of Mental Disorders, 4th edition (DSM-IV) criteria.
The approval of Wellbutrin(R) XL for this indication represents a significant milestone for Biovail and for Canadian healthcare, as it represents the first time in Canada that a medication has received an indication for the prevention of this type of major depressive illness. Many patients with major depressive disorder have a seasonal pattern to their disease. For the first time, their physicians will have the option to prescribe an agent specifically indicated to prevent their seasonal major depressive episodes.
"Seasonal major depressive illness is a serious and often under-diagnosed type of depression," says Scott Smith, Vice-President and General Manager of Biovail Pharmaceuticals Canada (BPC), the Canadian sales and marketing division of the Company, that will introduce this new indication to Canadian health care professionals in 2008. "The approval of Wellbutrin(R) XL as a prevention for this type of depression offers new hope to patients who dread the onset of winter, and the episodes of major depression that often come with it."
"Physicians who already appreciate the unique combination of first-line efficacy with low incidence of sexual dysfunction and weight gain offered by Wellbutrin(R) XL, will have a new reason to choose it for their patients."
The approval of Wellbutrin(R) XL in seasonal major depressive illness represents Biovail's third Notice of Compliance in the past six months.
The efficacy of Wellbutrin(R) XL for the prevention of seasonal major depressive episodes was established in three, double-blind, placebo-controlled trials in adult outpatients with a history of major depressive disorder with an autumn-winter seasonal pattern, as defined by Diagnostic and Statistical Manual of Mental Disorders, 4th edition (DSM-IV) criteria.
Collegium Pharmaceutical Inc. Announces Notice of Allowance for U.S. Patent for its DETERx Abuse Deterrent Sustained Release Technology
Feb 14, 2008 - Collegium Pharmaceutical, Inc., a specialty pharmaceutical company, today announced that it has received a Notice of Allowance from the U.S. Patent and Trademark Office (USPTO) for its patent application "Abuse-Deterrent Pharmaceutical Compositions of Opioids and Other Drugs", US Patent Application Number 10/614,866. The Notice of Allowance is the USPTO's official communication that the Company's application has successfully completed examination and that a patent will be issued.
Once issued, the patent will provide broad coverage for Collegium's abuse-deterrent, sustained-release, orally administered formulation platform, trademarked "DETERx(TM)". The DETERx(TM) platform consists of a multiparticulate matrix formulation in a capsule. While developed primarily to provide tamper resistant properties, the multiparticulate design has the potential to enable patients with difficulty swallowing to open the capsule and administer the contents on food or with water, while maintaining the desired sustained release properties of the product.
Collegium's lead DETERx(TM) product candidate, COL-003, a formulation of sustained release oxycodone, will be covered by the patent. As previously reported, COL-003 is currently under clinical development pursuant to an active investigational new drug application on file with the United States Food and Drug Administration ("FDA"). Based on in vitro testing and previously reported pharmacokinetic results, COL-003 is expected to provide adequate plasma concentrations to effectively treat pain over a 12 hour period while deterring abuse by oral administration (e.g. chewing, crushing), intravenous injection and nasal administration. Collegium recently reported receipt of Fast Track Designation for the product from the FDA.
"This is an important patent in that it provides coverage for our lead DETERx(TM) product candidate, COL-003, and the DETERx(TM) platform technology in general. Since the patent is for the delivery platform, it will cover any scheduled drug that we incorporate into DETERx including COL-171 (treatment of ADHD) and COL-172 (management of moderate to severe pain), both of which are in pre-clinical development. We plan to continue to strengthen the patent portfolio around the DETERx(TM) technology platform and we look forward to the allowance of complementary and specific product related IP," said Dr. Alison Fleming, Director of Product Research & Development, Collegium Pharmaceutical and one of the inventors of the technology.
Once issued, the patent will provide broad coverage for Collegium's abuse-deterrent, sustained-release, orally administered formulation platform, trademarked "DETERx(TM)". The DETERx(TM) platform consists of a multiparticulate matrix formulation in a capsule. While developed primarily to provide tamper resistant properties, the multiparticulate design has the potential to enable patients with difficulty swallowing to open the capsule and administer the contents on food or with water, while maintaining the desired sustained release properties of the product.
Collegium's lead DETERx(TM) product candidate, COL-003, a formulation of sustained release oxycodone, will be covered by the patent. As previously reported, COL-003 is currently under clinical development pursuant to an active investigational new drug application on file with the United States Food and Drug Administration ("FDA"). Based on in vitro testing and previously reported pharmacokinetic results, COL-003 is expected to provide adequate plasma concentrations to effectively treat pain over a 12 hour period while deterring abuse by oral administration (e.g. chewing, crushing), intravenous injection and nasal administration. Collegium recently reported receipt of Fast Track Designation for the product from the FDA.
"This is an important patent in that it provides coverage for our lead DETERx(TM) product candidate, COL-003, and the DETERx(TM) platform technology in general. Since the patent is for the delivery platform, it will cover any scheduled drug that we incorporate into DETERx including COL-171 (treatment of ADHD) and COL-172 (management of moderate to severe pain), both of which are in pre-clinical development. We plan to continue to strengthen the patent portfolio around the DETERx(TM) technology platform and we look forward to the allowance of complementary and specific product related IP," said Dr. Alison Fleming, Director of Product Research & Development, Collegium Pharmaceutical and one of the inventors of the technology.
Accu-Break Pharmaceuticals, Inc. Issued First Two Patents for Its Accu-Break Technologies
Feb 14, 2008 - Accu-Break Pharmaceuticals, Inc. ("ABP"), a company with a suite of pharmaceutical tablet technologies for creating divisible dosage forms, announced today the recent issuance of two patents covering its Accu-Break technologies. Tablets made in the Accu-Break format contain a drug-free layer that may be used as a break zone should the dose need to be adjusted. The technologies are intended to create pharmaceutical tablets that can be easily divided into precise doses to facilitate titration, dose adjustment and individualized dosing.
The first patent (U.S. 7,318,935) claims a layered immediate-release (IR) tablet having at least two different active ingredients segregated from each other by a drug-free layer. The innovative tablet design may be used to combine medications in a way that allows them to be administered together in a single tablet, as in traditional fixed-dose combination tablets, but also enables the two medications to be accurately separated if medically indicated simply by splitting the tablet through the drug-free layer. The invention also allows for the combination of active ingredients within a single tablet that are incompatible, providing a potential solution for useful combinations containing formulations that may be difficult to combine in a single tablet due to incompatibility reasons, among others.
The second patent (U.S. 7,329,418) also claims divisible tablets, but involves the creation of tablets that contain a half dose of the same active (or combination of the same actives) on each end of the tablet, separated by a drug-free break layer. Division of these tablets through the drug-free break layer would provide an accurate partial dose of the active(s), useful for titration and dose adjustment.
The first patent (U.S. 7,318,935) claims a layered immediate-release (IR) tablet having at least two different active ingredients segregated from each other by a drug-free layer. The innovative tablet design may be used to combine medications in a way that allows them to be administered together in a single tablet, as in traditional fixed-dose combination tablets, but also enables the two medications to be accurately separated if medically indicated simply by splitting the tablet through the drug-free layer. The invention also allows for the combination of active ingredients within a single tablet that are incompatible, providing a potential solution for useful combinations containing formulations that may be difficult to combine in a single tablet due to incompatibility reasons, among others.
The second patent (U.S. 7,329,418) also claims divisible tablets, but involves the creation of tablets that contain a half dose of the same active (or combination of the same actives) on each end of the tablet, separated by a drug-free break layer. Division of these tablets through the drug-free break layer would provide an accurate partial dose of the active(s), useful for titration and dose adjustment.
Sun Pharma Gets USFDA Tentative Approval for Generic Depakote Delayed Release Tablets
February 14, 2008: Sun Pharmaceutical Industries Ltd. announced that USFDA has granted tentative approval for the Company’s Abbreviated New Drug Application (ANDA) for generic Depakote ®, divalproex sodium delayed release tablets.
Divalproex sodium delayed release tablets are indicated as monotherapy and adjunctive therapy in the treatment of patients with complex partial seizures, as sole and adjunct therapy for patients with simple and complex absence seizures, for the treatment of the manic episodes associated with bipolar disorders, as well as for prophylaxis of migraine headaches.
These generic versions of divalproex sodium delayed release 125 mg, 250 mg and 500 mg (valproic acid activity) tablets are bio-equivalent to Depakote ® delayed release tablets distributed by Abbott Laboratories.
These strengths of Depakote ® delayed release tablets have annual sales of approximately USD 755 million in the US.
Divalproex sodium delayed release tablets are indicated as monotherapy and adjunctive therapy in the treatment of patients with complex partial seizures, as sole and adjunct therapy for patients with simple and complex absence seizures, for the treatment of the manic episodes associated with bipolar disorders, as well as for prophylaxis of migraine headaches.
These generic versions of divalproex sodium delayed release 125 mg, 250 mg and 500 mg (valproic acid activity) tablets are bio-equivalent to Depakote ® delayed release tablets distributed by Abbott Laboratories.
These strengths of Depakote ® delayed release tablets have annual sales of approximately USD 755 million in the US.
FDA Approves Generic Zidovudine Tablets, 300 mg
On February 14, 2008, FDA granted approval for a generic formulation of Zidovudine Tablets, 300 mg., manufactured by Matrix Laboratories, Inc. of Hyderabad, India. The application was reviewed under the expedited review provisions of the President's Emergency Plan for AIDS Relief (PEPFAR). However, because patent protections for the reference product, Retrovir Tablets,300 mg, made by GlaxoSmithKline have expired, this generic product can be marketed in the United States, as well as being available for purchase under the PEPFAR program.
A list of all FDA approved generic antiretroviral drugs for the treatment of HIV is available on the web at http://www.fda.gov/oashi/aids/viralsgeneric.html
Zidovudine is a Nucleoside Reverse Transcriptase Inhibitors (NRTI) indicated for the treatment of HIV in combination with other antiviral medications.
As with all FDA-approved generics, this product must meet all of FDA's manufacturing quality, and clinical safety and effectiveness standards.
A list of all FDA approved generic antiretroviral drugs for the treatment of HIV is available on the web at http://www.fda.gov/oashi/aids/viralsgeneric.html
Zidovudine is a Nucleoside Reverse Transcriptase Inhibitors (NRTI) indicated for the treatment of HIV in combination with other antiviral medications.
As with all FDA-approved generics, this product must meet all of FDA's manufacturing quality, and clinical safety and effectiveness standards.
Friday, February 8, 2008
US FDA agrees to review UCB's BLA for Cimzia
UCB said the US Food and Drug Administration (FDA) has agreed to accept, for filing and review, a biologics license application (BLA) for Cimzia (certolizumab pegol) for the treatment of adult patients with active rheumatoid arthritis (RA). Cimzia is an investigational agent. If approved, Cimzia will be the first and only PEGylated anti-TNF (Tumour Necrosis Factor) biologic therapy available for the treatment of rheumatoid arthritis.
"As a new anti-TNF, we believe that Cimzia would provide an important new option for people living with this disease," said Olav Hellebo, president Inflammation Operations, UCB.
The BLA is based on data from more than 2,367 patients and includes three multi-centre, placebo-controlled phase III trials which were recently presented at the American College of Rheumatology (ACR) Annual Scientific Meeting.
In these studies Cimzia, given with methotrexate, was shown to be significantly more effective than methotrexate alone for the inhibition of joint damage progression in patients with active RA as early as 24 weeks (RAPID 1 and RAPID 2). Cimzia was shown to rapidly reduce the signs and symptoms of active RA with peak ACR50 and 70 responses achieved at 14 and 16 weeks. Improvement in physical function and quality of life measures were also seen for up to one year (RAPID 1). Further, Cimzia administered as monotherapy showed significant improvement in signs and symptoms of RA from week 1 and this benefit was maintained through week 24 (Study 011). The most commonly occurring adverse reactions, were headache, nasopharyngitis, and upper respiratory tract infections. Reported serious adverse reactions were infections (including tuberculosis) and malignancies (including lymphoma), consistent with findings from other trials in the anti-TNF class.Preparation for submission of a Marketing Authorization Application (MAA) to the European Medicines Agency (EMEA) for Cimzia in the treatment of RA is ongoing, with filing planned in the first half of 2008, the company informed. In September 2007, Cimzia was approved in Switzerland for the treatment of Crohn's disease and it was launched in January 2008.
"As a new anti-TNF, we believe that Cimzia would provide an important new option for people living with this disease," said Olav Hellebo, president Inflammation Operations, UCB.
The BLA is based on data from more than 2,367 patients and includes three multi-centre, placebo-controlled phase III trials which were recently presented at the American College of Rheumatology (ACR) Annual Scientific Meeting.
In these studies Cimzia, given with methotrexate, was shown to be significantly more effective than methotrexate alone for the inhibition of joint damage progression in patients with active RA as early as 24 weeks (RAPID 1 and RAPID 2). Cimzia was shown to rapidly reduce the signs and symptoms of active RA with peak ACR50 and 70 responses achieved at 14 and 16 weeks. Improvement in physical function and quality of life measures were also seen for up to one year (RAPID 1). Further, Cimzia administered as monotherapy showed significant improvement in signs and symptoms of RA from week 1 and this benefit was maintained through week 24 (Study 011). The most commonly occurring adverse reactions, were headache, nasopharyngitis, and upper respiratory tract infections. Reported serious adverse reactions were infections (including tuberculosis) and malignancies (including lymphoma), consistent with findings from other trials in the anti-TNF class.Preparation for submission of a Marketing Authorization Application (MAA) to the European Medicines Agency (EMEA) for Cimzia in the treatment of RA is ongoing, with filing planned in the first half of 2008, the company informed. In September 2007, Cimzia was approved in Switzerland for the treatment of Crohn's disease and it was launched in January 2008.
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