Indian pharmaceutical companies are facing a steep rise in staff costs in recent years on account of frequent expansion programmes, rising investments in R&D and mergers and acquisitions. Increasing focus on skilled manpower and spending higher amounts to retain them are also substantially adding to the employee costs.
A Pharmabiz study of 25 leading Indian companies show that the employee costs had gone up by 33 per cent to Rs 1,575 crore during the first half of 2007-08 from Rs 1,185 crore in the same period of last year. Barring three companies, the employee costs moved up between 10 to 250 per cent during the first half. The cost of employees of Dishman Pharma, Dr Reddy's Laboratories (DRL), Biocon and Jubilant Organosys saw a growth of over 40 per cent. Similarly, leading companies like Cadila, Lupin, Aurobindo, Glenmark and Panacea Biotec also incurred significant higher employees cost during the first half.
Multinational companies in India, however, have been cutting costs through implementing VRS. However, Novartis reported a rise of 11 per cent in staff cost, but Wyeth has reduced it by 3.4 per cent. The Indian companies have started expanding aggressively in the international market and they need to invest in manpower for marketing there products as well as for manufacturing purpose. Further, contract manufacturing activity is gaining ground with requirement of more skilled people.
The Pharmabiz study has not included some leading companies like Ranbaxy Labs, Wockhardt, Stride Acrolab, Sterling Biotec and MNC like GSK, Aventis, Pfizer, Abbott, Merck, and AstraZeneca, as their financial year endings are in November- December. The staff cost of these companies have gone up by 14.6 per cent to Rs 791.46 crore for the nine month ended September 2007 as against Rs 690.37 crore in the corresponding period of last year. Stride Arcolab's staff cost increased by 41.1 per cent to Rs 39.08 crore from Rs 27.70 crore in the same period of last year. MNCs like Pfizer has successfully reduced its staff cost by 4.7 per cent during the first nine months of 2007. GSK and Merck pushed there staff cost marginally by 3.4 per cent and 2.2 per cent. Ranbaxy's staff cost increased by 17 per cent to Rs 289crore from Rs 247 crore in the corresponding period of last year.
Thursday, December 13, 2007
Abbott sues Glenmark in US court over trandolapril
Glenmark Pharmaceuticals Ltd confirmed that Abbott has filed suit on December 07, 2007 in the US district court of New Jersey, seeking to prevent Glenmark from proceeding with the commercialization of its trandolapril; verapamil hydrochloride products which is currently marketed by Abbott as Tarka.
Glenmark has filed an Abbreviated New Drug Application (ANDA) with the United States Food and Drug Administration (FDA) seeking regulatory approval to market a generic version of trandolapril; verapamil hydrochloride which included a paragraph IV certification with respect to patent listed by "Abbott" in the FDA "Orange Book." Glenmark believes it is the only applicant to have filed an ANDA for this product with a paragraph IV certification. In the event that Glenmark successfully challenges Abbott's patent, Glenmark will be entitled to a 180 day exclusivity period.
Tarka, extended release oral tablets are indicated for the treatment of hypertension. The product had sales of approximately $100 million in the US market.
With this filing, Glenmark has four first to file positions for various products e.g. ezetimibe, desloratadine, atomoxetine hydrochloride. On successful patent challenges company will have shared exclusivity for the desloratadine and atomoxetine whereas in the case of ezetimibe Glenmark will be the sole Company who will be entitled for the 180 days exclusivity.
Additionally, Glenmark has an on-going shared exclusivity on trileptal (an $800 million product). Having completed two months on the market, Glenmark has garnered a substantial market share to lead the generic pack.
The approval of trileptal offered Glenmark its first 180 day exclusivity in the US market and with this the company now has a portfolio of 21 generic products for the US market and has over 35 ANDAs undergoing US FDA approval process/launch.
Glenmark has filed an Abbreviated New Drug Application (ANDA) with the United States Food and Drug Administration (FDA) seeking regulatory approval to market a generic version of trandolapril; verapamil hydrochloride which included a paragraph IV certification with respect to patent listed by "Abbott" in the FDA "Orange Book." Glenmark believes it is the only applicant to have filed an ANDA for this product with a paragraph IV certification. In the event that Glenmark successfully challenges Abbott's patent, Glenmark will be entitled to a 180 day exclusivity period.
Tarka, extended release oral tablets are indicated for the treatment of hypertension. The product had sales of approximately $100 million in the US market.
With this filing, Glenmark has four first to file positions for various products e.g. ezetimibe, desloratadine, atomoxetine hydrochloride. On successful patent challenges company will have shared exclusivity for the desloratadine and atomoxetine whereas in the case of ezetimibe Glenmark will be the sole Company who will be entitled for the 180 days exclusivity.
Additionally, Glenmark has an on-going shared exclusivity on trileptal (an $800 million product). Having completed two months on the market, Glenmark has garnered a substantial market share to lead the generic pack.
The approval of trileptal offered Glenmark its first 180 day exclusivity in the US market and with this the company now has a portfolio of 21 generic products for the US market and has over 35 ANDAs undergoing US FDA approval process/launch.
BioMarin Announces FDA Approval for Kuvan
First Specific Drug Therapy Approved for the Treatment of PKU
NOVATO, Calif., Dec. 13 /PRNewswire-FirstCall/ -- BioMarin Pharmaceutical Inc. announced today that the U.S. Food and Drug Administration (FDA) has granted marketing approval for Kuvan(TM) (sapropterin dihydrochloride) Tablets, the first specific drug therapy approved for the treatment of phenylketonuria (PKU). Shipments to the distribution channel will commence tomorrow, and BioMarin will begin promotion of Kuvan immediately.
"The approval of Kuvan represents an important milestone for PKU patients and their families and also for BioMarin. We are extremely pleased to bring this promising treatment option to market in just a little over three years since the IND filing, and we are now ready for an immediate launch," said Jean-Jacques Bienaime, Chief Executive Officer of BioMarin. "We would like to thank all the patients, their families and physicians, our corporate partners, the FDA, and BioMarin employees for their hard work and dedication in making Kuvan a reality."
"In clinical trials, Kuvan has been shown to help control blood Phe levels in PKU patients, and I am thrilled that this new therapy is now commercially available to the PKU community," stated Dr. Barbara Burton, Professor of Pediatrics, Northwestern University Feinberg School of Medicine; Director, PKU Clinic at Children's Memorial Hospital; and Clinical Investigator in the Kuvan Phase 2 and Phase 3 trials. "With Kuvan now approved, physicians and patients have, for the first time, a drug therapy option to manage the disease."
Kuvan is indicated to reduce blood phenylalanine (Phe) levels in patients with hyperphenylalaninemia (HPA) due to tetrahydrobiopterin (BH4) responsive PKU and is to be used in conjunction with a Phe-restricted diet. To determine if there is a response to Kuvan, the recommended starting dose of Kuvan is 10 mg/kg/day taken once daily for up to a month. If there is no response, the drug dose may be increased to 20 mg/kg/day for up to a month. The dose may be adjusted within a range of 5 to 20 mg/kg/day in patients who respond to Kuvan. Kuvan is developed in partnership with Merck Serono, a division of Merck KGaA, Darmstadt, Germany.
NOVATO, Calif., Dec. 13 /PRNewswire-FirstCall/ -- BioMarin Pharmaceutical Inc. announced today that the U.S. Food and Drug Administration (FDA) has granted marketing approval for Kuvan(TM) (sapropterin dihydrochloride) Tablets, the first specific drug therapy approved for the treatment of phenylketonuria (PKU). Shipments to the distribution channel will commence tomorrow, and BioMarin will begin promotion of Kuvan immediately.
"The approval of Kuvan represents an important milestone for PKU patients and their families and also for BioMarin. We are extremely pleased to bring this promising treatment option to market in just a little over three years since the IND filing, and we are now ready for an immediate launch," said Jean-Jacques Bienaime, Chief Executive Officer of BioMarin. "We would like to thank all the patients, their families and physicians, our corporate partners, the FDA, and BioMarin employees for their hard work and dedication in making Kuvan a reality."
"In clinical trials, Kuvan has been shown to help control blood Phe levels in PKU patients, and I am thrilled that this new therapy is now commercially available to the PKU community," stated Dr. Barbara Burton, Professor of Pediatrics, Northwestern University Feinberg School of Medicine; Director, PKU Clinic at Children's Memorial Hospital; and Clinical Investigator in the Kuvan Phase 2 and Phase 3 trials. "With Kuvan now approved, physicians and patients have, for the first time, a drug therapy option to manage the disease."
Kuvan is indicated to reduce blood phenylalanine (Phe) levels in patients with hyperphenylalaninemia (HPA) due to tetrahydrobiopterin (BH4) responsive PKU and is to be used in conjunction with a Phe-restricted diet. To determine if there is a response to Kuvan, the recommended starting dose of Kuvan is 10 mg/kg/day taken once daily for up to a month. If there is no response, the drug dose may be increased to 20 mg/kg/day for up to a month. The dose may be adjusted within a range of 5 to 20 mg/kg/day in patients who respond to Kuvan. Kuvan is developed in partnership with Merck Serono, a division of Merck KGaA, Darmstadt, Germany.
Court Grants Depomed's Motion for Summary Judgment of Patent Infringement Against IVAX
MENLO PARK, Calif.--(BUSINESS WIRE)--Dec 13, 2007 - Depomed, Inc. (Nasdaq:DEPO), today announced that Judge Charles Breyer of the United States District Court for the Northern District of California has granted Depomed's motion for summary judgment of infringement of U.S. Patent Nos. 6,340,475 and 6,635,280 in the company's patent litigation against IVAX Corporation, and denied all three of IVAX's summary judgment motions.
The impact of the court's rulings is that IVAX's infringement of Depomed's patents has been established as a matter of law, without the need for a trial on that issue. The court ruled against IVAX on IVAX's motions for summary judgment related to the validity and enforceability of the patents, and the lack of willful infringement on the part of IVAX.
The court also rejected an interpretation of a disputed patent term proposed by IVAX in support of its invalidity arguments, and instead affirmed Depomed's interpretation of the disputed patent term.
The court has not yet set a trial date for the case.
Carl Pelzel, Depomed's president and chief executive officer, commented, "We are very pleased with the court's ruling, which we believe has significantly strengthened our case going to trial."
In January 2006, Depomed sued IVAX for infringement of U.S. Patent Nos. 6,340,475 and 6,635,280 by IVAX's extended release metformin hydrochloride tablets. The patents are held by Depomed and relate to the company's AcuForm(TM) drug delivery technology.
Depomed is represented by Michael Plimack of Heller Ehrman LLP.
The impact of the court's rulings is that IVAX's infringement of Depomed's patents has been established as a matter of law, without the need for a trial on that issue. The court ruled against IVAX on IVAX's motions for summary judgment related to the validity and enforceability of the patents, and the lack of willful infringement on the part of IVAX.
The court also rejected an interpretation of a disputed patent term proposed by IVAX in support of its invalidity arguments, and instead affirmed Depomed's interpretation of the disputed patent term.
The court has not yet set a trial date for the case.
Carl Pelzel, Depomed's president and chief executive officer, commented, "We are very pleased with the court's ruling, which we believe has significantly strengthened our case going to trial."
In January 2006, Depomed sued IVAX for infringement of U.S. Patent Nos. 6,340,475 and 6,635,280 by IVAX's extended release metformin hydrochloride tablets. The patents are held by Depomed and relate to the company's AcuForm(TM) drug delivery technology.
Depomed is represented by Michael Plimack of Heller Ehrman LLP.
Delhi Patent Office Turn Down Gefitinib Patent Application
Following pre-grant opposition hearing by Indian drug companies Natco Pharma Ltd. and JM Pharmaceuticals Ltd. made last year, the Delhi Patent Office lately rejected AstraZeneca’s Patent Application No. 841/DEL/1996 for its anticancer drug Gefitinib on the ground of “known prior use.” Both Natco and JM opposed the patent application citing that the drug has been in the public domain before the patent application filed in India. Natco spokesperson and company secretary Adi Narayana said his company filed a pre-grant opposition since the drug was not a new drug under the Patents Act, 1970 and lack inventive step. Gefitinib, worldwide marketed as Iressa, is oral tablet medication approved by the US Food and Drug Administration having three Orange Book listed US Patent Nos. 5,457,105 (genus); 5,616,582 (indication) and 5,770,599 (species). The ‘841 patent is Indian equivalent of the species patent.
Wednesday, December 12, 2007
Wyeth Settles With J&J Unit Over Effexor Patent
Johnson & Johnson unit Alza Corp. and rival pharmaceutical company Wyeth have settled a patent dispute over a drug-delivery system used in Wyeth’s popular antidepressant Effexor.
The parties asked Judge Ron Clark, of the U.S. District Court for the Eastern District of Texas, to dismiss the case with prejudice on Tuesday. The judge granted their request on Wednesday.
In the complaint, which was filed on July 26, 2006, Alza accused Wyeth of willfully infringing its patent covering controlled-release dosage technology for Effexor’s specific chemical compound. The technology allows a drug like Effexor to be released steadily into a user’s bloodstream.
Effexor has been a source of both revenue and legal action for Wyeth. During the first quarter of 2007, Wyeth sold about $891 million worth of Effexor. In both 2006 and 2005, Effexor accounted for 18% of Wyeth's net revenue, according to Wyeth's 2006 financial report.
Alza alleged that Wyeth knew and intended that users of Effexor would use the product in ways that infringed the dosage technology patent.
The patent in the case i.e. U.S. Patent No. 6,440,457., titled “Method of administering antidepressant dosage form,” assigned to Alza, was issued in August 2002 . It expires in August 2019.
Alza sought treble damages and attorneys’ fees.
Wyeth has been to court multiple times to protect its patents for venlafaxine, the active ingredient in Effexor. The patents were granted to Wyeth in 2001 and 2002.
In July, the company sued Mylan Pharmaceuticals Inc., after receiving a letter from Mylan giving notice that it had filed an abbreviated new drug application with the U.S. Food and Drug Administration to market a generic version of the drug.
Wyeth now wants the court to declare that the filing of the ANDA was an act of infringement with respect to each asserted patent and that the commercial manufacture, sale or importation of Mylan's venlafaxine hydrochloride extended-release capsules would infringe the patents.
Wyeth's complaint also asked that the effective date of any FDA approval not come before the expiration of each of the three patents and that the court enjoin Mylan from seeking approval of the ANDA in dispute, or making, selling or importing its proposed venlafaxine product until all three patents have expired.
Wyeth already filed similar lawsuits against several other generic drug makers, including Lupin Ltd., Anchen Pharmaceuticals, Osmotica Pharmaceutial Corp. and Impax Laboratories.
In 2005, it settled a lawsuit with Israeli generic drug company Teva Pharmaceuticals, which had also filed an ANDA to sell a generic version of Effexor.
The case is Alza Corp. v. Wyeth and Wyeth Pharmaceuticals Inc., case number 9:06-cv-00156, in the U.S. District Court for the Eastern District of Texas, in Lufkin.
The parties asked Judge Ron Clark, of the U.S. District Court for the Eastern District of Texas, to dismiss the case with prejudice on Tuesday. The judge granted their request on Wednesday.
In the complaint, which was filed on July 26, 2006, Alza accused Wyeth of willfully infringing its patent covering controlled-release dosage technology for Effexor’s specific chemical compound. The technology allows a drug like Effexor to be released steadily into a user’s bloodstream.
Effexor has been a source of both revenue and legal action for Wyeth. During the first quarter of 2007, Wyeth sold about $891 million worth of Effexor. In both 2006 and 2005, Effexor accounted for 18% of Wyeth's net revenue, according to Wyeth's 2006 financial report.
Alza alleged that Wyeth knew and intended that users of Effexor would use the product in ways that infringed the dosage technology patent.
The patent in the case i.e. U.S. Patent No. 6,440,457., titled “Method of administering antidepressant dosage form,” assigned to Alza, was issued in August 2002 . It expires in August 2019.
Alza sought treble damages and attorneys’ fees.
Wyeth has been to court multiple times to protect its patents for venlafaxine, the active ingredient in Effexor. The patents were granted to Wyeth in 2001 and 2002.
In July, the company sued Mylan Pharmaceuticals Inc., after receiving a letter from Mylan giving notice that it had filed an abbreviated new drug application with the U.S. Food and Drug Administration to market a generic version of the drug.
Wyeth now wants the court to declare that the filing of the ANDA was an act of infringement with respect to each asserted patent and that the commercial manufacture, sale or importation of Mylan's venlafaxine hydrochloride extended-release capsules would infringe the patents.
Wyeth's complaint also asked that the effective date of any FDA approval not come before the expiration of each of the three patents and that the court enjoin Mylan from seeking approval of the ANDA in dispute, or making, selling or importing its proposed venlafaxine product until all three patents have expired.
Wyeth already filed similar lawsuits against several other generic drug makers, including Lupin Ltd., Anchen Pharmaceuticals, Osmotica Pharmaceutial Corp. and Impax Laboratories.
In 2005, it settled a lawsuit with Israeli generic drug company Teva Pharmaceuticals, which had also filed an ANDA to sell a generic version of Effexor.
The case is Alza Corp. v. Wyeth and Wyeth Pharmaceuticals Inc., case number 9:06-cv-00156, in the U.S. District Court for the Eastern District of Texas, in Lufkin.
Roche files IND with US FDA for Genmab's antibody
Genmab A/S said Roche filed an Investigational New Drug application (IND) with the FDA for Genmab's antibody developed under the company's collaboration with Roche.
Genentech and Roche are collaborating on development of the antibody which selectively blocks the interaction of the OX40 ligand and its receptor. The companies are evaluating the antibody for the treatment of asthma. Genmab will receive a milestone payment from Roche which does not influence Genmab's financial guidance for 2007.
In pre-clinical data published in a recent article and commentary in The Journal of Clinical Investigation, treatment with the human OX40L blocking antibody led to significant therapeutic effects in a nonhuman primate model of allergic inflammation. The mechanisms of action of the human antibody include effective blockade of OX40L binding to its receptor, and depletion of cells expressing OX40L. Depletion of OX40L-expressing cells was shown to depend on interaction of immune effector cells with the therapeutic antibody. The observed in vivo efficacy of the OX40L-specific antibody may also involve restoration of peripheral tolerance mechanisms. Breaking of tolerance promotes development of autoimmune and allergic diseases.
Under the agreement with Roche, Genmab utilizes its broad antibody expertise and development capabilities to create human antibodies to a broad range of disease targets identified by Roche. Genmab receives milestone and royalty payments based on successful products. In certain circumstances, Genmab may obtain rights to develop products based on disease targets identified by Roche.
"Four of the antibodies developed by Genmab under our collaboration with Roche have now entered the clinic. We believe this achievement is a testament to the skill of Genmab's pre-clinical development team who work carefully to select the best product candidates and Roche's dedicated focus on progressing them to market," said Lisa N. Drakeman, Ph.D., chief executive officer, Genmab
Genentech and Roche are collaborating on development of the antibody which selectively blocks the interaction of the OX40 ligand and its receptor. The companies are evaluating the antibody for the treatment of asthma. Genmab will receive a milestone payment from Roche which does not influence Genmab's financial guidance for 2007.
In pre-clinical data published in a recent article and commentary in The Journal of Clinical Investigation, treatment with the human OX40L blocking antibody led to significant therapeutic effects in a nonhuman primate model of allergic inflammation. The mechanisms of action of the human antibody include effective blockade of OX40L binding to its receptor, and depletion of cells expressing OX40L. Depletion of OX40L-expressing cells was shown to depend on interaction of immune effector cells with the therapeutic antibody. The observed in vivo efficacy of the OX40L-specific antibody may also involve restoration of peripheral tolerance mechanisms. Breaking of tolerance promotes development of autoimmune and allergic diseases.
Under the agreement with Roche, Genmab utilizes its broad antibody expertise and development capabilities to create human antibodies to a broad range of disease targets identified by Roche. Genmab receives milestone and royalty payments based on successful products. In certain circumstances, Genmab may obtain rights to develop products based on disease targets identified by Roche.
"Four of the antibodies developed by Genmab under our collaboration with Roche have now entered the clinic. We believe this achievement is a testament to the skill of Genmab's pre-clinical development team who work carefully to select the best product candidates and Roche's dedicated focus on progressing them to market," said Lisa N. Drakeman, Ph.D., chief executive officer, Genmab
Carbamazepine Prescribing Information to Include Recommendation of Genetic Test for Patients with Asian Ancestry
ROCKVILLE, Md., Dec. 12, 2007--The U.S. Food and Drug Administration today announced that the manufacturers of drugs containing the active ingredient carbamazepine have agreed to add to the drugs' labeling a recommendation that, before starting therapy with the drugs, patients with Asian ancestry get a genetic blood test that can identify a significantly increased risk of developing a rare, but serious, skin reaction.
Carbamazepine is a drug used for treatment of epilepsy, bipolar disorder, and neuropathic pain. It is sold under the brand names Carbatrol, Equetro and Tegretol.
"Science is now letting us individually treat patients based on how their body might react to a drug," said Janet Woodcock, M.D., FDA's deputy commissioner for scientific and medical programs, chief medical officer, and acting director of the Center for Drug Evaluation and Research. "When being considered for treatment with carbamazepine, genetically high-risk patients can be given a test that will help their health care providers make personalized drug treatment decisions and help avoid potentially serious skin reactions."
The prescribing information for these drugs already includes a warning that for all patients starting carbamazepine therapy, regardless of ethnicity, rare but severe and sometimes life-threatening skin reactions can occur. These life-threatening skin reactions include toxic epidermal necrolysis and Stevens-Johnson syndrome, characterized by multiple skin lesions, blisters, fever, itching and other symptoms.
The risk of these reactions is estimated to be about 1 to 6 per 10,000 new users of the drug in countries with mainly white populations. However, the risk is estimated to be about 10 times higher in some Asian countries.
The skin reaction warnings will be moved to the current boxed warning section of the labeling. The new recommendation that health care providers give patients with Asian ancestry a genetic test before starting treatment will also be added to the boxed warning section.
To screen for this genetic marker, a patient's blood can be drawn by a health care provider and the test administered at a laboratory. It is estimated that about 5 percent of patients being considered for treatment with carbamazepine are of Asian ancestry and would need to have this test.
Studies have found a strong association between certain serious skin reactions and an inherited variant of a gene, HLA-B* 1502, an immune system gene, found almost exclusively in people with Asian ancestry. Patients testing positive for this gene should not be treated with carbamazepine unless the benefit clearly outweighs the increased risk of these serious skin reactions.
Patients who have taken carbamazepine for more than a few months and not experienced any skin reactions are unlikely to ever experience these reactions, regardless of ancestry or genetic test results. Patients currently taking carbamazepine who are concerned about these skin reactions should not stop taking the drug without first consulting their health care provider.
Carbatrol is manufactured by Shire Pharmaceuticals, Wayne, Penn.; Equetro is manufactured by Validus Pharmaceuticals Inc., Parsippany, N.J.; and Tegretol is manufactured by Novartis, East Hanover, N.J. Generic versions of carbamazepine are available
Carbamazepine is a drug used for treatment of epilepsy, bipolar disorder, and neuropathic pain. It is sold under the brand names Carbatrol, Equetro and Tegretol.
"Science is now letting us individually treat patients based on how their body might react to a drug," said Janet Woodcock, M.D., FDA's deputy commissioner for scientific and medical programs, chief medical officer, and acting director of the Center for Drug Evaluation and Research. "When being considered for treatment with carbamazepine, genetically high-risk patients can be given a test that will help their health care providers make personalized drug treatment decisions and help avoid potentially serious skin reactions."
The prescribing information for these drugs already includes a warning that for all patients starting carbamazepine therapy, regardless of ethnicity, rare but severe and sometimes life-threatening skin reactions can occur. These life-threatening skin reactions include toxic epidermal necrolysis and Stevens-Johnson syndrome, characterized by multiple skin lesions, blisters, fever, itching and other symptoms.
The risk of these reactions is estimated to be about 1 to 6 per 10,000 new users of the drug in countries with mainly white populations. However, the risk is estimated to be about 10 times higher in some Asian countries.
The skin reaction warnings will be moved to the current boxed warning section of the labeling. The new recommendation that health care providers give patients with Asian ancestry a genetic test before starting treatment will also be added to the boxed warning section.
To screen for this genetic marker, a patient's blood can be drawn by a health care provider and the test administered at a laboratory. It is estimated that about 5 percent of patients being considered for treatment with carbamazepine are of Asian ancestry and would need to have this test.
Studies have found a strong association between certain serious skin reactions and an inherited variant of a gene, HLA-B* 1502, an immune system gene, found almost exclusively in people with Asian ancestry. Patients testing positive for this gene should not be treated with carbamazepine unless the benefit clearly outweighs the increased risk of these serious skin reactions.
Patients who have taken carbamazepine for more than a few months and not experienced any skin reactions are unlikely to ever experience these reactions, regardless of ancestry or genetic test results. Patients currently taking carbamazepine who are concerned about these skin reactions should not stop taking the drug without first consulting their health care provider.
Carbatrol is manufactured by Shire Pharmaceuticals, Wayne, Penn.; Equetro is manufactured by Validus Pharmaceuticals Inc., Parsippany, N.J.; and Tegretol is manufactured by Novartis, East Hanover, N.J. Generic versions of carbamazepine are available
Mylan Announces Tentative FDA Approval for Lamotrigine Tablets
PITTSBURGH, December 12, 2007 /PRNewswire-FirstCall/ -- Mylan Inc. today announced that Mylan Pharmaceuticals Inc. has received tentative approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Lamotrigine Tablets, 25 mg, 100 mg, 150 mg and 200 mg.
Lamotrigine Tablets are the generic version of GlaxoSmithKline's Lamictal(R) Tablets, which had U.S. sales of approximately $1.97 million for the 12 months ending Sept. 30, 2007.
Lamotrigine Tablets are the generic version of GlaxoSmithKline's Lamictal(R) Tablets, which had U.S. sales of approximately $1.97 million for the 12 months ending Sept. 30, 2007.
AstraZeneca Files Patent Infringement Actions in Response to Crestor ANDAs
LONDON, Dec. 12, 2007-AstraZeneca today announced that it has filed patent infringement actions in United States District Court, District of Delaware, against seven generic drug manufacturers, which have submitted Abbreviated New Drug Applications (ANDAs) for Crestor™ (Rosuvastatin Tablets)
On 1st November 2007, AstraZeneca announced its receipt of a notice-letter from Cobalt Pharmaceuticals, Inc., notifying AstraZeneca that Cobalt had submitted an ANDA to the U.S. Food and Drug Administration (FDA). Cobalt’s ANDA sought approval to market generic versions of Crestor™ tablets prior to the expiration of patents covering Crestor™ tablets. Cobalt’s ANDA contained a Paragraph IV certification alleging that the U.S. patents owned or licensed by AstraZeneca, and listed in the FDA’s Orange Book referencing Crestor™, were not infringed or that the patents were otherwise invalid or unenforceable.
Since receiving Cobalt’s notice-letter, AstraZeneca has received similar Paragraph IV Certification notice-letters from eight additional generic drug manufacturers. AstraZeneca received notice letters from (1) Teva Pharmaceuticals, USA (Teva) on October 31, 2007; (2) Aurobindo Pharma Limited (Aurobindo) on November 5, 2007; (3) Apotex, Inc. (Apotex) on November 6, 2007 and December 5, 2007; (4) Par Pharmaceutical (Par) on November 6, 2007; (5) Sandoz Inc. (Sandoz) on November 12, 2007; (6) Mylan Pharmaceuticals Inc. (Mylan) on November 15, 2007; (7) Glenmark Pharmaceuticals, Inc. USA (Glenmark) on November 15, 2007; and (8) Sun Pharmaceutical Industries Ltd. (Sun) on November 19, 2007.
Each of the eight additional generic drug companies has notified AstraZeneca that it has submitted an ANDA to the FDA seeking approval to market generic versions of Crestor™ tablets before the expiration of the U.S. Patents owned or licensed by AstraZeneca. Each notice-letter contained a Paragraph IV certification notice alleging that one or more of the three Orange Book listed US patents referencing Crestor in the FDA’s Orange Book was not infringed or otherwise invalid or unenforceable.
Based on these various ANDA filings and Paragraph IV certifications, on 11th December 2007 AstraZeneca filed individual patent infringement actions in United States District Court, District of Delaware, against Aurobindo, Apotex, Cobalt, Par, Sandoz, Mylan, and Sun, alleging infringement of U.S. No. RE 37,314 (the ‘314 patent). AstraZeneca licenses the ‘314 patent from Shionogi & Co. Ltd.
On 1st November 2007, AstraZeneca announced its receipt of a notice-letter from Cobalt Pharmaceuticals, Inc., notifying AstraZeneca that Cobalt had submitted an ANDA to the U.S. Food and Drug Administration (FDA). Cobalt’s ANDA sought approval to market generic versions of Crestor™ tablets prior to the expiration of patents covering Crestor™ tablets. Cobalt’s ANDA contained a Paragraph IV certification alleging that the U.S. patents owned or licensed by AstraZeneca, and listed in the FDA’s Orange Book referencing Crestor™, were not infringed or that the patents were otherwise invalid or unenforceable.
Since receiving Cobalt’s notice-letter, AstraZeneca has received similar Paragraph IV Certification notice-letters from eight additional generic drug manufacturers. AstraZeneca received notice letters from (1) Teva Pharmaceuticals, USA (Teva) on October 31, 2007; (2) Aurobindo Pharma Limited (Aurobindo) on November 5, 2007; (3) Apotex, Inc. (Apotex) on November 6, 2007 and December 5, 2007; (4) Par Pharmaceutical (Par) on November 6, 2007; (5) Sandoz Inc. (Sandoz) on November 12, 2007; (6) Mylan Pharmaceuticals Inc. (Mylan) on November 15, 2007; (7) Glenmark Pharmaceuticals, Inc. USA (Glenmark) on November 15, 2007; and (8) Sun Pharmaceutical Industries Ltd. (Sun) on November 19, 2007.
Each of the eight additional generic drug companies has notified AstraZeneca that it has submitted an ANDA to the FDA seeking approval to market generic versions of Crestor™ tablets before the expiration of the U.S. Patents owned or licensed by AstraZeneca. Each notice-letter contained a Paragraph IV certification notice alleging that one or more of the three Orange Book listed US patents referencing Crestor in the FDA’s Orange Book was not infringed or otherwise invalid or unenforceable.
Based on these various ANDA filings and Paragraph IV certifications, on 11th December 2007 AstraZeneca filed individual patent infringement actions in United States District Court, District of Delaware, against Aurobindo, Apotex, Cobalt, Par, Sandoz, Mylan, and Sun, alleging infringement of U.S. No. RE 37,314 (the ‘314 patent). AstraZeneca licenses the ‘314 patent from Shionogi & Co. Ltd.
Lannett Receives FDA Approval for Phentermine
PHILADELPHIA--(BUSINESS WIRE)--Dec 12, 2007 - Lannett Company, Inc. (Amex:LCI) today announced it has received approval from the U.S. Food and Drug Administration (FDA) for the company's supplemental Abbreviated New Drug Application (ANDA) of Phentermine Hydrochloride Capsules 30 mg. The company expects to commence marketing this product immediately.
Phentermine Hydrochloride (HCl) is indicated for the short-term management of obesity. According to Wolters Kluwer, sales of generic Phentermine HCI Capsules exceeded $37 million for the 12 months ended October 2007.
"This approval complements our Phentermine HCI Tablet 37.5 mg which is the generic equivalent of Adipex-P(R), marketed by Gate Pharmaceuticals, a division of Teva Pharmaceutical Industries, and is an important addition to our product portfolio," said Arthur Bedrosian, president and chief executive officer of Lannett. "Through the hard work and dedication of our research and development team, we continue to build a robust pipeline despite a tremendous backlog of product applications pending at the FDA."
Phentermine Hydrochloride (HCl) is indicated for the short-term management of obesity. According to Wolters Kluwer, sales of generic Phentermine HCI Capsules exceeded $37 million for the 12 months ended October 2007.
"This approval complements our Phentermine HCI Tablet 37.5 mg which is the generic equivalent of Adipex-P(R), marketed by Gate Pharmaceuticals, a division of Teva Pharmaceutical Industries, and is an important addition to our product portfolio," said Arthur Bedrosian, president and chief executive officer of Lannett. "Through the hard work and dedication of our research and development team, we continue to build a robust pipeline despite a tremendous backlog of product applications pending at the FDA."
Teva Announces Approval of Generic Trileptal Tablets
JERUSALEM--(BUSINESS WIRE)--Dec 12, 2007 - 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 Novartis' antiepileptic therapy Trileptal(R) (Oxcarbazepine) Tablets, 150 mg, 300 mg and 600 mg. Shipment of the product will begin in the near future.
The brand product had annual sales of approximately $690 million in the United States for the twelve months ended September 30, 2007, based on IMS sales data.
Teva is currently involved in patent litigation concerning this product in the U.S. District Court for the District of New Jersey. A trial date has not been set.
The brand product had annual sales of approximately $690 million in the United States for the twelve months ended September 30, 2007, based on IMS sales data.
Teva is currently involved in patent litigation concerning this product in the U.S. District Court for the District of New Jersey. A trial date has not been set.
Pfizer Patented First Antiretroviral Compound in India
Mumbai Patent Office lately granted an Indian Patent No. 204132 (the ‘132 patent) to Pfizer for newly approved antiretroviral drug Selzentry, a second-line treatment for HIV, often prescribed to patients who develop resistance to first-line drug therapies. The ‘132 patent is issued against the mail-box Application No. 884/BOM/1999 filed December 02, 1999 under section 5(2) of the Patents Act, 1970 claiming earliest priority from Great Britain applications dated October 23, 1998. Selzentry, worldwide marketed as Maraviroc is the first antiretroviral drug compound to be awarded patent protection in India, which obviously will cause a concern among the generic pharmaceutical companies in India and also the Non-profit Government Organizations advocating affordable drugs for poor patients. Not only Pfizer will be able to keep generic competitors out of the market, but also fueled its market share value on the Bombay Stock Exchange, which clearly indicates the building confidence of Indian market for patent portfolio. Earlier this year in August, the US Food and Drug Administration approved Selzentry oral tablet prescription for the treatment of patients infected with CCR5-TROPIC HIV-1 through an accelerated regulatory approval process, and subsequently listed two US patents with the Orange Book. US Patent No. 6,586,430 is the US equivalent of the ‘132 patent. Although patent is granted in India, Pfizer still need to overcome the post-grant opposition period under section 25(2) of the Patents Act, 1970 which will be valid till one year from the date of grant of patent to have the real taste of Indian market exclusivity. However, there were no pre-grant oppositions for Pfizer’s patent application because Indian generic industry did not find any (financial) market potential for this newly approved drug (which still need to achieve market acceptability and monetary success), which in fact a clear indication that Indian Generic companies are more concern about the profit margins rather than patients’ well-being in India or other least-developed countries, and even so the NGOs who keep targeting patent applications which cover drugs already achieved market success. Despite Selzentry is a critical drug therapy, NGOs and Indian Generics completely failed to spot Pfizer’s patent application for pre-grant opposition because they keep focusing around blockbuster and profitable drug products, which again raises a crucial question who come first profit or patient
Pfizer Wins Dismissal of Ranbaxy's Counterclaims in Caduet Patent Litigation
Pfizer v. Ranbaxy, No. 07-138 (D. Del. 2007)
Pfizer sued Ranbaxy for infringement of U.S. Patent Nos. 4,681,893 and 6,455,574 after Ranbaxy filed paragraph IV certifications in its ANDA for a generic version of Caduet (atorvastatin calcium/amlodipine besylate). The '893 patent claims atorvastatin calcium, which is also the active ingredient in Lipitor; the '574 patent claims combinations of atorvastatin sodium and amlodipine besylate. Ranbaxy filed counterclaims seeking declaratory judgments that (1) the '893 patent is invalid; (2) the '574 patent is invalid and not infringed; and (3) a third patent, U.S. Patent No. 5,273,995, is invalid, unenforceable and not infringed. In an opinion filed November 29, the district court granted Pfizer's motions to dismiss Ranbaxy's counterclaims on the '893 and '995 patents, leaving only the '574 patent in the case.
On August 2, 2006, the Federal Circuit affirmed the validity of the '893 patent in Pfizer's case against Ranbaxy concerning Ranbaxy's ANDA for a generic version of Lipitor. Ranbaxy appealed to the Supreme Court, and in April, the Court denied Ranbaxy's cert petition. Accordingly, in the Caduet litigation, Pfizer moved to dismiss Ranbaxy's counterclaims of invalidity of the '893 patent on grounds of res judicata. In addition, Pfizer moved for partial summary judgment on the pleadings, asking for a judgment of infringement of the '893 patent on grounds of collateral estoppel.
In opposition to Pfizer's motion, Ranbaxy argued that res judicata principles should be narrowly applied because the issue of obviousness was not presented at trial or adjudicated in the Lipitor litigation, and "significant factual and legal changes have occurred since the Lipitor litigation that fundamentally alter the obviousness analysis of the '893 patent." Specifically, Ranbaxy argued that the Supreme Court's decision in KSR v. Teleflex "dramatically lowered the bar of 35 USC 103." The district court, however, was unconvinced, stating that Ranbaxy challenged the validity of the '893 patent in the Lipitor litigation, and therefore, absent fraud or a momentous legal change in constitutional rights, "Ranbaxy was required to raise all of its invalidity defenses at that time." Thus, the court granted Pfizer's motion to dismiss. In addition, because Ranbaxy did not contest infringement of the '893 patent, the court granted Pfizer's motion for a judgment of infringement of the '893 patent on the pleadings.
In the same August 2, 2006 decision, the Federal Circuit held that Claim 6 of the '995 patent is invalid. The '995 patent covers pharmaceutical compositions containing atorvastatin calcium. Pfizer is currently seeking a reissue of the '995 patent to correct the defect in Claim 6 and to correct defects in other claims. In the Caduet litigation, Pfizer moved to dismiss Ranbaxy's counterclaims on the '995 patent on grounds that it has provided Ranbaxy a covenant not sue Ranbaxy on all remaining claims of the original '995 patent.
In response to this motion, Ranbaxy argued that its declaratory judgment counterclaims of unenforceability of the '995 patent should not be dismissed, notwithstanding Pfizer's covenant not to sue, because "Pfizer has not agreed to provide Ranbaxy with a covenant not to sue related to any reissue of the '995 patent." Here too, however, the district court was unconvinced by Ranbaxy's arguments. The court stated: "the question of whether a new patent will ever be reissued is speculative, purely hypothetical and unripe for judicial determination. Accordingly, the Court concludes that these circumstances do not support jurisdiction under the MedImmune standard."
As a result of the district court's decision, Ranbaxy will not be able to launch its generic version of Caduet until at least 2010, when the '893 patent expires. Pfizer will now proceed with the case, aiming to keep Ranbaxy off the market until 2018, when the '574 patent expires.
Pfizer sued Ranbaxy for infringement of U.S. Patent Nos. 4,681,893 and 6,455,574 after Ranbaxy filed paragraph IV certifications in its ANDA for a generic version of Caduet (atorvastatin calcium/amlodipine besylate). The '893 patent claims atorvastatin calcium, which is also the active ingredient in Lipitor; the '574 patent claims combinations of atorvastatin sodium and amlodipine besylate. Ranbaxy filed counterclaims seeking declaratory judgments that (1) the '893 patent is invalid; (2) the '574 patent is invalid and not infringed; and (3) a third patent, U.S. Patent No. 5,273,995, is invalid, unenforceable and not infringed. In an opinion filed November 29, the district court granted Pfizer's motions to dismiss Ranbaxy's counterclaims on the '893 and '995 patents, leaving only the '574 patent in the case.
On August 2, 2006, the Federal Circuit affirmed the validity of the '893 patent in Pfizer's case against Ranbaxy concerning Ranbaxy's ANDA for a generic version of Lipitor. Ranbaxy appealed to the Supreme Court, and in April, the Court denied Ranbaxy's cert petition. Accordingly, in the Caduet litigation, Pfizer moved to dismiss Ranbaxy's counterclaims of invalidity of the '893 patent on grounds of res judicata. In addition, Pfizer moved for partial summary judgment on the pleadings, asking for a judgment of infringement of the '893 patent on grounds of collateral estoppel.
In opposition to Pfizer's motion, Ranbaxy argued that res judicata principles should be narrowly applied because the issue of obviousness was not presented at trial or adjudicated in the Lipitor litigation, and "significant factual and legal changes have occurred since the Lipitor litigation that fundamentally alter the obviousness analysis of the '893 patent." Specifically, Ranbaxy argued that the Supreme Court's decision in KSR v. Teleflex "dramatically lowered the bar of 35 USC 103." The district court, however, was unconvinced, stating that Ranbaxy challenged the validity of the '893 patent in the Lipitor litigation, and therefore, absent fraud or a momentous legal change in constitutional rights, "Ranbaxy was required to raise all of its invalidity defenses at that time." Thus, the court granted Pfizer's motion to dismiss. In addition, because Ranbaxy did not contest infringement of the '893 patent, the court granted Pfizer's motion for a judgment of infringement of the '893 patent on the pleadings.
In the same August 2, 2006 decision, the Federal Circuit held that Claim 6 of the '995 patent is invalid. The '995 patent covers pharmaceutical compositions containing atorvastatin calcium. Pfizer is currently seeking a reissue of the '995 patent to correct the defect in Claim 6 and to correct defects in other claims. In the Caduet litigation, Pfizer moved to dismiss Ranbaxy's counterclaims on the '995 patent on grounds that it has provided Ranbaxy a covenant not sue Ranbaxy on all remaining claims of the original '995 patent.
In response to this motion, Ranbaxy argued that its declaratory judgment counterclaims of unenforceability of the '995 patent should not be dismissed, notwithstanding Pfizer's covenant not to sue, because "Pfizer has not agreed to provide Ranbaxy with a covenant not to sue related to any reissue of the '995 patent." Here too, however, the district court was unconvinced by Ranbaxy's arguments. The court stated: "the question of whether a new patent will ever be reissued is speculative, purely hypothetical and unripe for judicial determination. Accordingly, the Court concludes that these circumstances do not support jurisdiction under the MedImmune standard."
As a result of the district court's decision, Ranbaxy will not be able to launch its generic version of Caduet until at least 2010, when the '893 patent expires. Pfizer will now proceed with the case, aiming to keep Ranbaxy off the market until 2018, when the '574 patent expires.
Tuesday, December 11, 2007
Perrigo to Launch Generic Prilosec OTC
After settling with AstraZeneca last month, Dexcel Pharma Technologies has received final FDA approval for generic Prilosec OTC.
The company’s marketing partner Perrigo plans to launch the product early next year.
Perrigo’s announcement came the same day the FDA confirmed there is no evidence of an increased risk of heart problems with Prilosec (omeprazole) or AstraZeneca’s other heartburn drug, Nexium (esomeprazole magnesium) (DID, Dec. 11).
AstraZeneca sued Dexcel in May 2006 after the company submitted an abbreviated new drug application with Paragraph IV certifications for Prilosec OTC (omeprazole magnesium). As part of the settlement, the companies agreed that Dexcel could market its product as soon as it received final approval (DID, Nov. 5). Other terms of the settlement were not disclosed.
Perrigo Chairman and CEO Joseph Papa said the Prilosec OTC launch during the first quarter of 2008 will likely be the largest in the company’s 120-year history.
Prilosec OTC has estimated annual sales of approximately $750 million, according to Perrigo. The company said it expects itsgeneric product to achieve annual sales of $150 million to $200 million.
Perrigo also raised its fiscal 2008 earnings guidance. Generic Prilosec OTC is expected to contribute between 20 cents and 25 cents earnings per share, resulting in earnings of approximately $1.32 to $1.47 per share.
Prilosec OTC, the first OTC proton-pump inhibitor, is a once-a-day, delayed-release tablet formulation that was approved in 2003.
The company’s marketing partner Perrigo plans to launch the product early next year.
Perrigo’s announcement came the same day the FDA confirmed there is no evidence of an increased risk of heart problems with Prilosec (omeprazole) or AstraZeneca’s other heartburn drug, Nexium (esomeprazole magnesium) (DID, Dec. 11).
AstraZeneca sued Dexcel in May 2006 after the company submitted an abbreviated new drug application with Paragraph IV certifications for Prilosec OTC (omeprazole magnesium). As part of the settlement, the companies agreed that Dexcel could market its product as soon as it received final approval (DID, Nov. 5). Other terms of the settlement were not disclosed.
Perrigo Chairman and CEO Joseph Papa said the Prilosec OTC launch during the first quarter of 2008 will likely be the largest in the company’s 120-year history.
Prilosec OTC has estimated annual sales of approximately $750 million, according to Perrigo. The company said it expects itsgeneric product to achieve annual sales of $150 million to $200 million.
Perrigo also raised its fiscal 2008 earnings guidance. Generic Prilosec OTC is expected to contribute between 20 cents and 25 cents earnings per share, resulting in earnings of approximately $1.32 to $1.47 per share.
Prilosec OTC, the first OTC proton-pump inhibitor, is a once-a-day, delayed-release tablet formulation that was approved in 2003.
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