PRINCETON, N.J., December 10, 2007 /PRNewswire-FirstCall/ -- Novo Nordisk Inc. today announced the company has settled a lawsuit against Pfizer claiming that Pfizer's product Exubera(R) infringed patents owned by Novo Nordisk. The patents cover inhaled insulin treatment for diabetes.
The lawsuit was originally filed in August 2006 in United States Federal Court in the Southern District of New York.
The five patents involved in the suit were U.S. Patent Numbers 5,884,620; 7028,686; 6167,880; 5,941,240 and 5,672,581.
In the patent suit, a federal judge denied a Novo Nordisk bid to barr Pfizer's sales of Exubera in December 2006, tossing a request for an injunction. U.S. District Judge Leonard B. Sands held that the public interest weighed in favor of denying the injunction, noting Pfizer's argument that Exubera offered diabetics who were not coping well with their disease or were afraid to inject insulin, a new, needle-free way to deal with their disease.
In October, however, Pfizer announced that it would no longer be making the diabetes treatment available because it has failed to gain the acceptance of patients and physicians.
That announcement came as a surprise to Pfizer's partner Nektar Therapeutics, which immediately responded by saying it had not been pleased with Pfizer's performance in marketing the diabetes drug.
Pfizer later agreed to pay Nektar Therapeutics $135 million in order to bow out of a marketing agreement the two companies had over Exubera. As part of that deal, Pfizer also agreed to hand over any remaining rights to the inhaled insulin treatment, including an number of regulatory filings and applications and the continuation of ongoing Exubera clinical trials, in the event that Nektar found another partner to market the diabetes drug.
That agreement also resolved contractual issues related to the development of an updated version of Exubera, which the companies said was currently in Phase 1 clinical development.
Tuesday, December 11, 2007
Nicholas Piramal secures patent for cancer compounds
Nicholas Piramal India Ltd has announced that the US Patent and trademark office has granted product patent to the company. The granted claims of the patent cover the novel compounds, including the company's clinical candidate P-276-00, and processes for their preparation. These compounds are being developed as therapeutic agents useful in the treatment of cancer.
Earlier the company has been granted a patent in South Africa for its CDK inhibitors. The company has related national phase applications in 14 other countries. The company has filed five other patent applications covering different aspects of its CDK inhibitors.
Dr Noopur Raje from Dr Ken Anderson group from Dana Faber Cancer Institute is giving an oral presentation at 49th Annual Meeting and Exposition of American Society of Haematology (ASH) being held at Atlanta, Georgia in US from December 8-10, 2007. They have carried out independent studies on the company's lead compound P-276-00 in Multiple Myeloma and will be presenting new data on its pre-clinical studies.
The ASH annual meeting is the premier forum for physicians and researchers to hear the most up-to-date developments in Haematology. The event attracts over 16,000 Haematologists and other health-care professionals from 100 countries around the world.
Dr Swati Piramal, director strategic alliances and communications of the company said, "The presentation of data on pre-clinical studies at annual conference of American Society of Haematology marks an important milestone for development of NPIL's Oncology compound".
Earlier the company has been granted a patent in South Africa for its CDK inhibitors. The company has related national phase applications in 14 other countries. The company has filed five other patent applications covering different aspects of its CDK inhibitors.
Dr Noopur Raje from Dr Ken Anderson group from Dana Faber Cancer Institute is giving an oral presentation at 49th Annual Meeting and Exposition of American Society of Haematology (ASH) being held at Atlanta, Georgia in US from December 8-10, 2007. They have carried out independent studies on the company's lead compound P-276-00 in Multiple Myeloma and will be presenting new data on its pre-clinical studies.
The ASH annual meeting is the premier forum for physicians and researchers to hear the most up-to-date developments in Haematology. The event attracts over 16,000 Haematologists and other health-care professionals from 100 countries around the world.
Dr Swati Piramal, director strategic alliances and communications of the company said, "The presentation of data on pre-clinical studies at annual conference of American Society of Haematology marks an important milestone for development of NPIL's Oncology compound".
Watson, Novartis settle Exelon lawsuit
Watson Pharmaceuticals, Inc, a leading specialty pharmaceutical company, said it has reached a settlement with Novartis on outstanding patent litigation related to Watson's generic version of Exelon (rivastigmine tartrate) capsules.
Under the terms of the settlement agreement, Novartis has granted Watson a license to its US patents covering Exelon for a generic version of Exelon. The agreement generally provides that Watson will not commence marketing its generic equivalent product until sometime prior to the expiration of the patents covering Exelon.
The specific date on which Watson may launch its generic product and other details concerning the settlement have not been disclosed. Watson's Abbreviated New Drug Application for its generic version of Exelon has been tentatively approved by the US Food and Drug Administration.
Under the terms of the settlement agreement, Novartis has granted Watson a license to its US patents covering Exelon for a generic version of Exelon. The agreement generally provides that Watson will not commence marketing its generic equivalent product until sometime prior to the expiration of the patents covering Exelon.
The specific date on which Watson may launch its generic product and other details concerning the settlement have not been disclosed. Watson's Abbreviated New Drug Application for its generic version of Exelon has been tentatively approved by the US Food and Drug Administration.
Provectus Pharmaceuticals Receives Patent in India for Lead Oncology Product
KNOXVILLE, Tenn.--(BUSINESS WIRE)--Dec 11, 2007 - Provectus Pharmaceuticals, Inc. (OTCBB:PVCT) (http://www.pvct.com) has received a patent in India protecting its lead oncology agent, PV-10, along with a number of related agents. The patent covers injectable and other forms of the drugs, including capsules, tablets, and oral suspensions and solutions. A range of active compounds are protected, each related to the active ingredient in PV-10.
"Obtaining patent protection in India for PV-10 and our additional pipeline products is a major milestone, assuring a viable route to access a market representing roughly one-fifth of the world's population," noted Craig Dees, Ph.D., CEO of Provectus. "Additionally, as the Indian pharmaceutical industry becomes a larger player in the worldwide market, this protection establishes an important right of ownership for products sold or made in India."
Dees Continued: "The Company is seeking protection of its assets in key markets worldwide, and this patent further validates the value of our science and our global intellectual property strategy to build value for our shareholders. As we focus on clinical development of our lead therapeutic products, PV-10 for cancer and PH-10 for dermatology, we believe that aggressively protecting the intellectual assets underlying our technologies will be vital to our eventual marketing success."
"Obtaining patent protection in India for PV-10 and our additional pipeline products is a major milestone, assuring a viable route to access a market representing roughly one-fifth of the world's population," noted Craig Dees, Ph.D., CEO of Provectus. "Additionally, as the Indian pharmaceutical industry becomes a larger player in the worldwide market, this protection establishes an important right of ownership for products sold or made in India."
Dees Continued: "The Company is seeking protection of its assets in key markets worldwide, and this patent further validates the value of our science and our global intellectual property strategy to build value for our shareholders. As we focus on clinical development of our lead therapeutic products, PV-10 for cancer and PH-10 for dermatology, we believe that aggressively protecting the intellectual assets underlying our technologies will be vital to our eventual marketing success."
Monday, December 10, 2007
Enantiomer Exclusivity Revisited - The Food and Drug Administration Amendments Act of 2007
Tucked away at the end of the Food and Drug Administration Amendments Act of 2007 (FDAAA) is a provision that modifies FDA?s long-standing refusal to award five-year new chemical entity (NCE) exclusivity to enantiomers of previously-approved racemic mixtures. Pub. L. No. 110-85, __ Stat. __ (2007); FDAAA § 1113.
The Food and Drug Administration (FDA) has the authority under the Hatch Waxman Act to grant five years of exclusivity to drugs that contain new chemical entities, referred to as NCE exclusivity in the Orange Book, but up until this legislation FDA had declined to grant NCE exclusivity to enantiomers that were part of previously-approved racemic mixtures. See Federal Food Drug and Cosmetic Act (FDCA) §§ 505(c)(3)(E)(ii) and 505(j)(5)(F)(ii). According to FDA, exclusivity was not justified because the enantiomer had been previously approved ? albeit as part of a racemic mixture. See 54 Fed. Reg. 28872 at 28898 (July 10, 1989).
In an effort to encourage the continued development of these important chemical species, the FDAAA has modified FDA?s policy with the addition of a new subsection (u) to section 505 of the FDCA, so that FDA can award NCE exclusivity to enantiomers under limited circumstances. However, to ensure that the exclusivity fosters significant medical innovation and does not become simply another tool for life cycle management, the legislation limits the award of exclusivity to particular circumstances.
Life cycle management was clearly a concern to Congress in granting this exclusivity, and the legislation contains several limitations that ensure exclusivity is only awarded in cases of significant medical innovation. For example, exclusivity is only available for new drug applications that do not rely on studies for a previously approved racemic mixture. FDCA § 505(u)(1)(A), as amended by FDAAA 1113. Exclusivity is also only available if the enantiomer is approved in a different therapeutic category than the racemic mixture. FDCA § 505(u)(1)(B), as amended by FDAAA 1113. Conversely, FDA will not approve the enantiomer for use in the same therapeutic category as the racemic mixture for ten years from the enantiomer?s approval date. FDCA § 505(u)(2)(A), as amended by FDAAA 1113.
Unless the legislation is reauthorized, the exclusivity is only available for new drug applications filed before October 1, 2012. FDCA § 505(u)(4), as amended by FDAAA 1113
The Food and Drug Administration (FDA) has the authority under the Hatch Waxman Act to grant five years of exclusivity to drugs that contain new chemical entities, referred to as NCE exclusivity in the Orange Book, but up until this legislation FDA had declined to grant NCE exclusivity to enantiomers that were part of previously-approved racemic mixtures. See Federal Food Drug and Cosmetic Act (FDCA) §§ 505(c)(3)(E)(ii) and 505(j)(5)(F)(ii). According to FDA, exclusivity was not justified because the enantiomer had been previously approved ? albeit as part of a racemic mixture. See 54 Fed. Reg. 28872 at 28898 (July 10, 1989).
In an effort to encourage the continued development of these important chemical species, the FDAAA has modified FDA?s policy with the addition of a new subsection (u) to section 505 of the FDCA, so that FDA can award NCE exclusivity to enantiomers under limited circumstances. However, to ensure that the exclusivity fosters significant medical innovation and does not become simply another tool for life cycle management, the legislation limits the award of exclusivity to particular circumstances.
Life cycle management was clearly a concern to Congress in granting this exclusivity, and the legislation contains several limitations that ensure exclusivity is only awarded in cases of significant medical innovation. For example, exclusivity is only available for new drug applications that do not rely on studies for a previously approved racemic mixture. FDCA § 505(u)(1)(A), as amended by FDAAA 1113. Exclusivity is also only available if the enantiomer is approved in a different therapeutic category than the racemic mixture. FDCA § 505(u)(1)(B), as amended by FDAAA 1113. Conversely, FDA will not approve the enantiomer for use in the same therapeutic category as the racemic mixture for ten years from the enantiomer?s approval date. FDCA § 505(u)(2)(A), as amended by FDAAA 1113.
Unless the legislation is reauthorized, the exclusivity is only available for new drug applications filed before October 1, 2012. FDCA § 505(u)(4), as amended by FDAAA 1113
Pfizer sues Cobalt over lipitor patent (contd.......)
Pfizer Inc. is alleging that when Cobalt Pharmaceuticals Inc. filed a New Drug Application for a product whose active ingredient would be atorvastatin sodium, the Canadian generics outfit infringed a patent covering the blockbuster cholesterol drug Litpitor.
Pfizer and a group of subsidiaries including Warner Lambert Co. filed a suit against Cobalt on Friday in federal court in Boston. The suit accused Cobalt of infringing a patent owned by Warner Lambert.
The same plaintiffs filed a suit against Cobalt in Delaware on Thursday. That suit accused Cobalt of infringing the same patent and referenced the same NDA. A Pfizer representative would not comment Monday on why the infringement claims were filed in different jurisdictions.
At issue is U.S. Patent Number 5,273,995, which was issued in 1993, is owned by Warner Lambert and covers Lipitor, the complaint said. Lipitor, a formulation of atorvastatin calcium, brought in $3.2 billion in worldwide revenues for Pfizer in the third quarter of 2007, according to a Pfizer press release dated Oct. 18.
Pfizer received a letter from Cobalt, dated Oct. 24, 2007, alerting Pfizer that Cobalt had filed NDA No. 22-245 asking for the U.S. Food and Drug Administration's approval to make and sell a product containing atorvastatin sodium as its active ingredient before the expiration of the '995 patent, the complaint said.
The expiration date on the '955 patent in Dec. 28, 2010, but Lipitor was granted an extension of exclusivity through June 28, 2011, Pfizer said.
Cobalt infringed the patent by submitting its NDA, Pfizer claimed
Claim 6 of the '995 patent was declared invalid by the U.S. Court of Appeals for the Federal Circuit in August 2006, but the complaint does not seek relief based on that claim, Pfizer said.
Indian generic drug maker Ranbaxy Laboratories Ltd. brought the appeal that led to claim 6's invalidation, following a December 2005 defeat in federal court in Delaware. Pfizer said it plans to rectify the flaw in the ‘995 patent through the U.S. Patent and Trademark Office.
The Federal Circuit's August ruling upheld U.S. Patent Number 4,681,893, which covers atorvastatin, Lipitor’s active ingredient.
The Federal Circuit deemed claim 6 of U.S. Patent Number 5,273,995 invalid because it failed to comply with the requirements of 35 U.S.C. Section 112, paragraph 4, which deals with dependent claims.
That paragraph specifically says that a dependent claim shall “specify a further limitation of the subject matter claimed.”
The Federal Circuit referenced the district court’s reluctance to declare the ‘995 patent — which deals with the calcium salt of atorvastatin — invalid. Although the lower court recognized that “there may be a technical problem in the drafting of claim 6,” it didn’t see that flaw as adequate grounds for a declaration of invalidity.
But the Federal Circuit disagreed, swayed by Ranbaxy’s argument that the claim failed to properly specify limits to the subject matter it refers to.
Pfizer wants a judgment from the Boston court holding that the effective date of any FDA approval for NDA 22-245 can't be earlier than June 28, 2011; a permanent injunction barring from making, selling or importing the product contemplated in the NDA; and attorneys' fees and costs.
A Cobalt representative could not be immediately reached to discuss the lawsuits.
In the Boston action, Pfizer is represented by Cesari & McKenna LLP. Connolly Bove Lodge & Hutz LLP is of counsel.
The case is Pfizer et al. v. Cobalt Pharmaceuticals Inc., case number 07-12257 in the U.S. District Court for the District of Massachusetts.
The Delware case is Pfizer Inc. et al v. Cobalt Pharmaceuticals, Inc. case number 07-790 in the U.S. District Court for the District of Delaware.
Remarks: This will give good detail about the case filed against Cobalt. I hope this will be useful. Enjoy................
Pfizer and a group of subsidiaries including Warner Lambert Co. filed a suit against Cobalt on Friday in federal court in Boston. The suit accused Cobalt of infringing a patent owned by Warner Lambert.
The same plaintiffs filed a suit against Cobalt in Delaware on Thursday. That suit accused Cobalt of infringing the same patent and referenced the same NDA. A Pfizer representative would not comment Monday on why the infringement claims were filed in different jurisdictions.
At issue is U.S. Patent Number 5,273,995, which was issued in 1993, is owned by Warner Lambert and covers Lipitor, the complaint said. Lipitor, a formulation of atorvastatin calcium, brought in $3.2 billion in worldwide revenues for Pfizer in the third quarter of 2007, according to a Pfizer press release dated Oct. 18.
Pfizer received a letter from Cobalt, dated Oct. 24, 2007, alerting Pfizer that Cobalt had filed NDA No. 22-245 asking for the U.S. Food and Drug Administration's approval to make and sell a product containing atorvastatin sodium as its active ingredient before the expiration of the '995 patent, the complaint said.
The expiration date on the '955 patent in Dec. 28, 2010, but Lipitor was granted an extension of exclusivity through June 28, 2011, Pfizer said.
Cobalt infringed the patent by submitting its NDA, Pfizer claimed
Claim 6 of the '995 patent was declared invalid by the U.S. Court of Appeals for the Federal Circuit in August 2006, but the complaint does not seek relief based on that claim, Pfizer said.
Indian generic drug maker Ranbaxy Laboratories Ltd. brought the appeal that led to claim 6's invalidation, following a December 2005 defeat in federal court in Delaware. Pfizer said it plans to rectify the flaw in the ‘995 patent through the U.S. Patent and Trademark Office.
The Federal Circuit's August ruling upheld U.S. Patent Number 4,681,893, which covers atorvastatin, Lipitor’s active ingredient.
The Federal Circuit deemed claim 6 of U.S. Patent Number 5,273,995 invalid because it failed to comply with the requirements of 35 U.S.C. Section 112, paragraph 4, which deals with dependent claims.
That paragraph specifically says that a dependent claim shall “specify a further limitation of the subject matter claimed.”
The Federal Circuit referenced the district court’s reluctance to declare the ‘995 patent — which deals with the calcium salt of atorvastatin — invalid. Although the lower court recognized that “there may be a technical problem in the drafting of claim 6,” it didn’t see that flaw as adequate grounds for a declaration of invalidity.
But the Federal Circuit disagreed, swayed by Ranbaxy’s argument that the claim failed to properly specify limits to the subject matter it refers to.
Pfizer wants a judgment from the Boston court holding that the effective date of any FDA approval for NDA 22-245 can't be earlier than June 28, 2011; a permanent injunction barring from making, selling or importing the product contemplated in the NDA; and attorneys' fees and costs.
A Cobalt representative could not be immediately reached to discuss the lawsuits.
In the Boston action, Pfizer is represented by Cesari & McKenna LLP. Connolly Bove Lodge & Hutz LLP is of counsel.
The case is Pfizer et al. v. Cobalt Pharmaceuticals Inc., case number 07-12257 in the U.S. District Court for the District of Massachusetts.
The Delware case is Pfizer Inc. et al v. Cobalt Pharmaceuticals, Inc. case number 07-790 in the U.S. District Court for the District of Delaware.
Remarks: This will give good detail about the case filed against Cobalt. I hope this will be useful. Enjoy................
Pfizer Sues Canadian Drug Company (Cobalt) Alleging Lipitor Patent Infringement
Pfizer Inc., the world's largest drugmaker, sued Canadian generic-drug company Cobalt Pharmaceuticals Inc. alleging infringement of a U.S. patent for Lipitor, a medicine used to lower cholesterol. "Pfizer will be irreparably harmed" if a judge doesn't stop Cobalt's infringement, Pfizer said in the suit filed yesterday in Delaware.
The company also seeks legal fees and expenses. Lipitor, the world's best-selling drug, logged US$9.2-billion in sales in the first nine months of 2007, or 26% of New York-based Pfizer's revenue. In the lawsuit, Pfizer asked a judge to stop Cobalt from selling a copy until the patent expires in June, 2011.
Remarks: This is the preliminary information available with me. As soon as I will get the detailed information I will update my blog w.r.t this topic.
The company also seeks legal fees and expenses. Lipitor, the world's best-selling drug, logged US$9.2-billion in sales in the first nine months of 2007, or 26% of New York-based Pfizer's revenue. In the lawsuit, Pfizer asked a judge to stop Cobalt from selling a copy until the patent expires in June, 2011.
Remarks: This is the preliminary information available with me. As soon as I will get the detailed information I will update my blog w.r.t this topic.
Amgen gets marketing nod from EC for cancer drug Vectibix
Amgen said the European Commission has granted a conditional marketing authorization to market its colorectal cancer treatment drug Vectibix.
EU approved Vectibix (panitumumab) as monotherapy for the treatment of patients with epidermal growth factor receptor (EGFr) expressing metastatic colorectal cancer (mCRC) with non-mutated (wild-type) KRAS genes after failure of standard chemotherapy regimens.
Vectibix, a fully human anti-EGFr monoclonal antibody, has been granted a positive Commission decision in the European Union (EU) based upon a positive opinion from the European Committee for Medicinal Products for Human Use (CHMP) for marketing authorization in September of this year. This approval is based on a positive benefit / risk assessment in a patient population that currently has few treatment options available to them. As part of the CHMP review, clinical data supporting the utility of KRAS mutation status as a biomarker for clinical outcome were provided.
"It is an exciting time in the oncology arena as we see a shift towards individualized patient care," said Willard Dere, M.D., senior vice president and international chief medical officer, Amgen. "We are pleased that Vectibix has received conditional marketing authorization allowing metastatic colorectal cancer patients to have access to a new targeted treatment option.
"These biomarker data were generated from a prospectively defined analysis of the phase III, randomised, controlled clinical trial "408" that investigated the treatment effect of KRAS status (non-mutated versus mutated) in Vectibix patients with mCRC. The analysis demonstrated that the effect of Vectibix on progression-free survival (PFS) was confined exclusively to the approximately 60 percent of patients whose tumours harbour normal, non-mutated (wild-type) KRAS. Vectibix had no clinical benefit in patients who had tumours with mutations in KRAS regardless of the endpoint studied. Previously reported pivotal results from "408" demonstrated that Vectibix monotherapy significantly improved PFS and response rates in heavily pre-treated patients with mCRC after failure of standard chemotherapy versus best supportive care.
KRAS plays an important role in cell growth regulation and oncogenesis. Anti-EGFr therapies work by blocking the activation of EGFr, thereby inhibiting downstream events that lead to malignant signalling. However, in patients with tumours harbouring a mutated or activated KRAS, the KRAS protein is always turned "on" regardless of whether EGFr has been activated or therapeutically inhibited. Thus, in patients with mutated KRAS, signalling continues despite anti-EGFr therapy. Mutant KRAS is detected in approximately 40 percent of CRC tumours.
"Being able to select which patients are more likely to respond to therapy is an important step forward in the treatment of metastatic colorectal cancer," said Professor Eric Van Cutsem, Digestive Oncology Unit, University Hospital, Leuven, Belgium, a Vectibix investigator. "The ability to predict the patient population more likely to respond to Vectibix could potentially reduce drug exposure in patients who we know will not respond."
EU approved Vectibix (panitumumab) as monotherapy for the treatment of patients with epidermal growth factor receptor (EGFr) expressing metastatic colorectal cancer (mCRC) with non-mutated (wild-type) KRAS genes after failure of standard chemotherapy regimens.
Vectibix, a fully human anti-EGFr monoclonal antibody, has been granted a positive Commission decision in the European Union (EU) based upon a positive opinion from the European Committee for Medicinal Products for Human Use (CHMP) for marketing authorization in September of this year. This approval is based on a positive benefit / risk assessment in a patient population that currently has few treatment options available to them. As part of the CHMP review, clinical data supporting the utility of KRAS mutation status as a biomarker for clinical outcome were provided.
"It is an exciting time in the oncology arena as we see a shift towards individualized patient care," said Willard Dere, M.D., senior vice president and international chief medical officer, Amgen. "We are pleased that Vectibix has received conditional marketing authorization allowing metastatic colorectal cancer patients to have access to a new targeted treatment option.
"These biomarker data were generated from a prospectively defined analysis of the phase III, randomised, controlled clinical trial "408" that investigated the treatment effect of KRAS status (non-mutated versus mutated) in Vectibix patients with mCRC. The analysis demonstrated that the effect of Vectibix on progression-free survival (PFS) was confined exclusively to the approximately 60 percent of patients whose tumours harbour normal, non-mutated (wild-type) KRAS. Vectibix had no clinical benefit in patients who had tumours with mutations in KRAS regardless of the endpoint studied. Previously reported pivotal results from "408" demonstrated that Vectibix monotherapy significantly improved PFS and response rates in heavily pre-treated patients with mCRC after failure of standard chemotherapy versus best supportive care.
KRAS plays an important role in cell growth regulation and oncogenesis. Anti-EGFr therapies work by blocking the activation of EGFr, thereby inhibiting downstream events that lead to malignant signalling. However, in patients with tumours harbouring a mutated or activated KRAS, the KRAS protein is always turned "on" regardless of whether EGFr has been activated or therapeutically inhibited. Thus, in patients with mutated KRAS, signalling continues despite anti-EGFr therapy. Mutant KRAS is detected in approximately 40 percent of CRC tumours.
"Being able to select which patients are more likely to respond to therapy is an important step forward in the treatment of metastatic colorectal cancer," said Professor Eric Van Cutsem, Digestive Oncology Unit, University Hospital, Leuven, Belgium, a Vectibix investigator. "The ability to predict the patient population more likely to respond to Vectibix could potentially reduce drug exposure in patients who we know will not respond."
FDA's Safety Reviews of Prilosec and Nexium Find No Evidence of Increased Rates of Cardiac Events
ROCKVILLE, Md., Dec. 10, 2007-Background: On May 29, 2007 AstraZeneca, the maker of Prilosec (omeprazole) and Nexium (esomeprazole), sent FDA data from two long-term studies in patients with severe gastroesophageal reflux disease (GERD) that were being treated with either Prilosec or Nexium. The studies were designed to assess the effectiveness of treatment with Prilosec, or Nexium, or surgery for severe GERD. Participants were randomly assigned to receive treatment with either a drug (Prilosec in one study and Nexium in the other) or surgery. During the studies, cardiovascular events raised a question about whether long-term use of these drugs increases the risk of heart attacks, heart failure, and heart-related sudden death in patients taking either one of the prescribed drugs compared to patients who received surgical treatment. On Aug. 9, 2007 FDA released an "Early Communication of an Ongoing Safety Review" of these drugs. The agency’s initial review determined that there was no increased risk of heart problems associated with long-term use of these drugs. At FDA’s request, AstraZeneca submitted a large amount of additional information about these and other studies and FDA undertook a comprehensive review of all available data regarding this potential safety concern. The following represents the agency’s current analysis of available data on these medications.
Current Information: FDA has completed a comprehensive, scientific review of known safety data for the drugs Prilosec and Nexium. While both of the long-term studies reported to FDA on May 29, 2007 collected safety data, the study protocols did not specify how heart problems, such as heart attacks, were defined or verified. As a result, evaluating the information that was gathered about the safety of both drugs in these studies was challenging. FDA’s assessment of the information from the data gathered was further supported by an additional analysis of 14 comparative studies of Prilosec, four of which were placebo-controlled. Although these studies were not specifically conducted to assess the risk of heart problems, and patient follow-up was incomplete, they do not suggest an increased risk of heart problems with the use of Prilosec or its newer formulation Nexium.
Based on everything now known at the agency, the reported difference in the frequency of heart attacks and other heart-related problems seen in the earlier analyses of the two small long-term studies does not indicate the presence of a true effect. Therefore, FDA continues to conclude that long-term use of these drugs is not likely to be associated with an increased risk of heart problems. FDA recommends that health care providers continue to prescribe, and patients continue to use, these products as described in the labeling for the two drugs.
Current Information: FDA has completed a comprehensive, scientific review of known safety data for the drugs Prilosec and Nexium. While both of the long-term studies reported to FDA on May 29, 2007 collected safety data, the study protocols did not specify how heart problems, such as heart attacks, were defined or verified. As a result, evaluating the information that was gathered about the safety of both drugs in these studies was challenging. FDA’s assessment of the information from the data gathered was further supported by an additional analysis of 14 comparative studies of Prilosec, four of which were placebo-controlled. Although these studies were not specifically conducted to assess the risk of heart problems, and patient follow-up was incomplete, they do not suggest an increased risk of heart problems with the use of Prilosec or its newer formulation Nexium.
Based on everything now known at the agency, the reported difference in the frequency of heart attacks and other heart-related problems seen in the earlier analyses of the two small long-term studies does not indicate the presence of a true effect. Therefore, FDA continues to conclude that long-term use of these drugs is not likely to be associated with an increased risk of heart problems. FDA recommends that health care providers continue to prescribe, and patients continue to use, these products as described in the labeling for the two drugs.
U.S. FDA Issues Approvable Letter for Requip XL Extended Release Tablets
LONDON, UK, 10 December 2007-- SkyePharma PLC (LSE: SKP) today announces that the United States Food and Drug Administration (FDA) has issued an approvable letter for GlaxoSmithKline's (NYSE:GSK) Requip(R) XL(TM) Extended Release tablets. An approvable letter is an official notification from the FDA that contains conditions that must be satisfied prior to obtaining final U.S.marketing approval.
Requip(R) XL(TM) is a once-daily oral dopamine agonist developed for the treatment of the signs and symptoms of idiopathic Parkinson's disease. The new Requip(R) XL(TM) formulation uses SkyePharma's patented GEOMATRIX(TM) technology and is designed to provide a steady rate of absorption in the body to help reduce daily blood plasma fluctuations. GSK is committed to working with the FDA to address any questions they have and evaluate the best way forward.
Requip(R) XL(TM) is approved in eight countries in Europe and a mutual recognition procedure was successfully completed on 27 November 2007, in 17 additional European countries. This step should result in approval of Requip(R) XL(TM) and launches in these countries from the first quarter of 2008 onwards.
Requip(R) XL(TM) is a once-daily oral dopamine agonist developed for the treatment of the signs and symptoms of idiopathic Parkinson's disease. The new Requip(R) XL(TM) formulation uses SkyePharma's patented GEOMATRIX(TM) technology and is designed to provide a steady rate of absorption in the body to help reduce daily blood plasma fluctuations. GSK is committed to working with the FDA to address any questions they have and evaluate the best way forward.
Requip(R) XL(TM) is approved in eight countries in Europe and a mutual recognition procedure was successfully completed on 27 November 2007, in 17 additional European countries. This step should result in approval of Requip(R) XL(TM) and launches in these countries from the first quarter of 2008 onwards.
Eisai to Acquire MGI Pharmafor $41 Per Share in an All Cash Transaction
TOKYO & BLOOMINGTON, Minn.--(BUSINESS WIRE)--Dec 10, 2007 - Eisai Co., Ltd. (TSE: 4523.JP) ("Eisai"), a research-based human health care (hhc) company that focuses on neurology, gastrointestinal disorders, oncology and critical care, and MGI PHARMA, Inc. (NASDAQ: MOGN) ("MGI PHARMA"), an oncology and acute care focused biopharmaceutical company, today announced that they have entered into a definitive merger agreement under which Eisai would acquire all of the outstanding shares of MGI PHARMA for US$41.00 per share in an all cash transaction, for a total consideration of approximately $3.9 billion.
The merger agreement has been unanimously approved by the MGI PHARMA Board of Directors. The acquisition is expected to occur by means of a tender offer followed by a cash merger, is subject to customary closing conditions and regulatory approvals, and is expected to be completed during the first quarter of 2008.
Eisai expects MGI PHARMA's marketed and pipeline products in oncology and acute care, as well as its R&D and commercial capabilities, including field sales specialists, together with Eisai's existing oncology products, global infrastructure and R&D capabilities, will create a base for continued sales growth, pipeline enhancement and the opportunity for synergies. Eisai expects that this transaction will enable it to grow further in the U.S. market and strengthen its already-focused oncology business platform. Following the completion of the transaction, Eisai anticipates that the transaction will be accretive to its cash EPS (excluding goodwill amortization) in fiscal year 2008 and GAAP EPS in fiscal 2009.
"The Board of Directors of MGI PHARMA, working with our legal and financial advisors, has been reviewing strategic alternatives for the company for the past several months," said Mr. Lonnie Moulder, President and CEO of MGI PHARMA. "During that time, we have had the opportunity to share the MGI PHARMA vision and business opportunity with many of the leading companies in the pharmaceutical and biotechnology industry. This transaction represents the successful conclusion of that process. Our Board of Directors and the management team are extremely pleased to announce this transaction and the opportunity to continue to bring important therapies to patients."
Mr. Haruo Naito, President and CEO of Eisai, said, "Eisai has enormous respect for MGI PHARMA's products, pipeline and people, and we look forward to working with their highly skilled team to address the unmet medical needs of patients throughout the world. Strategically, we expect this transaction to allow Eisai to significantly strengthen its oncology business and increase the likelihood of achieving our current strategic plan targets and our future revenue and earnings growth."
The merger agreement has been unanimously approved by the MGI PHARMA Board of Directors. The acquisition is expected to occur by means of a tender offer followed by a cash merger, is subject to customary closing conditions and regulatory approvals, and is expected to be completed during the first quarter of 2008.
Eisai expects MGI PHARMA's marketed and pipeline products in oncology and acute care, as well as its R&D and commercial capabilities, including field sales specialists, together with Eisai's existing oncology products, global infrastructure and R&D capabilities, will create a base for continued sales growth, pipeline enhancement and the opportunity for synergies. Eisai expects that this transaction will enable it to grow further in the U.S. market and strengthen its already-focused oncology business platform. Following the completion of the transaction, Eisai anticipates that the transaction will be accretive to its cash EPS (excluding goodwill amortization) in fiscal year 2008 and GAAP EPS in fiscal 2009.
"The Board of Directors of MGI PHARMA, working with our legal and financial advisors, has been reviewing strategic alternatives for the company for the past several months," said Mr. Lonnie Moulder, President and CEO of MGI PHARMA. "During that time, we have had the opportunity to share the MGI PHARMA vision and business opportunity with many of the leading companies in the pharmaceutical and biotechnology industry. This transaction represents the successful conclusion of that process. Our Board of Directors and the management team are extremely pleased to announce this transaction and the opportunity to continue to bring important therapies to patients."
Mr. Haruo Naito, President and CEO of Eisai, said, "Eisai has enormous respect for MGI PHARMA's products, pipeline and people, and we look forward to working with their highly skilled team to address the unmet medical needs of patients throughout the world. Strategically, we expect this transaction to allow Eisai to significantly strengthen its oncology business and increase the likelihood of achieving our current strategic plan targets and our future revenue and earnings growth."
Essilor acquires prescription labs in UK & US
Monday, December 10, 2007 16:00 IST Charenton-le-Pont, France
Essilor has strengthened its prescription laboratory network in Europe with the acquisition of majority stakes in Sinclair Optical Services and United Optical, two independent laboratories in the United Kingdom. The company has also acquired Premier Optics, Inc., Gold Optical Enterprises, Inc. and GK Optical in the United States.
Based in Gloucester, England, Sinclair Optical serves the entire English market with a broad array of products that includes stock lenses, prescription lenses and surface treatments. Its full-year sales amount to €8 million.United Optical is located in Belfast, North Ireland. It also operates a subsidiary in Athlone, Ireland that specializes in the edging and mounting of prescription safety lenses.
United Optical generates full-year revenue of around €5.8 million.In the United States, Essilor of America has acquired the assets of Premier Optics, Inc. and Gold Optical Enterprises, Inc., two prescription laboratories located, respectively, in Belmont and Fayetteville, North Carolina. Essilor has also acquired GK Optical, a group of two prescription laboratories in Greenwood and Fort Wayne, Indiana. The three companies' combined full-year revenue totals $8.5 million.Essilor is one of the leaders in corrective lenses.
The company designs, manufactures and customizes corrective lenses to meet all visual requirements. Worldwide, Essilor offers lightweight, thin, strong lenses that protect eyes and restore perfect vision. The company has 550 researchers at 4 R&D centres.
Essilor has strengthened its prescription laboratory network in Europe with the acquisition of majority stakes in Sinclair Optical Services and United Optical, two independent laboratories in the United Kingdom. The company has also acquired Premier Optics, Inc., Gold Optical Enterprises, Inc. and GK Optical in the United States.
Based in Gloucester, England, Sinclair Optical serves the entire English market with a broad array of products that includes stock lenses, prescription lenses and surface treatments. Its full-year sales amount to €8 million.United Optical is located in Belfast, North Ireland. It also operates a subsidiary in Athlone, Ireland that specializes in the edging and mounting of prescription safety lenses.
United Optical generates full-year revenue of around €5.8 million.In the United States, Essilor of America has acquired the assets of Premier Optics, Inc. and Gold Optical Enterprises, Inc., two prescription laboratories located, respectively, in Belmont and Fayetteville, North Carolina. Essilor has also acquired GK Optical, a group of two prescription laboratories in Greenwood and Fort Wayne, Indiana. The three companies' combined full-year revenue totals $8.5 million.Essilor is one of the leaders in corrective lenses.
The company designs, manufactures and customizes corrective lenses to meet all visual requirements. Worldwide, Essilor offers lightweight, thin, strong lenses that protect eyes and restore perfect vision. The company has 550 researchers at 4 R&D centres.
Sunday, December 9, 2007
Federal Circuit Rejects King's Bid for Rehearing in Altace Case
The U.S. Court of Appeals for the Federal Circuit Dec. 3 rejected King Pharmaceuticals Inc.'s bid for a rehearing and rehearing en banc in a case that invalidated the composition of matter patent for the blood pressure medication Altace (ramipril) due to obviousness (Aventis Pharma Deutschland GmbH v. Lupin Ltd., Fed. Cir., No. 06-1530, rehearing denied 12/3/07).
King filed a petition for rehearing or rehearing en banc arguing that the court misapplied the U.S. Supreme Court's 2007 holding in KSR International Co. v. Teleflex Inc., 127 S. Ct. 1727 (2007), which cautions against a rigid application of the "teaching, suggestion, or motivation" (TSM) test for obviousness, to invalidate the Altace patent on the basis of obviousness.
King argued that "this application of the law [in KSR] is not consistent with other recent rulings of the Federal Circuit Court." King also argued that the Federal Circuit's decision in the Altace case (5 PLIR 929, 9/14/07 ) relied on factual inaccuracies.
King said in a statement it was "evaluating its remaining legal options with respect to the patent" after the petition's denial.
If the ruling stands, it means that India-based Lupin Ltd., which is seeking to market generic ramipril capsules before the patent on Altace expires, will be able to enter the market with a generic version of Altace before the patent expiration date of Oct. 19, 2008.
The patent at issue, U.S. Patent No. 5,061,722, (the '722 patent), is held by Aventis Pharma Deutschland GmbH, but Bristol, Tenn.-based King is the exclusive licensee. The '722 patent, which covers ramipril isomers, their hypotensive compositions, and their method of use for reducing blood pressure.
King has called Altace, which in 2006, accounted for $653 million worth of sales for King, its "flagship cardiovascular product."
King filed a petition for rehearing or rehearing en banc arguing that the court misapplied the U.S. Supreme Court's 2007 holding in KSR International Co. v. Teleflex Inc., 127 S. Ct. 1727 (2007), which cautions against a rigid application of the "teaching, suggestion, or motivation" (TSM) test for obviousness, to invalidate the Altace patent on the basis of obviousness.
King argued that "this application of the law [in KSR] is not consistent with other recent rulings of the Federal Circuit Court." King also argued that the Federal Circuit's decision in the Altace case (5 PLIR 929, 9/14/07 ) relied on factual inaccuracies.
King said in a statement it was "evaluating its remaining legal options with respect to the patent" after the petition's denial.
If the ruling stands, it means that India-based Lupin Ltd., which is seeking to market generic ramipril capsules before the patent on Altace expires, will be able to enter the market with a generic version of Altace before the patent expiration date of Oct. 19, 2008.
The patent at issue, U.S. Patent No. 5,061,722, (the '722 patent), is held by Aventis Pharma Deutschland GmbH, but Bristol, Tenn.-based King is the exclusive licensee. The '722 patent, which covers ramipril isomers, their hypotensive compositions, and their method of use for reducing blood pressure.
King has called Altace, which in 2006, accounted for $653 million worth of sales for King, its "flagship cardiovascular product."
Sandoz, Zydus sued over epilepsy drug
Abbott Laboratories sued Novartis AG's Sandoz and Cadila Healthcare Ltd.'s Zydus to prevent them from selling generic versions of the epilepsy drug Depakote ER in the U.S.
Sandoz, the world's second-largest generic drug-maker, and Zydus are separately seeking U.S. Food and Drug Administration approval to sell copycat versions of the medicine, whose active ingredient is divalproex sodium. Abbott contends the generic drugs would infringe four patents for the controlled-release version of Depakote that expire in 2018.
In their applications, Sandoz and Zydus said they wouldn't infringe the patents "but did not argue that any of these patents are invalid or unenforceable," North Chicago-based Abbott said in the complaints. It contends the generic versions would infringe the patents and seeks a court order to prevent regulatory approval of the applications until the patents expire.
Sandoz, the world's second-largest generic drug-maker, and Zydus are separately seeking U.S. Food and Drug Administration approval to sell copycat versions of the medicine, whose active ingredient is divalproex sodium. Abbott contends the generic drugs would infringe four patents for the controlled-release version of Depakote that expire in 2018.
In their applications, Sandoz and Zydus said they wouldn't infringe the patents "but did not argue that any of these patents are invalid or unenforceable," North Chicago-based Abbott said in the complaints. It contends the generic versions would infringe the patents and seeks a court order to prevent regulatory approval of the applications until the patents expire.
Sutura settles patent litigation with Abbott
Saturday, December 08, 2007 09:00 IST Fountain Valley, CaliforniaSutura, Inc, a California-based medical device company, said it has settled a patent infringement lawsuit it had against Abbott Laboratories. Abbott has agreed to pay Sutura $23 million as part of the settlement agreement.
The settlement provides for a cross license of the Hathaway patents, licensed to Abbott by Indiana University, and the Sutura Nobles patents.
"We are pleased to have reached this agreement with Abbott and resolved this patent infringement dispute with them," said David Teckman, president and CEO, Sutura. "We now look forward to moving on with our continued enhancement of Sutura's product line of vascular suturing devices, in particular the Sutura EL device."
Sutura, Inc. is a medical device company that has developed a line of innovative, minimally invasive, vascular suturing devices to suture the puncture created in arteries during open surgery and catheter-based procedures.
The settlement provides for a cross license of the Hathaway patents, licensed to Abbott by Indiana University, and the Sutura Nobles patents.
"We are pleased to have reached this agreement with Abbott and resolved this patent infringement dispute with them," said David Teckman, president and CEO, Sutura. "We now look forward to moving on with our continued enhancement of Sutura's product line of vascular suturing devices, in particular the Sutura EL device."
Sutura, Inc. is a medical device company that has developed a line of innovative, minimally invasive, vascular suturing devices to suture the puncture created in arteries during open surgery and catheter-based procedures.
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