Monday, December 31, 2007
Sunday, December 30, 2007
Priority review is granted to those products that address significant unmet medical needs and provides for a review period of six months from the date of submission. The FDA has issued an action date of April 26, 2008, under the Prescription Drug User Fee Act (PDUFA) for the NDA.
In addition, the FDA has scheduled a Pulmonary-Allergy Drugs Advisory Committee meeting on February 20, 2008, to discuss Icatibant. Advisory committees provide advice to the agency and are often held as part of the review process for first-in-class drugs. Although the committee provides advice to the agency, final decisions are made by the FDA.
"We are very pleased with the successful completion of this important regulatory step and the FDA's decision to include an advisory panel as part of the review process," said Jens Schneider-Mergener, CEO, Jerini. "We are confident that our phase III data demonstrate Icatibant's safety and efficacy in treating HAE, and we look forward to having the opportunity to present our data package to the panel.
" Icatibant, a synthetic peptidomimetic, works by blocking the B2 receptor as an antagonist to the peptide hormone bradykinin. Bradykinin has been shown to be elevated in HAE patients and responsible for edema formation during HAE attacks. Icatibant has been granted orphan drug status for the treatment of angioedema by the US Food and Drug Administration (FDA) and the European Medicines Evaluation Agency (EMEA), potentially securing upon approval, market exclusivity for seven and ten years, respectively.
HAE is a debilitating and potentially life-threatening genetic disease characterized by unpredictable recurring swelling attacks of the hands, feet, face, larynx, and abdomen. It is estimated that approximately 10,000 patients in the United States and Europe have been diagnosed with HAE. HAE attacks affecting the hands, face, and feet can be disfiguring, while attacks in the gastrointestinal tract result in severe pain caused by swelling of the intestinal wall. Attacks that affect the larynx are life-threatening because swelling of the larynx constricts the upper airways and can lead to death by suffocation. The prevalence of HAE is estimated between one in 50,000 and one in 10,000 individuals, and it is estimated that between 15,000 and 75,000 people are affected with HAE in the European Union and the United States.
Cetirizine HCl Tablets are the generic version of Pfizer's Zyrtec(R) Tablets, which had U.S. sales of approximately $1.4 billion for the 12 months ending Sept. 30, 2007.
This product will be shipped immediately.
The product will be marketed under store brand labels and is comparable to McNeil Consumer Healthcare's Cetirizine Hydrochloride Tablets, 5 and 10 mg, which will be marketed as Zyrtec(R) Tablets, indicated for allergy and hives relief. According to Wolters Kluwer data, brand sales for the original prescription strength version of the product for the 12 months ending October 2007 were approximately $1.4 billion.
Caraco Pharmaceutical Laboratories, Ltd. Announces FDA Approval to Market Generic OTC Versions of Zyrtec Allergy Tablet and Zyrtec Hives Relief Tablet
Cetirizine HCl, which will be marketed as two separate OTC products in two strengths of 5 mg and 10 mg, is an antihistamine drug, which is used to treat allergies, hives, and other allergic inflammatory conditions. These new products are the bioequivalent to Zyrtec Allergy Tablets(R) and Zyrtec Hives Relief Tablets(R), registered trademarks of Pfizer, Inc.
Daniel H. Movens, Caraco's Chief Executive Officer, said, "We are pleased to have the opportunity to market these products as they represent the first "over-the counter" products to be added to our current portfolio of prescription products. Zyrtec Allergy(R) has just been approved for the OTC market and we are pleased to be able to market a generic OTC version as an alternative. It previously was marketed strictly as a prescription product under the Zyrtec(R) brand name where it had done over $1.3 billion in prescription sales. We continue to focus on working towards expanding our product offering as quickly and effectively as possible. We plan to market these products to the generic pharmaceutical and OTC market immediately. This will bring our total product selection to 45 different products represented by 96 various strengths."
Friday, December 28, 2007
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.
Thursday, December 27, 2007
The requested correction relates to FDA's assessment of progression-free survival (PFS) in the phase III trial of Genasense (oblimersen sodium injection) that was presented to the Oncology Drug Advisory Committee (ODAC) that considered Genta's New Drug Application for Genasense in patients with advanced melanoma.
"Melanoma is a key indication in our current phase III development program", said Dr Loretta M. Itri, MD, president for pharmaceutical development and chief medical officer, Genta. "A methodological error may have impacted ODAC deliberations, which voted unanimously that an improvement in PFS of some magnitude represents clinical benefit that could support regular approval in advanced melanoma.
"Genta Incorporated is a biopharmaceutical company with a diversified product portfolio that is focused on delivering innovative products for the treatment of patients with cancer.
The application includes 48-week data from two phase III studies, ARTEMIS and TITAN, which were presented at HIV conferences earlier this year, as well as 96-week data from the phase IIb studies, POWER 1, 2, and 3.
Prezista received accelerated approval in June 2006 based on the 24-week analysis of HIV viral load and CD4+ cell counts from the pooled analysis of the TMC114-C213 (POWER 1) and TMC114-C202 (POWER 2) phase IIb studies. As part of the post-marketing commitment, 48-week data from ongoing phase III studies (ARTEMIS and TITAN) and 96-week data from POWER 1, 2, and 3 are required before the FDA can consider traditional approval for Prezista.
Prezista, co-administered with 100 mg ritonavir and with other antiretroviral agents, is currently indicated for the treatment of human immunodeficiency virus (HIV) infection in antiretroviral treatment-experienced adult patients, such as those with HIV-1 strains resistant to more than one protease inhibitor.
This indication is based on Week 24 analyses of plasma HIV RNA levels and CD4+ cell counts from two controlled trials of Prezista/ritonavir in combination with other antiretroviral drugs. Both studies were conducted in clinically advanced, treatment-experienced (NRTIs, NNRTIs, and PIs) adult patients with evidence of HIV-1 replication despite ongoing antiretroviral therapy.
The sNDA submission includes the 48-week efficacy and safety results of Artemis (AntiRetroviral Therapy with TMC114 Examined In naïve Subjects), a phase III, randomised, controlled, open-label study that compared the efficacy and safety of Prezista/r with the PI lopinavir/r in treatment-naïve HIV-1-infected adult patients. Patients were randomised to receive a Prezista/r dose of 800 mg/100 mg once daily (an investigational dose) or, based on approved dosing in each country, either lopinavir/r 800 mg/200 mg once daily or 400 mg/100 mg twice daily, plus an optimized background regimen (OBR) of tenofovir and emtricitabine once daily. Data from this study were presented at the 47thInterscience Conference on Antimicrobial Agents and Chemotherapy(ICAAC) in Chicago on September 18, 2007.
The sNDA submission also includes data from TITAN (TMC114/r In Treatment-experienced patients Naïve to lopinavir/ritonavir), a 96-week, phase III, randomised, controlled, open-label study, comparing the efficacy and safety of a Prezista/r dose of 600 mg/100 mg twice daily with lopinavir/r 400 mg/100 mg twice daily, each with OBR, in treatment-experienced HIV-1-infected adult patients who were lopinavir/r-naïve. Forty-eight week data from this study were published in the July 7, 2007, issue of The Lancet and presented at the 4th International AIDS Society Conference on HIV Pathogenesis, Treatment, and Prevention in Sydney, Australia, on July 24, 2007.Prezista does not cure HIV infection or AIDS, and does not prevent passing HIV to others.
Coadministration of Prezista/r is contraindicated with drugs that are highly dependent on CYP3A for clearance and have a narrow therapeutic index (e.g., astemizole, terfenadine, dihydroergotamine, ergonovine, ergotamine, methylergonovine, cisapride, pimozide, midazolam, or triazolam) and for which elevated plasma concentrations are associated with serious and/or life-threatening events. Coadministration is not recommended with carbamazepine, phenobarbital, phenytoin, rifampin, lopinavir/ritonavir, saquinavir, lovastatin, pravastatin, simvastatin, or products containing St. John's wort (Hypericum perforatum).
Severe skin rash, including erythema multiforme and Stevens-Johnson Syndrome, has been reported in subjects receiving Prezista during the clinical development programme. In some cases, fever and elevations of transaminases have also been reported. In clinical trials, rash (all grades, regardless of causality) occurred in seven percent of subjects treated with Prezista; discontinuation due to rash was 0.3 per cent. Rashes were generally mild-to-moderate, self-limiting and maculopapular.
New-onset or exacerbations of pre-existing diabetes mellitus and hyperglycaemia, and increased bleeding in hemophiliacs have been reported in patients receiving protease inhibitors. A causal relationship between protease inhibitors and these events has not been established.Redistribution and/or accumulation of body fat have been observed in patients receiving ARV therapy. The causal relationship, mechanism, and long-term consequences of these events have not been established.
Tibotec, Inc., based in Yardley, Pennsylvania, is a pharmaceutical research and development company, with headquarters in Ireland and an operating affiliate in Belgium. Tibotec Inc., is dedicated to the discovery and development of novel, new drugs for HIV/AIDS and other infectious diseases.
The FDA states in the letter that it has completed its review of the amended Stavzor(TM) NDA and that it is tentatively approved. "Tentative approval" generally means that the FDA has concluded that a drug product has met all required quality, safety and efficacy standards, but because of existing patents and/or exclusivity rights, it cannot yet be marketed in the United States.
The NDA for Stavzor(TM), which was submitted by Banner Pharmacaps Inc. (the NDA holder and developer of the product) under Section 505(b)(2) of the Federal Food, Drug, and Cosmetic Act, references Abbott Laboratories' Depakote(R) product. Based on receipt of the tentative approval letter and Noven's understanding of Depakote(R) exclusivity, Noven continues to expect FDA final approval of Stavzor(TM) by the end of July 2008.
Stavzor(TM) was developed using Banner's patent-pending EnteriCare(TM) enteric soft gelatin capsule delivery system. Noven acquired a license to market and sell Stavzor(TM) in the U.S. as part of Noven's acquisition of JDS Pharmaceuticals in August 2007. If approved for marketing, Stavzor(TM) will be a branded product; it will not be AB-rated to or generically substitutable for Depakote(R), nor will Depakote(R) or any Depakote(R) generics be substitutable for Stavzor(TM). Promotion of the Stavzor(TM) brand will occur through the Noven/JDS sales force.
"We are very pleased that Banner's response to the FDA's October 2007 approvable letter for Stavzor(TM) was deemed a complete response by the FDA, and that the FDA has granted tentative approval of this important new product for the treatment of three indications," said Robert C. Strauss, Noven's President, CEO & Chairman. "Stavzor(TM) launch and production planning is underway in support of an expected 2008 launch through the Noven/JDS sales and marketing organization."
FDA's letter does not raise any specific concerns about the safety or efficacy of Stavzor(TM). Noven expects that the product label will contain similar warnings to those described in the Depakote(R) product label, including those relating to life threatening adverse reactions concerning hepatotoxicity, teratogenicity, and pancreatitis.
Banner Pharmacaps Inc., headquartered in High Point, North Carolina, is a global drug delivery and specialty pharmaceutical company developing a proprietary portfolio of unique products and oral dosage forms, including soft gelatin capsules.
EnteriCare(TM) is a trademark of Banner; Depakote(R) is a registered trademark of Abbott Laboratories or its affiliates.
Suven has so far filed 29 product patent applications through PCT covering more than 145 countries, out of which 5 product patents are granted in various countries. There are several other patent applications from Suven Discovery Research are in the pipeline that have completed the administrative and technical diligence from the patent offices from major countries and would be granted shortly.
Suven has filed its first Investigational New Drug (IND) application with DCGI to conduct the clinical Phase-I study on their developmental candidate SUVN-502 and several candidates are in discovery pipeline undergoing GLP pre-clinical studies.
“We are very pleased by the issuance of this patent to Suven by US Patent office for our drug candidates that are being developed for CNS disorders which targets a $18 billion potential market opportunity “ says Venkat Jasti, CEO of Suven.
Suven Life Sciences is a biopharmaceutical company focused on discovering, developing and commercializing novel pharmaceutical products, which are first in class or best in class therapies through the use of GPCR targets. The company has six internally-discovered therapeutic drug candidates currently in pre- clinical stage of development targeting conditions such as ADHD, dementia, depression, Huntington’s disease, Parkinson’s’ disease and obesity in addition to developmental candidates in Alzheimer’s disease and Schizophrenia.
For the full report, see attachment.
On December 20, 2007 (U.S. EST), the U.S. District Court for the District of New Jersey issued a ruling dismissing the lawsuit against Mutual on the procedural grounds that there is no case or controversy between the parties, because Mutual did not make a certification challenging the patent and does not yet have FDA approval to market its product. The Court recognized that Mutual is required, by a stipulation entered between the parties and signed by the Court, to give Eisai 45 days' notice of any launch of a generic version of Aricept ODT(R), and Eisai may during that 45-day period bring an action against Mutual for patent infringement and seek injunctive relief against Mutual's sales of any such product. Therefore, Mutual cannot market the generic version of Aricept ODT(R) immediately.
The Court did not address the substantive merits of Eisai's infringement action against Mutual. Eisai believes that its donepezil composition of matter patent is valid and enforceable until its expiration date of November 25, 2010, and that Mutual would clearly infringe its donepezil composition of matter patent if Mutual were to launch a generic version of Aricept ODT(R) in the United States prior to the expiration. Eisai intends to vigorously enforce and defend that patent.
The Court's ruling has no impact on Eisai's ongoing infringement action against Teva Pharmaceuticals for its ANDA for generic Aricept(R) (donepezil hydrochloride).
Wednesday, December 26, 2007
The US regulator recently published a draft guidance on studies designed to show non-inferiority as a basis for approving antibacterial drug products and requested Pfizer to provide additional data with regard to Dalbavancin. Pfizer is working with the FDA to respond to these new requirements.
Also, the FDA approvable letter refers to deviations from current good manufacturing practices (cGMP) at a third party manufacturer, not specifically related to Dalbavancin. The third-party manufacturer is working with the FDA to resolve outstanding manufacturing issues. Pfizer is also addressing a question from the FDA regarding length of storage time following reconstitution of Dalbavancin.
Dalbavancin, a member of the Glycopeptide class of antibiotics, represents an important addition to Pfizer's broad portfolio of antibacterial products and product candidates. Dalbavancin was acquired by Pfizer in September 2005 as part of its acquisition of Vicuron Pharmaceuticals, Inc.
The company has a long history of developing new medicines for treating infectious diseases and remains committed to providing physicians with this important new treatment option for skin infections caused by MRSA.
MRSA is a virulent and potentially deadly bacterium, and MRSA infections are on the rise in hospitals, long-term care facilities and within communities. MRSA is resistant to many classes of commonly used antibiotics and can cause several types of infections, with skin infections being the most common. The Infectious Diseases Society of America (IDSA) has included MRSA on a reported Hit List of top-priority, dangerous drug resistant microbes that require additional research and new treatments.
Forest Laboratories, Inc. will market the prescription drug to the US under the name Bystolic and will pay Mylan undisclosed royalty payments as part of their collaboration agreement. . Forest licensed US and Canadian rights to Bystolic from Mylan Inc. in January 2006. Forest will market Bystolic in the US. The company expects Bystolic would be available to physicians, patients, and pharmacies in January 2008.
Bystolic is a once daily medication that can be used alone or in combination with other hypertension treatments. Hypertension affects approximately 72 million adults in the US and 65 per cent of patients diagnosed with hypertension have not reduced their blood pressure to an acceptable range, underscoring the need for additional therapeutic options.
Beta blockers are one of the most widely used classes of drugs in the United States. In an extensive clinical trial program involving more than 2,000 patients, Bystolic demonstrated significant reductions in sitting diastolic and systolic blood pressure in a general hypertensive population, which included 26 per cent Black, 54 per cent male, 19 per cent elderly and 8 per cent diabetic patients. The studies also found that Bystolic was well tolerated, with a low incidence of traditional beta blocker side effects. Like other beta blockers, Bystolic decreases heart rate and myocardial contractility, and suppresses renin activity. Bystolic is a selective beta 1 blocker at doses less than or equal to 10 mg per day and has the added pharmacological properties of producing vasodilation and reducing total peripheral resistance.
"Bystolic is the newest beta blocker approved for the treatment of hypertension in the US and should prove useful due to its efficacy in a broad range of patients and its favourable side effect profile," said Michael Weber, MD, Professor of Medicine at SUNY Downstate College of Medicine. "These features will be attractive to both physicians and patients."
Howard Solomon, chairman and chief executive, Forest, commented: "We, along with our partner Mylan, are pleased to have received final Food and Drug Administration marketing approval for Bystolic. Bystolic represents an important advance for patients with hypertension and the physicians who treat them and will be an important new product for our Company."
Bystolic is already approved and successfully marketed for the treatment of hypertension in more than 50 countries outside of North America. Mylan licensed the US and Canadian exclusive rights to nebivolol from Janssen Pharmaceutica N.V., Belgium in 2001.
Patients being treated with Bystolic should be advised against abrupt discontinuation of therapy. Severe exacerbation of angina and the occurrence of myocardial infarction and ventricular arrhythmias have been reported following the abrupt cessation of therapy with beta blockers. When discontinuation is planned, the dosage should be reduced gradually over a one to two week period and the patient carefully monitored.
Bystolic is contraindicated in severe bradycardia, heart block greater than first degree, cardiogenic shock, decompensated cardiac failure, sick sinus syndrome (unless a permanent pacemaker is in place), severe hepatic impairment (Child-Pugh >B), and in patients who are hypersensitive to any component of this product.Like other beta blockers, Bystolic should be used with caution in patients with peripheral vascular disease, thyrotoxicosis, severe renal impairment, and any degree of hepatic impairment or in patients undergoing major surgery. The most common adverse events with Bystolic were headache, fatigue and dizziness.
For Luvox CR (fluvoxamine maleate) extended-release capsules Jazz and Solvay are seeking marketing approval for the treatment of two anxiety disorders - social anxiety disorder (SDA) and obsessive compulsive disorder (OCD), according to the company sources
However, FDA has requested information related to the companies' response concerning the previously disclosed CMC issue. The companies are seeking clarification from FDA and look forward to working with FDA to resolve this as quickly as possible.
The approvable letter did not raise any questions related to safety or efficacy of Luvox CR. The approvable letter included the FDA's proposed labelling.
The FDA approved Luvox (fluvoxamine maleate) for the treatment of OCD on December 20, 2007.
The approval was based on data from the pivotal phase III AVOREN trial, which showed that patients with advanced RCC who received Avastin in combination with IFN lived nearly twice as long without their disease progressing ("progression free survival"), as those who received IFN alone.
Kidney cancer, known as renal cell carcinoma (RCC) is a disease that kills over 100,000 people per year world-wide2.
There are few early symptoms in kidney cancer which means that unfortunately the majority of patients are diagnosed with advanced disease, where current treatment options are limited. Kidney cancer is highly resistant to chemotherapy and radiotherapy, which are often key weapons against other cancer types3.
"The approval by European health authorities is a significant step forward in the treatment of advanced renal cell cancer. Avastin effectively doubles the time in which patients live without their disease getting worse, so this approval has the potential to change the treatment landscape for this disease, where treatment options have been limited" said William M. Burns, CEO, Pharmaceutical Division, Roche.
Kidney cancer is the fourth cancer type in which Avastin has demonstrated positive survival benefits for patients. Data from the comprehensive Avastin cancer clinical development programme have resulted in approvals in advanced colorectal, breast, lung, and kidney cancer:
The AVOREN study is a randomised, controlled, double-blind, phase III study that included 649 patients with advanced kidney cancer from 101 study sites across 18 countries. Study participants received treatment with either Avastin and IFN alpha-2a or placebo and IFN alpha-2a, the standard of care in patients with advanced kidney cancer.
The results of the AVOREN trial showed that by adding Avastin to IFN a progression free survival (PFS) was almost doubled from a median of 5.4 to 10.2 months while the tumour response was significantly increased from 12.8 per cent with IFN alone to 31.4 per cent when Avastin was added. Dose-reduction of IFN did not appear to affect the efficacy of the combination with Avastin (based on PFS event free rates over time, as shown by a sub-group analysis). The study also showed a trend towards improved overall survival; however, these data are still pending. No new or unexpected adverse events were observed.
An interim analysis of AVOREN was performed in December 2006 and the benefits provided by Avastin were so positive that the Drug Safety Monitoring Board recommended that the trial was unblinded and all patients were offered treatment with Avastin. The study demonstrated for the first time that Avastin benefits patients in combination with an immunotherapeutic, the class of drugs to which IFN belongs.
Kidney cancer is more common in men than women (approximately 62 per cent of patients with kidney cancer are men) and incidence increases with age2.
As the most common type of kidney cancer, RCC accounts for approximately nine out of ten cases of the disease4. Within this cancer type, there are several sub-types of cancer based on looking at the cells under a microscope. Clear cell renal cell cancer is the most common type. If RCC is diagnosed at an early stage when the cancer is still confined to the kidney, the 5-year survival rates are relatively good at 60 to 75 per cent. However, if diagnosis is made at a later stage and the cancer has already spread to distant sites the 5-year survival rate is less than 5 per cent. Unfortunately, because kidney cancer is often asymptomatic, the majority of patients are diagnosed at later disease stages.
Treatment options for patients with kidney cancer are limited. Surgical removal of part or the entire kidney forms the mainstay of treatment but is only really successful in early stage disease. In later stage disease, treatment is more often employed with a view of controlling the cancer and improving associated symptoms.
Avastin is the first treatment that inhibits angiogenesis - the growth of a network of blood vessels that supply nutrients and oxygen to cancerous tissues. Avastin targets a naturally occurring protein called vascular endothelial growth factor (VEGF), a key mediator of angiogenesis, thus choking off the blood supply that is essential for the growth of the tumour and its spread throughout the body (metastasis).
Roche and Genentech are pursuing a comprehensive clinical programme investigating the use of Avastin in various tumour types (including colorectal, breast, lung, pancreatic, ovarian, renal cell cancer, and others) and different settings (advanced and adjuvant i.e. post-operation). The total development programme is expected to include over 40,000 patients worldwide.
"Teva has not disputed that its product infringes the United States Protonix compound patent exclusively licensed to Wyeth by Altana, recently acquired by Nycomed," said Lawrence V. Stein, senior vice president and general counsel, Wyeth. "We believe our patent is valid and enforceable and that Teva will be required to compensate Wyeth for the substantial damages caused by Teva's violation of our patent rights."
On September 6, 2007 the United States District Court for the District of New Jersey denied Wyeth and Altana's motion for a preliminary injunction against the launch of a generic pantoprazole tablet by Teva and Sun Pharmaceuticals prior to resolution of a pending patent infringement proceeding. Although Teva and Sun did not dispute that such a launch would infringe the Protonix patent, the court found that the defendants had raised sufficient questions about the validity of the patent to preclude the issuance of the extraordinary remedy of a preliminary injunction. The court did not conclude that the patent was invalid and emphasized that its findings were preliminary. The court stated that at trial, the generic companies would face the higher burden of demonstrating by clear and convincing evidence that the patent is not valid. At trial, Wyeth will seek to recover its lost profits and other damages resulting from Teva's infringing sales and a permanent injunction against future sales of generic pantoprazole prior to expiration of the Protonix patent.
The patent will expire in July 2010, but Wyeth's marketing exclusivity may be extended until January 2011 as a result of clinical research undertaken by the company regarding the paediatric use of the product.
Sales of Protonix for the first nine months of 2007 totalled approximately $1.4 billion.
Wyeth Pharmaceuticals, a division of Wyeth, has leading products in the areas of women's health care, infectious disease, gastrointestinal health, central nervous system, inflammation, transplantation, haemophilia, oncology, vaccines and nutritional products.
Wyeth Receives Approvable Letter from FDA for Bazedoxifene for the Prevention of Postmenopausal Osteoporosis
In its letter, the FDA identified several remaining questions regarding issues that had been previously identified during the review process and that were not fully resolved by the Company's complete response to the first approvable letter. The FDA has requested further analyses and discussion concerning the incidence of stroke and venous thrombotic events. The Agency also identified certain issues concerning data collection and reporting and requested additional source documents.
The FDA stated that the Wyeth Asian studies that were submitted on November 9 and December 14, 2007, were not reviewed for this action. Wyeth believes the data from these nearly 1,000 women provide additional support for a favorable benefit to risk ratio for bazedoxifene in the prevention of postmenopausal osteoporosis.
The Agency did not request the initiation of any new studies and has suggested an end-of-review conference between Wyeth and the FDA to address the remaining issues.
"We look forward to working with the FDA to resolve these issues. Wyeth is dedicated to identifying therapies for the millions of postmenopausal women who are at risk for increased bone loss," says Gary L. Stiles, M.D., Executive Vice President, Chief Medical Officer, Wyeth Pharmaceuticals.
The Company received the first approvable letter on April 23, 2007, and submitted data requested in June 2007. In July 2007, Wyeth submitted a separate New Drug Application to the FDA for bazedoxifene for the treatment of postmenopausal osteoporosis, which was accepted for filing in September 2007, with an action date in May 2008.
On August 23, 2007, Eisai obtained approval for additional efficacy and dosage for Aricept® for the treatment of severe AD as well as for the marketing authorization for the new 10 mg dose formulations in Japan. The new 10 mg dose formulations were added to the National Health Insurance (NHI) drug price list as of December 21, 2007.
In the treatment of severe AD, dose of Aricept® is increased to 10 mg once daily, after four weeks and later at 5 mg. Currently, Aricept® is marketed in 3 mg tablet or 5 mg tablet formulations. With introduction of 10 mg tablets, one tablet a day administration treatment becomes available for all stages of AD (mild, moderate and severe) which can be beneficial for the patients and their families, as well as their caregivers.
Tuesday, December 25, 2007
Dr. Reddy's Laboratories Ltd., one of the leading pharmaceutical companies in India, has received a tentative approval from the US Food and Drug Administration (USFDA) to sell a generic version of Wyeth's heartburn drug Protonix.
The Hyderabad-based company has been granted the tentative approval by the USFDA to sell tablets of Pantoprazole Sodium, or generic Protonix, in multiple strengths, the US drug regulator said on its web site.
Monday, December 24, 2007
Sunday, December 23, 2007
NEW YORK--(BUSINESS WIRE)--Dec 21, 2007 - Pfizer Inc today announced that it has received an approvable letter from the U.S. Food and Drug Administration (FDA) issued for dalbavancin HCl, Pfizer's once-weekly two-dose antibiotic under FDA review for the treatment of adult patients with complicated skin and skin structure infections, including those caused by methicillin-resistant Staphylococcus aureus (MRSA).
The FDA recently published a draft guidance on studies designed to show non-inferiority as a basis for approval of antibacterial drug products and has requested that Pfizer provide additional data with regard to dalbavancin. Pfizer is working with the FDA to respond to these new requirements.
Separately, the FDA approvable letter refers to deviations from current good manufacturing practices (cGMP) at a third-party manufacturer, not specifically related to dalbavancin. The third-party manufacturer is working with the FDA to resolve outstanding manufacturing issues.
Pfizer is also addressing a question from the FDA regarding length of storage time following reconstitution of dalbavancin.
Dalbavancin, a member of the glycopeptide class of antibiotics, represents an important addition to Pfizer's broad portfolio of antibacterial products and product candidates. Dalbavancin was acquired by Pfizer in September 2005 as part of its acquisition of Vicuron Pharmaceuticals, Inc.
Pfizer has a long history of developing new medicines for treating infectious diseases and remains committed to providing physicians with this important new treatment option for skin infections caused by MRSA. FDA-approved products, including Pfizer's ZYVOX(R) (linezolid IV/Oral), are currently available for the treatment of complicated skin and skin structure infections caused by MRSA.
MRSA is a virulent and potentially deadly bacterium, and MRSA infections are on the rise in hospitals, long-term care facilities and within communities. MRSA is resistant to many classes of commonly used antibiotics and can cause several types of infections, with skin infections being the most common. The Infectious Diseases Society of America (IDSA) has included MRSA on a reported Hit List of top-priority, dangerous drug resistant microbes that require additional research and new treatments.
Friday, December 21, 2007
With the completion of the deal, Reliant's cardiovascular medicines join the GSK portfolio in the US. These include Lovaza (omega-3-acid ethyl esters), an FDA-approved treatment for adult patients with very high levels of triglycerides. Triglycerides are fatty substances in the blood associated with increased risks of coronary artery disease.
Lovaza (formerly known as Omacor) is indicated as an adjunct to diet to reduce triglyceride levels in adults with very high (=500 mg/dL) triglyceride levels. In the nine months ending September 30, 2007, net sales of Lovaza were $206 million, an increase of 115 per cent over the first nine months of 2006.
GSK acquired Reliant, based in Liberty Corner, NJ, for $1.65 billion (£800 million) in cash and expects the transaction will be slightly accretive to earnings in 2008, excluding integration costs, and will create additional value in following years.
"We're eager to begin building on Reliant's success with Lovaza," said Chris Viehbacher, president, US Pharmaceuticals, GSK. "We think this medicine has significant potential to help larger numbers of patients, and we expect it to become an important driver of sales growth in the US."
The acquisition gives GSK marketing rights to Lovaza in the US and Puerto Rico. Pronova BioPharma ASA (Oslo:PRON), the compound's originator, has licensed rights in other markets to several other companies.
In addition to Lovaza, three other cardiovascular products marketed by Reliant will join the GSK portfolio in the US. They are DynaCirc CR (isradipine) and InnoPran XL (propanolol HCl), which treat high blood pressure, and Rythmol SR (propafenone), which treats abnormal heart rhythms, or arrhythmia.
Isentress (raltegravir) from MSD, First Integrase Inhibitor, Approved by the European Union Commission
The Commission’s decision, reflecting the positive opinion of the European Medicines Agency, was based on efficacy and safety data from two double-blind, placebo-controlled trials of 24 weeks duration in treatment-experienced patients. In these studies raltegravir, in combination with optimised background therapy (OBT), significantly reduced HIV RNA viral load (p<0.001), and significantly increased CD4 cell counts (p<0.001). The efficacy and safety of raltegravir have not been established in treatment-naïve adult patients or paediatric patients, although studies in these populations are underway.
“Raltegravir is an important new advancement in the treatment of HIV, because it is the first therapy in a new class of drugs that attacks the virus in a completely different way from other available medicines,” said Ken Frazier, executive vice president and president, Global Human Health, Merck & Co., Inc. “This approval marks another milestone in MSD's continued commitment to combating HIV and AIDS by conducting research for breakthrough medicines, developing business models that help our products reach as many people as possible, and participating in partnerships to help build infrastructure and address health and development challenges around the world."
Despite the availability of drugs to treat HIV and AIDS, the pandemic continues. In the EU, nearly 250,000 cases of HIV have been reported since 2002, according to the European Centre for the Epidemiological Monitoring of HIV and AIDS. Additionally, resistance to current HIV therapies in treatment-experienced patients has been noted in numerous international studies, suggesting that resistance to at least one class of antiretroviral agents may be as high as 76 percent. The World Health Organisation (WHO) has called resistance an emerging public health concern and has partnered with the International AIDS Society to develop the Global HIV Drug Resistance Surveillance Network to track emerging resistance patterns in developing and developed countries.
“Treatment-experienced HIV patients have limited options for therapies that are well-tolerated and can reduce viral loads while boosting CD4 counts,” said Jürgen Rockstroh, professor of medicine and head of the HIV Outpatient Clinic, University of Bonn, Germany. “The approval of raltegravir in the EU represents a significant scientific advancement, but more importantly, it addresses a much-needed evolution in the treatment of HIV and AIDS.”
Reduction in viral load and increase in CD4 cell counts
Raltegravir is being studied in two ongoing Phase III multi-centre, double-blind, randomised, placebo-controlled studies (BENCHMRK-1 and BENCHMRK-2) in 699 treatment-experienced adult patients with documented resistance to at least one drug in each of three classes [nucleoside reverse transcriptase inhibitors (NRTIs), non-nucleoside reverse transcriptase inhibitors (NNRTIs) and protease inhibitors (PIs)] of ARTs. Raltegravir 400 mg taken twice daily in combination with OBT was significantly (p<0.001) more effective at both reducing levels of HIV RNA and increasing CD4 cell counts in these patients, when compared to a regimen of placebo plus OBT. The efficacy responses were evaluated based upon the 699 patients from the pooled studies who had completed 24 weeks of treatment or discontinued earlier.
The studies showed that after 24 weeks of therapy, 75 percent of patients (347 out of 462) receiving raltegravir in combination with OBT achieved HIV RNA load reduction to below 400 copies/mL, compared to 40 percent of patients (95 out of 237) receiving placebo plus OBT. In addition, after 24 weeks of therapy, 63 percent of patients (289 out of 462) receiving raltegravir plus OBT achieved viral load reduction to below 50 copies/mL, compared to 34 percent of patients (80 out of 237) receiving placebo plus OBT. After 24 weeks of therapy, increases in CD4 cell counts from baseline were 84 and 37 cells/mm3 for patients receiving raltegravir plus OBT and for those receiving placebo plus OBT, respectively.
Raltegravir is a single 400 mg tablet taken twice daily without regard to food. Raltegravir does not require boosting with ritonavir. In Phase II and III clinical trials, the side effect profile was comparable with placebo. The most common side effects are diarrhoea, nausea, headache and pyrexia.
The United States Patent and Trademark Office Orders the Re-Examination of Two Patents Included in the Patent Litigation between Illumina and Affymetr
Any person may at any time request that the U.S. Patent Office re-examine a patent on the basis of prior art. The request for re-examination must explain the relevance of the prior art being brought to the attention of the Patent Office, and the manner of applying the cited prior art to every claim for which reexamination is requested. In its request for re-examination of the '432 and 243 patents Illumina has asked the Patent Office to re-examine all of the patent claims. Once, as in this case, the Patent Office has found that the cited prior art raises a substantial new question of patentability, the re-examination process typically takes about one year.
Detailed information about these re-examinations can be found on the U.S. Patent Office website which can be accessed at http://portal.uspto.gov/external/portal/pair. The U.S. Patent Office has yet to rule on the other requests for re-examination filed by Illumina regarding the three other patents that are the subject of the 2004 suit.
"We are pleased to hear that the U.S. Patent Office has decided to re-examine the validity of these two patents. We expect the Patent Office to consider closely the applicability of the prior art in their evaluation of whether these patents should be amended or invalidated in their entirety," said Jay Flatley, President and Chief Executive Officer of Illumina.
Teva Health Systems is a part of Teva Pharmaceuticals, the leading pharmaceutical manufacturer for both new and total prescriptions.‡ The company has an aggressive Research and Development effort and one of the best overall ANDA approval records in the industry.‡
The terms of the agreement specify a reduction in royalties owed to BioMarin on Merck Serono sales outside the United States and Japan. Based on the structure of the amended agreement, the reduction in royalties cannot exceed an undisclosed cap.
Kuvan is an oral small molecule for the treatment of phenylketonuria (PKU) developed in partnership with Merck Serono. Based on published literature, there are approximately 1,200 to 1,500 people under the age of 40 with PKU in Canada.
"Acquiring rights to Kuvan in Canada allows BioMarin to better coordinate commercialisation efforts in the North American market," said Stephen Aselage, Senior Vice President, Global Commercial Development, BioMarin. "This agreement with Merck Serono comes at an exciting time for the company and the PKU community after Kuvan was approved in the United States last week.
"Kuvan (sapropterin dihydrochloride) Tablet is indicated to reduce blood phenylalanine (Phe) levels in patients with hyperphenylalaninemia (HPA) due to tetrahydrobiopterin- (BH4-) responsive phenylketonuria (PKU). Kuvan is to be used in conjunction with a Phe-restricted diet.
The active ingredient in Kuvan, sapropterin dihydrochloride, is the synthetic form of 6R-BH4 (tetrahydrobiopterin), a naturally occurring enzyme cofactor that works in conjunction with phenylalanine hydroxylase (PAH) to metabolize Phe. BioMarin and Merck Serono estimate that Kuvan could be a potential treatment option for approximately 30 percent to 50 percent of the estimated 50,000 identified PKU patients in the developed world.
Kuvan has received orphan drug designation from both the US Food and Drug Administration (FDA) and the European Medicines Agency (EMEA). Kuvan has received seven years of market exclusivity in the United States. In November 2007, Merck Serono submitted a Marketing Authorization Application (MAA) to the EMEA for sapropterin dihydrochloride as an oral treatment for patients suffering from HPA due to PKU or BH4 deficiency. If approved in the EU, it will receive 10 years of market exclusivity for this indication.
PKU, a genetic disorder affecting approximately 50,000 diagnosed patients in the developed world, is caused by a deficiency of the enzyme phenylalanine hydroxylase. PAH is required for the metabolism of phenylalanine, an essential amino acid found in most protein-containing foods. If the active enzyme is not present in sufficient quantities, Phe accumulates to abnormally high levels in the blood and becomes toxic to the brain, resulting in a variety of complications including severe mental retardation and brain damage, mental illness, seizures, tremors, and limited cognitive ability.
The collaboration will apply Ambrx's unique protein optimisation technology, Recodetm, with Lilly's expertise in biologics discovery, development and commercialisation to pursue first-in-class or best-in-class drug candidates, including therapeutic antibodies and improved variants of native proteins, a company press release said.
"We are pleased to enter into this agreement with Lilly, a biologics leader with a proven ability to launch successful medicines in areas of strategic interest to Ambrx," said Stephen W. Kaldor, Ph.D., president and chief executive officer, Ambrx. "This new collaboration allows us to use our existing Recodetm technology to produce high quality protein clinical candidates while simultaneously affording us the ability to expand our reach into new areas such as therapeutic antibodies. In addition, this agreement will further solidify Ambrx's financial condition for the next several years."
Under the terms of the agreement, Ambrx will receive an initial upfront payment and ongoing research support payments. Ambrx may also receive potential research and development milestones and, if assets resulting from the collaboration are successfully commercialised, Ambrx would receive additional milestones and royalties. Other terms of the deal were not disclosed. This collaboration builds on an earlier agreement signed between the two companies in January 2007.
"Lilly continues to be impressed with the technical breadth and depth of the Ambrx scientific staff," commented Thomas Bumol, M.D., Lilly vice president, biotech discovery research and president of Lilly's Applied Molecular Evolution subsidiary. "By leveraging Ambrx technology with our protein engineering capabilities, we hope to accelerate the development of several promising compounds in our pipeline."
Ambrx Inc. is a biopharmaceutical company focused on the discovery and development of first-in-class and best-in-class BioSuperior, protein-based drugs. Using its technology, the company can overcome the performance limitations of high-value commercial proteins by improving their efficacy, safety and ease of use.
Thursday, December 20, 2007
Pfizer's European unit is a manufacturing centre for the US-based global major, which it decided to sell earlier this year. A group of Indian companies, mostly those focussed on contract manufacturing, are in the race to buy the asset, estimated to be between $60 and $100 million.
Financial terms which is expected to close in the first quarter were not disclosed.
With the deal, Pfizer is looking forward to the completion of its new Biotherapeutic and Bioinnovation Centre based in California. Based in La Jolla, California, CovX will operate as a division of Pfizer's new Biotherapeutic and Bioinnovation Centre, the company said in a recent press statement.
"The acquisition of CovX is a further step in Pfizer's strategy to acquire and identify new product candidates that we can put into development, leveraging both Pfizer's expertise and that of world-class scientists charged with discovering and bringing in new compounds," said Jeffrey Kindler, chairman and chief executive officer, Pfizer. ". We are looking for the best science wherever we can find it, with a special focus in our priority areas, such as biotherapeutics.
" CovX's biotherapeutic platform is a technology that links therapeutic peptides to an antibody "scaffold". The peptide targets the disease while the antibody scaffold allows the peptide to remain in the body long enough to achieve therapeutic benefit. The technology thereby allows half-life extension and bioavailability to support optimal dosing regimens for peptide therapeutics.
As validation of this technology, CovX has generated three early- stage compounds, one diabetes and two oncology compounds, that are expected to further strengthen Pfizer's biologic pipeline portfolio.
"This deal demonstrates Pfizer's ongoing commitment to build a competitive biotherapeutics enterprise through the acquisition of talented scientists, promising product candidates and a cutting edge technology platform," said Dr. Corey Goodman, president, Biotherapeutic and Bioinnovation Centre, Pfizer. "CovX scientists will remain in place, which reflects our decision to partner differently and maximize the productivity of the research initiatives underway outside of our walls."
"We are pleased to transition the CovX technology to Pfizer's Biotherapeutic and Bioinnovation group and are confident they have the vision and resources to scale the platform and realize the opportunity to make efficacious drugs which will make a difference in peoples' lives," stated Shehan Dissanayake, chairman, CovX and CEO, Tavistock Life Sciences. The acquisition is subject to customary closing conditions (including approval under the Hart-Scott-Rodino Antitrust Improvements Act of 1976), and is expected to close in the first quarter of 2008.
LEXINGTON, Mass., December 19, 2007 /PRNewswire-FirstCall/ -- Indevus Pharmaceuticals, Inc. today announced that it has received a non-approvable letter from the U.S. Food and Drug Administration (FDA) for Valstar(TM) related to its chemistry, manufacturing and controls (CMC) NDA supplement submitted to the FDA in May 2007. The letter was received following the Company's response to an August 2007 approvable letter.
The VALSTAR-specific issues that caused the 2002 withdrawal of the product from the market have been satisfactorily resolved. However, during a recent FDA pre-approval inspection of the Company's third-party manufacturing facility for VALSTAR, deficiencies were identified that require resolution prior to approval. The Company believes that successfully addressing the deficiencies at the manufacturing plant is the only remaining item for product approval. Upon resolution, which the Company expects to occur within several months, the Company will respond to the FDA and request re-inspection of the facility.
"We and our third-party manufacturer firmly believe we will be able to resolve the open cGMP issues within the next several months," stated Glenn L. Cooper, M.D., chairman and chief executive officer of Indevus. "We have been in direct communication with the FDA and they have committed to working closely with us and our manufacturer to resolve the open cGMP issues in an expeditious manner. They appreciate the need and desire to return VALSTAR, currently on the FDA Drug Shortages List, to the market as quickly as possible."
VALSTAR, a sterile solution of valrubicin for intravesical instillation, is the only product approved by the FDA for therapy of bacillus Calmette- Guerin (BCG)-refractory carcinoma in situ (CIS) of the urinary bladder. VALSTAR was removed from the market in 2002 due to impurities in the original formulation and was placed on the FDA Drug Shortages List. Indevus acquired VALSTAR through its acquisition of Valera Pharmaceuticals and after completing the resolution of the impurity issue, submitted a chemistry, manufacturing and controls (CMC) NDA supplement to the FDA in May 2007.
GlaxoSmithKline Files for FDA Approval of Promacta (eltrombopag) to be the First Oral Platelet Growth Factor for Rare Blood Disorder
PHILADELPHIA and LONDON, December 20, 2007 /PRNewswire-FirstCall/ -- GlaxoSmithKline today announced the submission of a New Drug Application (NDA) to the United States Food and Drug Administration (FDA) for approval to market PROMACTA(TM) (eltrombopag). If approved, eltrombopag would be the first oral platelet growth factor therapy for the short-term treatment of previously treated patients with chronic idiopathic thrombocytopenic purpura (ITP) to increase platelet counts and reduce or prevent bleeding. Chronic ITP is a disorder marked by increased platelet destruction and/or inadequate platelet production in the blood, which causes an increased risk of bruising and bleeding.(1,2) Eltrombopag is an investigational, once-daily oral treatment that induces the proliferation and differentiation of cells in the bone marrow to produce platelets.
"Patients with chronic ITP do not have a treatment option that offers the convenience of an oral platelet growth factor," said Paolo Paoletti, M.D., Senior Vice President of the Oncology Medicine Development Center at GSK. "GSK is pleased with the data provided to support the NDA and hopeful that, if approved, PROMACTA may provide physicians and chronic ITP patients with a new, convenient and effective option for treating this difficult disease."
GSK also plans to submit a Marketing Authorization Application (MAA) for eltrombopag in Europe in 2008.
Eurand initiated its rolling NDA submission in June 2007 and was granted fast-track designation by the FDA.
In the NDA, the Company included results from two Phase III trials, one pivotal trial, and a supportive trial of Zentase in pediatric patients. Also included in the NDA were results from a gastrointestinal (GI) bioavailability study of Zentase conducted in chronic pancreatitis patients in the U.S., which was completed in November 2007.
Gearoid Faherty, Chief Executive Officer of Eurand, commented, "The completion of our NDA filing for Zentase marks an important milestone for Eurand. With the file now under review, our current focus is on the build out of our Sales and Marketing infrastructure for the anticipated launch of Zentase and integrating the recently announced SourceCF acquisition."
Zentase is a porcine-derived pancreatic enzyme replacement therapy which is being developed to treat EPI, a condition associated with cystic fibrosis (CF), chronic pancreatitis and other conditions. The product is a highly stable formulation that includes eight key enzymes and a number of coenzymes and cofactors and is biologically similar to endogenous human pancreatic secretions necessary for proper human digestion
ABBOTT PARK, Ill., December 20, 2007 /PRNewswire-FirstCall/ -- Abbott has received marketing authorization from the European Commission for the use of HUMIRA(R) (adalimumab) as a treatment for moderate-to-severe plaque psoriasis. HUMIRA is the first fully human, self-injectable biologic for the treatment of psoriasis. In one clinical trial, more than 80 percent of patients taking HUMIRA achieved skin clearance of 75 percent or better and in another, almost three quarters of patients achieved 75 percent clearance. In both trials, nearly half of the patients taking HUMIRA achieved 90 percent clearance as early as 16 weeks into treatment. Psoriasis is the fifth approved indication for HUMIRA in the European Union. A regulatory application for HUMIRA to treat psoriasis is also under review with the U.S. Food and Drug Administration.
"Psoriasis is not only a skin disease -- it is a systemic, autoimmune disorder that, in its more severe forms, may require systemic treatment," said Professor Jean-Hilaire Saurat, M.D., chairman, department of dermatology, University of Geneva, Switzerland. "HUMIRA is the first and only biologic that has been compared to methotrexate, and this approval brings an important new option for dermatologists to treat this disease."
Psoriasis is a non-contagious, chronic autoimmune disease that causes the body to attack itself. The most obvious physical symptom of the condition is raised, inflamed, scaly, red skin lesions known as plaques, which may crack and bleed. Psoriasis is more than painful skin lesions; data also suggest an association with other health conditions, including psoriatic arthritis. Patients may also suffer from poor self-image and social isolation.
"Patients taking HUMIRA for psoriasis experienced rapid, significant skin clearance and maintained improvement for up to a year," said Eugene Sun, M.D., vice president, Global Pharmaceutical Clinical Development, Abbott. "This fifth indication for HUMIRA demonstrates its versatility in effectively treating multiple autoimmune disorders from rheumatoid arthritis to Crohn's disease and now psoriasis."
According to the European Patent Office (EPO) EPC2000 will bring the EPC up-to-date with the latest legal developments concerning patents internationally, will retain the time-tested structure and the high standards of quality for which the system in known and is intended to make the procedures before the EPO quicker, clearer and more efficient.
* Format for Allowable Patent Claims
Under the old law, if an invention related to a new medical use for a known compound, it was necessary to formulate the claims into the so-called "Swiss-type" format, i.e. "Use of a substance or composition X in the manufacture of a medicament for therapeutic application Y".
In contrast, under the new law, such a claim format is no longer necessary and for the first and each subsequent medical use of a compound or composition the more straightforward language of "Substance or composition X for use as a medicament" or "Substance or composition X for use in the treatment of Y" will be potentially allowable.
* Missed deadlines
Under the old law, if a European patent application was refused or deemed withdrawn following failure to reply to an official letter, the application could be reinstated without a loss of rights by requesting 'further processing', paying a 'further processing fee' and completing the omitted act within the extended time period set by the EPO. However, further processing could only be requested in limited circumstances. In other circumstances, where rights were lost, but it was not possible to request further processing a complex and costly process for re-establishing rights exists, but it was necessary to provide by filing evidence supporting the fact that it was not possible to meet the deadlines despite all due care having been taken.
In contrast, under the new law it will be possible to request further processing in the majority of cases where a deadline has been missed. This will greatly simplify the procedure involved, reduce costs and provide more certainty for applicants.
Other notable changes include the relevance of 'novelty only' prior art documents in the designated states, the requirements for obtaining a valid filing date for a European patent application and the introduction of a post grant central limitation and revocation procedure.
Whilst implementation of the new law will provide many advantages for applicants in the pharmaceutical sector and elsewhere, there is at least one change that will be unfavourable.
* "Multi-invention" applications
It is the established practice in most jurisdictions that a patent may only be granted for a single invention.
Under the old law, if an International patent application entered the European regional phase, and it related to more than one invention, it was possible to choose upon which invention future examination of the application should be based. This situation typically arose in a patent application relating to more than one gene sequence or protein where the EPO considered each gene sequence or protein to relate to a separate invention. The old law provided a convenient way for applicants to file a single patent application covering a large number of gene sequences or proteins and then to decide which gene sequences or proteins were the most important once further experiments had been performed.
Under the new law, if the EPO established the International Search Report (ISR), the resultant European patent application will automatically proceed on the basis of the first invention identified in the claims. If protection is required for other inventions included within the application, then it will be necessary to file one or more divisional applications, which can prove to be a costly exercise.
Accordingly, when preparing International patent applications which are to be examined by the EPO, it is advisable to decide upon the most important subject matter and to prepare the application so that this subject matter is the first subject matter identified in the claims.
If the EPO did not establish the ISR, then it will be possible to amend the claims on entry into the European regional phase to relate to the invention of choice.
Mark Sweetinburgh, a European Patent Attorney from Fry Heath Spence commented "In general, it appears that the changes to the law brought about by EPC2000 will be of benefit to applicants. However, it remains to be seen whether the benefits to those in the pharmaceutical industry will be outweighed by the restrictions imposed during the examination of multi-invention applications."
Tentative approval means that although existing patents and/or marketing exclusivity prevent the approval of the product in the United States at this time, the product meets all of FDA's manufacturing quality and clinical safety and efficacy requirements.
The action marks the first tentative approval for a nucleotide analog reverse transcriptase inhibitor (nRTI). The nRTIs block an enzyme called reverse transcriptase, which is important to HIV production.
“The fight to save lives with high-quality anti-retroviral treatment is of significant importance to FDA,” said Gary Buehler, director of FDA’s Office of Generic Drugs. “Our scientists have been working diligently to make safe and effective treatments for AIDS available as quickly as possible to combat this worldwide problem.”
Tenofovir disoproxil fumarate is the latest addition of an anti-retroviral product that can be considered for purchase under the President’s Emergency Plan for AIDS Relief (PEPFAR), a five-year, $15 billion effort to fight the HIV/AIDS pandemic — the largest commitment ever by a single nation toward an international health initiative.
All FDA reviews of applications received in association with the PEPFAR program are expedited. FDA reviewed this application for generic tenofovir disoproxil fumarate tablets in less than six months.
The U.S. Department of Health and Human Services and its agencies, including FDA, are part of an interagency effort under PEPFAR to accomplish the President's goals of treating 2 million HIV-infected people, preventing 7 million new infections, and caring for 10 million people infected with and affected by HIV/AIDS, including orphans and vulnerable children.
As of Sept. 30, 2007, PEPFAR supported life-saving anti-retroviral treatment for a total of more than 1.3 million men, women and children in 15 focus countries in sub-Saharan Africa, Asia and the Caribbean. On May 30, 2007, President Bush announced that he would work with Congress to reauthorize PEPFAR for another five years.
The tenofovir disoproxil fumarate 300 milligram tablets are manufactured by Matrix Laboratories, LTD, of Andhra Pradesh, India.
Wednesday, December 19, 2007
IV Busulfex is an oncologic product marketed and sold by PDL in the United States (US) and Canada, and through distributors in a number of other countries.
"The acquisition of IV Busulfex, a first-in-class drug therapy for conditioning prior to allogeneic haematopoietic progenitor cell transplantation, and the oncology expertise of PDL accelerates Otsuka's global oncology business," said Tatsuo Higuchi, President and Representative Director of Otsuka Pharmaceutical Co., Ltd. "We are currently developing first-in-class oncology drugs in the United States, including drugs to treat severe cancer pain (currently in phase II), along with oral mucositis and leukaemia (currently in phase I). Our focus is on global opportunities to contribute to the health of patients who are suffering from severe illness."
"We're pleased to enter into this agreement with Otsuka, which builds on the successful efforts of PDL's commercial team and enables this important product to continue to benefit patients worldwide," said L. Patrick Gage, Ph.D., PDL's interim chief executive officer.
"This transaction is a first step to deliver on our strategic goal to maximize value for our stockholders through our ongoing strategic process."This transaction follows PDL's decision, announced on October 1, 2007, to actively pursue the sale of its key assets. PDL continues with this strategic process, which includes working to maximize the value of its royalty stream, commercial products and antibody discovery, development and manufacturing assets.
Following the close of the transaction, OPC will oversee the outsourced manufacturing of the product, while its U.S. affiliate, Otsuka Pharmaceutical Development & Commercialization, Inc. (OPDC), will initiate clinical studies to investigate potential new indications for IV Busulfex.
Another OPC affiliate, Otsuka America Pharmaceutical, Inc. (OAPI), will market the product for its current indication in the United States. OPDC was established in 2007 and OAPI was established in 1989 by Otsuka America, Inc. (OAI). Both OPDC and OAPI are wholly owned by OAI, which is the holding company for OPC's interests in the US. OAI is wholly owned by OPC.
The transaction has been approved by the boards of directors of both companies and is expected to close in the first quarter of 2008, subject to antitrust clearance under the Hart-Scott-Rodino Act and satisfaction of other customary conditions.
Montgomery and Co., LLC is acting as financial advisor and Heller Ehrman LLP is acting as legal advisor to OPC in connection with the transaction. Merrill Lynch & Co. is acting as financial advisor and DLA Piper is acting as legal advisor to PDL in connection with the transaction. ]
IV Busulfex was approved by the U.S. Food and Drug Administration (FDA) in 1999 for use in combination with cyclophosphamide as a conditioning regimen prior to allogeneic haematopoietic progenitor cell transplantation (also referred as blood or bone marrow transplantation or BMT) for chronic myelogenous leukemia (CML). IV Busulfex is the only drug that is FDA-approved for use in combination with cyclosphosphamide as a conditioning agent in allogeneic haematopoietic stem cell transplantation for CML.
During the 12 months ended September 30, 2007, IV Busulfex sales were $29.4 million, a 29.7 percent increase over the $22.7 million in sales in the prior 12-month period. IV Busulfex is marketed in more than 40 countries worldwide.
Tuesday, December 18, 2007
The agency sent the company an approvable letter for the drug’s proposed prevention indication, requesting data from a Phase III trial, including information on bone fractures.
The data Wyeth submitted come from two trials conducted in Asia. These data also supplement the company’s pending NDA for Viviant (bazedoxifene) to prevent postmenopausal osteoporosis.
The action date for the prevention NDA is the end of this month, but no labeling discussions have taken place yet, the company said. It added that the agency may issue an action letter by the end of the year or extend the review period by 90 days as a result of the new data submission.
The FDA action date for Wyeth’s separate NDA for Viviant as a treatment for postmenopausal osteoporosis remains the end of May 2008, the company said. — Martin Gidron
Pfizer first announced the acquisition of Coley last month. The publicly held biopharmaceutical company specializes in vaccine adjuvant technology and a new class of immunomodulatory drug candidates designed to fight cancers, autoimmune diseases and allergy and asthma disorders.
Acquiring Coley is part of Pfizer’s strategy to research new vaccines to prevent infectious diseases and treat cancers and other debilitating conditions, Jeffrey Kindler, Pfizer chairman and CEO, said. Areas where the two firms already are cooperating on research include Alzheimer’s disease, asthma, infectious diseases and oncology.
CovX specializes in preclinical oncology and metabolic research and is a developer of a biotherapeutics technology platform that has led to three early-stage compounds — one in diabetes and two in oncology. Pfizer’s acquisition of the firm is expected to close in the first quarter of 2008. — Martin Gidron
Insmed Receives FDA Orphan Drug Designation for Iplex in the Treatment of Myotonic Muscular Dystrophy
"This Orphan Drug Designation is another milestone for Insmed in our development and commercialization plan for IPLEX(TM) in MMD," said Geoffrey Allan Ph.D., Insmed's President and Chief Executive Officer. "Orphan status, combined with the recent $2.1 million MDA grant, positions us well to continue advancing this important product candidate through clinical development, and maximize the market opportunities for MMD available to us."
Orphan status is granted by the FDA to promote the development of products that demonstrate promise for the treatment of rare diseases affecting fewer than 200,000 Americans annually. This orphan drug designation for IPLEX(TM), grants Insmed seven years of market exclusivity upon approval for the MMD indication. In addition, Insmed is eligible for tax credits relative to its development costs, as well as assistance from the FDA in advancing the drug candidate through the regulatory process.
MMD affects approximately 37,000 Americans, and nearly 60,000 people in the European Union. MMD is a genetic disease characterized by endurance loss, muscle wasting, weakness, pain, cognitive impairment and gastro-intestinal dysfunction. There is currently no cure for the disease, and no specific treatment has been developed to satisfactorily reverse or ameliorate the common symptoms associated with the disease.
Epeius Biotechnologies Gains Commercial Approval for Rexin-G(R), a Tumor-Targeted Gene-Based Medicine for Metastatic Cancer
Beta blockers are one of the most widely used classes of drugs in the United States. In an extensive clinical trial program involving more than 2,000 patients, Bystolic demonstrated significant reductions in sitting diastolic and systolic blood pressure in a general hypertensive population, which included 26 percent Black, 54 percent male, 19 percent elderly and 8 percent diabetic patients. The studies also found that Bystolic was well tolerated, with a low incidence of traditional beta blocker side effects. Like other beta blockers, Bystolic decreases heart rate and myocardial contractility, and suppresses renin activity. Bystolic is a selective beta 1 blocker at doses less than or equal to 10 mg per day and has the added pharmacological properties of producing vasodilation and reducing total peripheral resistance.
"Bystolic is the newest beta blocker approved for the treatment of hypertension in the U.S. and should prove useful due to its efficacy in a broad range of patients and its favorable side effect profile," said Michael Weber, MD, Professor of Medicine at SUNY Downstate College of Medicine. "These features will be attractive to both physicians and patients."
Howard Solomon, Chairman and Chief Executive of Forest, commented: "We, along with our partner Mylan, are pleased to have received final Food and Drug Administration marketing approval for Bystolic. Bystolic represents an important advance for patients with hypertension and the physicians who treat them and will be an important new product for our Company."
Bystolic is already approved and successfully marketed for the treatment of hypertension in more than 50 countries outside of North America. Mylan licensed the U.S. and Canadian exclusive rights to nebivolol from Janssen Pharmaceutica N.V., Belgium in 2001.
Forest licensed U.S. and Canadian rights to Bystolic from Mylan Inc. in January 2006. Forest will market Bystolic in the U.S. and will pay Mylan undisclosed royalty payments as part of their collaboration agreement.
Forest expects Bystolic to be available to physicians, patients, and pharmacies in January 2008.
Bystolic is a beta blocker, a well-established class of medications that reduces blood pressure by reducing the force with which the heart pumps. It is a new drug not previously approved in the United States.
Nearly one in three adults in the United States has high blood pressure, also called hypertension, which can increase the risks for stroke, heart failure, heart attack, kidney failure, and death.
"High blood pressure is often called the 'silent killer' because it usually has no symptoms until it causes damage to the body," said Douglas C. Throckmorton, M.D., FDA's deputy director of the Center for Drug Evaluation and Research. "Bystolic offers a new treatment option for people who need to control their high blood pressure."
The safety and efficacy of Bystolic in lowering blood pressure was assessed in three randomized, double-blind, multi-center, placebo-controlled clinical trials that ran for up to three months.
A fourth placebo-controlled clinical trial demonstrated additional blood pressure-lowering effects when Bystolic was given with up to two other antihypertensive medications in patients with inadequate blood pressure control. In total, more than 2,000 people received Bystolic during the trials. Its efficacy during the trials was similar to those of other FDA-approved beta blockers.
The most common side effects reported by patients taking Bystolic in clinical trials were headache, fatigue, dizziness and diarrhea.
Mylan Bertek Pharmaceuticals Inc. of Research Triangle Park, N.C., is the sponsor of Bystolic. New York City-based Forest Laboratories, Inc. owns the rights for the sales and marketing of the drug.
Eisai Enters Into In-licensing Agreement Minophagen Pharmaceutical for Liver Disease/Allergic Disease Agents Stronger Neo-Minophagen and Glycyron tab
With this agreement, Eisai will assume exclusive rights for development and marketing of these products in Japan and in the Euro-Asia countries and region where the products are yet to be sold.*1 For China and the Euro-Asia countries and region where the products are currently sold*2, Eisai will assume exclusive first negotiation rights, with exclusive marketing rights in China upon termination of the existing agreement between Minophagen Pharmaceutical and its current local marketing partner. The companies expect to transfer the marketing activities to Eisai in China on April 1, 2009. In Japan, transfer of the marketing activities for Stronger Neo-Minophagen® C and Glycyron® Tablets are expected to take place on April 1, 2008 and October 1, 2008, respectively.
It has been reported that about 170 million people in China are affected with viral hepatitis and 70 percent of these cases are hepatitis B, which is treated by antiviral therapy and immunotherapy including interferon or hepato-protector therapy. Currently, Eisai is developing clevudine, an antiviral agent for viral hepatitis B that has been licensed by Bukwang (Korea), and by introducing the two agents announced today to Eisai's product lineup, Eisai can make further contributions to the patients and their families in China.
In Japan, approximately 2.8 million people are estimated to be affected with viral hepatitis, with more than half of this population being afflicted with chronic hepatitis C. Introduced in 1948 and in 1957, Stronger Neo-Minophagen® C and Glycyron® Tablets have been widely used in the treatment for improvement of abnormal hepatic function in chronic hepatitis C, especially when eradication of hepatitis C virus is difficult.
Moreover, the studies conducted in Europe have shown the effectiveness of Stronger Neo-Minophagen® C in improving abnormal hepatic function in patients with chronic hepatitis C where interferon therapy does not work. The results of the studies were presented at the American Association for the Study of Liver Diseases conference in November, 2007.
Eisai has been making efforts for research activities in the hepatic disease area with support from medical specialists in Japan since the 1960's. The results of these efforts have led to the introduction of the PIVKA-II series, a diagnosis product for hepatocellular cancer in 1989, which has been enabling Eisai to address the needs in the area of hepatic diseases. Additionally, Eisai has been focusing on gastrointestinal disorders as one of the strategic areas. In Japan, Eisai markets a proton pump inhibitor Pariet® and gastritis/gastric ulcer treatment Selbex®.
With this agreement, Eisai can enhance its product lineup for the gastrointestinal disorders area that is available in countries in Asia including Japan and China, and thereby make further contributions to increase the benefits to patients and their families.