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PTSM: Pharmaceutical Technology Sourcing and Management
Volume 3, Issue 7

Paris (June 29)Sanofi-Aventis withdrew its new drug application for rimonabant for the treatment of obesity in the United States. A US Food and Drug Administration (Rockville, MD) advisory panel recently said that the drug should not be approved because it may increase suicidal thoughts and depression. European regulatory authorities are reviewing the safety and efficacy data for the drug. Sanofi says it is working with FDA on required modification to resubmit its file at a future date.

Titusville, NJ (June 28, 2007)—The European Commission (Brussels) granted marketing authorization for Johnson & Johnson's (New Brunswick, NJ) "Invega" (paliperidone prolonged release tablets), an atypical antipsychotic medication for the treatment of schizophrenia. This once-daily medication is specifically designed to deliver paliperidone, the active ingredient in Invega, through the osmotic delivery system "OROS." Invega was approved in the United States in December 2006.

Darmstadt, Germany (June 28)Merck KGaA reported that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has issued a positive opinion recommending marketing authorization of a new formulation of "Rebif" (interferon beta-1a) for treating relapsing multiple sclerosis. The CHMP recommendation will now be considered by the European Commission, which will deliver its final decision on the granting of the marketing authorization.

Whitehouse Station (June 27) Merck & Co., Inc. reported the US Food and Drug Administration (Rockville, MD) has accepted the new drug application for "Isentress" (raltegravir). Isentress is an antiviral agent called an integrase inhibitor that inhibits the insertion of HIV DNA into human DNA. FDA granted Isentress priority review status. Merck anticipates FDA action by mid-October and is moving forward with regulatory filings in countries outside of the United States.

London (June 22)—The competition between biosimilars and branded drugs intensified followong favorable reviews of three biosimilar products for a popular treatment for anemia. During a June 18–21 meeting, the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) recommended marketing authorization for three products shown to be similar to "Eprex/Erypo" (epoetin alfa) manufactured by Janssen-Cilag, a subsidiary of Johnson & Johnson (New Brunswick, NJ). CHMP granted positive opinions to "Binocrit" from Sandoz GmbH (Holzkirchen, Germany), "Epoetin alfa Hexal" from Hexal Biotech Forschungs GmbH (Holzkirchen, Germany), and "Abseamed" from Medice Arzneimittel Puetter GmbH & Co

Epoetin alfa is an injectable protein drug for treating anemia associated with chronic kidney disease and in oncology patients. It also is the active ingredient in "Epogen" (epoetin alfa recombinant) from Amgen (Thousand Oaks, CA) and "Procrit" (epoetin alfa) from Ortho Biotech (Bridgewater, NJ), a Johnson & Johnson Company.

Washington, DC (June 22)—Senators Orrin Hatch (R-UT), Edward Kennedy (D-MA), Michael Enzi (R-WY), and Hillary Clinton (D-NY) agreed on legislation that would authorize the US Food and Drug Administration (Rockville, MD) to approve follow-on versions of biologic therapies. The legislation establishes standards by which FDA would approve follow-on biologics, a means to quickly resolve patent disputes, and incentives that encourage innovation and the development of new therapies.

Announcing the legislation, titled the "Biologics Price Competition and Innovation Act of 2007," Senator Hatch stated that biologics are the future of medicine. He remarked, "Just as we did with Hatch–Waxman in 1984, we're giving incentives for both pioneer and generic drug firms. We're ensuring that we continue to get the latest medical breakthroughs while creating a clear pathway to get less expensive biologics on the market quickly."

The act would require an applicant to demonstrate the absence of clinically meaningful differences in safety, purity, and potency between its biosimilar product and the brand product. The demonstration includes analytical data, animal testing, and at least one clinical study, unless FDA determines this requirement is unnecessary.

Under the legislation, FDA could approve a biosimilar product as interchangeable, thus allowing it to be substituted for the brand product without the intervention of the prescribing healthcare provider. To demonstrate interchangeability would require evidence that the biosimilar product produces the same clinical result as the brand product in any patient and presents no additional risk in terms of safety or diminished efficacy if a patient changes between products.

As an incentive for the development of new biological products and interchangeable biosimilar products, the act grants 12 years of data exclusivity for the brand company, during which a biosimilar product may not be approved. The act also provides one year of exclusivity for the first interchangeable biological product.

The legislation outlines a process for identifying and resolving patents that the biosimilar product may infringe. The biosimilar applicant and the brand company together would identify the patents at issue and offer their opinions as to their validity. The two parties then would either agree to a list of these patents to be litigated first or exchange lists. The brand company must then sue the biosimilar applicant within 30 days to defend the patents. If a court decides that a patent is valid and was infringed by the biosimilar product before the 12-year data exclusivity has ended, the court must enjoin infringement of the patent until it expires. For identified patents not included in this initial litigation, the biosimilar applicant must give the brand company notice 180 days before it launches its product, and the brand company may then seek a preliminary injunction to block the launch.

New York (June 20)Pfizer Inc discontinued its development program in lung cancer for PF-3512676, an investigational compound, in combination with cytotoxic chemotherapy. This includes two Phase III clinical trials and two Phase II clinical trials. Pfizer licensed PF-3512676 from Coley Pharmaceutical Group (Wellesley, MA).

New York (June 20)Pfizer Inc. reported that the US Food and Drug Administration (Rockville, MD) issued an approvable letter for maraviroc, which is under review as a therapy for treatment-experienced patients infected with CCR5-tropic HIV-1.

New York (June 19)—The US District Court for the Southern District of New York affirmed the validity and enforceability of Sanofi-Aventis's (Paris) patent on clopidogrel bisulfate. Clopidogrel is the active ingredient in "Plavix," the company's treatment for coronary artery disease. The court's decision effectively maintains patent protection for this product in the United States until November 2011. Sanofi-Aventis and Bristol-Myers Squibb (New York) market Plavix jointly.

The court found that Apotex 's (Weston, ON, Canada) generic clopidogrel bisulfate infringed on Sanofi-Aventis's patent and prohibited Apotex from marketing the product in the United States until its patent expires. The Court rejected Sanofi's and BMS's request to make Apotex recall product it had already shipped.

On August 31, 2006, the court granted Sanofi's and BMS's request for a preliminary injunction to halt sales of Apotex's generic version of clopidogrel. Apotex subsequently filed a motion to stay the injunction, which the court denied.

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