PHARMACY

P&G wins patent infringement lawsuit for Actonel

BY Allison Cerra

CINCINNATI The U.S. Court of Appeals for the Federal Circuit ruled in favor of Procter & Gamble in the patent infringement lawsuit filed by P&G against Teva Pharmaceuticals over an osteoporosis therapy.

The ruling protects P&G’s rights in the United States to exclusively market the osteoporosis therapy Actonel (risedronate sodium) tablets. Actonel is commercialized through a collaboration between Procter & Gamble Pharmaceuticals and Sanofi-Aventis.

On August 13, 2004, P&G filed a patent infringement lawsuit against Teva to enforce P&G’s U.S. composition of matter patent for risedronate, the active ingredient in Actonel. Teva sought to market a generic version of Actonel in the United States under the assertion that the Actonel patent was not valid due to obviousness of the invention. On Feb. 28, 2008, the Court ruled in favor of P&G, expressly rejecting Teva’s validity challenge. Shortly afterwards, Teva filed an appeal of the decision. Oral arguments for the appeal were heard in December 2008.

The Actonel patent life extends through June 2014, including a pediatric extension, which was granted last month. Actonel was approved in 2000 by the FDA for the prevention and treatment of osteoporosis in postmenopausal women. Actonel is the only oral monthly postmenopausal osteoporosis therapy approved to reduce the risk of both spine and non-spine fractures (non-spine fractures were measured as a group, not separately).

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Sanofi-Aventis U.S. acquires rights to leukemia drug

BY Alaric DeArment

BRIDDGEWATER, N.J. The U.S. subsidiary of French drug maker Sanofi-Aventis has acquired the rights to a drug for treating chronic lymphocytic leukemia, the company announced.

Sanofi-Aventis U.S. said it acquired the drug Oforta (fludarabine phosphate) from biotech company Antisoma. Oforta, a tablet, is approved in the United States for treating B-cell chronic lymphocytic leukemia in adults.

“We are extremely pleased to add Oforta to our existing oncology portfolio and believe it represents an exciting opportunity for Sanofi-Aventis U.S.,” the company’s VP and head of its Oncology Business Unit John Harrington stated. “Sanofi-Aventis is a company committed to identifying and exploring new treatment options for patients facing serious diseases, such as CLL.”

Antisoma licenses certain rights and purchases Oforta from Bayer Schering Pharma. Sanofi-Aventis U.S. will acquire the agreements under the transaction.

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McKesson to oversee strategic vaccine reserve

BY Jim Frederick

SAN FRANCISCO McKesson Corp. has been tapped by the Centers for Disease Control and Prevention to store and supply the nation’s strategic reserve of 2008-2009 seasonal influenza vaccines.

Under a contract signed with the CDC, McKesson will warehouse and potentially distribute up to 500,000 flu vaccine doses from its specialty distribution centers.

Behind the agency’s choice of McKesson: the company’s ability to handle the special storage and supply-chain requirements of distributing vaccines. The health services and distribution giant also holds the appropriate local, state and federal licenses for safely handling and transporting regulated drug products.

“Outsourced vaccine storage requires a distributor with experience and infrastructure to assure that supply chain systems are stable and secure,” said Philip Bolger, VP and general manager for distribution and physician services at McKesson Specialty Care Solutions. “In addition, McKesson can support the compressed timetable for vaccine distribution across the U.S. and its territories.”

Given their composition and limited shelf life, vaccines require special handling to maintain their viability through the storage and distribution process. “Precise cold chain management is critical to the product being received by the end user in manufacturer-recommended conditions,” the company noted.

Through a previous contract with the CDC, McKesson already supplies vaccines for public-sector needs. Two of its specialty distribution centers are primarily dedicated to that program, which shifted to a centralized distribution model in 2007 and delivers pediatric and adult vaccines to more than 46,000 providers across the United States and its territories.

“The demands of CDC programs require a distributor with experience, flexibility and vision, and we are honored by the CDC’s continued confidence in McKesson to meet these needs,” said Pat Blake, president of McKesson Specialty Care Solutions.

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