PHARMACY

GSK, Impax ink licensing deal for Parkinson’s drug

BY Allison Cerra

LONDON and HAYWARD, Calif. — GlaxoSmithKline will pay Impax Pharmaceuticals $11.5 million upfront to exclusively sell Impax’s investigational Parkinson’s disease treatment.

In addition to the $11.5 million upfront payment, Impax Pharmaceuticals, the branded drug division of Impax Labs, is eligible to receive potential payments of up to $175 million upon the successful achievement of development and commercialization milestones.

Impax Pharmaceuticals will manufacture and supply IPX066 — which currently is undergoing late-stage clinical trials — to GSK, which will have the opportunity to sell IPX066 throughout the world, except in the United States and Taiwan.

Impax said it expects to file a new drug application in the United States for the Parkinson’s disease drug in late 2011, and will be responsible for commercialization here.

“We are very pleased to announce this development and collaboration agreement with GSK, which is a significant milestone in the development of Impax and an important achievement in the planned global commercialization for IPX066 for the treatment of Parkinson’s disease,” stated Michael Nestor, Impax Pharmaceuticals president. “GSK is an ideal partner for IPX066, combining global best-in-class development [and] regulatory and commercial experience in Parkinson’s disease, which will be an asset in the successful commercialization of IPX066.”

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FDA looks to pull the plug on Avastin’s breast cancer indication

BY Allison Cerra

SILVER SPRING, Md. — Just a few months after a Food and Drug Administration advisory committee recommended limiting the use of a Genentech drug designed to treat breast cancer, the regulatory agency is looking to revoke the approval altogether.

The FDA on Thursday said it was in the process of removing the breast cancer indication from Avastin (bevacizumab) after reviewing the results of four clinical studies, which indicated that the drug "does not prolong overall survival in breast cancer patients or provide a sufficient benefit in slowing disease progression to outweigh the significant risk to patients," the agency said.

The FDA issued its proposal to withdraw the drug to Genentech. The drug maker has the opportunity to request a public hearing if it wishes to contest the agency’s determination.

“After careful review of the clinical data, we are recommending that the breast cancer indication for Avastin be removed based on evidence from four independent studies,” said Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research. “Subsequent studies failed to confirm the benefit observed in the original trial. None of the studies demonstrated that patients receiving Avastin lived longer, and patients receiving Avastin experienced a significant increase in serious side effects. The limited effects of Avastin combined with the significant risks led us to this difficult decision. The results of these studies are disappointing. We encourage the company to conduct additional research to identify if there may be select groups of patients who might benefit from this drug.”

In July, the Oncologic Drugs advisory committee voted 12-to-1 that use of Avastin (bevacizumab) combined with paclitaxel chemotherapy as a first-line treatment for advanced HER2-negative breast cancer be removed from the drug’s labeling.

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NACDS Foundation grants funds to expand CPRPs

BY Allison Cerra

ALEXANDRIA, Va. — The education, research and charitable affiliate of the National Association of Chain Drug Stores announced its contribution of $1.5 million in grants to expand the availability of Community Pharmacy Residency Programs for pharmacy graduates.

CPRPs allow pharmacy residents to focus on providing direct patient care, developing patient care services with pharmacist preceptor oversight, the NACDS Foundation said. The NACDS Foundation seeks to jumpstart 30 new community pharmacy residencies nationwide — a 25% increase in total residency positions.

“The NACDS Foundation is pleased to help support the growth of community pharmacy residencies. These programs have been integral in enhancing patient care services and integrating these services into the community pharmacy practice setting,” said NACDS Foundation president Edith Rosato.

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