PHARMACY

FDA pushes back GSK-Valeant drug review

BY Allison Cerra

LONDON The Food and Drug Administration has pushed back its review date for a drug made by GlaxoSmithKline and Valeant Pharmaceuticals.

The FDA has not yet completed the review of the new drug application for ezogabine, a drug designed to treat epileptic adults with partial onset seizures, after a formal risk evaluation and mitigation strategy was submitted to the agency from GSK and Valeant, per its request.

The FDA is expected to review the application by Nov. 30.

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MedImmune confirms second CRL from FDA for motavizumab

BY Allison Cerra

GAITHERSBURG, Md. AstraZeneca’s biologics unit has received a second complete response letter from the Food and Drug Administration regarding an investigational drug designed to treat respiratory syncytial virus disease.

In the second CRL, the FDA requested that MedImmune complete an additional clinical trial that supports a satisfactory risk/benefit profile to advance the registration of motavizumab, its investigational monoclonal antibody.

MedImmune filed the original biologics license application in January 2008 and received its first complete response letter in November 2008. Motavizumab was reviewed by the FDA’s Antiviral Drugs Advisory committee on June 2 of this year.

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Somaxon, P&G to co-promote Silenor

BY Allison Cerra

SAN DIEGO A drug maker and a consumer packaged goods company will co-promote a newly approved insomnia treatment.

Somaxon Pharmaceuticals and Procter & Gamble announced their co-promotion agreement for Silenor, in which Somaxon’s promotion of the drug will target physicans, while P&G will promote Silenor to targeted pharmacies.

Somaxon will record all sales of Silenor and will pay P&G a combination of fixed fees and a royalty based on U.S. net sales. Each party will be responsible for the costs of maintaining and operating its own sales force, and Somaxon is responsible for all other costs pertaining to the commercialization of Silenor.

The term of the agreement runs through Dec. 31, 2012, renewable thereafter, and Somaxon will pay P&G a reduced royalty based on U.S. net sales of Silenor for one year after the expiration of the agreement or its earlier termination under certain circumstances. Governance of the collaboration will occur through a joint commercialization committee.

 

“We are extremely excited to add Procter & Gamble’s highly regarded and tenured professional sales force to our commercialization effort for Silenor,” said Richard Pascoe, Somaxon’s president and CEO. “With the combined effort of both sales forces, we will target 35,000 of the highest prescribers of insomnia products, as well as 25,000 pharmacies, which we believe will allow us to be highly competitive in the insomnia market. In addition, we are excited about the potential to partner with Procter & Gamble for the OTC rights to Silenor as a future life cycle management opportunity.”

 

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