PHARMACY

Sigmapharm files ANDA for generic Hepsera

BY Allison Cerra

FOSTER CITY, Calif. A generic drug maker has filed an abbreviated new drug application for its version of a Gilead Sciences drug.

FOSTER CITY, Calif. A generic drug maker has filed an abbreviated new drug application for its version of a Gilead Sciences drug.

Sigmapharm is looking to receive regulatory approval from the Food and Drug Administration for generic Hepsera (adefovir dipivoxil). In a notice letter sent to Gilead, Sigmapharm alleged that two patents associated with Hepsera — U.S. Patent Numbers 5,663,159 and 6,451,340 — owned by Gilead Sciences are invalid, unenforceable and/or will not be infringed by Sigmapharm’s manufacture, use or sale of the product described in its ANDA submission.

 

Gilead currently is reviewing the notice letter and has 45 days from the date of receipt to commence a patent infringement lawsuit against Sigmapharm. Such a lawsuit would restrict the FDA from approving Hepsera’s ANDA for up to 30 months or until a district court decision that is adverse to Gilead, whichever occurs first.

 

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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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