PHARMACY

Affordable Care Act pays off for Medicare beneficiaries, Sebelius says

BY Allison Cerra

WASHINGTON More than 1 million Medicare beneficiaries have received prescription drug cost relief through the Affordable Care Act, Department of Health and Human Services secretary Kathleen Sebelius announced.

Eligible beneficiaries automatically receive rebate checks in the mail — which are designed to help beneficiaries save money on their prescription drugs — when they reach the coverage gap, or “doughnut hole,” and they don’t have to sign up to be eligible for the rebates. Next year, those who fall into the doughnut hole will receive a 50% discount on covered brand-name medications while in the coverage gap. In addition to helping Medicare beneficiaries save on prescription drug costs, the Affordable Care Act also seeks to prevent fraud against seniors, Sebelius said.

“Many seniors and people with disabilities on Medicare face extraordinary prescription drug costs, and too often stop following the drug regimens that their doctors have recommended as a result,” Sebelius said. “These checks will make a difference in helping seniors continue to get the medications they need, and are one of many ways that the Affordable Care Act is helping seniors.”

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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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