PHARMACY

AstraZeneca gets six more months of Arimidex exclusivity

BY Drew Buono

WILMINGTON, Del. The Food and Drug Administration has granted AstraZeneca an additional six-month period of exclusivity to market Arimidex for its breast cancer indications until June 2010.

The drug is currently approved to treat postmenopausal women with hormone receptor positive early breast cancer following surgery or without radiation. The drug is also indicated for first-line treatment for unknown locally advanced or metastatic breast cancer, as well as treatment following tamoxifen therapy.

In the U.S., Arimidex sales were $507 million for the first nine months of 2007.

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IMPAX announces limited resumption of sales of oxycodone

BY Drew Buono

STAMFORD, Conn. IMPAX Laboratories and its distributor DAVA Pharmaceuticals will resume sales of its oxycodone hydrochloride extended-release tablets in a limited capacity starting today.

This is in response to an agreement the companies signed with Purdue Pharma, who manufactures the brand version, Oxycontin, which is used for the management of moderate to severe pain when a continuous around-the-clock analgesic is needed for an extended period of time. The agreement said that IMPAX acknowledged that Purdue’s patents for Oxycontin were valid, enforceable and infringed on by their generic version. Purdue in return, allowed the companies to continue selling the product on the market until June 14, and to resume the distribution at a future date for a limited period of time.

The sales of the generic are expected to continue until around Jan. 28, 2008, or until the company’s sales quota under the license agreement with Purdue has been reached.

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Isis grants Excaliard license for development of antisense drugs

BY Drew Buono

CARLSBAD and ENCINITAS, Calif. Isis and Excaliard Pharmaceuticals have entered into an agreement to discover and develop antisense drugs for the local treatment of fibrotic diseases, including scarring. Isis has granted Excaliard an exclusive worldwide license for the development and commercialization of certain antisense drugs.

Under the agreement, Excaliard made an upfront payment in the form of equity and paid $1 million cash to Isis for the licensing of a particular gene target. Isis will also be eligible to receive development milestones and royalties on antisense drugs developed by Excaliard.

“Isis has made superb progress in the development of second-generation antisense drugs over the last few years, as evidenced by its clinical pipeline and current collaborations with companies such as Bristol-Myers Squibb, Eli Lilly and Ortho-McNeil, among others,” said Excaliard co-founder J. Gordon Foulkes, acting chief executive officer for Excaliard and managing director of RiverVest Venture Partners. “Having access to Isis’ antisense technology and expertise provides a great opportunity for Excaliard.”

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