PHARMACY

Biogen Idec looks to sell itself by 2008

BY Drew Buono

CAMBRIDGE, Mass. The biotech company Biogen Idec is trying to sell itself before the year ends and is now accepting offers from major pharmaceuticals companies, according to boston.com.

The shares of the company have fallen off steeply over the last month, based on worry that the company would not accept much of a premium. Others worry that the company might not even sell at all.

Biogen’s key drugs are manufactured under deals with other companies like Genentech and Elan. Rituxan, which is used to treat cancer patients with indolent and aggressive non-Hodgkin’s lymphoma is manufactured under an agreement between Biogen and Genentech. Tysarbi, a multiple sclerosis drug, is made under a deal between the company and Elan.

Tysarbi seems to be the key in the deal. The drug was removed from the market two years ago, when it was found the drug was linked to a rare brain disease. Since it has been put back on the market, the company has announced that the drug has not repeated these symptoms.

The company also forecasts that use of the drug will rise from 17,000 patients today to 100,000 by 2010. So far, a number of major drug companies have been mentioned as potential bidders, including Pfizer, GlaxoSmithKline, Novartis, Merck, Johnson & Johnson and Bristol-Myers Squibb, though it’s unclear which of them—if any—have actually submitted bids.

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Cephalon submits application to FDA for supplemental uses of Fentora

BY Drew Buono

FRAZER, Pa. Cephalon has submitted a supplemental application to the Food and Drug Administration to market its cancer drug Fentora as a “breakthrough pain” drug that would treat chronic pain conditions that could include lower back and neuropathic pain, according to the Philadelphia Business Journal.

Breakthrough pain is characterized as pain that is rapid on its onset and moderate-to-severe in intensity and relatively short in duration. If the application is approved, Fentora would also be indicated for breakthrough pain in chronic pain conditions experienced by opiod-tolerant patients.

In September, the FDA and Cephalon issued warnings to patients and doctors alerting them of the potential fatal risk factors associated with improper use of Fentora in such cases as patients using them to treat migraines or other types of short-term pain. Cephalon is also working with the FDA to update the package insert of the drug to include revised patient selection criteria and dosing instructions.

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Reverse-payment bill held up in Congress by pharmaceutical lobbying

BY Drew Buono

WASHINGTON Legislation aimed at speeding up the availability of cheaper generic drugs has stalled in Congress due to major lobbying by the drug industry, according to the Associated Press.

The Senate bill would ban most reverse payments, which occur when a brand-name company pays a generic manufacturer to delay the introduction of a drug.

An Associated Press review of lobbying reports, from July 1, 2006, through June 30, 2007, found that $38.8 million was spent by at least a dozen generic and brand-name companies and their trade associations on issues including the Senate legislation.

More than half of those expenses were piled up by the Pharmaceutical Research & Manufacturers of America, which represents brand-name drug companies. PhRMA spent $19.5 million in the 12-month period ended June 30 on in-house lobbying expenses, an increase of about $3 million over the previous 12-month period.

And the Generic Pharmaceutical Association reported lobbying expenses of around $420,000 for the first six months of this year. The remaining $19 million was spent by a variety of drug companies, including Bayer, Schering-Plough, Pfizer and Teva Pharmaceuticals.

“Lobbyists have a lot of influence in Washington,” said the bill’s sponsor, Sen. Herb Kohl, D-Wis., who chairs the Senate Judiciary subcommittee on antitrust, competition policy and consumer rights. “If we can just get this to a vote, it will be pretty hard for people to vote against it. A vote against this is a vote against consumers.”

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