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Biotech / Medical : Biotech Valuation -- Ignore unavailable to you. Want to Upgrade?


To: Biomaven who wrote (14611)12/9/2004 6:27:31 PM
From: Biomaven  Read Replies (1) | Respond to of 52153
 
This is a more reasonable version - suggests a new formulation is ready for submission (but that makes a proposed 2005 launch unlikely). Note also Barr's comment that they have never launched before litigation at trial:

Associated Press
Kos Pharmaceuticals Stock Dips 13 Percent
Thursday December 9, 5:26 pm ET
Kos Pharmaceuticals Stock Dips 13 Percent on Concerns Over Generic Competition on Cholesterol Drug

NEW YORK (AP) -- Shares of Kos Pharmaceuticals Inc. sank 13 percent in heavy trading Thursday after an investment bank suggested that the company's key cholesterol drug may face generic competition as soon as April.

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Deutsche Bank wrote in a report that Barr Pharmaceuticals Inc. could launch a generic version of Kos' Niaspan cholesterol treatment before the companies' patent trial begins in February 2006 and potentially right after a hold by the Food and Drug Administration expires at the end of March 2005.

The FDA puts a 30-month hold on generic drug applications once a patent challenge has been filed. If the case has not gone to court by the end of the 30 months, the generic drug maker can launch its copycat treatment "at risk," meaning that it would have to pay large damages if it loses the case.

Barr spokeswoman Carol Cox said that the company is evaluating all of its options.

"When the 30-month stay expires on March 30, the FDA can grant Barr final approval, but that doesn't mean we'll launch then," Cox said. She said Barr has never launched a product before a patent challenge was at least in the lower courts.

Kos shares closed down $5.41, or 13.1 percent, at $35.82 on the Nasdaq. They gained 18 cents in after-hours trading. Barr stock gained 90 cents, or 2.1 percent, to close at $42.96 on the New York Stock Exchange.

Niaspan works to balance patients' cholesterol levels by increasing levels of high-density, or "good" cholesterol. The drug, Kos' biggest seller, posted revenue of $226.5 million in 2003.

SG Cowen analyst Ian Sanderson said it might be to Barr's advantage to launch at risk because Kos has a reformulated version of Niaspan ready to submit to the FDA.

"That way they would be able to at least capture the generic market while it exists," Sanderson said. He suggested that a generic version of Niaspan could quickly grab about 50 percent of the market, both because of a discounted price and health care plans that automatically substitute generics.