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To: vestor who wrote (1713)9/20/2000 4:53:50 PM
From: Thure Meyer  Respond to of 1837
 
A little more on the taxol story.

Taken from Bloomberg today.

"Hot Stocks Wed, 20 Sep 2000, 4:33pm EDT

Mylan Shares Rise on Tentative Approval of Cancer Drug Taxol
By Joe Richter

Pittsburgh, Sept. 20 (Bloomberg) -- Shares of Mylan Laboratories Inc., the world's No. 2 generic-drug maker, rose as much 12 percent after it received tentative regulatory approval to market a generic version of Bristol-Myers Squibb Co.'s No. 1 cancer-drug Taxol.

Shares of the Pittsburgh-based company rose 1 5/16 to 26 1/16 in early afternoon trading. Earlier the shares touched 27 5/8.

The U.S. Food and Drug Administration approval for Mylan's generic version of Taxol, which had $1.5 billion in 1999 sales, is tentative because another drugmaker, Ivax Corp., is expected to have six months of exclusive marketing rights for its generic version, analysts said. The tentative approval for the 30-milligram version could allow Mylan to sue if Ivax fails to begin marketing the drug soon. Ivax said it plans to start selling the drug shortly.

``It depends what happens with Ivax in its Taxol launch, but it could open the door for Mylan,'' said Sidney Taubenfeld, an analyst at New Vernon Associates. ``Mylan has been successful at suing on these things in the past.''

A spokeswoman at Mylan wasn't available for comment.

The FDA generally gives the first approved generic version of a drug six month on the market before a competitor can be introduced.

Ivax said it will soon announce details of its generic-Taxol introduction, and that Mylan can begin selling the drug only after Ivax's six-month exclusivity expires. Ivax also said it has approval to sell the drug in 150-milligram to 300 milligram-dosages, which make up the bulk of Taxol sales.

``We've always said that when our exclusivity ends we expect to have competition, though it's a tough product to make so we don't think there will be many other companies,'' said Neil Flanzraich, vice chairman and president of Ivax. Under recent FDA guidelines, Ivax, which won FDA approval on the drug after a prolonged court fight with Bristol-Myers, could lose exclusivity if it waited too long to begin selling the drug. ""

This doesn't quite jive with the NY Times article which stated that the FDA still hasn't given Ivax approval to sell the drug because Bristol-Myers has not removed their patent from the Orange book.

In any case, it seems that there is some momentum for generic manufacturers.