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To: SSP who wrote (93339)	10/10/2001 11:02:26 AM
From: Evan	Respond to of 150070

Did IAMR strike gold? lets keep it to ourselves :-)

To: SSP who wrote (93339)	10/10/2001 11:33:03 PM
From: Jim Bishop	Read Replies (1) \| Respond to of 150070

UTHR long time LIST stock, check this: United Therapeutics Anticipates FDA Nod for Hypertension Drug By Adam Feuerstein Staff Reporter 10/09/2001 12:31 PM EDT United Therapeutics (UTHR:Nasdaq - news - commentary - research) CEO Martine Rothblatt is telling fund managers at a biotech conference that the company's pulmonary arterial hypertension drug will receive an "approvable" letter from the Food and Drug Administration in the next week. An FDA "approvable" letter means the regulatory agency will grant final approval to market a drug once the drug company takes care of relatively minor issues. Related Stories Selective Disclosure Is Still the Norm in Drug Research FDA Sends Back Genentech's Psoriasis Drug for More Testing FDA Not Solely to Blame for Drug-Approval Delays In a private meeting with fund managers, Rothblatt said the FDA has all but signed off on the approval of Remodulin, according to the managers. The meeting took place Monday afternoon at the UBS Warburg Global Life Sciences Conference, being held this week in New York. Rothblatt couldn't be reached for comment. "She told us that all major outstanding issues with Remodulin have been worked out between the FDA and the company, and that the drug will be approved," said one hedge fund manager attending the meeting. FDA's approval of Remodulin, if it does come, will be a big boost for United Therapeutics, which has more than its share of critics on Wall Street. Until now, predicting whether the drug would get approved has been one of the tougher calls in the biotech sector. Remodulin won't be a huge seller -- analysts have pegged annual peak sales at between $100 million and $200 million. United Therapeutics has posted negligible revenue to this point; Remodulin would be its first approved drug. Regulators seem split on the drug's effectiveness and safety. On Aug. 8, FDA reviewers released a fairly scathing review of Remodulin in advance of an FDA advisory panel meeting. Investors fled the stock, fearing the drug's rejection, pushing the company below $9 per share. But when the advisory panel met the next day, it surprised many biotech observers by actually recommending Remodulin's approval, bolstered by bullish comments from a top FDA official. Investors jumped back in, pushing United Therapeutics back above $14 per share. The stock was trading early Tuesday afternoon at $13.30, up 15 cents or 1.14%. The company's shares could move higher on a Remodulin approval, but expectations for the drug are fairly low. There aren't many patients who suffer from pulmonary arterial hypertension. And Remodulin, which is injected, won't get very far from the gate without encountering competition from drugs in oral form. Alexion and Genentech (DNA:NYSE - news - commentary - research) are expected to gain approval soon for one such drug, called Tracleer. Still other competing drugs are being developed. But United Therapeutics will also give investors another reason to take a look at the company next month at the annual scientific meeting of the American Heart Association. There, United Therapeutics will present late-stage test results for Beraprost, an experimental oral drug to treat peripheral vascular disease. If the results are positive, an FDA filing for Beraprost is expected in the first quarter next year. Beraprost, if eventually approved, could be a much bigger profit driver for United Therapeutics. There are 6 million patients in the United States who suffer from peripheral vascular disease, of which about 1.5 million could qualify for treatment with the drug, according to projections compiled by one hedge fund manager. The same manager has recently taken a long position in United Therapeutics. "I think the real value in United Therapeutics is Beraprost," he says. "If the drug is approved and the company gets the [drug] label it wants, you could see peak sales of about $500 million."