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Biotech / Medical : Kos Pharmaceuticals, Inc (KOSP)

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To: AARON DIDICH who wrote (15)	9/14/1997 9:51:00 PM
From: Tom D	of 118

The product inserts were mailed to practicing physicians on 9/11. It appears that flushing is much less frequent and severe than with immediate-release niacin. It is reported "by as many as 88% of patients" with Niaspan. But, "following 4 weeks of maintenance therapy at daily doses of 1500 mg, the incidence of flushing over the 4 week period averages 8.56 events per patient with immeiated release niacin, and 1.88 taking Niaspan." The discontinuation rate with Niaspan due to flushing was 6% (14/245). As you may know, flushing is mitigated by taking low-dose aspirin. Almost all paeople who need niacin also need low-dose aspirin as prophylaxis against atherosclerotic complications. It is not clear if these people were already on aspirin or not, I would guess not, since I doubt the FDA would let patients take a second medication which conceals side effects of the experimental medicine. But I will have to get this clarified. But if these patients were not already on aspirin, the rate of flushing will be much less. The data on liver function abnormalities are better than I expected. In 245 patients who received Niaspan (500 to 3000 mg daily) for a mean duration of at least 17 weeks, none had elevated Liver Function Tests (LFT's) over three times the Upper Limit of Normal (ULN). (In severe hepatitis, the LFT's can go up over 20 times the ULN). Only 2 patients had to stop the medication due to increased LFT's between 2 and 3 times the ULN. In an ongoing study of over 700 patients, (617 who have been treated for a mean duration 50 weeks) only 4/717 have stopped the medication because of LFT's over 3X the ULN. I think Kos is an excellent long-term investment under $30 per share. I am accumulating a "waiting list" of patients for whom I will prescribe the Niaspan when it is available in November. But I am holding off on my initial purchase of stock until a full quarter of sales results are available, (i.e. 1998). I will change this strategy if I hear anything unexpected from the pharmaceutical rep who details my office. Tom D

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