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Biotech / Medical : IVAX Insider Trading -- Ignore unavailable to you. Want to Upgrade?

To: 5,17,37,5,101,... who wrote (368)	12/29/1997 10:02:00 PM
From: flickerful	Respond to of 756

apologies, and credit to to sylvia plath, in relevant part: "...Fractured pillars frame prospects of rock; While you stand heroic in coat and tie, I sit Composed in Grecian tunic and psyche-knot, Rooted to your black look, the play turned tragic: With such blight wrought on our bankrupt estate, What ceremony of words can patch the havoc? " from "Conversation Among the Ruins" 1956 can you say glaxo? yes, better luck tomorrow. from our mouths to frosty's ummmm...ears. randy

To: 5,17,37,5,101,... who wrote (368)	12/29/1997 10:13:00 PM
From: flickerful	Read Replies (1) \| Respond to of 756

Top Stories: Update: NaPro and Ivax Strike Out with the FDA By Jesse Eisinger Staff Reporter 12/29/97 4:27 PM ET For NaPro (NPRO:Nasdaq) and Ivax (IVX:AMEX), the year is ending with a case of severe good news, bad news. For good news, the two companies "received a tentative approval" for Paxene, essentially a generic form of Bristol-Myers' (BMY:NYSE) blockbuster cancer drug Taxol. But here's the bad news: The Food and Drug Administration said the drug "may not be finally approved until August 4, 2004." Oh. No one ever said it was going to be easy. In late September, the two companies got a positive FDA committee recommendation saying that Paxene was safe and effective. That was the simple part. (Please see this previous story.) The background: Taxol, which is off-patent, is a billion-dollar cancer drug, made from ornamental yew trees, that Bristol licensed from the National Cancer Institute in 1992 for five years. It's Bristol's second-largest drug. As of this weekend, that licensing period expired. NaPro, which had figured out its own new way of making paclitaxel, the active ingredient in Taxol, filed for approval at the end of March for its drug, dubbed Paxene, for Kaposi's sarcoma, a rare skin cancer that primarily affects AIDS patients. It got the thumbs-up from the committee in late August. Bristol had gotten wind of the imminent filing and had quietly filed for approval to treat KS in mid-February, before the two smaller companies had filed. In August, before the committee recommendation on Ivax/NaPro's Paxene, it won approval. But that's not all. Bristol also corralled "orphan drug status" from the regulatory agency. That gives the company a seven-year period of market exclusivity. Never mind that there are other KS drugs on the market, including one with orphan drug status already, and never mind that Taxol has been widely used for years in other cancers. The upshot is that BMY seems to have won a lobbying struggle and outmaneuvered the two smaller companies. Ivax had filed a full new drug application instead of a generic drug application in order to get around the orphan drug status issue, but it seems to have failed. Ivax had hoped to show something besides equivalent safety and efficacy to Taxol, but didn't do so, at least to the FDA's reckoning. Now, Ivax will explore "whatever avenues" are available, says Robert Jaffe, Ivax's spokesman. He wouldn't say what exactly the company would do, citing concern about tipping Ivax's hand to Bristol. He says the company has done "extensive clinical studies" in breast and ovarian cancers and could filed for approval in those diseases. Bristol, however, has patents on unique dosing of Taxol for those cancers, so that's a harder row to hoe for the two companies. Jaffe points out that the FDA ruled Paxene safe and effective, which could help approval in European countries. About half of Taxol sales come from abroad, he says. NaPro officials were not immediately available for comment. The FDA move wasn't so hard to predict. After all, NaPro investors have been bailing out of the stock for months. Today the stock fell 39%, or 1 3/8, to 2 1/8. The stock is down 78% since late August. Ivax, a troubled generic drug maker, was less damaged, down 3/8 to 7 1/4 on heavy volume of 1.04 million shares. c 1997 TheStreet.com, All Rights Reserved.