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Biotech / Medical : Zonagen (zona) - good buy? -- Ignore unavailable to you. Want to Upgrade?

To: biodoc who wrote (5892)	10/16/1998 10:54:00 AM
From: Linda Kaplan	Read Replies (2) \| Respond to of 7041

Thanks, again, for your expert info on the FDA process. I think that the bad news on Viagra sales is portentous for Vasomax, given that Vasomax doesn't work as well, if at all. There should be virtually no sales of Vasomax even if it's approved, six months after approval, judging from the Viagra and Muse story. I suppose people will realize that. IMO, if VVUS is worth $2, ZONA is also worth $2: given that Muse actually works quite well, but is negatively balanced by a delivery system that is undesireable. ZONA has a preferred delivery system but a drug that doesn't work much better than a placebo. All this adds up to ZONA being a fairly worthless company right now, IMO. --Linda

To: biodoc who wrote (5892)	10/23/1998 6:37:00 PM
From: Linda Kaplan	Read Replies (1) \| Respond to of 7041

Biodoc-- Would you, Bradpalm, or someone else familiar with the FDA regs, let us know if it is expectable that they would reject a new drug that is only equivalent and not superior to an existing drug? I'm asking since they might feel that Vasomax is not superior to Viagra, and then would reject on that basis. I'm attaching below a copy of a rejection that was received today, on that basis. I note that the company that developed the rejected drug felt their drug did have an edge, but the FDA did not agree. FDA panel rejects Hirulog drug for angioplasty Reuters, Friday, October 23, 1998 at 16:23 BETHESDA, Md., Oct 23 (Reuters) - A new drug that keeps blood from clotting during angioplasty was judged not ready for U.S. Food and Drug Administration (FDA) approval by a panel of federal advisers on Friday. Hirulog, derived from leech saliva, will be sold by The Medicines Company, a privately held concern based in Cambridge, Mass. It specifically blocks the production of thrombin, a key component of clots. The Medicines Company licensed rights to Hirulog from Biogen Inc. (NASDAQ:BGEN) in 1997. Biogen abandoned Hirulog development in 1994 saying it was no longer a strategic fit, and will receive a sales-based royalty upon approval. The FDA committee said bivalirudin, the generic term for Hirulog, was equivalent but not superior to the blood thinner heparin in preventing angioplasty complications. "I believe that it's equivalent or better, but belief doesn't quite get you there," said panelist Marvin Konstam of the New England Medical Center. Most advisers said they doubted The Medicine Company's claim that Hirulog was safer because it caused less major bleeding. The heparin dose used in the company's studies, completed in 1995, was much higher than that used today, panelists said. "This regimen of heparin was relatively aggressive," said panelist Dan Roden of Vanderbilt University, adding that it may have caused more bleeding in patients taking heparin. The Medicines Company claimed Hirulog cut major bleeding by at least 60 percent. But panelist John DiMarco of the University of Virginia Hospital said: "I can't be certain (Hirulog) would be superior in a trial today using a different protocol." The FDA usually follows its panels' advice. Hirulog is given intravenously during angioplasty to help prevent death or heart attacks from clots that might break off. The aim is to use Hirulog instead of heparin, which can cause heart attack or death in up to 10 percent of patients, said Clive Meanwell, president of the Hirulog development program at The Medicines Company. Heparin can also cause dangerous hemorrhaging. In the company's two main studies, each of which had 2,000 patients, Hirulog reduced death, heart attacks, or other significant complications in the first week by about 11-17 percent -- not as much as the hoped for 33 percent. And the results were not significantly better than those seen with heparin. If approved, Hirulog would likely be used in combination with drugs like Eli Lilly's Reopro and Cor Therapeutics' Integrilin, which block platelets from clumping. Eric Topol, a cardiologist from the Cleveland Clinic Foundation and consultant to The Medicines Company, said Hirulog's safety made it an attractive alternative to heparin. "The chance of hemorrhage risk is higher than ever before," said Topol, noting that many angioplasty patients get multiple blood-thinning drugs, including the anti-platelet therapies. "Anything we can have that reduces that risk is welcome." 898-8383, E-Mail washington.equities.newsroom@reuters.com)) Copyright 1998, Reuters News Service Companies or Securities discussed in this article: Symbol Name NASDAQ:BGEN Biogen Inc