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Biotech / Medical : PFE (Pfizer) How high will it go? -- Ignore unavailable to you. Want to Upgrade?

To: scaram(o)uche who wrote (7983)	6/24/1999 1:53:00 PM
From: scaram(o)uche	Respond to of 9523

Can someone in this thread please point me to the "Sibia" prior art? I've been looking for it, tracking the Cadus litigation, for over two years. I'm pretty well trained to find stuff like this, and I can't find it. Any damage control yet for that gut tox report in NEJM? That sort of report, at this early stage in the marketing of Vioxx, could have a trickle down for bucks$$big...... even if it doesn't hold. Merck is a highly ethical company. If they start to distribute data showing an efficacy advantage for Vioxx, investors should take it seriously, even if there's a spanking from FDA. It's interesting that one good scientist contributor here at SI also reports that Searle has a backup cox-2 inhibitor in development. Does the Pfizer/Monsanto deal cover that molecule also? TIA for any help. Good luck out there.

To: scaram(o)uche who wrote (7983)	6/25/1999 3:29:00 PM
From: margie	Read Replies (2) \| Respond to of 9523

<<Has anyone here heard anything about this observation?....... <Any damage control yet for that gut tox report in NEJM?> If this was any company besides Pfizer, you would call it a non-event :- ) I am surprised that this topic is a worthy of an article. Searle has never claimed there are no GI related side effects, only that there are LESS side effects. Message 8386292 <Like other NSAIDs, Celebrex carries a warning about the possibility for harm to the gastrointestinal tract. Monsanto was helped, though, by the FDA's decision to let the drugmaker add information about studies that indicate Celebrex is less likely to cause ulcers than some other NSAIDS As far as the labeling, before Vioxx received FDA approval, Merck was claiming that their studies were bigger and better and they were sure they would get that coveted "safety" labeling. They didn't. The FDA is conservative and this is a new class of drugs. Overall the incidence of ulcers with Celebrex is about 4%; the incidence of ulcers with the Cox -1 inhibitors is about 16%. celebrex.com "Adverse Reactions" Incidence of Gastroduodenal Ulcers from 3-Month Serial Endoscopy Studies in OA and RA Patients (Study 3, Table 3) " Celebrex 200 mg BID Week 4 4% (10/252)* Week 8 2.2% (5/227)* Final 7.5% (20/266)* * p=<.05 Naproxen 500 mg BID Week 4 19.0% (47/247) Week 8 14.2% (26/182) Final 34.6% (89/257 <Merck is a highly ethical company. If they start to distribute data showing an efficacy advantage for Vioxx >>â€¦â€¦ I have no doubt that Merck will claim to have some early data showing that Vioxx is better than Celebrex. I have seen their claims before. I don't share your respect for Merck, nor your disrespect for Pfizer. I remember Merck's claims for Crixivan BID.....that their "early preliminary data" showed that Crixivan BID was just as good as Crixivan TID, and there were many press releases to that effect, around the time of 1998 World AIDS conference in Geneva. About a month later, Merck discontinued their Crix BID trials; larger studies now showed Crix BID was worse than Crix TID. When Viracept was first approved, Merck claimed that Crixivan was more potent. It wasn't true. Merck also claimed that all protease inhibitors show complete cross-resistance. It wasn't true. And then there was Abbot issuing strong press releases at Geneva about the superiority of Ritonavir/Fortovase combinations. A few weeks later they announced that Ritonavir capsules would no longer be available and would be substituted with a foul tasting liquid. Abbot already knew about the problems with the capsules when they presented at Geneva, but didn't mention them. The capsules are still unavailable, almost a year later, but a new version should be approved by the FDA soon. And then there was infamous Dupont Study 006 with 38% dropout rate for Crixivan which was the basis for Dupont's claims at Geneva that Sustiva was superior to Crixivan. The FDA reviewed their studies, and said there was no basis for claims of superiority. Dupont had to restate their previous claims of superiority in all their press releases. fda.gov << the adverse events that lead to discontinuation in the control arm were milder than those in the efavirenz-containing arms. â€¦Since dropouts are considered to be virologic failures in the primary analysis, these dropouts impacted the analysis substantially..>>. <<Therefore, while the results seen in this study demonstrate the efficacy of efavirenz, they do not demonstrate superiority of either of the two efavirenz-containing arms over the control arm. Further, they suggest that the present study may be too small to evaluate the relative efficacy of EFV+IDV and IDV+ZDV+3TC.>> ___________ What do you think of Schering Plough and their ongoing attempts in Congress to pass bill H.R. 1598, to extend their patent for Claritin? There are other drugs and companies involved: Relafen SKB; Cardiogen-82 BMS; Eulexin Schering-Plough; Nimotop Bayer; Dermatop HMS; Penetrex RPR. The hearings are July 1, 1999. aegis.com www.citizen.org/congress/drugs/stopclaritin.htm I hope that Pfizer and SIBI will resolve their differences soon, without a lawsuit. Is it normal to expect royalties if a company discovers a new product, using a licensed drug discovery technology from another company? It does raise some issues.