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Biotech / Medical : Monsanto Co. -- Ignore unavailable to you. Want to Upgrade?

To: Dan Spillane who wrote (679)	12/1/1998 8:41:00 PM
From: chirodoc	Read Replies (1) \| Respond to of 2539

mtc still is seen as an ag bio co. few folks know about duract, and arthrotech, etc. this co. still is not viewed accurately don't worry about the lack of market response as the drug begins to fly off the shelves this new year, with the help of pfe the price will climb there will be lots of funds adding this to their portfolio once the analysts start calliing mtc a "buy." this will hold the price up for 1999 then in 2000 there will be huge profits from agbiotech this is a great long term hold imho curtis

To: Dan Spillane who wrote (679)	12/1/1998 9:39:00 PM
From: Anthony Wong	Read Replies (1) \| Respond to of 2539

20:19 T =FDA Panel -4: Needleman Cites 'Extensive' Trial >MTC The FDA panel unanimously backed Celebrex for both osteoarthritis and rheumatoid arthritis. However, the panel declined to endorse Celebrex for "management of pain," because the panel said it was too broad of an indication, since it refers to a wide variety of pain including pain resulting from dental work, broken bones or menstrual causes. However, the panel said most of the Celebrex's studies looked at the drug in only bone-related pain. The panel also recommended that Celebrex labels carry a modified version of gastrointestinal warnings found on NSAIDs. It said Celebrex labels should describe the drug's study findings that showed that there is still a risk of bleeding and ulcers, but that the studies showed a reduced incidence compared to NSAIDs. Panel chairman Dr. Steven Abramson, said although Celebrex had a better safety profile than existing NSAIDs, the drug still gave patients relief via the same mechanism as NSAIDs by inhibiting Cox-2. The panel debated about whether this would call for the drug to be the sole member of a new class of drugs. Dr. Philip Needleman, co-president at Searle and chief scientist at Monsanto, said if the company intended for Celebrex classified as an NSAID, the studies could have only looked at 1,500 patients. The company tackled larger clinical trials to establish the drug as the first in a new class. "We looked at 10 times that," Needleman said. "This was such an extensive trial, the biggest of its kind in arthritis." After the meeting, Needleman told analysts and reporters the company is pleased with the panel's recommendations. "We're really very satisfied with the outcome," Needleman said, stressing that the panel serves only to advise the FDA, which will have the final say after further meetings with the company. "This is the beginning of a new era of smart drugs." The company expects to hear from the FDA by the end of December. Ira Loss, pharmaceutical analyst for HSBC Washington Analysis, said the modified gastrointestinal, or GI, warning is a victory for Searle. "The modified GI warning is significant. No other product has been able to get a major modification," Loss said after attending the meeting. "This is a step on the road to carving out a new class of drugs." Although he didn't have exact sales projections, Loss said the potential market for Celebrex if approved is the entire NSAID market. "That's a lot," Loss said. "Billions of dollars." If Celebrex ultimately receives FDA approval, Pfizer Inc. (PFE) will market the drug with Searle. - Otesa Middleton; 202-862-6654 (END) DOW JONES NEWS 12-01-98 08:19 PM