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

To: Anthony Wong who wrote (7827)	6/9/1999 2:50:00 PM
From: Anthony Wong	Respond to of 9523

Pfizer's Trovan Antibiotic Use Should Be Limited, FDA Says Bloomberg News June 9, 1999, 2:35 p.m. ET Pfizer's Trovan Antibiotic Use Should Be Limited, FDA Says Washington, June 9 (Bloomberg) -- Pfizer Inc.'s Trovan antibiotic should only be used to treat patients with serious or life threatening illness because of concerns about liver problems, the U.S. Food and Drug Administration said. The FDA said the drug's use -- especially the oral form of the drug -- should be restricted. Spokeswoman Susan Cruzan said the company was working to limit the distribution of the drug. Last month, Pfizer, the U.S.'s No. 2 drugmaker, said that Trovan would get a stricter label in the U.S. and Europe after reports of five deaths and three liver transplants linked to use of the drug. Trovan is an important product for Pfizer, the No. 2 U.S. drugmaker, and had sales of $160 million in 1998, its first year on the market after being approved in December 1997. Pfizer shares fell 1 to 110 in afternoon trading.

To: Anthony Wong who wrote (7827)	6/9/1999 3:06:00 PM
From: Anthony Wong	Read Replies (1) \| Respond to of 9523

EULAR: Celebrex Effective In RA, OA Without Affecting Platelet Function, Clotting GLASGOW, SCOTLAND -- June 9, 1999 -- In separate clinical studies presented at the 14th meeting of the European League Against Rheumatism (EULAR) in Glasgow, celecoxib -- a compound developed for the treatment of arthritis pain and inflammation -- was shown to effectively treat adult rheumatoid arthritis (RA), osteoarthritis (OA) of the hip and have no significant effect on platelet function or normal blood clotting. Additionally, data was presented demonstrating that G.D. Searle & Co.'s and Pfizer Inc.'s Celebrex (celecoxib) provides equivalent relief of osteoarthritis symptoms when taken either in a once-daily dose of 200mg or a twice-daily dose of 100mg. In the first study, more than 1,100 patients with RA in a flare state and with a Functional Capacity Classification of I-III (age range: 21 to 84) were randomised to receive celecoxib (100mg BID, 200mg BID, or 400mg BID), placebo, or a widely prescribed non-steroidal anti-inflammatory drug (NSAID), naproxen (500mg BID). All study participants received multiple clinical evaluations of their arthritis condition and regular physical examinations and laboratory tests during the 12 week study. At all time points, the efficacy of celecoxib in the 100mg BID, 200mg BID, and 400mg BID treatment groups were similar in reducing the signs and symptoms of RA as demonstrated by ACR-20, Patient and Physician Global Assessments, number of tender/painful joints and number of swollen joints. By these same measures, all doses of celecoxib were comparable to naproxen and statistically superior to placebo. When tested at Week 12, the celecoxib treatment groups and the naproxen group demonstrated improvements in the HAQ Functional Disability Index with the improvement of each of the groups being statistically different from placebo. All doses of celecoxib were well tolerated and the incidences of adverse events in the celecoxib groups were similar to those in the placebo group. In a second study, more than 1,000 patients with OA of the hip (age range: 28 to 93) with a Functional Capacity Classification of I-III were randomised to receive celecoxib (50mg BID, 100mg BID, or 200mg BID), naproxen (500mg BID) or placebo for up to 12 weeks. Using both patient and physician arthritis assessments, including Patient and Physician Global Assessments, Patient Assessment of Pain and the Osteoarthritis Severity Index, 100mg BID and 200mg BID doses of celecoxib were highly efficacious in treating the signs and symptoms of OA of the hip. These doses of celecoxib were statistically superior to placebo and comparable to naproxen at weeks two, six and 12. As with the RA study, celecoxib therapy was well tolerated by patients in the trial. Together with previously reported results, these data demonstrate that celecoxib is highly effective for relieving the signs and symptoms of OA whether it occurs in the knee or hip. In another clinical study presented at EULAR, healthy male and female volunteers (age range: 19 to 53 years) received single doses of either celecoxib, at up to double the total-daily arthritis dose (100mg, 400mg or 800mg), or ibuprofen at the standard arthritis dose (800mg). Normal blood-clotting ability in the study was assessed by collagen- and arachidonate-induced platelet aggregation and serum thromboxane B2 (TxB2) levels in the blood that indicate normal platelet function. When tested three hours after dosing, platelet function in the celecoxib treatment groups was statistically indistinguishable from the placebo group. In contrast, the ibuprofen treatment group demonstrated clinically-significant impairment of platelet function. Blood levels of serum TxB2 were also reduced three to four times more in the ibuprofen group than in the celecoxib or placebo groups. This difference was also statistically significant. A final study presented at the meeting demonstrated that celecoxib effectively relieved OA pain and inflammation when taken in either once-daily or twice-daily doses. In this study, nearly 700 patients with OA of the knee in a flare state (age range: 29 to 88 years) and with a Functional Capacity Classification of I-III were randomised to receive celecoxib (100mg BID or 200mg QD) or placebo for six weeks. Arthritis assessments and laboratory tests were completed at baseline and at Weeks two and six. At both the two and six-week time points, the efficacy of a once-daily dose of 200mg was equally effective as a twice-daily dose of 100mg in relieving OA pain and inflammation in the knee. Additionally, both celecoxib dosing regimens were equally well tolerated. The most common side effects of celecoxib were dyspepsia, diarrhoea and abdominal pain, which were generally mild to moderate. Although celecoxib has a low potential for stomach ulcers, serious GI tract ulcerations can occur without warning. Physicians and patients should remain alert for signs of GI bleeding. Patients who have a known allergic reaction to celecoxib, sulfonamides, aspirin or NSAIDs should not use celecoxib. pslgroup.com:80/dg/105556.htm