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

To: jttmab who wrote (863)	1/11/1999 10:17:00 PM
From: Anthony Wong	Respond to of 2539

Merck's Cox-2 Pain Drug to Get Expedited FDA Review (Update1) Bloomberg News January 11, 1999, 5:12 p.m. ET Merck's Cox-2 Pain Drug to Get Expedited FDA Review (Update1) (Adds detail, background, closing markets.) Washington, Jan. 11 (Bloomberg) -- Merck & Co. said its Vioxx painkiller, a member of the new class of Cox-2 drugs with multibillion-dollar sales potential, will get an accelerated review from the U.S. Food and Drug Administration. The priority review designation generally means that the FDA takes six months instead of the usual year to complete reviewing an application for a drug approval. That means Merck, which filed an application for Vioxx in November, could have the drug on the market by late May. Time is crucial for Merck as it races to join Monsanto Co., currently the only company with an approved Cox-2 drug on the market. Monsanto's Celebrex won FDA approval on Dec. 31. Analysts had anticipated that Merck would win the accelerated review status after the agency sped its review of Monsanto's Celebrex. ''It's expected, but it's good news,'' said Carl Seiden, a J.P. Morgan Securities analyst with a ''market perform'' rating on Merck. Shares in Whitehouse Station, New Jersey-based Merck, the world's biggest drugmaker, fell 3 1/8 to 150 11/16. Shares of St. Louis-based Monsanto fell 1 5/8 to 43 3/4. Monsanto and marketing partner Pfizer Inc., maker of the impotence drug Viagra, sell Celebrex in all countries except Japan. Celebrex was approved for treating pain caused by age- related arthritis and by a more serious form of the disease called rheumatoid arthritis. Merck said today it asking the FDA to approve the drug for general pain relief, as well as specifically approving it for age-related osteoarthritis. Wider Uses Merck said its studies support wider uses for its drug, including treatment of menstrual pain, post-dental-surgery pain and pain after orthopedic surgery. It is in final-stage studies on using Vioxx to treat rheumatoid arthritis pain. Both Vioxx and Celebrex work by interfering with production of an enzyme, cyclooxygenase-2, linked to pain and swelling. Cox- 2 also plays a role in other diseases, according to researchers. Unlike existing anti-inflammatory painkillers, a Cox-2 inhibitor doesn't suppress a related enzyme, Cox-1, that triggers production of the stomach's natural protective lining. That could reduce the gastrointestinal side effects such as ulcers and bleeding caused by existing painkillers. The two companies are gearing up for a marketing battle once both drugs are approved, analysts have said. The two drugs together were expected to achieve annual sales of as much as $5 billion if their makers could claim a safety advantage over existing pain drugs. Warning Labels The FDA requires Celebrex's label to note that problems such as ulcers and bleeding can occur in about 2 percent to 4 percent of patients treated with anti-inflammatory drugs or painkillers for one year. However the label will also say that it is unclear whether that rate will apply to patients who use Celebrex. The label will also cite company research that shows only about 0.04 percent of patients who took Celebrex for six months or less experienced significant bleeding. In December, Merck told analysts its studies of Vioxx are more extensive than was the research Monsanto did to support Celebrex. And Merck has also said that its research supports claims that the drug is no more likely to cause stomach ulcers than a sugar placebo pill. If the FDA agrees with Merck's safety research, it could allow the company to omit the standard warning about potential side effects, such as ulcers, carried by existing prescription painkillers -- including Celebrex. For its part, Monsanto has said it will sell Celebrex at prices that are as low as or lower than comparable brand-name painkillers. That's expected to keep insurers from raising any major objections to the drug and should help it win prescriptions among doctors, and reimbursement from insurers. --Kristin Reed in Washington (202) 624-1858 with Kristin Jensen