To: Vector1 who wrote (843 ) 1/14/1999 1:10:00 AM From: Beltropolis Boy Respond to of 1686
Johnson & Johnson's MS Drug Panel Hearing Canceled Bloomberg News January 13, 1999, 1:37 p.m. PT Washington, Jan. 13 (Bloomberg) -- Johnson & Johnson, the world's fifth-biggest drugmaker, won't push for a recommendation of its multiple sclerosis drug by a government panel on Jan. 29, as it was scheduled to do. The U.S. Food and Drug Administration confirmed that the advisory panel meeting has been canceled, though neither agency nor company officials were available to explain why. The next tentatively scheduled meeting for the advisory panel in charge of such drugs is in late April, according to the FDA's hotline. It's unusual for the FDA to schedule an advisory committee meeting and then cancel it. Reasons can range from timing conflicts to an agency decision that it doesn't need the advice of experts because it's already decided for or against a drug. ''My suspicion is that it's bad'' that the hearing was canceled, said Ira Loss, an analyst with HSBC Washington Analysis who covers the FDA. ''It's just the latest in what seems to be a consecutive strike-out string here.''Good News Needed In the last two years, Johnson & Johnson has faced a series of drug setbacks at the FDA and the loss of a near-monopoly on a profitable heart device known as a stent. Last month, it announced it would cut 4,100 jobs and close 36 plants amid sluggish sales growth. ''They are going through a very rough period,'' said Sergio Traversa, an analyst with Mehta Partners. A drug approval would ''be good for the image and the morale. They need something good happening,'' he said. Shares of the New Brunswick, New Jersey-based company fell 1 1/8 to 78 11/16. Still, analysts aren't expecting big sales from the drug, known as cladribine, even if it does win approval for MS. The drug is currently approved to treat a form of leukemia and has side effects similar to anti-cancer drugs that would make it a second-tier option for MS, Traversa said. ''The potential for this kind of drug is really limited,'' said Traversa, who has a ''neutral'' rating on the company. The $1 billion MS market is currently dominated by Biogen Inc. and Schering AG. Biogen, one of the world's largest biotechnology companies, said yesterday that fourth-quarter sales of its Avonex drug for MS exceeded $120 million.$150 Million Sales Traversa predicted Johnson & Johnson's entry would have peak annual sales of about $150 million and would probably be used by patients who aren't helped by the Biogen or Schering drugs. Ares-Serono SA also sells a MS treatment known as Rebif outside the U.S., and Israel's Teva Pharmaceuticals Ltd. has FDA approval to sell its Copaxone MS treatment in the U.S. The disease destroys the insulation that protects and transmits impulses around nerve fibers in the spinal cord, brain and optic nerves, so that nerve impulses to and from the brain are distorted and interrupted. Scientists are stymied about what causes the disease, which often strikes people in their 20s or 30s and is found most frequently among women in colder climates. There is no cure.