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Biotech / Medical : Ionis Pharmaceuticals (IONS) -- Ignore unavailable to you. Want to Upgrade?

To: Petrus who wrote (2255)	8/28/1998 11:04:00 AM
From: Mailbu	Read Replies (1) \| Respond to of 4676

August 28, 1998 From Todays NY Times: F.D.A. Approves Retinitis Treatment, a Gene Blocker By LAWRENCE M. FISHER he Food and Drug Administration has approved the first drug that works by blocking the action of a gene. Isis Pharmaceuticals Inc., a biotechnology company in Carlsbad, Calif., said it had received approval late Wednesday for its drug, fomivirsen, for the treatment of CMV retinitis, a virus that can cause blindness in AIDS patients. Fomivirsen will be made by Isis and marketed as Vitravene by Ciba Vision Corp., the eye-care unit of Novartis AG, the Swiss pharmaceutical giant. Shares of Isis rose 56.25 cents Thursday, to $9.8125, in Nasdaq trading. Vitravene is based on a technology known as antisense, which holds great promise for harnessing genetic information to make potent drugs with few side effects. Antisense drugs, which are essentially snippets of DNA that switch off genes that prompt cells to produce disease-causing proteins, could in theory treat all manner of infections, inflammatory diseases and cancers. But it has been difficult to make the technology work in practice, and the field has been beset by skepticism that it could work at all. The FDA's rapid approval, which comes just five months after the application for Vitravene was submitted, "should give people more confidence in the antisense platform as a way to make drugs," said Paul Boni, an analyst with Punk, Ziegel & Knoell. "With any brand new technology, you never know when the world will be ready for it," he said. "This could be the first important step for antisense to get accepted." The size of the market for Vitravene is not clear because the incidence of CMV retinitis has been in decline as AIDS patients live longer, healthier lives thanks to antiviral drugs. But recent studies show many patients either resisting or not tolerating those drugs, so infections like CMV retinitis may increase. Some analysts expect the market to be less than $20 million. Vitravene is injected directly into the eye, where it interferes with the replication of the cytomegalovirus, which destroys the retina. The side effects of Vitravene are minimal, while existing therapies are extremely toxic, so it could become the primary therapy for the disease. "It's very exciting from a patient-care point of view," said Dr. Debra Goldstein, an assistant professor of ophthalmology at the University of Illinois and a principal investigator on Vitravene. "All of the other drugs we have are very similar, so if you are resistant to one there's a chance you're resistant to all of them. This acts by a whole new mechanism." The only side effects are some inflammation and pressure in the eye, both of which are temporary and treatable, she said. Because Vitravene is administered directly into the eye instead of into the body, it may not silence the skeptics, and some may say that while it works, it does not work by antisense. But Isis has other drugs, including a treatment for the inflammatory bowel condition known as Crohn's disease and two cancer drugs, in clinical trials. Those drugs are injected into the body, and the company is also working on second- and third-generation antisense compounds that could be given orally. The success of Vitravene "is one more piece in a mosaic of evidence that antisense can be used to make drugs," said Stanley Crook, the chairman and chief executive of Isis. "By itself, it is not enough to make me say that antisense will be the revolution I believed it would be, but it is an important piece. The evidence is overwhelming that antisense can work."