(Adds updated shares in fourth paragraph, company comment in paragraphs 13 and 14.) Washington, Aug. 5 (Bloomberg) -- Bristol-Myers Squibb Co. said it won U.S. regulatory approval to market its blockbuster cancer drug Taxol to patients with an AIDS-related skin cancer.
The U.S. Food and Drug Administration approved Taxol's use in treating patients with Kaposi's sarcoma, a skin cancer that often strikes the devastated immune systems of AIDS patients. The drug, currently approved for fighting breast and ovarian cancer, had U.S. sales of about $391 million in 1996, according to IMS America.
``To ensure the widest availability and reimbursement of this treatment for Kaposi's sarcoma, we invested in the necessary clinical development,'' said Renzo Canetta, vice president of oncology research for Bristol-Myers.
Shares of New York-based Bristol-Myers rose 1 1/2 in trading today to close at 79 7/8.
At a FDA advisory panel meeting in June, panel members said the drug appeared to greatly help the small population of patients with KS. ``I've never seen such dramatic improvements'' in patients, said Dr. Donald Abrams, director of the AIDS activities division at San Francisco General Hospital.
The approval could help the drugmaker in its bid to stave off competition from NaPro BioTherapeutics Inc. and Ivax Corp.
NaPro and IVAX have developed a form of Taxol, expected to be cheaper, and are trying to win FDA approval for treating Kaposi's sarcoma. Bristol-Myers is trying to block the effort by winning its own approval for KS.
Bristol-Myers fears that if the cheaper drug is allowed on the market for treatment of KS, doctors would end up using it for other types of cancer as well, analysts said.
Bristol-Myers applied for and the FDA granted ``orphan drug'' designation to the indication for Taxol, the company said. The designation would give it seven years of marketing exclusivity against generic or branded versions of the drug for that use. The FDA grants the designation to encourage drug development in cases where a disease affects few people, providing a small market opportunity.
Earlier today, IVAX and NaPro said the FDA plans a panel hearing in September for their version of the yew-tree derived paclitaxel compound, but agency approval of Taxol under the orphan drug status would block alternative forms of the drug for that indication, analysts said. The IVAX panel meeting on the 19th of September ``has no meaning,'' said Ira Loss, an analyst with HSBC Washington analysis.
``Unless they have some way of showing their drug is in some way different, Bristol-Myers has seven years of exclusivity,'' Loss said. Still, company officials at IVAX said they believed the drug would get its chance in September even though the FDA awarded orphan drug approval to Bristol-Myers.
We ``continue to advance our application,'' said Robert Jaffe, director of corporate communications for IVAX.
At the Taxol panel hearing in June, researchers presented two studies showing the drug could improve the condition of between 59 percent and 69 percent of KS patients. Though the FDA's analysis showed a slightly lower rate of effectiveness, the FDA reviewer said the drug is effective and can help patients who need new treatments.
Taxol is approved for KS patients who have failed to respond to other therapies.
NeXstar Pharmaceuticals Inc. and Sequus Pharmaceuticals Inc. are
among the companies that currently sell KS treatments. The
approximate $30 million market for the drugs is shrinking, analysts
said, as AIDS patients develop fewer opportunistic infections
thanks to powerful drugs fighting the underlying virus.