ILXO,MLNM continued:(MLNM added to Nasdaq 100 on Monday)
UPDATE 2-FDA panel backs ILEX, Millennium cancer drug
(adds analyst comment, background; edits throughout)
By Lisa Richwine
BETHESDA, Md. Dec 14 (Reuters) - ILEX Oncology Inc. (NASDAQ: ILXO) and Millennium Pharmaceuticals Inc. (NASDAQ: MLNM) won a U.S. panel's support Thursday for their experimental cancer drug Campath as a treatment for a rare type of leukemia.
Campath would be the first product to hit the market for both biotechnology companies if the U.S. Food and Drug Administration (FDA) takes its panel's advice, by a 14-1 vote, to approve the drug. The agency typically follows its panels' recommendations, and the companies hope to launch the drug early next year.
While Campath can cause serious side effects, panel members said the benefit for people with chronic lymphocytic leukemia (CLL), a disease that nearly always is fatal, outweighed the risks. The companies are seeking permission to market the drug for patients who have tried the two other approved CLL therapies, but are no longer responding to the drugs.
"Is (Campath) a perfect drug? No, not at all ... but this appears to offer hope in a situation where there isn't a great deal of hope," said Barbara Lackritz, the panel's patient representative.
About 10,000 U.S. adults are diagnosed with CLL each year. In late stages of the disease, life expectancy is between 18 months and three years.
Like many cancer drugs, Campath can have strong side effects, including making patients vulnerable to serious infections and causing dangerous blood toxicity.
In a study of 93 patients treated with intravenous Campath three times a week, 14 patients died from what the FDA said was toxicity possibly or probably related to the drug. Most of those deaths were from infections, FDA reviewer Genevieve Schechter said.
But deaths in the study were from "typical causes one expects to see" in CLL patients, whose immune systems are weak, said Millennium Senior Vice President Lee Brettman. Meanwhile, 33 percent, or 31 patients, who would have had no other treatment options, responded positively to Campath treatment, and many saw an improvement in symptoms such as fever, fatigue and anemia, Brettman said.
Campath "has the potential to meet an unmet need," Brettman told the panel.
Campath is a humanized monoclonal antibody, a protein that binds to the CD52 antigen on cancerous white blood cells, thereby slowing proliferation of the cells. The drug is jointly owned by Millennium, of Cambridge, Mass., and San Antonio-based ILEX. They asked the FDA for marketing approval in December 1999.
Millennium, one of the nation's best financed biotechs with a cash hoard of over $1 billion, acquired co-ownership of Campath late last year when it merged with hometown neighbor LeukoSite Inc.
The FDA is considering clearing Campath under accelerated approval, which means the agency likely will require further studies once the drug hits the market.
Industry analysts said Campath's revenues depended in part on whether physicians use the drug for other diseases besides the small population of CLL patients.
"If approved, Campath could be a $100 million drug in a few years," said Lance Willsey, a partner in Boston investment firm DCF Capital. He said that figure assumes, however, that doctors also prescribe Campath on an "off-label" basis for lymph cancers and other diseases.
Both Millennium and ILEX were among the top net gainers on the Nasdaq in afternoon trading. Millennium was up $5-3/4, or 10 percent, at $61-3/8. ILEX was up $1-7/8, or 7 percent, at $28-3/8 amid a slightly down day for biotechs.
Germany's Schering AG has U.S. marketing rights to Campath.
(with additional reporting by Ransdell Pierson in New Yo |
