Both XOMA and Genentech got a good boost on CNBC this morning after the following news item. CNBC said the word on the street is that FDA will approve everything, "creating a buying opportunity."
LOS ANGELES, Sept 5 (Reuters) - A Genentech Inc. (DNA) experimental psoriasis drug faces a crucial step in the U.S. approval process on Tuesday, as regulatory advisors review its safety and effectiveness.
A committee of dermatology experts that advises the U.S. Food and Drug Administration is scheduled to vote on whether to recommend approval of the drug, Raptiva, as an injected treatment for moderate-to-severe psoriasis,
An estimated 4.5 million Americans suffer from the chronic disease marked by scaly bumps and raised patches on the skin, including about 1.5 million with moderate-to-severe forms.
A final decision by the FDA, which usually follows the advice of its expert panels, is expected before year-end.
Genentech, the world's second largest biotechnology company, and development partner Xoma Ltd. (XOMA) submitted the latest Raptiva application to the FDA in December. They first sought approval of the drug last April, but the FDA asked for confirmation that Genentech facilities could duplicate earlier batches of the drug without changing its chemical composition.
Raptiva is an antibody engineered to inhibit the binding of immune system cells to other cells.
"I think the dermatology panel review will go just fine," said Jason Kantor, an analyst at WR Hambrecht, noting that the FDA in February approved Biogen Inc.'s (BGEN) Amevive as the first biologic treatment for the skin disorder.
"The Biogen panel gave them (the company) a pretty easy walk in the park," he said.
Genentech, based in South San Francisco, California, emphasizes that its database of nearly 3,000 clinical trial patients is the largest out of all the biotech drugs being considered for treating psoriasis.
CONTINUOUS THERAPY
"They've run three Phase III trials -- that's unusual. And, they've all been positive and all shown similar results," Kantor said.
Biogen, however, maintains that Amevive has the advantage of a long remission period. The drug is given weekly by injection or intravenously for 12 weeks, and patients who respond will undergo a new phase of treatment when the disease reappears. Their blood must be monitored weekly because the drug works by destroying immune system cells.
"We see a significant clinical response in about two-thirds of patients and on average they maintain remission from the disease for seven months," said Akshay Vaishnaw, Biogen's senior director of medical research.
Raptiva is also administered weekly, but it must be done so constantly in order to be effective. Because it interferes with the immune system, patients may need to go off the drug from time to time, such as when surgery or pregnancy is planned.
The FDA panel is expected to focus on the tendency for psoriasis patients to rapidly relapse if they stop Raptiva treatment.
Dr. Charles Johnson, senior director of specialty biotherapeutics at Genentech, said investigators have been able to manage patients who need to stop treatment by switching them to light therapy or topical treatments before withdrawing Raptiva. "We are going to argue that the best way to use this drug is as a continuous therapy," he said.
In clinical trials around 29 percent of patients on Raptiva showed a 75 percent improvement in psoriasis symptoms, compared with about 20 percent of patients on Amevive.
Biogen said about 2,300 patients are being treated with Amevive, which costs $7,000 to $10,000 per 12-week course of therapy.
"It is very unlikely that we would be required to monitor patients .... The long-term safety record with Raptiva is very favorable," Johnson said.
He also said that Raptiva therapy is relatively convenient because patients can administer injections of the drug at home, while Amevive must be given in a doctor's office.
"I think they will have a positive panel review, but the market for these drugs is getting tougher and tougher," said Sena Lund, an analyst at Cathay Financial.
Within two or three years, he believes Amgen Inc.'s (AMGN) arthritis drug Enbrel will be the top choice for serious psoriasis sufferers, followed by Raptiva then Amevive.
Amgen filed in July for FDA approval of its psoriasis application for Enbrel, which blocks a protein associated with inflammation, but the injected drug is already being prescribed by dermatologists on an "off-label" basis. REUTERS
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