Competition expected for new, improved psoriasis drugs
Bernadette Tansey, Chronicle Staff Writer
Monday, March 24, 2003
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No clear winner is emerging in a horse race among big biotechnology firms to provide better and safer relief to patients with serious cases of psoriasis, experts said at a conference for dermatologists this week in San Francisco.
On the whole, however, the generation of new drugs on the runway from Amgen, Genentech, Biogen and Johnson & Johnson could bring improved options over conventional treatments that can have serious side effects, said Dr. Alexa Boer Kimball, an assistant professor of medicine at Stanford University.
She said she doesn't know whether any will emerge as "the treatment of choice" because each of the new class of drugs has advantages and disadvantages as a remedy for the inflamed, sometimes painful patches of skin that plague psoriasis patients.
As a result, there's room for healthy competition in the development of products for a worldwide psoriasis market that a Foster City market research firm estimates could top $3.2 billion by 2007.
Frontline Strategic Consulting Inc. projects a 28 percent annual growth rate in psoriasis-related sales through 2007 as the new therapies replace older, cheaper drugs that are less safe.
Of the 4.5 million people suffering from psoriasis in the United States, 20 to 30 percent develop the moderate to severe symptoms that the new drugs are designed to treat. Until recent years, the available drugs for serious cases of the disease were oral preparations like methotrexate, which can cause liver damage, and cyclosporine, which is associated with kidney damage and high blood pressure, Kimball said.
Given intravenously or by injection, the psoriasis drugs consist of biological molecules, known as biologics, that block the abnormal immune system responses believed to cause the disease.
So far, Biogen's drug Amevive is the only member of the new class of biologics to receive marketing approval from the Food and Drug Administration. The drug seems to work in 1 of 5 patients, and its benefits continue for months after the treatment stops, said Dr. John Koo, vice chairman of UC San Francisco's dermatology department.
"With Amevive, the bad news is that it doesn't work very fast," said Koo, who has carried out clinical studies on the drug for Biogen.
Genentech applied for FDA approval this year for its psoriasis drug Raptiva.
Data presented Friday at the American Academy of Dermatology's annual meeting at the Moscone Center confirmed earlier reports that Raptiva reduces a standard disease-rating score by 75 percent for 27 percent of patients, and achieves a 50 percent reduction for 58.5 percent of patients. All took a three- month series of weekly injections.
Hal Barron, Genentech's vice president of medical affairs, said significant reductions in scaly skin patches were seen in as little as two weeks. No significant increase in side effects occurred in an open-label study of patients on an extended course of treatment, he said.
Amgen plans to apply for approval this year for Enbrel, which helped 49 percent of patients reach a 75 percent reduction in the disease rating score when they took the higher of two dosage levels studied.
The drug is already FDA-approved for rheumatoid arthritis, as is Johnson & Johnson's Remicade, another drug being tested for psoriasis, though in earlier stage trials.
In that early-stage data presented at the dermatology conference Friday, Remicade helped 88 percent of patients reach a 75 percent reduction in their disease scores. The need for later-stage trials may mean Remicade could take as long as three years to gain FDA approval.
E-mail Bernadette Tansey at btansey@sfchronicle.com.
A NEW CLASS OF DRUGS FOR PSORIASIS
Drug Name COMPANY TESTING STAGE FDA ACTION
Amevive Biogen Phase III approved
Raptiva Genentech/Xoma Phase III application submitted
Enbrel Amgen Phase III application expected in 2003
Remicade Johnson & Johnson Phase II approval could be three
years away
Source: Chronicle research |
