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28th June 2001

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Biogen, Genentech battle with psoriasis drugs
Reuters - New York

NEW drugs to relieve pain and itching in millions of psoriasis sufferers showed promise in studies detailed by major US biotechnology companies, including industry heavyweights Biogen Inc and Genentech Inc.

Biogen and Genentech, in a neck-and-neck race to bring a new psoriasis drug to the market, both said they achieved statistically significant results that met their primary goals. Both companies plan to file for new drug approval with regulators by the end of this year or early next year.

Cambridge, Massachusetts-based Biogen said 40 per cent of patients tested with its Amevive drug experienced a 75 per cent reduction in their condition, as measured by a medical index. The company conducted two trials that tested 1,000 subjects.

South San Francisco-based Genentech conducted a single study of 498 patients, of which 39 per cent achieved a 75 per cent level of improvement. Of 123 patients who did not experience a 75 per cent improvement after 12 weeks, and were given a second dose, 20 per cent experienced a 75 per cent improvement.

The results of the phase III trials, the last needed before a company can apply for new drug approval, will be closely scrutinised by analysts seeking clues as to which drug may gain a greater share of the market. Between 1 and 2 per cent of the world’s population suffer from psoriasis, a condition characterised by thick, scaly patches on the skin.

There are some 4 million sufferers in the United States alone. Both companies presented their data at the International Psoriasis Symposium in San Francisco. Genentech released its data after the market closed.

Biogen announced its results earlier. Its shares rose $2.62, or 4.08 per cent, to close at $66.80. In Biogen’s trial, 71 per cent of patients achieved a 50 per cent reduction in the severity of their condition. Genentech said 61 per cent of its patients achieved the same result. Genentech said it will present the results of a second phase III trial at the America Academy of Dermotologists conference in late July.

The drugs use different delivery methods. Biogen conducted trials using both intramuscular and intravenous delivery mechanisms. Results were comparable in both trials and the company plans to file for approval for both. The dosage level for the intramuscular treatment is 15 milligrams. The dosage for the intravenous method is 7.5 milligrams, said Gunther Winkler, programme executive for the trial.

Genentech’s drug is delivered by injection under the skin. Like insulin injections for diabetes, patients can administer Xanelim to themselves at home. Genentech’s trial showed that patients given a higher dose of Xanelim showed less improvement than those given a lower dose. The company said, however, that it had not decided which dose level to take forward.

Biogen and Genentech have lots of rivals fighting for a share of the market, with at least 30 other psoriasis drugs in development. Brunswick, New Jersey-based Johnson & Johnson presented information at the conference about its Remicade drug. Already approved for treatment of Crohn’s disease and rheumatoid arthritis, Remicade has shown promise as a psoriasis treatment, but has yet to go through phase III clinical trials. Alice Gottlieb, principal investigator of a phase II, 10-week study of 33 patients, told the conference that the trial found that 82 per cent of patients receiving 5 milligrams per kilogram of Remicade achieved a 75 per cent reduction in psoriasis symptoms as measured by the psoriasis severity index. 73 per cent of patients receiving 10 milligrams per kilogram achieved a 75 per cent reduction.

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