Forum Archive Index - January 2003

["G Stolwyk" <stolwyk@wave.co.nz>]

Transferred from the Ozestock PTD site-The Adder:
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Amgen Arthritis Drug EffectiveAgainst psoriasis

Friday January 17

LOS ANGELES (Reuters) - Amgen Inc. on Friday said a pivotal-stage trial shows that its arthritis drug Enbrel is also an effective treatment for psoriasis, a market which could dramatically expand the drug's sales potential.
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Amgen, the world's top biotechnology company, is racing Biogen Inc., Johnson & Johnson and Genentech Inc. to market the first effective treatment for the disorder characterized by red, scaly patches on the skin that affects more than 100 million people worldwide. By some estimates, the market for an effective psoriasis drug could reach $5 billion.

Biogen has said it expects the U.S. Food and Drug Administration to approve in the first quarter of this year its application for Amevive, which works by targeting an immune system cell that plays a central role in the disease.

Amgen has projected 2003 sales of Enbrel as high as $1.4 billion. The drug, which works by blocking a protein that causes inflammation, is approved for treatment of joint disorders rheumatoid arthritis and psoriatic arthritis.

In the 600-patient Phase III trial, Enbrel improved psoriasis symptoms by at least 75 percent in nearly half of patients after 12 weeks of treatment, while nearly 60 percent achieved that goal after 24 weeks, Amgen said.

Patients in the psoriasis trial were injected twice a week with double the amount of Enbrel, 50 milligrams, as the dose for which the drug is approved for rheumatoid arthritis patients.

Side effects were similar to placebo pills, according to company spokeswoman Rebecca Hamm.

She said full results from the trial will likely be presented in March at the annual meeting of the American Academy of Dermatology.

Amgen will not, however, file for with the FDA for approval of Enbrel in psoriasis until results are in from a second Phase III trial of 600 patients. Those results are expected sometime later this year, Hamm said.

Joel Sendek, an analyst at Lazard Freres & Co., said the Enbrel results compare favorably with data seen with other biologics.

After 12 weeks of treatment, Biogen's Amevive was shown to be 75-percent effective in 21 percent of patients, while Genentech's Raptiva was shown to reach that goal in 23 percent of patients, he said in a report, while noting that it is difficult to compare the drugs without head-to-head studies.

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My comment: I forgot to report some Phase some time ago. Investors need to seriously consider the implications.

Gerry