By Kim Coghill
Biogen Inc. said it intends to file worldwide regulatory applications later this year for approval of Amevive, a psoriasis drug expected to generate millions in revenue for the Cambridge, Mass.-based company.
Amevive is a novel immunomodulatory agent that selectively targets the CD45RO+ subset of T cells (memory effector T cells). The T cells are the mediators of disease in psoriasis and in other autoimmune disorders. Amevive reduces the number of these disease-causing cells, while not disrupting normal immune function.
According to the American Academy of Dermatology, there are about 100 million people worldwide with psoriasis, an inflammatory skin disorder that can cause considerable discomfort. Although there are some treatment options on the market, there¿s nothing available that offers patients long-term, effective and safe disease control and improved quality of life.
But that could all change if Amevive is approved. Biogen expects that Amevive will be ¿commercially viable¿ by the end of 2002, said Kathleen O¿Donnell, Biogen¿s associate director of public affairs.
¿At its peak, somewhere in the order of about five years, Amevive has the potential to become a multihundred-million-dollar product,¿ said Elise Wang, senior biotechnology analyst with Salomon Smith Barney in New York. She added that the only current competition is a product called Xanelim being developed by Genentech Inc., of South San Francisco, and Xoma Ltd., of Berkeley, Calif.
Biogen¿s stock (NASDAQ:BGEN) closed Tuesday at $64.97, up $1.45.
Amevive (alefacept) had statistically significant results in two worldwide Phase III clinical trials in patients with moderate-to-severe plaque psoriasis, Biogen said. In intramuscular and intravenous studies, Amevive met the primary efficacy endpoint, a 75 percent or greater improvement in the Psoriasis Area and Severity Index (PASI) score two weeks after completion of a 12-week course of treatment.
Additional analyses showed 71 percent of patients receiving two IV courses of Amevive therapy achieved a 50 percent or greater reduction in the baseline PASI score and 40 percent achieved a 75 percent or greater reduction in the baseline PASI score.
The trials also assessed the impact of therapy on a patient¿s quality of life. In both studies, patients in the Amevive-treated groups achieved a statistically significant quality of life benefit (p< .001), as measured by the Dermatology Life Quality Index. A 50 percent or greater reduction in the baseline PASI score significantly correlated with improved quality of life.
The Phase III double-blind, placebo-controlled clinical trials enrolled more than 1,100 patients at 100 clinics in the U.S., Europe and Canada. Participating patients were 16 to 84 years old with chronic plaque psoriasis that covered at least 10 percent of their total body surface. Overall rates of adverse events were similar in both Amevive and placebo groups. The most common observed adverse events among Amevive-treated patients in either trial were accidental injury, headache, pruritis, infection (common cold), pharyngitis and rhinitis.
O¿Donnell said that by the end of the year Biogen will be testing Amevive in other indications, including scleroderma and rheumatoid arthritis.
Biogen¿s lead product, Avonex, (interferon beta 1-a) for treatment of relapsing forms of multiple sclerosis, produced $761 million in revenues last year.
The company has several other products in the pipeline including Antegren, a monoclonal antibody being developed with Elan Corp. plc, of Dublin, Ireland, for multiple sclerosis and Crohn¿s disease. It is scheduled to enter Phase III trials by the year¿s end.