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Alefacept (Biogen).
1Department of Dermatology, University of California, San Francisco 94143-0989, USA. saqib@itsa.ucsf.edu
Summary
Alefacept, a novel LFA-3-Ig fusion protein, is in Phase III trials for psoriasis treatment. This CD2 antagonist shows promise for autoimmune diseases, with regulatory filings anticipated in late 2001.
Area of Science:
- Immunology
- Dermatology
- Pharmacology
Background:
- Alefacept (B-9273) is an investigational LFA-3-Ig fusion protein.
- It functions as a CD2 antagonist.
- Biogen is developing alefacept for autoimmune diseases like psoriasis and transplant rejection.
Purpose of the Study:
- To evaluate alefacept in Phase III clinical trials for chronic plaque psoriasis.
- To assess the potential of alefacept as a treatment for autoimmune conditions.
Main Methods:
- Pivotal Phase III trial initiated in December 1999 for chronic plaque psoriasis patients.
- A second Phase III trial has also been initiated.
- Ongoing clinical trials are gathering efficacy and safety data.
Main Results:
- Regulatory filings were anticipated in the second half of 2001 in Europe and the US.
- Product launch was estimated for 2001-2002.
- Projected sales for 2001 and 2002 were US $20 million and US $100 million, respectively.
Conclusions:
- Alefacept is a critical component for Biogen's future earnings growth.
- The drug is progressing through late-stage clinical development for psoriasis.
- Potential for significant market penetration in autoimmune disease treatment.