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Positive Clinical Data on CC-10004 Confirms Potential as Novel Oral,Approach to Treating Inflammatory Diseases

Celgene to Advance Clinical and Regulatory Development of Oral Anti-Inflammatory Franchise

SUMMIT, N.J., May 22, 2007 /PRNewswire-FirstCall/ -- Celgene Corporation announced its plans to advance the development of leading oral anti-inflammatory candidates across a broad range of inflammatory diseases. CC-10004 (apremilast), an oral TNF antagonist and anti-inflammatory agent has demonstrated significant activity and an excellent side effect profile in a placebo controlled proof-of-mechanism trial in psoriasis.

The multicenter, randomized, double blind, placebo-controlled Phase II study achieved the primary endpoint after 12 weeks of treatment with 24% of patients receiving CC-10004 twice daily achieving a PASI-75 score compared to 10% of those receiving placebo. The Psoriasis Area and Severity Index (PASI) is a standard measurement of response utilized to assess improvement in patients with moderate to severe psoriasis. In addition, 57% of patients receiving CC-10004 twice daily achieved a PASI-50 compared to 23% of those receiving placebo. Most importantly, patients receiving CC-10004 continued to improve over time.

"The data from the Phase II study in patients with moderate-to-severe psoriasis are clinically and statistically significant compared with placebo. In addition, patients continued to improve throughout the 12 week treatment regimen with an oral therapy that has a good side effect profile addressing an unmet medical need," said Alice Gottlieb, M.D., Ph.D., Dermatologist in Chief and Chair, Department of Dermatology of Tufts-New England Medical Center. "The PASI-90 response of 14% for CC-10004 is comparable to Enbrel dosed at 25 mg twice weekly."

Based on these results, Celgene is accelerating clinical and regulatory strategies for CC-10004 in psoriasis, psoriatic arthritis, rheumatoid arthritis and other inflammatory diseases. The Company is also initiating development plans to a
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