Biotech Values

[DewDiligence]

RGEN rises on BMY’s RA results:

[RGEN and BMY own distinct but mutually blocking patents to CTLA4, which gives RGEN leverage over BMY for CTLA4 in the treatment of RA and certain other diseases. (RGEN also has a patent suit against IMCL regarding the manufacturing of Erbitux, but RGEN’s case against IMCL has some holes: #msg-3786194, #msg-3127821.) Although RGEN is now up sharply from the low point reached following the failure of its lead drug, Secretin, in autism, the stock is still quite cheap as a speculative IP play on BMY’s results in RA.]

http://biz.yahoo.com/prnews/041021/neth020_1.html

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Repligen Notes Presentation of Positive Phase 3 Results of CTLA4-Ig for Rheumatoid Arthritis at the American College of Rheumatology Annual Meeting

WALTHAM, Mass., Oct. 21 /PRNewswire-FirstCall/ -- Repligen Corporation (Nasdaq: RGEN) today noted presentation of the results of two positive Phase 3 clinical trials of CTLA4-Ig in patients with rheumatoid arthritis at the annual meeting of the American College of Rheumatology. These studies, sponsored by Bristol-Myers Squibb Company, focused on two different rheumatoid arthritis patient populations: those who do not adequately respond to treatment with methotrexate and those who do not respond to the class of biologic therapy known as tumor necrosis factor (TNF) inhibitors such as Enbrel®, Humira® and Remicade®. The data presented today suggests that CTLA4-Ig may represent a new treatment option for patients with rheumatoid arthritis. Bristol-Myers Squibb has previously stated that it intends to file a New Drug Application for its form of CTLA4-Ig by the end of the year.

"The efficacy observed in the clinical trials suggests that CTLA4-Ig may benefit patients who do not adequately respond to current treatments, including TNF inhibitors," stated Walter C. Herlihy, President and Chief Executive Officer of Repligen. "The current combined revenues for TNF inhibitors are more than $3 billion per year despite the fact that at least 25% of patients are refractory to treatment."

The first study was a 1-year, randomized, double-blind, placebo- controlled, multicenter Phase 3 trial of CTLA4-Ig at 10mg/kg plus methotrexate compared to methotrexate alone. CTLA4-Ig or placebo was administered in a single 30-minute infusion on days 1, 15 and 29 and every 28 days thereafter. The primary endpoint in the study was the percentage of patients achieving at least a 20 percent improvement in multiple measures of disease activity (ACR 20). After six months of treatment, 67.9% of patients receiving CTLA4-Ig plus methotrexate achieved a ACR 20 response compared to 39.7% receiving placebo plus methotrexate (p<0.001). In addition, after 1 year of treatment, statistically significant improvements were achieved on the ACR 20 (p<0.001), ACR 50 (p<0.001) and ACR 70 (p<0.001). CTLA4-Ig was generally safe and well tolerated with a low incidence of infusion reactions and serious infections, 3.9% in the CTLA4-Ig group and 2.3% in the placebo group.

The second study was a 24-week, randomized, double-blind, placebo- controlled, multicenter Phase 3 trial of CTLA4-Ig at 10mg/kg in patients with active rheumatoid arthritis who were not adequately responding to >/= 3 months of treatment with TNF inhibitors. CTLA4-Ig or placebo was administered to patients in a single 30-minute infusion on days 1, 15 and 29 and every 28 days thereafter. After six months of treatment, 50.4% of patients receiving CTLA4- Ig achieved a ACR 20 response compared to 19.5% receiving placebo (p<0.001). In addition, statistically significant improvements were achieved on the ACR 50 (p<0.001) and the ACR 70 (p<0.005). CTLA4-Ig was generally safe and well tolerated with a similar incidence of adverse events and serious infections (2.3%), between the groups.

CTLA4-Ig Intellectual Property

Repligen owns the rights to U.S. patent # 6,685,941 entitled "Methods of Treating Autoimmune Disease via CTLA4-Ig." The patent, which will remain in force until 2021, covers a method of treating rheumatoid arthritis, multiple sclerosis, systemic lupus erythematosis and scleroderma with CTLA4-Ig and the use of CTLA4-Ig in combination with other immunosuppressants. Repligen has also been granted a patent in Europe for the use of CTLA4-Ig for the treatment of autoimmune disease including rheumatoid arthritis, as well as organ transplant, which will remain in force until 2013. Repligen owns the exclusive rights to these patents through license agreements with The University of Michigan and the United States Navy.
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