respond at BV:
Message 19288314
Press Release Source: Regeneron Pharmaceuticals, Inc.
Regeneron Moving Forward with AXOKINE Phase III Program for Treatment of Obesity
Tuesday September 9, 4:30 pm ET
TARRYTOWN, N.Y.--(BUSINESS WIRE)--Sept. 9, 2003--Regeneron Pharmaceuticals (Nasdaq:REGN - News) announced today that it will move forward with the Phase III development program of AXOKINE® for the treatment of obesity. This decision was made following a meeting with the U.S. Food and Drug Administration (FDA) to review results from the initial pivotal trial completed earlier this year and the Company's plans for future development of AXOKINE.
ADVERTISEMENT
The remaining Phase III program is expected to consist of a one-year confirmatory pivotal trial similar to the initial trial, a separate one-year study in obese type 2 diabetic patients, and several smaller and shorter studies. The trials will continue to enroll a broad range of overweight and obese individuals. In total, approximately 2,300 additional people are expected to be enrolled in future trials.
"Based on our discussions with the FDA, we believe that AXOKINE has demonstrated a favorable risk-benefit profile in clinical trials performed to date," said George D. Yancopoulos, M.D., Ph.D., Executive Vice President and Chief Scientific Officer. "Our discussions also indicate that if the results of the remaining development program parallel the results we saw in our initial pivotal trial, we would have the basis for applying for approval of AXOKINE for the treatment of obesity."
"The recently announced collaboration with Aventis covering the VEGF Trap and our corporate partnership with Novartis covering the IL-1 Trap have freed up Company resources to support the continued development of the AXOKINE program," said Leonard S. Schleifer, M.D., Ph.D., President & Chief Executive Officer. "Obesity is a complicated chronic disease, and like many other such diseases, there may not be a single magic bullet that helps all patients. AXOKINE has the potential to be a new weapon in the battle against obesity. Though it causes moderate weight loss in most patients, a significant proportion of patients exhibit substantial weight loss with AXOKINE treatment. In the completed pivotal trial, almost three times as many patients treated with AXOKINE plus a weight control program lost over 10% of their body weight over twelve months of treatment compared to those on a weight control program alone (11.3% versus 4.2%), and these patients averaged more than 30 pounds of weight loss." |
