If the very small amount of pre-market trading is an indication, this is being interpreted as a disappointment (which of course it is) rather than a to-be-welcomed business decision to conserve cash:
Alnylam Accelerates RSV Infection Program and Provides Update on AMD Program
Tuesday September 20, 8:00 am ET
Rapid Progress with RSV Program Supports IND Filing by Year End
CAMBRIDGE, Mass.--(BUSINESS WIRE)--Sept. 20, 2005--Alnylam Pharmaceuticals, Inc. (Nasdaq: ALNY - News), a leading RNAi therapeutics company, today updated its product pipeline guidance for the remainder of 2005. The company now expects to file an investigational new drug (IND) application for ALN-RSV01, its proprietary RNAi therapeutic candidate for RSV infection, with the Food and Drug Administration (FDA) by the end of the year, rather than in the first half of 2006 as previously forecast. In addition, given the reported efficacy in recent Phase III studies from competing drugs targeting vascular endothelial growth factor (VEGF) for the treatment of age-related macular degeneration (AMD), the company has made a strategic business decision to suspend further development of ALN-VEG01, its RNAi therapeutic candidate targeting VEGF for AMD, in order to allocate resources to other product opportunities.
"Our RSV program continues to generate compelling pre-clinical data, as was presented Sunday by Alnylam scientists at the RSV Symposium 2005," said John Maraganore, Ph.D., President and Chief Executive Officer of Alnylam Pharmaceuticals. "There exists a significant unmet medical need for novel therapies to effectively treat patients infected with RSV, and we are pleased to report that, based on the tremendous progress we have made with this proprietary program, we are able to move our therapeutic candidate into human clinic trials ahead of schedule. Based on our interactions with regulatory authorities we believe we have a clear path forward to conduct a Phase I safety study."
"We have also made an important business decision to put the development of ALN-VEG01, part of our Merck ocular collaboration, on hold," continued Dr. Maraganore. "ALN-VEG01 had been expected to advance into Phase I clinical trials in the second half of 2005. With the increasingly competitive landscape for VEGF-targeting AMD therapeutics on the market and in late-stage human trials, we have made the strategic decision to allocate resources to higher-value product opportunities, such as ALN-RSV01. However, Alnylam and Merck continue to work together on the discovery of other RNAi therapeutics for the treatment of ocular disease." |
