Alnylam, Sanofi deal

Alnylam granted Sanofi's Genzyme Corp. unit exclusive rights in Japan and other Asia-Pacific countries to develop and commercialize RNAi therapeutics for transthyretin (TTR). The deal includes two products for TTR-mediated amyloidosis: IV ALN-TTR02, in Phase II testing; and subcutaneous ALN-TTRsc, in preclinical testing. Alnylam plans to submit an IND to FDA by year end to begin Phase I testing of ALN-TTRsc. An international Phase III trial of ALN-TTR02 is slated to start by the end of next year. Genzyme said the companies have yet to decide whether the trial will include patients from Japan and Asia-Pacific, but the company said clinical testing in Japan will likely start as part of or in parallel with the global trial.

In July, Alnylam reported data from a Phase I trial of ALN-TTR02. The product has Orphan Drug designation in the U.S. to treat familial amyloidotic polyneuropathy (FAP), a predominant clinical manifestation of TTR-mediated amyloidosis (see BioCentury, July 23). ...