Alnylam grants Genzyme Asian rights for ALN-TTR program

Alnylam Pharmaceuticals Inc. (NASDAQ:ALNY) granted Genzyme Corp. 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 2013. 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.

Alnylam, which retains rights to the program elsewhere, will receive $22.5 million up front, plus up to $50 million in milestones. Alnylam is also eligible for tiered, double-digit royalties ranging from the mid-teens to mid-twenties. Genzyme also received a right of first negotiation to license rights to the ALN-TTR program if Alnylam decides to partner the program outside of the Asia-Pacific region. This is Genzyme's first deal involving rights only in Japan and the Asia Pacific region since a 2003 deal with Transkaryotic Therapies Inc. for a mucopolysaccharidosis II (MPS-II, Hunter syndrome) therapy. Genzyme is a unit of Sanofi (Euronext:SAN; NYSE:SNY). Transkaryotic was acquired by Shire plc (LSE:SHP; NASDAQ:SHPGY) in 2005. ...