2:11 PM
Mar 12, 2018
 |  BC Extra  |  Company News

Sanofi declines option for Alnylam's lumasiran

Alnylam Pharmaceuticals Inc. (NASDAQ:ALNY) said the Genzyme Corp. unit of Sanofi (Euronext:SAN; NYSE:SNY) declined to exercise its exclusive option to obtain development and commercialization rights to lumasiran (ALN-GO1) outside the U.S., Canada and Western Europe. The company also said FDA granted breakthrough therapy designation to the candidate to treat primary hyperoxaluria type 1 (PH1).

Alnylam said it plans to begin a Phase III trial of lumasiran in late 2018, and hopes to commercialize it worldwide. Lumasiran is a subcutaneous RNAi therapeutic targeting glycolate oxidase using the GalNAc-conjugate delivery platform to treat PH1.

Under a 2014 deal, Alnylam granted Genzyme options to obtain exclusive rights outside the U.S., Canada and Western Europe to Alnylam's "5x15" pipeline of products, which includes RNAi therapeutics.

The partners restructured the deal in January. Alnylam now has global development and commercialization rights to transthyretin (TTR)-mediated amyloidosis candidates patisiran (ALN-TTR02) and ALN-TTRsc02, and Genzyme has full global rights to hemophilia candidate fitusiran (ALN-AT3, SAR439774) (see BioCentury, Jan. 12).

Genzyme still may opt to gain rights from Alnylam to other undisclosed rare genetic disease programs in territories outside of the U.S., Canada and Western Europe. It also may opt to obtain one global license.

Alnylam gained $9.02 to $142.04 on Monday.

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