CAMBRIDGE, Mass.—Alnylam Pharmaceuticals, Inc. and Genzyme, a Sanofi company, have announced an alliance to develop and commercialize RNAi therapeutics as genetic medicines. Alnylam will retain product rights in North America and Western Europe, and Genzyme will be granted the right to access Alnylam’s “5x15” and future genetic medicines pipeline in the rest of the world, which includes global product rights for certain programs. The “5x15” strategy was launched in January 2011 to develop genetic medicine programs, with the goal of having five candidates in clinical development by the end of 2015, though early this year, that goal was updated to having six to seven candidates in clinical development, including at least two programs in Phase III and five to six with human proof of concept.
Genzyme will also become a major shareholder in Alnylam, thanks to an upfront purchase of $700 million of newly issued stock at approximately $80 per share. The transaction provides Genzyme with roughly 12-percent ownership in the company. Genzyme also has the right to purchase up to but no more than 30 percent of Alnylam stock during the active collaboration. Both companies’ boards of directors approved the transaction, which is subject to customary closing conditions such as the Hart-Scott Rodino Antitrust Improvements Act.
“This new relationship with Genzyme is transformational for Alnylam. It is a game-changer for both the advancement of RNAi therapeutics as a new class of genetic medicines to patients around the world, and for our commitment to build a leading, independent biopharmaceutical company that delivers value to our shareholders,” John Maraganore, Ph.D., CEO of Alnylam, commented in a statement. “In this new alliance, Alnylam benefits enormously from Genzyme’s proven global capabilities, enabling us to accelerate and expand market access for our ‘Alnylam 5x15’ products. At the same time, we retain our product rights in North America and Western Europe, where we remain committed to develop and commercialize our RNAi therapeutics pipeline. We also retain full global product rights for all RNAi therapeutic products outside the genetic medicine field. In addition, this new collaboration significantly expands our balance sheet to over $1 billion in cash to increase our investment in new RNAi therapeutic programs, while securing a cash runway that we believe will allow us to develop and launch multiple products as breakthrough medicines for patients in need.”
Once the transaction closes, Genzyme will opt-in to patisiran (ALN-TTR02). The companies have also agreed to expand their existing collaboration on ALN-TTRsc. Genzyme will have the right to co-develop and co-promote ALN-AT3 or gain a global license to ALN-AS1, and will exercise that right once both programs complete human proof of concept. Genzyme has also gained the right to a global license for a single future genetic medicine program not included in the current “5x15” programs.
As of January 1 of next year, Alnylam will receive R&D funding for the programs into which Genzyme has decided to opt-in for development and commercialization. Genzyme will pay 20 percent of global development expenses in the rest of the world territories where it will develop and commercialize programs, 50 percent of expenses for co-develop/co-promote programs and 100 percent of expenses for global programs, such as its future global opt-in right. Alnylam also stands to receive up to $75 million in milestones per product for regional and co-develop/co-promote programs, and up to $200 million in milestones for global programs. Alnylam will also be eligible for tiered double-digit royalties up to 20 percent on net sales. All told, including equity, R&D funding and potential milestones, this alliance could be worth over $1 billion.
“Genzyme holds a longstanding commitment to improving the lives of patients through the development and commercialization of treatments for rare diseases, both through internal R&D and by working with valuable external collaborators,” said David Meeker, M.D., Genzyme’s president and CEO. “Our relationship with Alnylam has been highly collaborative, and we believe that their world-class RNAi technology holds the promise to provide a platform for sustained drug development for rare genetic diseases for years to come. With this new alliance, we are significantly broadening our relationship with Alnylam and expanding Genzyme’s pipeline of innovative medicines for the treatment of genetic diseases.”
