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Sanofi and Alnylam enter into strategic restructuring of RNAi therapeutics rare disease alliance

Nachrichtenquelle: GlobeNewswire
07.01.2018, 21:00  |  564   |   |   
  Press Release
Source: Sanofi (EURONEXT: SAN) (NYSE: SNY)
 

Sanofi and Alnylam enter into strategic restructuring of RNAi therapeutics rare disease alliance


  • Restructuring enables streamlined development and optimization of commercial opportunities for ATTR amyloidosis and hemophilia programs
  • Sanofi obtains global rights for investigational therapeutic fitusiran in hemophilia and other rare bleeding disorders
  • Alnylam obtains global rights for investigational ATTR amyloidosis programs: patisiran and ALN-TTRsc02
 

Paris and Cambridge, Mass. - January 7, 2018 - Sanofi and Alnylam Pharmaceuticals, Inc. (Nasdaq: ALNY), the leading RNAi therapeutics company, announced today a strategic restructuring of their RNAi therapeutics alliance to streamline and optimize development and commercialization of certain products for the treatment of rare genetic diseases. Specifically:

 

  • Sanofi will obtain global development and commercialization rights to fitusiran, an investigational RNAi therapeutic, currently in development for the treatment of people with hemophilia A and B. Global commercialization of fitusiran, upon approval, will be done by Sanofi Genzyme, the specialty care global business unit of Sanofi. Alnylam will receive royalties based on net sales of fitusiran products.
  • Alnylam will obtain global development and commercialization rights to its investigational RNAi therapeutics programs for the treatment of ATTR amyloidosis, including patisiran and ALN-TTRsc02. Sanofi will receive royalties based on net sales of these ATTR amyloidosis products.
  • With respect to other products falling under the RNAi therapeutics alliance, the material terms of the 2014 Alnylam-Sanofi Genzyme alliance remain unchanged. 
"The restructured alliance reflects Sanofi Genzyme's sustained interest in the strong potential of Alnylam's portfolio of genetic medicines. The new structure simplifies operations, providing both parties the agility needed to make these medicines available to patients as quickly as possible once approved," said Bill Sibold, Executive Vice President and Head of Sanofi Genzyme. "This restructuring will enable both parties to maximize the value of each asset and allows us to maintain shared economics across the alliance program."

 

Fitusiran complements Sanofi Genzyme's rare hematology portfolio, and creates a focus on bringing an innovative product to market globally, upon approval, for people living with hemophilia, one of the most common rare diseases.

 

"This strategic restructuring enables streamlined development and an optimized approach to bringing innovative medicines to patients with ATTR amyloidosis and hemophilia around the world, maximizing the commercial opportunities for these programs," said John Maraganore, Ph.D., Chief Executive Officer of Alnylam. "For Alnylam, this provides strategic clarity and operational alignment with regard to the development and commercialization of patisiran and ALN-TTRsc02. This will allow us to develop both products in a comprehensive manner, potentially addressing the full spectrum of transthyretin-mediated amyloidosis disease treatment and prevention. At the same time, we will continue to support and benefit - via royalties - from the fitusiran opportunity through Sanofi's significant development and commercial leadership."

 

This restructuring provides Alnylam with the opportunity to consolidate its ATTR amyloidosis business to maximize its value, and the opportunity for near-term acceleration of product revenue growth based on newly obtained rights to commercialize patisiran around the world, once approved. In addition, it enables Alnylam to build a global presence and commercial infrastructure that can be leveraged for ALN-TTRsc02 and additional programs, including givosiran, an investigational RNAi therapeutic for the treatment of acute hepatic porphyrias, and cemdisiran, an investigational RNAi therapeutic for the treatment of complement-mediated diseases - where Alnylam has retained global ownership.

 

Terms of the Agreements

 

Fitusiran
The restructuring will enable Sanofi to assume full responsibility for development and commercialization of fitusiran, including costs. However, during the anticipated transition period Alnylam will fund such costs. Alnylam intends to substantially complete the transition of fitusiran to Sanofi by mid-2018. Sanofi will pay Alnylam a milestone of $50 million following dosing of the first patient in the ATLAS Phase 3 program for fitusiran. 

 

Patisiran and ALN-TTRsc02
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