Merck and Dr. Reddy’s Laboratories Announce Collaboration to Develop and Commercialize Biosimilars
Combined Biologics expertise of Merck and Dr. Reddy’s to deliver on promise of biosimilars
Merck and Dr. Reddy’s Laboratories Ltd. announced a partnership to co-develop a portfolio of biosimilar compounds in oncology, primarily focused on monoclonal antibodies (MAbs). The partnership covers co-development, manufacturing and commercialization of the compounds around the globe, with some specific country exceptions.
The Merck Serono and Dr. Reddy’s partnership marks the first step by Merck to enter the biosimilar space. The Merck Serono division began exploring the opportunity last year to assess how it could capitalize on its expertise in biopharmaceuticals and its growing presence in key markets including select Emerging Markets. Earlier this year, it set up a dedicated biosimilars unit that will be based in the Canton of Vaud in Switzerland, where the main biologics manufacturing facilities of the division are located. The investment required for this initiative is fully reflected in the guidance provided for Merck’s 2012 and mid-term financial performance, which was provided to the Capital Markets on May 15, 2012.
The deal structure calls for Merck and Dr. Reddy’s to co-develop the molecules included in the agreement. Dr. Reddy’s will lead early product development and complete Phase I development. Upon completion of Phase I, the Merck Serono division will take over manufacturing of the compounds and will lead Phase III development. The agreement is based on full R&D cost sharing.
Merck Serono will undertake commercialization globally, outside the US and with the exception of select emerging markets which will be co-exclusive or where Dr. Reddy’s maintains exclusive rights. At the time of commercialization, Dr. Reddy’s will receive royalty payments from Merck Serono. In the US, the parties will co-commercialize the products on a profit-sharing basis. Additional terms of the deal were not disclosed.
The move into biosimilars by Merck Serono is a part of the Merck Group’s transformation program, through a diversified business focused on delivering long-term value and growth opportunities.
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Topic world Antibodies
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