Strides Arcolab’s arm enters into a Joint Venture to develop Biosimilar products

16 Apr 2013 Evaluate

Agila Biotech, a subsidiary of Strides Arcolab and Pfenex Inc have entered into a joint venture to develop, manufacture and commercialize an initial pipeline of six biosimilar products for the global market. Operating as a JV, wherein both parties will equally share in decision making regarding product development and commercialization, Agila Biotech will be a 51% equity stakeholder.

This multiproduct joint venture combines Pfenex's industry-leading expertise in strain engineering and process development with Agila Biotech's biologics manufacturing and clinical development excellence. The lead product for the joint venture is Interferon beta-1b, a biosimilar to Betaseron, indicated for relapsing- remitting and secondary-progressive forms of multiple sclerosis, commencing human clinical trials by 04 2013.

Under the terms of the agreement, Pfenex will assume primary responsibility for development of an optimized production strain, process and analytical package for each product, while Agile Biotech will be responsible for pre-clinical and Phase 1 development, as well as cGMP manufacturing. The joint venture will then progress the products through Phase 3 and into commercialization. Manufacture of the collaboration products will be carried out at Agila Biotech's state-of-the-art manufacturing facility being built with Bio-XCell at Nusajaya, Johor, Malaysia –a 160 acre site comprised of customized biotech facilities.

Strides Arcolab is a global pharmaceutical company headquartered in Bangalore, India that develops and manufactures wide range of IP-lead niche pharmaceutical products with an emphasis on sterile injectables.

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