Pfenex, Agila Biotech In Biosimilar JV

Pfenex, Inc. and Agila Biotech Private Ltd., a subsidiary of Strides Arcolab, have entered into a joint venture to develop, manufacture and commercialize an initial pipeline of six biosimilar products for the global market. Both companies will equally share development decisions and commercialization. Agila will hold 51% equity. The JV combines Pfenex’s expertise in strain engineering and process development with Agila’s biologics manufacturing and clinical development expertise.
 
The lead product is a biosimilar to Betaseron indicated for relapsing-remitting and secondary-progressive forms of multiple sclerosis, with clinical trials beginning in 4Q13. Pfenex will assume responsibility for development of an optimized production strain, process and analytical package for each product, and Agila will be responsible for preclinical and Phase I development, as well as cGMP manufacturing. The JV will then progress the products through Phase III and into commercialization. Products will be manufactured at Agila’s customized biotech facilities being built with Bio-XCell in Malaysia on a 160-acre site.
 
“One of the global challenges for the future of healthcare is to develop and produce products within the confines of a constrained cost environment,” said Dr. Bertrand Liang, chief executive officer at Pfenex. “Biosimilars are and will play an increasingly important role in patient disease management. This venture between Pfenex and Agila Biotech will allow us to leverage our infrastructure for the development of safe, reliable and cost-effective therapies for patients to address unmet medical needs all over the world.”
 
“Successful foray into the biologics space for companies like Agila Biotech would hinge not only on building a state-of-the-art infrastructure and strong technical foundation, but also on creative partnerships such as the one that Agila Biotech has entered into with Pfenex.  This will allow us to not only leverage time and cost advantage of developing products in India and Malaysia, but also serve as a gateway to a vast region in South Asia, South-East Asia and the OIC region currently underserved as a result of the lack of high quality, cost effective biologics,” said Dr. Anand Iyer, chief executive officer at Agila Biotech.