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Pfenex Inc, a biotechnology company developing biosimilars and vaccines, and Agila Biotech Private Limited, a subsidiary of Bangalore-based Strides Arcolab Limited today announced that they have entered into a joint venture to develop, manufacture and commercialise 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 commercialisation, Agila Biotech will be a 51% equity stakeholder. This multi-product joint venture combines Pfenex’s 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 Q4 2013, Strides said in a statement.
Under the terms of the agreement, Pfenex will assume primary responsibility for development of an optimised production strain, process and analytical package for each product, while Agila 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 commercialisation.
Manufacture of the collaboration products will be carried out at Agila Biotech’s manufacturing facility being built with Bio-XCell at Nusajaya, Johor, Malaysia – a 160 acre site comprised of customised biotech facilities.
“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,” Bertrand Liang, CEO at Pfenex said.
“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 Anand Iyer, CEO at Agila Biotech.
