Agila Biotech, a subsidiary of Strides Arcolab and San Diego, California-based Pfenex have entered into a joint venture (JV) to develop, manufacture and commercialise an initial pipeline of six biosimilar products for the global market.
As per the JV agreement, wherein both parties will equally share in decision making regarding product development and commercialisation, Agila Biotech will be a 51 per cent equity stakeholder. This multi-product JV 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 JV 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. 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 JV will then progress the products through Phase 3 and into commercialisation.
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 customised biotech facilities.
“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, CEO, 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,” he added.
“Successful foray into the biologics space for companies like Agila Biotech would hinge not only on building state-of-the-art infrastructure and a 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, CEO, Agila Biotech. Iyer also noted that its facility in Malaysia represents a strategic move to bolster Agila Biotech’s manufacturing presence in the region and tap into unmet global demand for quality biologics at affordable prices.
Pfenex is a biotech company developing biosimilars and innovative vaccines to address unmet and growing global healthcare needs. Utilising the company’s core technology, Pfenex Expression Technology for recombinant protein expression, Pfenex is able to rapidly develop and produce high quality therapeutics. In addition, Pfenex also produces and markets research proteins and reagent proteins for the research and drug development community through its Reagent Proteins division.
EP News Bureau – Mumbai