CPL Biologicals, Novavax' joint venture (JV) with Cadila Pharmaceuticals in India, has claimed significant progress with its vaccine-development programmes in 2011 and is now preparing to start work on clinical studies of vaccine candidates to prevent influenza and rabies during 2012 and 2013, respectively. CPL was established in 2009 to combine Novavax' vaccine technology and Cadila's product development and manufacturing expertise to develop vaccine candidates from both companies and manufacture and market them in India. Novavax retains rights to products developed for markets outside of the country.
A rabies vaccine candidate developed by Novavax claims to show "great promise" in preclinical testing. CPL completed positive preclinical immunogenicity studies of the rabies G-protein nanoparticle vaccine and has recently received approval from the Review Committee on Genetic Manipulation (RCGM) to begin toxicology studies of this vaccine prior to initiating human trials. The RCGM is responsible for regulating preclinical and clinical testing of recombinant vaccines, diagnostics and biologics in India.
In addition, CPL has made progress with gaining official recognition for its manufacturing facility in Dholka, India, which is now operational and capable of producing a significant volume of vaccine doses every year. This facility uses the single-use vaccine bioprocessing system that Novavax employs at its pilot plant in Rockville, MD. The facility in Dholka will initially be used to produce clinical supplies of vaccine candidates to prevent flu and rabies and will later for production of commercial product as well as clinical supplies for other undisclosed new vaccine candidates.
CPL is also now pursuing early development of undisclosed new vaccine candidates to prevent other diseases. The targets of these vaccine candidates will be identified as they progress into preclinical and clinical studies.