Cadila-Novavax JV gets nod for clinical test of new vaccines

CPL Biologics (CPLB), a joint venture between Indravadan Modi-led Cadila Pharmaceuticals Ltd and Novavax Inc, a US-based biopharmaceutical player, has received a regulatory approval for conducting rabies vaccine toxicology studies in India and clinical study of influenze vaccine, which is planned for 2012.

In a statement filed with Nasdaq, Novavax informed that the joint venture is preparing to initiate clinical studies of vaccine candidates to prevent influenza and rabies in 2012 and 2013, respectively. "Our JV with Novavax is progressing well and remains on track to begin clinical testing of two new vaccine candidates," the statement quoted IA Modi, chairman of Cadila Pharmaceuticals as saying.

CPLB is also pursuing early development of undisclosed new vaccine candidates to prevent other diseases."Novavax can utilise CPLB's development work on vaccine candidates like rabies to initiate similar efforts in other territories that would benefit from such a program. We see CPLB as a long-term strategic partner that expands Novavax's vaccine development capability and adds to our global manufacturing capacity," said Stanley Erck, president and CEO of Novavax in the statement.

Among the JV’s recent achievements is the development of a rabies vaccine candidate engineered by Novavax which has shown great promise in preclinical testing. CPLB completed positive preclinical immunogenicity studies of a 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 clinical trials. The RCGM is responsible for regulating preclinical and clinical testing of recombinant vaccines, diagnostics and biologics in India, the statement said.

CPLB has made rapid progress with the validation of its manufacturing facility in Dholka, near Ahmedabad. The facility is operational and capable of producing a significant volume of novel vaccine doses every year.

"This facility utilises the single-use vaccine bioprocessing system that Novavax employs at its pilot plant in Rockville, Maryland. The facility in Dholka will be used initially to produce clinical supplies of vaccine candidates to prevent influenza and rabies and later will be used to produce commercial products as well as." the statement said.