NOVAVAX Reports Progress Under Joint Venture in India With Cadila Pharmaceuticals

CPLB was established in 2009 to combine Novavax's novel 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 India.

Among the joint venture's recent achievements is the development of a rabies vaccine candidate engineered by Novavax which has shown great promise in preclinical testing. Rabies remains a significant public health hazard in India where 36 percent of the world's rabies deaths occur. According to the World Health Organization, the majority of these deaths are the result of children under the age of 15 coming in contact with infected dogs. 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.

In addition, CPLB has made rapid progress with the validation of its state-of-the-art manufacturing facility in Dholka, India, which is now operational and capable of producing a significant volume of novel vaccine doses every year. This facility utilizes 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 will later be used to produce commercial product as well as clinical supplies for other undisclosed new vaccine candidates to meet critical medical needs.

CPLB 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.

Stanley Erck, President and CEO of Novavax, stated: "CPLB has made great progress this year with its state-of-the-art manufacturing facility and vaccine pipeline. It continues to demonstrate the power of combining our technology with world-class research, clinical development and manufacturing expertise to develop potential in-border vaccine solutions. I am particularly excited about the team's accelerated vaccine development efforts this year and the approval by the RCGM to initiate the rabies toxicology studies which is an important milestone. In addition to sharing directly in any success from CPLB's efforts to commercialize vaccine products in India, Novavax can utilize 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 plus adds to our global manufacturing capacity. I look forward to reporting more about their current and new vaccine programs in 2012."

Indravadan A. Modi, Chairman of Cadila Pharmaceuticals Ltd., stated: "Our joint venture with Novavax is progressing well and remains on track to begin clinical testing of two new vaccine candidates. In addition, we have continued to add talented new scientific and manufacturing staff as we prepare for the launch of our production facility and expand preclinical testing of new vaccine candidates for undisclosed targets."