Novavax Reports Significant Vaccine Development Progress

Novavax, Inc. recently announced that CPL Biologics (CPLB), its joint venture in India with Cadila Pharmaceuticals Ltd., has made significant progress with its vaccine development programs in 2011 and is preparing to initiate clinical studies of vaccine candidates to prevent influenza and rabies in 2012 and 2013, respectively.

Cadila is one of the largest private pharmaceutical companies in India. 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% 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, MD. 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.

“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,” said Stanley Erck, President and CEO of Novavax. “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.”

“Our joint venture with Novavax is progressing well and remains on track to begin clinical testing of two new vaccine candidates,” added Indravadan A. Modi, Chairman of Cadila Pharmaceuticals Ltd. “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.”

Novavax, Inc. is a clinical-stage biopharmaceutical company creating novel vaccines to address a broad range of infectious diseases worldwide. Using innovative virus-like particle (VLP) and recombinant nanoparticle technology, as well as new and efficient manufacturing approaches, the company produces potent vaccine candidates to combat diseases, with the goal of allowing countries to better prepare for and more effectively respond to rapidly spreading infections. Novavax is committed to using its technology platforms to create geographic-specific vaccine solutions and is therefore involved in several international partnerships, including collaborations with Cadila Pharmaceuticals of India and LG Life Sciences of Korea.

Cadila Pharmaceuticals Ltd. is one of the largest privately held pharmaceutical companies in India, headquartered at Ahmedabad, in the state of Gujarat. Throughout the past 5 decades, it has been developing and manufacturing pharmaceutical products and selling and distributing these in India and in over 50 countries around the world. Cadila Pharmaceuticals is an integrated healthcare solutions provider with a pharmaceutical product basket in therapeutic areas that include cardiovascular, gastrointestinal, analgesics, haematinics, anti-infectives and antibiotics, respiratory agents, antidiabetics, and immunologicals. The state-of-the-art R&D facility at Cadila Pharmaceuticals is manned by more than 350 scientists and engineers from various disciplines, including biology, pharmacology, clinical research, chemistry, toxicology, phytochemistry, and different disciplines of engineering.

The company also participates in public-private partnerships for developing preventive and curative pharmaceutical and diagnostic products. Throughout the past decade, Cadila Pharmaceuticals has focused on novel approaches to cancer management and is the first Indian company to get multiple INDs cleared by USFDA. The company has state-of-the-art manufacturing facilities conforming to the most stringent international norms at Dholka, Ankleshwar, Kadi and Hirapur in Gujarat; Samba in Jammu and Kashmir, and Addis Ababa in Ethiopia. Cadila Pharmaceuticals has recently emerged on the world map with the development of Polycap – a novel and world’s first drug combination for primary prevention of cardiovascular heart disease.