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Cadila Pharmaceuticals Launches Joint Venture With Novavax, Inc. (NVAX) in India


7/9/2009 6:34:39 AM

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ROCKVILLE, Md., July 9 /PRNewswire-FirstCall/ -- Novavax, Inc. (Nasdaq: NVAX - News) and Cadila Pharmaceuticals today announced the launch of their joint venture in India under the agreement signed between the two companies in March 2009. This joint venture, called CPL Biologicals Pvt. Ltd., will develop and manufacture vaccines, biological therapeutics and diagnostics in India using technology contributed from Novavax and Cadila Pharmaceuticals. In addition, CPL Biologicals will establish manufacturing facilities in India and develop, produce and sell products such as seasonal influenza vaccine and potentially other novel vaccines against dengue fever and chikungunya fever based on Novavax's virus-like-particle (VLP) vaccine technology. CPL Biologicals also expects to develop the pandemic H1N1 influenza vaccine candidate in India that Novavax is developing in the United States.

Mr. I. A. Modi, Chairman of CPL Biologicals, noted: "This joint venture represents an important strategic alliance for vaccine development and manufacturing in India and uses unique and cutting-edge vaccine technology. Our vision is to be a leading provider of high quality, affordable vaccines, biological therapeutics and diagnostics through world-class research and innovative manufacturing to address current and future global health challenges."

Rahul Singhvi, President and Chief Executive Officer of Novavax, stated: "We are excited to see the agreement with Cadila announced in March come to fruition with the official launch of CPL Biologicals today. We look forward to a long and successful effort to bring important new vaccines and other pharmaceutical products to the people of India."

About Cadila Pharmaceuticals Ltd.

Cadila Pharmaceuticals Ltd. is one of the largest privately held pharmaceutical companies in India, headquartered at Ahmedabad, in the State of Gujarat. Over the last five 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 Research and Development (R&D) facility at Cadila Pharmaceuticals is manned by more than three hundred and fifty 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. Over the last decade, Cadila Pharmaceuticals has focused on novel approaches to cancer management and is the first Indian company to get multiple investigational new drug applications (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 (CHD).

About Novavax

Novavax, Inc. (Nasdaq: NVAX - News) is a clinical-stage biotechnology company creating novel vaccines, including against pandemic H1N1 influenza, to address a broad range of infectious diseases worldwide using advanced proprietary virus-like-particle (VLP) technology. The company produces these VLP-based, potent, recombinant vaccines utilizing new and efficient manufacturing approaches. The Company is currently conducting Phase 2 clinical studies of a seasonal flu vaccine and recently announced a research agreement with the National Institutes of Health to evaluate a VLP-based vaccine against the novel H1N1 influenza strain. The company also plans to initiate a seasonal flu vaccine study in elderly subjects later this year. Additional information about Novavax is available at www.novavax.com and in the company's various filings with the Securities and Exchange Commission.

About VLP's

With Virus-like Particle (VLP) Technology, Novavax has created vaccines with structure similar to a virus but without the genetic material required for viral replication. Once injected into the body, VLPs trigger an immune response to the virus. Because VLPs do not contain viral nucleic acids (DNA or RNA), they cannot replicate, and therefore, they present no threat of infection to a person being vaccinated.

The VLP is believed to be well suited to the development of vaccines against diseases endemic to India and surrounding regions like dengue fever and chikungunya fever. Dengue fever is a mosquito-borne disease, which has re-emerged in India and has a very high mortality rate. Currently, there is no vaccine or definitive treatment for Dengue fever.

Forward Looking Statement

Statements herein relating to future development results and performance, conditions or strategies and other matters, including expectations regarding product and clinical developments, are forward-looking statements within the meaning of the Private Securities Litigation Reform Act. Novavax cautions that these forward-looking statements are subject to numerous assumptions, risks and uncertainties, which change over time. Factors that may cause actual results to differ materially from the results discussed in the forward-looking statements or historical experience include risks relating to regulatory requirements in India, continued capitalization of the joint venture, facility construction and product development proceeding as planned, the early stage of product candidates under development; current results may not be predictive of future pandemic results, results of our seasonal influenza vaccine or any other vaccine that we may develop; further testing is required before regulatory approval can be applied for and the FDA may not approve a vaccine even if further trial results are similar to those disclosed previously by the company; uncertainties relating to clinical trials; dependence on the efforts of third parties; competition for clinical resources and patient enrollment from drug candidates in development by other companies with greater resources and visibility; and risks that we may lack the financial resources and access to capital to fund our operations including further clinical trials. Further information on the factors and risks that could affect Novavax's business, financial conditions and results of operations, is contained in Novavax's filings with the U.S. Securities and Exchange Commission, which are available at http://www.sec.gov. These forward-looking statements speak only as of the date of this press release, and Novavax assumes no duty to update forward-looking statements.


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