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- Regulatory approval received for rabies vaccine toxicology studies in India
- Clinical study of influenza vaccine candidate planned for 2012
- Validated manufacturing facility ready for clinical production
- Additional new vaccines in development for undisclosed targets
Novavax, Inc. (Nasdaq:NVAX) today 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 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."
About Novavax, Inc.
Novavax, Inc. (Nasdaq:NVAX) 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. Together, these companies have worldwide commercialization capacity and the global reach to create real and lasting change in the biopharmaceutical field. Additional information about Novavax is available on the company's website: www.novavax.com.
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).
Forward Looking Statements
Statements herein relating to the future of Novavax and its relationship with CPLB are forward-looking statements. Novavax cautions that these forward-looking statements are subject to numerous risks and uncertainties, which could cause actual results to differ materially from those expressed or implied by such statements. These risks and uncertainties include those identified under the heading "Risk Factors" in the Novavax Annual Report on Form 10-K for the year ended December 31, 2010, and filed with the Securities and Exchange Commission. We caution investors not to place considerable reliance on the forward-looking statements contained in this press release. You are encouraged to read our filings with the SEC, available at www.sec.gov, for a discussion of these and other risks and uncertainties. The forward-looking statements in this press release speak only as of the date of this document, and we undertake no obligation to update or revise any of the statements. Our business is subject to substantial risks and uncertainties, including those referenced above. Investors, potential investors, and others should give careful consideration to these risks and uncertainties.
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Frederick W. Driscoll
VP, Chief Financial Officer and Treasurer
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