Novavax and CPL Biologicals Break Ground on New Influenza Vaccine Manufacturing Facility in India

Novavax and CPL Biologicals Break Ground on New Influenza Vaccine Manufacturing Facility in India

- State of the art 25,000 sq. ft. facility to be operational in 4 months
- 60 million doses of annual vaccine capacity anticipated

ROCKVILLE, Md., Oct. 28 /PRNewswire-FirstCall/ -- Novavax, Inc. (Nasdaq: NVAX - News) announced today that CPL Biologicals Pvt. Ltd., the new joint venture between Cadila Pharmaceuticals in India, has begun construction of a state-of-the-art manufacturing facility that will be used to produce pandemic and seasonal influenza vaccines. CPL Biologicals will utilize Novavax's virus-like particle (VLP) vaccine technology to produce commercial-scale quantities of VLP-based influenza vaccines using Novavax's innovative disposable manufacturing solution. The CPL Biologicals facility is expected to be operational within four months and should be capable of producing over 60 million doses annually at full capacity. This facility will also be used to produce other novel vaccines being developed by CPL Biologicals, based on Novavax's VLP vaccine technology.

 "This new facility is being 100% supported financially by our partner, Cadila Pharmaceuticals Ltd. We anticipate creating sufficient capacity for CPL Biologicals to sell influenza vaccines in India and at the same time become a potential supplier to Novavax for sale of vaccines in other markets where Novavax maintains complete commercial rights," commented John Trizzino, Senior Vice President, International and Government Alliances for Novavax and Interim Chief Executive Officer of CPL Biologicals. "We believe this model will show how an efficient and scalable vaccine platform can help address the growing demand for pandemic and seasonal influenza vaccines. Moreover, the construction of this manufacturing facility is consistent with Novavax's strategy to establish regional partnerships and regional manufacturing capabilities that allow our VLP influenza vaccines to be licensed, manufactured and sold throughout the world."

About VLPs

Virus-like particles (VLPs) mimic the external structure of viruses but lack the live genetic material that causes viral replication and infection. VLPs can be designed quickly to match individual viral strains and be produced efficiently using portable cell-culture technology. Novavax VLP-based vaccine candidates are produced more rapidly than egg-based vaccines by using proprietary, portable, recombinant cell-culture technology.

About Novavax

Novavax, Inc. is a clinical-stage biotechnology company, creating novel vaccines to address a broad range of infectious diseases worldwide, including H1N1, using advanced proprietary virus-like-particle (VLP) technology. The company produces potent VLP-based recombinant vaccines utilizing new and efficient manufacturing approaches. Novavax is committed to using its VLP technology to create country-specific vaccine solutions. The Company has formed a joint venture with Cadila Pharmaceuticals, named CPL Biologicals, to develop and manufacture vaccines, biological therapeutics and diagnostics in India. Additional information about Novavax is available on the company's website:

About CPL Biologicals

CPL Biologicals is a newly formed company evolved from a joint venture by Cadila Pharmaceuticals Ltd and Novavax, Inc. CPL Biologicals will be developing and manufacturing 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.

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 future financial or business performance, conditions or strategies and other financial and business matters, including expectations regarding construction, scale-up and capacity of CPL Biologicals' manufacturing facility, and clinical developments and anticipated milestones 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 and uncertainties, including CPL Biologicals' ability to progress any product candidates in clinical trials; the scope, rate and progress of the clinical trials and other research and development activities; clinical trial results; even if the data from preclinical studies or clinical trials is positive, the product may not prove to be safe and efficacious; the product candidates have not been, and may not be, approved by the appropriate regulatory authorities; the estimated costs of the manufacturing facility may exceed the amount budgeted; the manufacturing facility will be subject to inspection and validation, which may result in delays; unanticipated costs and delays during construction and scale-up of the manufacturing facility; Novavax has a minority interest in CPL Biologicals and therefore does not control its clinical development, manufacturing or commercialization activities; Novavax's investment in CPL Biologicals may never produce a return, even if its clinical development, manufacturing and commercialization activities are successful; Novavax's ability to enter into future collaborations with industry partners and the government and the terms, timing and success of any such collaboration; the cost of filing, prosecuting, defending and enforcing any patent claims and other intellectual property rights; Novavax's ability to obtain rights to technology; competition for clinical resources and patient enrollment from drug candidates in development by other companies with greater resources and visibility; Novavax's ability to obtain adequate financing in the future through product licensing, co-promotional arrangements, public or private equity or debt financing or otherwise; general business conditions; competition; business abilities and judgment of personnel; and the availability of qualified personnel. 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 These forward-looking statements speak only as of the date of this press release, and Novavax assumes no duty to update forward-looking statements.