ROCKVILLE, Md., Oct. 28 /PRNewswire-FirstCall/ -- Novavax, Inc. 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.
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 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.
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 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.
Novavax, Inc.
