MALVERN, Pa., Sept. 13 /PRNewswire-FirstCall/ -- Novavax, Inc. and Wave Biotech, LLC located in Somerset, NJ, today jointly announced that they will collaborate on the development of a commercial scale production process for Novavax's pandemic influenza virus (avian flu) vaccine and other biological products. Initially, the companies will focus on Novavax's H9N2 avian flu Virus-Like Particle (VLP) vaccine that has shown promising results in preclinical studies.
Wave Biotech will provide process and equipment expertise for the proprietary technology based on disposable equipment for the manufacture of biologicals. Novavax scientists will work with the engineering team at Wave Biotech to further develop the process for the manufacture of vaccines and other biological products.
"We are very pleased to be able to work with Wave Biotech as we proceed to expand the production of our pandemic and seasonal flu vaccine candidates. The process is reliable and can be readily scaled up to meet the needs of large populations," said Dr. Rahul Singhvi, President and CEO of Novavax. "We have experienced excellent results to-date with Wave Biotech's equipment in the production of influenza as well as HIV/AIDS, SARS, and other VLP vaccines for human diseases. A manufacturing strategy based on Wave Biotech's technology combined with our recombinant DNA based approach to vaccine production should enable us to rapidly respond to demand. In addition, this new technology allows us to go into commercial scale manufacturing with lower capital investment than with traditional production methods for vaccines."
"Wave Biotech's disposable cell culture technology is ideal for the Novavax application," commented Dr. Vijay Singh, President of Wave Biotech. "It provides scalable technology that can be delivered, installed and commissioned quickly for possible worldwide use."
About Virus-Like Particle (VLP) Technology
Novavax's VLP vaccine approach uses recombinant DNA technology to create components of the influenza virus in structures optimized to elicit a protective immune response. The three dimensional virus like structures are designed to give protection without the risk of infection and without the addition of chemical adjuvants. Novavax's proprietary process produces vaccines aseptically, reduces contamination risk and leads to high, cost-effective yields.
About Wave Biotech's Disposable Manufacturing Technology
Wave Biotech is a research-based company that develops and manufactures innovative process equipment for the pharmaceutical and biotechnology industry. The Company's focus is on developing disposable bioprocess equipment for operations traditionally requiring stainless-steel tanks and piping. Key products, such as the Wave Bioreactor(R), Wave Mixer(R), FlexMixer(TM) and Sterile Tube Fuser, feature disposable contact materials that eliminate cleaning and validation, thereby reducing costs in operations ranging from cell culture, media preparation, buffer dissolution and thawing process intermediates to patient-specific cell therapy in hospitals. These unique, patented, devices can be installed and commissioned rapidly, drastically reducing the time-to-market for biological products. Wave Biotech's equipment is in use with hundreds of companies worldwide, both for R&D, as well as commercial applications.
About Novavax, Inc.
Novavax, Inc. is a specialty biopharmaceutical company focused on the research, development and commercialization of products utilizing its proprietary drug delivery and biological technologies for large and growing markets. Novavax currently distributes a line of prescription pharmaceutical products, including its topical emulsion for estrogen therapy ESTRASORB, and prenatal vitamins.
Statements made in this press release that state Novavax's or management's intentions, hopes, beliefs, expectations, or predictions of the future are forward-looking statements. Forward-looking statements include but are not limited to statements regarding usage of cash, product sales, future product development and related clinical trials and future research and development, including FDA approval. Novavax's actual results could differ materially from those expressed in such forward-looking statements. Such forward-looking statements involve known and unknown risks, uncertainties and other factors which may cause the actual results, performance or achievements of the Company, or industry results, to be materially different from those expressed or implied by such forward-looking statements. Such factors include, among other things, the following: general economic and business conditions; ability to enter into future collaborations with industry partners, including an ESTRASORB(R) licensing agreement; competition; unexpected changes in technologies and technological advances; ability to obtain rights to technology; ability to obtain and enforce patents; ability to commercialize and manufacture products; ability to establish and maintain commercial-scale manufacturing capabilities; results of clinical studies; progress of research and development activities; business abilities and judgment of personnel; availability of qualified personnel; changes in, or failure to comply with, governmental regulations; the ability to obtain adequate financing in the future through product licensing, co-promotional arrangements, public or private equity financing or otherwise; and other factors referenced herein. Additional information is contained in Novavax's annual report on Form 10K for the year ended December 31, 2004 and quarterly reports on Form 10Q for the quarters ended March 31, 2005 and June 30, 2005, incorporated herein by reference. Statements made herein should be read in conjunction with Novavax's annual and quarterly reports filed with the SEC. Copies of these filings may be obtained by contacting Novavax at 508 Lapp Road, Malvern, PA 19355 Tel 484-913-1200 or the SEC at http://www.sec.gov.