Novavax Announces Strategic Alliance With PacificGMP on Pandemic Influenza Vaccine Production Technologies
MALVERN, Pa., Feb 28, 2006 /PRNewswire-FirstCall via COMTEX News Network/ -- Novavax, Inc. (Nasdaq: NVAX) and PacificGMP, LLC located in San Diego, California, announced today that they have formed a strategic alliance to collaborate on the development of a commercial scale production process for Novavax's experimental pandemic influenza virus (avian flu) vaccine and other biological products. Under the alliance, PacificGMP will assist Novavax in developing the capability of manufacturing large quantities of vaccine to accommodate the surge capacity that must be met in the event of a pandemic outbreak of influenza.
PacificGMP will utilize disposable bioprocessing technology to manufacture and produce Novavax's VLP avian flu vaccine. Use of this disposable bioprocessing technology will allow for faster production, with greatly reduced overall manufacturing costs. This process also mitigates the possibility for cross-contamination in production which should ultimately result in a VLP avian flu vaccine that will be available to the public in a much shorter time period.
"This agreement with PacificGMP brings another critical capability to Novavax in the development of our H5N1 avian influenza VLP vaccine, and puts Novavax a step closer to servicing the world at large in the event of a pandemic." said Dr. Rahul Singhvi, President and CEO of Novavax. "To ensure true surge capacity for production of our pandemic influenza vaccine, we have designed our manufacturing process around the use of disposable equipment designed by Wave Biotech LLC. PacificGMP is ideally suited to support us on the manufacturing scale-up and the commercialization of the product since they are industry experts in the use of such disposable process equipment."
"PacificGMP is excited to assist Novavax on this critical project. We anticipate that this new product will be the first vaccine produced in a closed system using disposable bioprocessing technology, thus avoiding the type of cross-contamination that has plagued the production of other vaccines in the past. We are delighted to be able to announce this strategic alliance between PacificGMP and Novavax and are committed to assisting Novavax to meet the regulatory hurdles that will allow this breakthrough vaccine to become available to the public" said Leigh Pierce, President of PacificGMP.
Novavax is continuing with research and development on its avian flu vaccine and is currently conducting pre-clinical work before submitting an Investigational New Drug Application to the United States Food and Drug Administration ("FDA").
About Virus-Like Particle (VLP) Technology
Novavax's VLP vaccine technology utilizes recombinant DNA to present components of the influenza virus in three-dimensional virus-like structures optimized to elicit a protective immune response without the risk of infection and without the addition of chemical adjuvants. Using the proprietary process associated with this VLP technology, Novavax intends to further develop vaccines which can be produced aseptically, thereby reducing contamination risk, while achieving high, cost-effective yields.
About PacificGMP, LLC
PacificGMP is a Contract Manufacturing Organization (CMO) that specializes in the development and manufacturing of biologics using disposable technology. PacificGMP has extensive experience in process development and production of antibodies, recombinant proteins, gene therapy and vaccine products. PacificGMP assists drug developers through the early stages of process design, development and scale-up, to pre-clinical and clinical manufacturing.
About Novavax, Inc.
Novavax is focused on creating differentiated, value-added pharmaceutical and vaccine products and technologies. These include the Company's virus-like particle (VLP) manufacturing technology utilizing the baculovirus expression system in insect cells, as well as novel vaccine adjuvants based on Novasomes and dendrimer technologies. Novavax, Inc. is also a product development company focused on the research, development and commercialization of new products utilizing its proprietary drug delivery and biological technologies for large and growing markets. Novavax's drug delivery technologies include the micellar nanoparticle (MNP) technology which is the basis for the development of its first FDA-approved product, ESTRASORB. In addition to MNP, Novavax drug delivery technologies include Novasomes(R) (paucillamellar non- phospholipid liposomes) and Sterisomes(R) (subcutaneous depot injection).
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, 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 and September 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.
SOURCE Novavax, Inc.
Kathy Hamilton of Novavax, Inc., +1-484-913-1213,
Gary L. Pierce, General Counsel & Vice President of Business Development of PacificGMP LLC, +1-858-550-4094,