Novavax Succeeds in Making Vaccine to Protect Against New Mutation of Avian Influenza
Novavax to begin pre-clinical testing immediately
MALVERN, Pa., July 31 /PRNewswire-FirstCall/ -- Novavax Inc. (Nasdaq: NVAX) -- Novavax Inc. said today its scientists have succeeded in making a vaccine candidate designed to protect against the H5N1 clade 2 influenza virus. Pre-clinical testing of the vaccine has already started.
"We believe this is the first vaccine to be made that targets the H5N1 clade 2 virus isolated from people in Indonesia who have been infected with this mutated version of avian influenza," said Novavax President and Chief Executive Officer Rahul Singhvi. "This is a very significant milestone for Novavax and our proprietary virus-like particle (VLP) vaccine technology. This demonstrates how rapidly we can respond by making a vaccine to protect against emerging pathogens worldwide, compared to older egg-based manufacturing methods."
The H5N1 avian influenza virus is rapidly evolving into antigenically distinct clades, or families. H5N1 clade 1 flu viruses were identified in Vietnam in 2003; by last winter, a second clade was identified in Indonesia. Department of Health and Human Services Secretary Michael O. Leavitt has said that the emergence of clade 2, which is the strain that is spreading throughout Asia and parts of Europe, "dictates that we begin developing a second pre-pandemic vaccine."
Leavitt and other global public health experts maintain that due to H5N1's rapidly mutating nature, multiple vaccines will be needed to protect against the many variations of the virus. The H5N1 vaccines currently in clinical trials by many manufacturers and being stockpiled around the world target only the clade 1 family of the virus.
"It is critical that we have vaccines that can protect against the multiple variations of the virus and, most importantly, against the strains of bird flu that are currently infecting and killing people," said Dr. Rick Bright, Novavax's Vice President of Vaccine Development. "Our vaccine technology allows us to create a vaccine directed at mutated viruses very rapidly so that we can protect people from the newest circulating strains of bird flu. We have also demonstrated in pre-clinical models that we are able to generate protective levels of antibodies against influenza using a single dose of VLP vaccine without the requirement of adding an adjuvant."
Novavax's new vaccine candidate uses the company's VLP technology, which allows scientists to create a particle that is nearly identical to the virus but does not have the virus's genetic material required for replication or infection. When inoculated into the body, these particles have the ability to attach to cells and trigger a natural immune response -- sometimes from a single dose -- that is capable of protecting against viral infection.
"We are eager to see if this vaccine is as effective in pre-clinical models as we expect it to be," Dr. Bright said. Novavax has already seen successful results from pre-clinical studies of its other pandemic and seasonal influenza vaccines.
Pre-clinical testing of the H5N1 clade 2 vaccine has already been initiated and is likely to take several months. "Once we collect and analyze results of our pre-clinical tests, we will then be in a position to take this timely vaccine into human clinical trials," Dr. Bright said.
About Novavax Inc.
Novavax Inc. is committed to leading the global fight against infectious disease by creating novel, highly potent vaccines that are safer and more effective than current preventive options. Using the company's proprietary virus-like particle (VLP) and Novasome(R) adjuvant technologies, Novavax is developing vaccines to protect against H5N1 pandemic influenza, seasonal flu and other viral diseases. Novavax's particulate vaccines closely match disease-causing viruses while lacking the genetic material to cause disease, which provides potential for greater immune protection at lower doses than current vaccines. With an exclusive portable manufacturing system that allows for rapid mass-production of vaccines, Novavax is uniquely positioned to meet global public health needs.
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, 2005 and quarterly report on Form 10Q for the quarter ended March 31, 2006 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.
CONTACT: Mariann Caprino, Novavax Inc., +1-484-913-1213