Novavax Successfully Completes Additional Vaccine Milestone
- Validation of cGMP Biological Manufacturing Facility Complete -
MALVERN, Pa., April 17 /PRNewswire-FirstCall/ -- Novavax, Inc. (Nasdaq: NVAX) announced today that it has successfully completed the renovation and validation for current "Good Manufacturing Practices" (cGMP) compliance of it's industrial facility located in Rockville, Maryland. This validation will allow production of clinical grade materials of its virus-like particle (VLP) vaccine candidates against H5N1 and other pandemic influenza as well as for human seasonal influenza. The facility, located at One Taft Court, Rockville, Maryland, was released for manufacture of biological products in compliance with current U.S. Food and Drug Administration (FDA) standards by a leading independent consulting firm.
Commenting on this additional milestone achievement, Dr. Rahul Singhvi, President and Chief Executive Officer of Novavax stated, "This is an important event in our overall plan to evaluate our VLP pandemic influenza vaccine candidate in human clinical trials anticipated later this year. The completion of this goal, which was achieved ahead of schedule, is a testament to the dedication and hard work of the many employees at Novavax that participated in this significant effort. We are now in a position to take advantage of the FDA Draft Guidance on clinical data that would support accelerated approval of pandemic influenza vaccines. The FDA has recently provided guidance on the surrogate markers of efficacy and the safety data required to support an accelerated approval for licensing of a pandemic influenza vaccine. The guidance applies not only to currently licensed vaccines where an indication is sought for pandemic influenza, but also to vaccines that are not currently licensed. This Guidance will be the roadmap for our clinical development plans."
More information on the FDA's Draft "Guidance to the Industry: Clinical Data to Support the Licensure of Pandemic Influenza Vaccines" issued March 2006 for comment can be obtained at the FDA Web site: http://www.fda.gov/cber/gdlns/panfluvac.pdf .
"To validate a facility compliant with current GMP standards is a difficult and challenging hurdle and can become a rate-limiting step in the development of vaccines. We are delighted to have initiated the cGMP manufacture of VLP influenza vaccines well ahead of schedule. With a validated cGMP production capability now in-house, we can produce the requisite clinical trial materials in an efficient and timely manner to support the human testing planned of our pandemic and seasonal influenza vaccine programs. Clinical manufacturing at our Rockville facility will allow us to now complement the preparation work being conducted at our partner's PacificGMP's facility located in San Diego, California," stated Dr. Gale Smith, Vice President of Vaccine Development at Novavax.
About Novavax, Inc.
Novavax is focused on creating differentiated, value-added pharmaceutical and vaccine products and technologies. The company's technology platforms include the virus-like particle (VLP) manufacturing technology utilizing the baculovirus expression system in insect cells, as well as novel vaccine adjuvants based on Novasomes(R), non-phospholipid vesicles and dendrimer technologies. The company is developing a pandemic flu vaccine against H5N1, H9N2 and other avian influenza viruses and a seasonal flu vaccine against human influenza strains using its VLP and Novasome adjuvant technologies. 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(R). In addition to MNP, Novavax drug delivery technologies include Novasomes(R) and Sterisomes(R), solvent and oil free emulsions for subcutaneous depot injection. The company has several products utilizing the MNP technology in various stages of development.
Forward Looking Statements
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 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: Kathy Hamilton, Investor Relations, of Novavax Inc.,