HYDERABAD, India and MALVERN, Pa., March 6 /PRNewswire-FirstCall/ -- Novavax, Inc. and Bharat Biotech International Limited (BBIL), today jointly announced a strategic alliance to pursue the rapid development of pandemic influenza vaccine for India and certain other south Asian markets. Under the terms of the agreement, BBIL will fund 100% of the pre-clinical and clinical studies for these markets and assist in developing an efficient manufacturing process for the Virus-Like Particle (VLP) based influenza vaccine. BBIL will be responsible for the sale and distribution of the vaccine in India and other surrounding countries. Novavax will receive unrestricted access to all pre-clinical and clinical data generated by BBIL and will receive a double digit royalty on all future sales located within BBIL’s geographic territories.
Cases of avian influenza (Bird Flu) in poultry and humans have been occurring sporadically throughout the world, prompting the World Health Organization to call avian flu the greatest concern to human health. There are at least 16 Hemagglutinin and 9 Neuraminidase genes within various subtypes of influenza viruses known to circulate in wild waterfowl, each with the potential to infect and cause severe disease in poultry and humans. Three avian influenza subtypes (H9N2, H7N7, and H5N1) have transmitted to humans in recent years and are considered major threats for a pandemic outbreak.
Novavax’s Virus-Like Particle Vaccines use recombinant DNA technology to produce antigenic structures that mimic a virus to produce a protective immune response without the risk of infection or disease. Viral proteins can self-assemble into VLPs when over-expressed in certain cells. The use of VLP technology has already been proven with the success of the Hepatitis B vaccine. In addition, the developmental Human Papilloma Virus vaccines are also based on VLP technology. This is the first time that VLP technology has been applied to create an influenza virus vaccine. The technology is a particularly good fit for addressing pandemic influenza because it obviates the reliance on the supply of embryonated eggs for the production of the vaccine. Novavax has recently adopted a manufacturing process that reduces contamination risk and produces high, cost-effective yields of the influenza VLP vaccine (See Press Releases dated September 13, 2005 and February 28, 2006). In addition, this technology can be used to rapidly create vaccines against emerging threats or new strains of existing pathogens.
Commenting on the agreement, Dr. M.K. Bhan, Secretary, Department of Biotechnology, Government of India said, “This is a very positive development. In the spirit of combining global expertise to collectively combat the threat posed by the rapidly spreading avian influenza virus, the department of biotechnology and the Government of India stand ready to provide all enabling support to ensure the success of this partnership between Novavax and BBIL”.
Dr. Rahul Singhvi, President and CEO of Novavax said, “We are delighted that BBIL has chosen Novavax’s VLP and Novasome(R) adjuvant technologies to develop, produce, and distribute a vaccine against H5N1 and other strains of avian influenza for the Indian population. BBIL has established itself as a leader in adopting innovative vaccine technologies as evidenced by their collaborations with Wyeth and Acambis. We believe that by leveraging the clinical, process and manufacturing capabilities of BBIL, we will be able to expedite the development and regulatory approval of our VLP-based pandemic influenza vaccines around the world”.
Dr. Krishna M. Ella, Chairman and Managing Director of Bharat Biotech International Ltd, said “We are extremely pleased to announce this unique partnership between Novavax and BBIL, with the guidance and support of the Department of Biotechnology, Government of India. This agreement between our companies is bigger than just business. It is an attempt to bring together capabilities of two different organizations across the world to address the global public health and economic threat posed by pandemic influenza. Novavax’s VLP technology is clearly one of the most effective in addressing emerging strains of the virus and BBIL’s proven capabilities in process development, clinical development, and manufacturing infrastructure will help expedite the availability of a VLP-based vaccine for pandemic influenza to the Indian public and the world at large. By joining hands with Novavax, BBIL would be making, in a modest way, its contribution to the cause of Public Health in India and the Developing World”.
This alliance will be overseen by a Steering Committee chaired by Dr. Richard Klausner, eminent scientist and Former Executive Director of the Bill and Melinda Gates Foundation and Former Director of the US National Cancer Institute. Dr. Klausner is a special advisor to both the Government of India and to Novavax, Inc. Commenting on this agreement, Dr. Klausner said “I am heartened by this partnership between Novavax and BBIL. I have had a chance to work with each of these organizations and I know the principals in both firms well. These organizations and their management teams are serious in their commitment and are uniquely suited to develop a vaccine against pandemic influenza. I am confident that by combining their mutual capabilities and by working closely with the Department of Biotechnology, Government of India, they will be more effective in arriving at a solution for the good of public health worldwide”.
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 Novavax, Inc.
Novavax is focused on creating differentiated, value-added pharmaceutical and vaccine products and technologies. The Company’s platforms include the virus-like particle manufacturing technology utilizing the baculovirus expression system in insect cells, as well as novel vaccine adjuvants based on Novasomes and dendrimers. The Company is developing vaccines against the H5N1 and other strains of avian influenza and human seasonal influenza viruses using its VLPs and Novasomes. Novavax’s drug delivery platforms 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 (paucillamellar non-phospholipid vesicles) and Sterisomes(R) (subcutaneous depot injection). The company has several products utilizing the MNP technology in various stages of development.
About Bharat Biotech International Inc.
Bharat Biotech International Limited based in Hyderabad, India, is a privately held, multidimensional biotechnology company specializing in product-oriented research, development and manufacturing of vaccines and biotherapeutics. Bharat is engaged in developing next-generation vaccines and biotherapeutics through innovative and collaborative research. Bharat’s state-of-the-art manufacturing plant is the largest of its kind in Asia-Pacific. The first bio-pharma facility in the country to be audited and approved by Korean Food & Drugs Administration (KFDA), it sprawls over a picturesque campus at Genome Valley, Hyderabad. Built with an investment of over INR 1000 million, the facility’s manufacturing, control procedures and protocols, conform to the stringent standards laid down by internationally recognized institutions such as USFDA, UKMCA, and WHO. Bharat has set new benchmarks in Innovation and Quality that epitomizes the tremendous progress of Indian biotechnology in the global arena.
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, 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 www.sec.gov.
Novavax, Inc.
CONTACT: Kathy Hamilton, Investor Relations of Novavax Inc.,+1-484-913-1213, khamilton@novavax.com; or Dr. V. Krishna Mohan, Presidentof Bharat Biotech International Inc, +91-40-2348-0567,kmohan@bharatbiotech.com
Web site: http://www.novavax.com//
