NOVAVAX AND BHARAT BIOTECH ANNOUNCE STRATEGIC
ALLIANCE FOR PANDEMIC INFLUENZA VACCINE DEVELOPMENT
HYDERABAD, INDIA & MALVERN, PA., March 6, 2006 – Novavax, Inc. (NASDAQ:
NVAX) 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 urrounding 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 overexpressed
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 iotechnology 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® 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 orldwide”.
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®. In addition to MNP, Novavax drug delivery technologies include Novasomes (paucillamellar nonphospholipid vesicles) and Sterisomes® (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.
For Further Information Contact:
Novavax Inc.
Kathy Hamilton
Investor Relations
Tel: (484) 913-1213
Email: khamilton@novavax.com
Bharat Biotech International Inc
Dr. V. Krishna Mohan
President
Tel: 91 40 2348 0567
Email: kmohan@bharatbiotech.com