Collaboration with
General Electric Healthcare
December 10, 2007 GE Healthcare, a unit of General Electric Company (NYSE: GE), and Novavax Inc. (NASDAQ: NVAX), today announced a collaboration agreement to develop and market a pandemic influenza vaccine manufacturing solution for selected international countries. This collaboration leverages GE Healthcare’s bioprocess solutions and design expertise and Novavax’s virus-like particle (VLP) and manufacturing platform.
Pandemic influenza remains a global public health threat with 372 WHO confirmed human cases resulting in 235 deaths from avian H5N1 influenza (2003-2008)1. According to public health experts, a potential pandemic outbreak of avian influenza is inevitable and simply a matter of time. Governments around the world are developing pandemic influenza preparedness plans to minimize the impact on public health and the economy within their borders. Prophylactic vaccination against avian influenza is widely accepted as the best countermeasure against this threat.
Currently, most influenza vaccine manufacturers have adapted their respective seasonal influenza vaccine production processes to create vaccine candidates against the H5N1 subtype of avian influenza. These processes use either egg or cell culture substrates to propagate a H5N1 virus that has been genetically modified to render it non-pathogenic in humans, and then processed by licensed techniques to create either split or whole inactivated virus vaccine or a live-attenuated influenza vaccine. Some manufacturers have shown the utility of novel adjuvants to reduce potency requirements which suggest the potential to stretch the supply of the vaccine.
In spite of significant efforts by pharmaceutical companies to create vaccine supply for a potential pandemic, a large gap remains between the global demand for vaccine and supply. Developed countries, like the U.S. with substantial investment have created a multi-tiered risk mitigation strategy to procure candidate vaccines against virus strains predicted to cause a pandemic. However, there is widespread belief that even with these well planned measures, global preparedness against a pandemic outbreak is woefully inadequate. This is due to lack of surge capacity and rapid production for pandemic first-wave protection using a strain matched vaccine.
Developing countries face these and other unique challenges including lack of available funding for in-border large scale traditional manufacturing facilities that can cost in excess of 200MM USD with commissioning timelines exceeding 4 years. Furthermore, developing countries are at the mercy of foreign companies and their governments who might or might not allow cross-border shipments of vaccines during the pandemic.
Finally, given the relative ease of human-to-human transmission of the influenza virus, enhanced by the ease of global travel, there really is no country that is immune from the impact of a pandemic until the threat is comprehensively addressed from a global perspective.
The ideal vaccine solution against an influenza pandemic would include a vaccine that is highly and broadly immunogenic, affordable, and readily-available in adequate supply to cover a country’s population.
Novavax, Inc. is developing a unique vaccine solution against the pandemic threat. The company has created a virus-like particle (VLP) H5N1 influenza vaccine that can be manufactured within 12 weeks of knowing the genetic sequence of a target influenza strain in cell culture without the use of live influenza viruses. The VLPs, spherical particles coated with the surface proteins of influenza, have the same structure as the influenza virus, but lack the genetic material required for viral replication. The H5N1 influenza VLPs contain hemagglutinin (HA) and neuraminidase (NA) antigens arranged on the surface of the matrix (M1) protein. The surface antigens are presented in their native three-dimensional conformation which contributes to a robust and cross-protective immune response across H5N1 clades as observed in pre-clinical studies. Interim data from a phase I/IIa clinical trial of the H5N1 VLP influenza vaccine including 70 subjects showed that the vaccine was well tolerated and immunogenic in healthy adults. Two injections of 15 mcg and 45 mcg (based on HA content) were immunogenic. Sixty-three (63) percent of subjects who received the 45 mcg dose developed neutralizing antibody titers against the homologous H5N1 strain of >1:20 (4-fold rise in titer from baseline). These data indicate that the VLP vaccine is highly immunogenic without the addition of an adjuvant and support further development. The vaccine formulation has been further optimized and a dose-ranging study evaluating the safety and immunogenicity of three different doses as compared with placebo is underway.
As announced in December 2007, Novavax has partnered with GE Healthcare to co-market a pandemic solution that can quickly scale-up production of influenza VLP vaccines at high yields using fully closed, disposable, and mobile equipment. Such an integrated production approach could address issues of cost and timely supply, both relevant for preparing a global vaccine solution for a pandemic situation. Disposable manufacturing capacity is approximately four fold less expensive to build and one half of the time to commission relative to traditional facility approaches. As an example, a traditional egg-based inactivated influenza vaccine plant with 50MM doses/annum capacity may cost 150-200MM USD, take four years to build and commission. Furthermore, the only planned U.S. cell-culture facility with capacity of 50MM doses/annum of seasonal flu vaccine has been projected to cost over 600MM USD. By way of comparison, a Novavax VLP vaccine plant capacity of 75-100MM doses could be built and commissioned for 35-40MM USD within 24 months. Importantly, this plant would be able to begin shipping VLP vaccine within 12 weeks ensuring a rapid response during a pandemic. And unlike other traditional vaccine plants, the Novavax facility can support other vaccines beyond pandemic. This creates even greater value and vaccine self-sufficiency for the country and its citizens.
http://www.who.int/csr/disease/avian_influenza/country/
cases_table_2008_03_11/en/index.html