Which Small Biotech Firms Could Reap Benefits From Government's Flu Vaccine Initiative?
Written by Peter DePalma
Monday, 25 May 2009 00:00
Another small biotech who has thrown their hat in the ring is Rockville, Md.-based Novavax Inc. (Nasdaq: NVAX), which is in Phase II development of its VLP-based recombinant seasonal influenza vaccine has the necessary certified GMP manufacturing capabilities for producing up to 30 million doses of vaccine if necessary.
In response to the outbreak, Novavax quickly shifted gears, said CEO Rahul Singhvi. The company was able to change its dynamic to address the H1N1 virus while continuing to service its ongoing programs. Singhvi told Thomson BioWorld that his firm is confident that its VLP technology can "make a difference" addressing the 2009 H1N1 virus strain or any other future flu threats.
Using its VLP technology, Novavax builds a structure similar to a virus, without the genetic material required for viral replication, and a VLP vaccine can be produced using recombinant DNA technology starting with the viral genetic sequence information.
Therefore, Singhvi believes, the timeframe for making a vaccine can be shrunk from the normal four months to six months to between 10 weeks and 12 weeks. "With these innovations, we can make a significant improvement in the speed with which a new vaccine can be created to address potential emerging diseases," he said.
On Friday, CDC scientists unveiled the most detailed genetic examination yet of the novel virus, finding that the new swine flu may have been circulating undetected in pigs for years.
That report, in the journal Science, still fails to solve the bigger mystery of when and where the virus made the jump to people and what genetic change allowed it to start spreading so rapidly (see the alarming related video about how the H1N1 virus is spreading quickly througout Wisconsin). The virus was first detected last month, and at least 42 countries now have confirmed it in more than 11,000 people. At least 85 people have died from it.
The confirmed cases don’t represent anywhere near the full scope of the outbreak: For every reported case of swine flu, there may be 20 people sickened with it, said CDC’s Dr. Anne Schuchat — more than 100,000 people in the U.S. There are signs that it is declining in parts of the country, although school-related outbreaks in New York City and elsewhere have led to the closings of about 60 schools affecting 42,000 students, Schuchat said.
Tom Bustamante, the Managing Partner at Ludlow BioVenture's commented, "Their can be no doubt that a bulk of this funding will find its way to the major players in vaccine production, such as Sanofi-Aventis (SASY.PA), Novartis (NOVN.VX), and GlaxoSmithKline (GSK.L).
"But, with the pending production of a new H1N1 vaccine now competing along for capacity with the standard seasonal flu vaccine, money may find its way to companies who can assist in solving such issues as production capacity, cost, and scalability. These abilities may also become especially important if needed for emergency use in poorer emerging nations that will need a more cost effective means for vaccine production."
"It is in our understanding that the Company has already put the feelers out offering their technology and solutions to US Federal agencies, so it will be interesting to see what may develop over the coming weeks. If this becomes a political issue like it did several years back when there weren't enough vaccine shots for the seasonal flu, then this could become a whole new animal. They have the production infrastructure, and the technology, all they need from the government is the green light to move ahead."
"Unlike other vaccine makers, Novavax uses a unique process separated from old egg-based technology, which in turn provides for not only cheaper production costs, but a much greater turn around to end product."
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