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Biotech / Medical : Novavax NVAX -- Ignore unavailable to you. Want to Upgrade?


To: Glenn Petersen who wrote (61)9/2/2009 8:16:10 AM
From: Rock_nj  Read Replies (1) | Respond to of 166
 
Novavax, Inc. To Apply For H1N1 Vaccine Trials In Fourth Quarter-Reuters

Tuesday, 1 Sep 2009 03:47pm EDT
Reuters reported that Novavax, Inc. will apply to U.S. health regulators in the fourth-quarter to start human clinical trials of its new H1N1 swine flu vaccine. Last month, Novavax said its vaccine protected ferrets against the new pandemic strain. Ferrets are the closest animals to humans when it comes to being infected with influenza.

reuters.com



To: Glenn Petersen who wrote (61)9/4/2009 8:56:16 AM
From: Rock_nj  Respond to of 166
 
That harsh reality is hitting home, with the media in India criticizing the government for having no vaccine orders in place, and domestic vaccine production not due to come on-stream until next spring. The Times of India says, ’H1N1 vaccine ready, India napping’. The Indian government has responded that it is in discussions with international vaccines makers to carry out clinical trials of the vaccine in India, and to announce its first orders, of undisclosed size, this week for vaccine that would be available in December (a href="http://www.deccanherald.com/content/22883/2-foreign-firms-ready-try.html">)Deccan Herald.

blogs.nature.com

Hmmm, India set to announce its first orders, of undisclosed size, this week for vaccine that would be available in December? I wonder who could be supplying those orders? Novavax's Indian partner Cadila Pharmaceutical is publicly talking about H1N1 Swine Flu manufacturing coming online in November 2009.



To: Glenn Petersen who wrote (61)9/8/2009 2:16:46 PM
From: Rock_nj  Respond to of 166
 
Novavax in talks with "half dozen" countries-CEO
Tue Sep 8, 2009 2:01pm EDT

* Countries drawn to quicker, cheaper vaccine, CEO says
* Method 80 percent cheaper than egg-based flu vaccine

By Julie Steenhuysen

CHICAGO, Sept 8 (Reuters) - U.S. biotech company Novavax (NVAX.O) is in discussions with officials from several different countries looking for quick ways to make flu vaccines to protect their populations from swine flu and other potential pandemics, the company's chief executive told Reuters.

"We're talking with at least half a dozen countries if not more," Novavax Chief Executive Rahul Singhvi said in a telephone interview.

Although the clinical-stage biotechnology company does not expect to have a flu vaccine approved for use in the United States until 2012, it has already signed a licensing deal with Spanish drugmaker Rovi(ROVI.MC) and started a vaccine joint venture with Indian drugmaker Cadila Pharmaceuticals.

The World Health Organization predicts a third of the world's population -- roughly 2 billion people -- will eventually be infected with the new H1N1 virus, and has warned there is not enough production capacity to make vaccine for everyone.

Singhvi said the H1N1 pandemic has been a wake-up call for many governments who rely on foreign suppliers for flu vaccines. "A lot of these countries are finding out it is better to have control of vaccine supply within their own borders," he said.

He said the Rockville, Maryland-based company's technology, uses engineered bits of genetic material called virus-like particles or VLPs that mimic a flu virus. Vaccines based on VLPs can be made more cheaply in about half the time of old-fashioned vaccine methods, which use specially grown chicken eggs, Singhvi added.

Investors have embraced the stock. Since April, when the new H1N1 strain emerged, Novavax shares have risen more than 1,000 percent. The shares were up 29 cents in Tuesday's mid-afternoon trade on the Nasdaq to $5.81, up more than 1,000 percent off its 52-week low of 52 cents on April 2.

Some analysts, including Oppenheimer, cut their ratings on the company's stock to "perform" from "outperform" last week.

"They think the stock went up too much too fast," Singhvi said. "I think they're wrong, but that is for us to prove."

SIMILAR VACCINES

Several companies are working on vaccines that use similar technology. Novavax grows them in caterpillar cells, which are harvested and purified. The process is done in disposable, ready-to-use equipment.

While no flu vaccines made this way are licensed yet, VLPs have been used to make Merck & Co Inc's (MRK.N) cervical cancer vaccine Gardasil, which has been used in more than 7 million girls and women.

Singhvi, a former Merck vaccine researcher, estimates it could cost 80 percent less to build plants to make his VLP flu vaccine than conventional egg-based manufacturing facilities. Continued.

reuters.com