Novavax - Vergessene Aktie feiert ein Comeback. Gute Chancen dank aktueller Nachrichtenlage ( Seite 90)

Antwort auf Beitrag Nr.: 37.934.882 von binda am 08.09.09 07:52:49toller Bericht!

08.09.2009 20:17
Novavax in talks with 'half dozen' countries-CEO
By Julie Steenhuysen

CHICAGO, Sept 8 (Reuters) - U.S. biotech company Novavax 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 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 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.

'That has been attractive to other countries, and other companies in other countries, not only because it's cheaper, but also because the technology transfer is simpler,' he said.

Developing a pandemic vaccine has been the company's focus since 2005, when it began making a vaccine for H5N1 avian flu. 'This is not something we just started dabbling in because flu became a sexy thing,' Singhvi said.

The company's seasonal flu vaccine has been through two rounds of mid-stage testing in humans. The company hopes to test its seasonal flu vaccine in the elderly this fall.

'We demonstrated our capability in this current pandemic by making H1N1 -- the novel swine flu strain -- within 4 weeks of identifying the strain and sent that to the CDC for testing,' Singhvi said.

Those tests showed the vaccine protected ferrets -- which get human-like flu.

Novavax will seek approval to start human trials of its H1N1 vaccine in the fourth quarter, and it hopes to start late-stage trials in 2011. 'The earliest we could get on the market would be 2012. That is under standard licensing conditions. But these are not standard times,' Singhvi said.

'If the pandemic becomes very severe, I think whatever would need to be done, the U.S. government would do,' he added, saying that other countries have expressed interest in a faster approval process.

(Editing by Maggie Fox, Leslie Gevirtz) Keywords: FLU/NOVAVAX

(julie.steenhuysen@thomsonreuters.com; +1 312 408 8131)


COPYRIGHT


Copyright Thomson Reuters 2009. All rights reserved.

Da scheinen weitere Mega-Deals auf Novavax zuzukommen.

Die Aktie ist noch immer am Anfang.

Antwort auf Beitrag Nr.: 37.941.784 von binda am 08.09.09 21:03:36kann das mal einer auf deutsch übersetzen oder den inhalt kommentieren danke

Antwort auf Beitrag Nr.: 37.943.667 von sharp2008 am 09.09.09 09:38:30An Interessantem und Neuem steht für mich im Artikel folgendes:
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,
'We're talking with at least half a dozen countries if not more,'

Novavax verhandelt mit mind. 6 Ländern über die Möglichkeit eines schnellen Einsatzes von Impfstoffen dh. für mich auch fast tracking

there is not enough production capacity to make vaccine for everyone.

Es stehen zu wenig Dosen zur Verfügung, auch hier gehts Richtung fast tracking

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.

Novavax - Stoffe können schneller hergestellt werden und sind billiger

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

"Die Analysten, die eine Zurückstufung gemacht haben, behaupten die Aktie sei zu stark gestiegen. Ich glaube, da liegen sie falsch und es liegt an uns dies zu beweisen."

So eine Aussage von einem CEO habe ich noch nie gehört: da steckt entweder sehr viel Selbstvertrauen dahinter oder er weiß etwas, was wir (noch) nicht wissen


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.
'That has been attractive to other countries, and other companies in other countries, not only because it's cheaper, but also because the technology transfer is simpler,' he said.

Der Bau von Fabriken ist bei Novavax 80 % billiger und somit attraktiv für viele. Auch der Technologietransfer ist einfacher.

saying that other countries have expressed interest in a faster approval process.

andere Länder sind am Fast track Prozess interessiert, was eine deutliche Beschleinigung in der zulassung bedeuten würde.

Good luck

Antwort auf Beitrag Nr.: 37.944.851 von basset69 am 09.09.09 11:43:18'They think the stock went up too much too fast,' Singhvi said. 'I think they're wrong, but that is for us to prove.'

Das ist die Hammeraussage schlechthin. Ein Teil der Bio-Fonds sind wahrscheinlich draussen, da die nach Analystenkommentaren handeln ich warte nur bis diese wieder einsteigen werden. Es spricht in dieser heissen Phase alles für Novavax und ein fast track. Novartis hat heute verkündet sie können die versprochene Menge an Impfstoff Ende Oktober doch nicht so schnell liefern da die Impfstoffausbeute geringer ist als erwartet. NVAX wird meiner Meinung nach bei der nächsten Hiobsbotschaft die 8 streicheln....