Novavax gestartet! News...

 

mit einer zeitlichen Verzögerung wird auch Nordamerika betroffen sein.  

Riems - Eine Impfung von Geflügel gegen die Vogelgrippe ist umstritten. In Asien wird sie praktiziert. Auch die Niederlande und Frankreich wollen spezielle Geflügelbestände auf diese Weise schützen. In Deutschland ist die Impfung bisher gesetzlich verboten.
Was spricht für eine Impfung?

Nach Angaben des Friedrich-Loeffler-Instituts für Tiergesundheit auf der Insel Riems wird die Erregerausscheidung im Fall einer Infektion des Tieres zwar nicht vollständig unterbunden, aber drastisch reduziert. Deshalb lässt sich die Ausbreitung der Vogelgrippe in Nutzgeflügelbeständen durch eine Impfung verlangsamen.

Was spricht dagegen?

Geimpfte Tiere lassen sich nicht von infizierten unterscheiden. Beide bilden Antikörper gegen das Virus aus. Ein Eintrag der Infektion in einen geimpften Tierbestand ist schwer zu erkennen, weil Krankheitssymptome bei geimpften Tieren verschleiert werden. Damit sind Verzögerungen bei der Bekämpfung der Seuche vorprogrammiert.

Problematisch ist die Impfung großer Tierbestände: Sie kann oft nicht 100-prozentig sichergestellt werden.

Geimpfte Tiere dürfen zudem nicht gehandelt werden.

Bei Einsatz eines nicht in der EU zugelassenen Impfprogramms, würde Deutschland den Status der Vogelgrippe-Freiheit verlieren.

Gibt es einen Ausweg?

Das Friedrich-Loeffler-Institut und andere Forscher entwickeln einen Marker-Impfstoff, mit dem sich erkrankte und infizierte Tiere unterscheiden lassen. Dieser Impfstoff ist nach Schätzungen des Instituts allerdings erst in rund drei Jahren marktreif.



© dpa - Meldung vom 25.02.2006 13:22 Uhr

=============================================

siehe Posting #15  

München/Berlin/Riems - Erstmals seit Ausbruch der Vogelgrippe ist das gefährliche Virus H5N1 in Europa bei einem Säugetier gefunden worden: Eine tote Katze von der Insel Rügen war mit dem Erreger infiziert. Ob es sich um den aggressiven Asia-Stamm handelt, an dem Menschen in Asien erkrankten und starben, wird untersucht.
Das Bundeslandwirtschaftsministerium rief Haustierhalter in Vogelgrippe-Sperrbezirken am Dienstag zu besonderen Schutzmaßnahmen auf. Der Nationale Krisenstab Tierseuchenbekämpfung von Bund und Ländern tagt an diesem Mittwoch, um über die Konsequenzen des Falles zu beraten.

In Mecklenburg-Vorpommern sollen verstärkt tote Säugetiere auf den Krankheitserreger getestet werden. Landesagrarminister Till Backhaus (SPD) sagte in Schwerin, bisher seien drei Katzen, zwei Füchse, einen Marderhund, einen Marder, einen Nerz und zwei Wildschweine überprüft worden. Das infizierte Tier sei ein gut genährter Kater. "Er war kein Stubentiger und erst recht kein Schmusekater", sagte Backhaus. Dennoch sei nur zu vermuten, dass er tote oder kranke Vögel gefressen hat. Der Darmtrakt sei leer gewesen.

Unterdessen greift die Vogelgrippe weiter um sich: Die Tierseuche erreichte Bayern und damit das fünfte Bundesland. Dort und in Baden- Württemberg wurden nach Bekanntwerden der ersten Infektion eines Säugetiers mit dem H5N1-Virus die Vorsorgemaßnahmen verschärft. In den Sperrbezirken müssen Katzen ab sofort im Haus bleiben und Hunde angeleint werden, in den Beobachtungsgebieten wird es empfohlen. Bei Wildvögeln in der Uckermark in Brandenburg und Konstanz am Bodensee wurde der hochansteckende H5N1/Asia-Stamm bestätigt. Derweil meldete Schweden als neunter Staat der Europäischen Union Vogelgrippefälle.

"Katzen sollten in und um Schutzzonen zu Hause gelassen werden", sagte die Sprecherin des Bundesagrarministeriums, Ulrike Hinrichs, in Berlin. Ein enger Kontakt mit den Tieren sollte vermieden werden. "Wir werden im Krisenstab überlegen, was es über die Sofortmaßnahmen für Haustiere hinaus zu beachten gibt", sagte sie. Die tote Katze war nach dpa-Informationen in einem Hochinfektionsgebiet in der Nähe der Wittower Fähre auf Rügen gefunden worden - dort war vor zwei Wochen erstmals H5N1 bei verendeten Wildvögeln entdeckt worden.

Mecklenburg-Vorpommerns Ministerpräsident Harald Ringstorff (SPD) will nach dem Vogelgrippefall der Katze zunächst "abwarten, wie das von Wissenschaftlern bewertet wird". Er schlug vor zu prüfen, ob die Regelung, nach der Katzen außerhalb von Siedlungsgebieten gejagt und getötet werden könnten, zu einer Pflicht umgewandelt werden sollte.

"Dass Katzen sich infizieren können, wenn sie infizierte Vögel fressen, ist seit längerem aus Asien bekannt", sagte der Präsident des Friedrich-Loeffler-Instituts für Tiergesundheit auf der Ostseeinsel Riems, Thomas Mettenleiter. Eine Ansteckung von Menschen durch infizierte Tiere sei nicht nachgewiesen worden. Nach Angaben des Instituts starben in den vergangenen Jahren in Asien Großkatzen in Zoos, die mit infiziertem Geflügel gefüttert worden waren. Auch Hauskatzen erwiesen sich als empfänglich für den Erreger.

In Bayern betonte Umweltminister Werner Schnappauf (CSU) nach dem Nachweis von H5N1 bei zwei Wildvögeln, für Menschen bestehe keine unmittelbare Gefahr. Jetzt komme es darauf an, ein Übergreifen auf Nutztierbestände zu verhindern. Ob es sich bei den Funden in Bayern um die hochansteckende Asia-Variante handelt, wird derzeit vom EU- Referenzlabor im britischen Weybridge ermittelt. Mit einem Ergebnis rechnet das Umweltministerium bis Mittwoch.

Vor Bayern war die Vogelgrippe in Baden-Württemberg, Brandenburg, Schleswig-Holstein und Mecklenburg-Vorpommern nachgewiesen worden. In Schweden wurde bei zwei toten Wildenten eine Vogelgrippeinfektion nachgewiesen, wie Agrarministerin Ann-Christin Nykvist am Dienstag in Stockholm mitteilte. Nach den noch vorläufigen Analysen handele es sich um das Virus H5N1, berichtete der Rundfunksender SR. Nykvist: "Das Auftauchen der Vogelgrippe bei uns ist ernst, kommt aber nicht unerwartet."

Von den EU-Mitgliedsländern hatten nach Angaben der EU-Kommission zuvor Deutschland, Frankreich, Griechenland, Italien, Österreich, die Slowakei, Slowenien und Ungarn das Virus H5N1 bei Tieren entdeckt. Die Weltgesundheitsorganisation (WHO) betonte, der Erreger habe sich im Februar so rasch wie nie zuvor in weltweit 17 neue Länder verbreitet. Trotz hoher Ansteckungsgefahr unter Vögeln sei das Virus nach wie vor nicht ohne weiteres auf den Menschen übertragbar.

Seit Dezember 2003 wurden laut WHO weltweit 173 Infektionen bei Menschen bekannt, 93 Patienten starben. Kein einziger Fall stehe in Zusammenhang mit dem Verzehr ausreichend gekochten Geflügels.

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Novavax wird dabei sein! Siehe Posting #15  

Im 4.Quartal wurde zum 1. Mal ein Gewinn von 0,13 $ erzielt
Für das Jahr erwartete die Analysten noch ein Minus von 0,51 $, erreicht wurde aber ein Minus von 0,28 $.
Mal schauen, wie der Markt auf den Bericht reagiert.



Novavax Announces Fourth Quarter and Year-End 2005 Financial Results


MALVERN, Pa., March 1 /PRNewswire-FirstCall/ -- Novavax, Inc. (Nasdaq: NVAX) today announced its fourth quarter and year-end 2005 financial results.

Recent Significant Events at Novavax include:
-- Completed $38.0 million in equity capital raises at $4.30-$4.35 per
share (November 2005/February 2006)
- Total of $42.0 million of new equity capital raised within last
twelve months
-- Completed License Agreement on ESTRASORB(R) with Esprit Pharma Inc. for
North American distribution (October 2005)
- Minimum $12.5 million in mandatory payments over twelve months
(received $10.0 million in 2005 and $2.5 million due in October 2006)
- Double digit royalty on all ESTRASORB sales
- Significant future milestone payments
- Novavax maintains product manufacturing, and international markets
outside of North America
-- Converted $6.0 million of outstanding convertible notes to equity
(October 2005)
- Reduced convertible notes outstanding to $29.0 million
- Reduced annual interest expense by $285,000
- Remaining bondholders cannot " Put" remaining convertible notes to the
Company until July 2007
-- Expanded the Vaccine Initiative
- Research collaboration initiated with the University of Pittsburgh
School of Medicine on efficacy seasonal and pandemic influenza.
(February 2006)
- Formed strategic alliances with Wave Biotech and Pacific GMP on the
development of a commercial scale manufacturing and production
process for vaccines. (September 2005/February 2006)
- Formed Special Governmental Relations Committee of the Board.
(December 2005)
-- Filed a new $100.0 Million Shelf Registration Statement (December
2005)
-- Nominated two new experienced Board Members from within the bio-
pharmaceutical industry.
Commenting on the fourth quarter and year-end 2005 operating results, Dr. Rahul Singhvi, President and Chief Executive Officer, stated, " Novavax continued its transformation into a new, dynamic company focused on development of new important products in the fourth quarter of 2005. The licensing of North American marketing rights of Estrasorb to Esprit Pharma was critical to our business plan. We assumed a leadership position in addressing the global pandemic influenza threat by leveraging our virus-like particle (VLP), Novasome adjuvants, and portable manufacturing technologies. We now believe we have the necessary financial and human resources to develop a vaccine against H5N1 and other strains of avian and seasonal influenza vaccines and we look forward to reporting our progress on these programs in the near future."

Fourth Quarter Financial Results

Total revenues for the fourth quarter ended December 31, 2005 were $2.2 million compared with total revenues of $2.0 million for the same period last year. The increase was due to a $1.0 million license payment offset by decreases in product sales due to the sale or license of the Company's vitamin, AVC and ESTRASORB products in September and October 2005. For the twelve-month periods ended December 31st, in 2005, total revenues were $7.4 million compared with $8.3 million in 2004. Of the total decrease in revenues, product sales accounted for $1.8 million, due to the sales and license of products, partially offset by a $0.9 million increase, in royalties, milestone and licensing fees.

Cost of products sold for the three-month period ended December 31, 2005 was reduced significantly to $717 thousand compared with $1.4 million for the three-month period ended December 31, 2004, primarily due to the sale of the majority of the Company's product lines. In the three month period ended December 31, 2005 the Company also took a $1.5 million charge to write down ESTRASORB inventory to values which reflected future selling cost. Cost of products sold for the twelve month period, which includes fixed idle capacity costs at our manufacturing facility, increased to $5.8 million in 2005, compared to $3.5 million in 2004, a 66% increase. Of the $5.8 million costs of products sold for 2005, $3.2 million was due to idle plant capacity costs at our manufacturing facility compared to $0.7 million in 2004. The remaining $2.6 million increase was primarily due to ESTRASORB, which accounted for 45% of net product sales in 2005, as compared to 28% of net product sales in 2004.

Research and development costs for the three-month period ended December 31, 2005, were $1.3 million compared to $1.5 million for the three-month period ended December 31, 2004. For the full year research and development costs decreased from $7.4 million in 2004 to $5.1 million in 2005. The decrease of $2.3 million or 31% was due to manufacturing start-up costs in 2004 being accounted for in the research and development category until production began in April 2004. We expect research and development costs to increase in 2006 as we progress on the development of other products in our pipeline, primarily related to vaccine research and development.

Selling and marketing costs were reduced to $89 thousand for the three- month period ended December 31, 2005, compared with $6.3 million for the same period last year. The decrease of $6.2 million was primarily due to the prior investment in the marketing launch of ESTRASORB in 2004, as well as elimination of our sales force over the past year and the decision to discontinue any further marketing efforts solely within our Company. Selling and marketing expenses were $6.9 million for the twelve month period ended December 31, 2005, compared with $23.6 million for the same twelve-month period last year. The $16.7 million decrease was primarily due to the significant marketing investment made in 2004 for the initial launch of ESTRASORB as well as our business strategy of transitioning to our core competency of new product development.

Total general and administrative costs were $2.0 million for the three- month period ended December 31, 2005, compared with $2.7 million for the three-month period ended December 31, 2004. The reduction in general administrative costs during this period of $0.7 million was due to reductions in various categories of expenses, including accounting, consulting, investor relations, and salary expense. Total general and administrative costs were $8.1 million for the twelve-month period ended December 31, 2005, compared with $8.7 million for the similar period in 2004.

In October 2005, the Company entered into License and Supply Agreements for its primary product, ESTRASORB. In consideration for the rights granted, the Company was paid $10.0 million in the fourth quarter of 2005. A minimum amount of another $2.5 million will be paid during the fourth quarter 2006, along with other contingency royalties and milestone payments. As part of this transaction the Company also wrote off $2.2 million which represented the remaining net balance of its intangible asset for ESTRASORB. The Company incurred $0.2 million of fees related to this transaction and recorded a gain of $10.1 million during the fourth quarter of 2005.

For the three-month period ended December 31, 2005, the Company had a net profit of $6.2 million, or $0.13 per share, compared with a net loss of $10.3 million, or ($0.26) per share, for the same three-month period last year. For the twelve-month period ended December 31, 2005, the Company had a net loss of $11.2 million, or ($0.26) per share, compared with a net loss of $25.9 million, or ($0.70) per share for the similar 2004 period.

As of December 31, 2005, the Company had $31.9 million in cash and cash- equivalents compared with $17.9 million at December 31, 2004. The February 2006 equity offering, with gross proceeds of $20.0 million, adds to this year end balance. In November 2005, the Company also completed an equity offering of 4,186,047 shares of common stock at $4.30 per share for gross proceeds of $18.0 million. The equity raised in November 2005 and February 2006 were both issued pursuant to existing " shelf" registration statements.

Conference Call

The Company will hold an investor conference call to discuss its financial results at 10:00 a.m. ET on March 1, 2006. The call will be hosted by Mr. Gary C. Evans, Chairman of the Board and Dr. Rahul Singhvi, President and CEO of Novavax. Other participants on the call will include senior management of Novavax. A question and answer session will follow the financial results overview. The dial in number for the conference call is (866) 356-3093, pass code 67425359.

A live audio webcast and presentation of the conference call will be available through http://www.novavax.com. Please connect to this website at least 15 minutes prior to the conference call to ensure adequate time for any software download that may be needed to hear the webcast. A replay of the webcast will be available for 90 days starting on March 1, 2006 at http://www.novavax.com. A replay of the conference call will also be available by telephone on March 1, 2006 through June 1, 2006. To access the replay, dial (888) 286-8010 and enter pass code 63645862 followed by the number sign.

About Novavax, Inc.

Novavax is focused on creating differentiated, value-added pharmaceutical and vaccine products and technologies. These include the Company's virus-like particle (VLP) manufacturing technology utilizing the baculovirus expression system in insect cells, as well as novel vaccine adjuvants based on Novasomes and dendrimer technologies. Novavax, Inc. is also a product development company focused on the research, development and commercialization of new products utilizing its proprietary drug delivery and biological technologies for large and growing markets. Novavax's drug delivery technologies 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(R) (paucillamellar non- phospholipid liposomes) and Sterisomes(R) (subcutaneous depot injection).

NOVAVAX, INC.
CONSOLIDATED STATEMENTS OF OPERATIONS
(in thousands, except share and per share information)

Unaudited
Three-months ended Year ended
December 31, December 31, December 31, December 31,
2005 2004 2005 2004
Revenues:
Net product sales $641 $ 2,207 $ 4,549 $6,397
Contract research &
development 562 (161) 1,798 1,738
Royalties, milestone
and licensing fees 1,041 - 1,041 125
Total revenues 2,244 2,046 7,388 8,260

Operating costs and expenses:
Cost of products sold 717 1,362 5,791 3,490
Excess inventory costs
over market 1,519 - 1,519 -
Research and
development 1,315 1,541 5,075 7,369
Selling and
administrative 89 6,327 6,920 23,588
General and
administrative 2,005 2,724 8,114 8,716
Facility exit costs - - 105 723
Gain on sales of
product assets (10,109) - (10,965) -
Gain on redemption
of debt - - - (11,162)
Total operating
costs and expenses (4,464) 11,954 16,559 32,724

Gain/(Loss) from
operations 6,708 (9,908) (9,171) (24,464)

Interest expense, net (553) (450) (2,003) (1,526)
Other income - 70 - 70

Net gain/(loss) $ 6,155 $(10,288) $(11,174) $(25,920)

Basic and diluted
gain/(loss) per share $0.13 $ (0.26) $ (0.26) $(0.70)

Basic and diluted
weighted average
number of common
shares
outstanding 47,887,656 39,553,876 42,758,302 36,926,034


Selected Balance Sheet Data
(in thousands)

As of December As of December
31, 2005 31, 2004

Cash and cash equivalents $ 31,893 $ 17,876
Total current assets $ 37,611 $ 23,937
Working capital $ 32,735 $ 15,361
Total assets $ 84,382 $ 77,993
Long term obligations $ 29,678 $ 35,970
Stockholders' equity $ 49,652 $ 33,281

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, 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 http://www.sec.gov.

SOURCE Novavax, Inc.
 

www.novavax.com  

50% meiner Position verkauft und Gewinne realisiert.  

Tradingmöglichkeit sein.  

Allianz an...

06.03.2006 13:01
Novavax and Bharat Biotech Announce Strategic Alliance for Pandemic Influenza Vaccine Development

HYDERABAD, India and MALVERN, Pa., March 6 /PRNewswire-FirstCall/ -- Novavax, (Nachrichten) Inc. 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 surrounding 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 over-expressed 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 biotechnology 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(R) 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 worldwide".

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(R). In addition to MNP, Novavax drug delivery technologies include Novasomes (paucillamellar non-phospholipid vesicles) and Sterisomes(R) (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 http://www.sec.gov/.


 

überschritten. Der nächste Wiederstand liegt im Bereich von 6,25$. Sollte diese Marke nach eine Konsolidierung überschritten werden, wird es weitergehen bis knapp über 8$ wo der letzte Widerstand liegt.  

10.03.2006 00:46
U.S. Senator Rick Santorum (R-PA) Will Tour Novavax Facility

MALVERN, Pa., March 9 /PRNewswire-FirstCall/ -- Novavax, (Nachrichten) Inc. today announced that United States Senator Rick Santorum (R-PA), Chairman of the Senate Republican Conference, will personally visit the Novavax Headquarters on Friday morning, March 10, 2006, located at 508 Lapp Road, Malvern, PA.

Senator Santorum plans on touring the Novavax facility, host a Town Hall Meeting, and meet with Company management and employees.

For more information about Senator Santorum go to http://santorum.senate.gov/

About Novavax, Inc.

Novavax is focused on creating differentiated, value-added pharmaceutical and vaccine products and technologies. The company's technology platforms include the virus-like particle (VLP) manufacturing technology utilizing the baculovirus expression system in insect cells, as well as novel vaccine adjuvants based on Novasomes and dendrimer technologies. The company is developing vaccine against the H5N1 strain of avian influenza virus and the human seasonal influenza virus using its VLP and Novasome technologies. Novavax's drug delivery technologies 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(R) (paucillamellar non-phospholipid vesicles) and Sterisomes(R) (subcutaneous depot injection). The company has several products utilizing the MNP technology in various stages of development.



 

kommt aber an die obere Begrenzung des Aufwärtstrends.
Hab ja mit einer Aufwärtsbewegung bei Novavax gerechnet, aber gute 70% in 4 Wochen ?  :-)

Novavax Shares Up Amid Bird Flu Focus
Tuesday March 14, 9:28 am ET
Novavax Shares Rise Amid Focus on Bird Flu, Analyst Recommendation

NEW YORK (AP) -- Shares of pharmaceutical company Novavax Inc. gained in premarket trading Monday, after an analyst called its potential flu vaccine "the best" and the U.S. government said it would spend more than half its bird flu budget on developing vaccines.

The company's shares rose 20 cents, or 3.3 percent, to $6.34 in electronic trading before the markets opened. Since the year began, the Malvern, Pa., company's shares have risen 58 percent.

Novavax, which has mainly focused on developing prescription drugs for women such as prenatal vitamins, contraceptives and hormone replacement therapies, is now working on creating a virus-like particle based vaccine for avian flu. The company has said it believes it will be competitive for government funds going toward bird flu preparations.

Navdeep S. Jaikaria, an analyst at Rodman & Renshaw, on Monday raised his target share price for Novavax to $10, saying the company's vaccine development operations have been "outstanding" so far.

"We believe Novavax VLP (virus-like particle) technology to be the best novel flu vaccine technology in development," Jaikaria said, saying the technology could be readily adaptable and scaled up to meet a surge in demand during a pandemic in a cost-effective way.

On Monday, Health and Human Services Secretary Michael Leavitt said the federal government plans to spend a little more than half of its $3.3 billion bird flu budget on developing vaccines, or $1.78 billion.

Novavax shares hit a new 52-week high on Monday of $6.18.

Elsewhere in the sector, biopharmaceutical company AVI Biopharma Inc. rose 19 cents, or 2.7 percent, to $7.15 in premarket trading. Hemispherx Biopharma Inc. rose 5 cents to $3.29, and Generex Biotechnology Corp. edged up 5 cents, or 2.3 percent, to $2.23.

http://biz.yahoo.com/ap/060314/novavax_mover.html  

aber nach dem heutigen Anstieg von 10% dürfte bald eine Korrektur einsetzten. Wenn danach weiterhin positive News folgen, steht wohl den 10 $ nichts mehr im Weg.  

Novavax Receives Additional Government Funding for IV/AIDS Vaccine Research

MALVERN, Pa., March 16 /PRNewswire-FirstCall/ -- Novavax, (Nachrichten) Inc. , announced approval today from the National Institute of Allergy and Infectious Diseases (NIAID), a component of the National Institutes of Health (NIH), of an additional commitment of approximately $1.0 million to fund the third year of a 4 1/2 year research program. Novavax is developing a novel HIV/AIDS virus-like particle (VLP) vaccine as part of an NIH Integrated Preclinical/Clinical AIDS Vaccine Development Program comprised of scientists from the University of Alabama at Birmingham, Emory University, and Harvard Medical School. All three institutions are working with Novavax in a collaboration to accelerate HIV/AIDS vaccine development.

Dr. Gale Smith, Vice President of Vaccine Development, explains, "We believe the only realistic solution to the global HIV/AIDS pandemic is an effective vaccine. Novavax is extremely pleased to be working with such an acknowledged group of world leaders in developing a novel HIV/AIDS vaccine. Our research is based on our insect cell technology for the production of recombinant virus particles that mimic HIV-1, but without the risk of infection." According to Dr. Beatrice Hahn, one of the principal investigators at the University of Alabama at Birmingham, "Globally circulating strains of HIV-1 are extraordinarily variable, and this diversity poses a major obstacle to AIDS vaccine development. Currently, all candidate vaccines are derived from contemporary HIV-1 isolates, often selected solely based on availability. With VLP vaccines produced by Novavax, we are now testing whether consensus immunogens can elicit broadly cross-reactive immune responses and thus protect against a wide range HIV-1."

In the first two years of the program, Novavax developed a process to manufacture HIV-1 VLPs from consensus sequences of the HIV-1 envelope glycoprotein, the principle target for virus neutralization. These synthetic genes were shown to be incorporated into particles that are structurally similar to HIV-1. Scientists at UAB, Emory, and Harvard discovered that the novel HIV/AIDS VLP vaccines induced a range of immune responses and antibodies in small animals and non-human primates that neutralized both laboratory strains and acute, contemporary HIV-1 isolates. The objectives for the team during 2006 are to maximize efficiency of incorporation of the HIV-1 envelope glycoprotein into particles. Novavax then plans to begin preparations for human clinical trials of an improved HIV/AIDS VLP vaccine.

About HIV/AIDS Pandemic

According to a 2005 report from the World Health Organization (WHO), HIV/AIDS has killed more 25 million people, making it one of the most destructive epidemics in recorded history. HIV claimed the lives of more than half a million children and about 3.1 million people overall in 2005. In the United States alone, more than 40,000 become infected with HIV annually.

About Virus-Like Particle (VLP) Technology

Novavax's virus-like particle (VLP) 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 over-expressed in certain cells. The use of VLP technology has already been proven with the success of the hepatitis B vaccine and more recently with developmental human papillomavirus vaccines. This is the first time that VLP technology has been applied to create a potential HIV/AIDS vaccine and is the same technology Novavax is using to produce influenza VLP vaccines that are readily adaptable and could be scaled up to meet a surge in demand during a pandemic.

About Novavax, Inc.

Novavax is focused on creating differentiated, value-added pharmaceutical and vaccine products and technologies. The company's technology platforms include the virus-like particle (VLP) manufacturing technology utilizing the baculovirus expression system in insect cells, as well as novel vaccine adjuvants based on Novasomes(R), non-phospholipid vesicles and dendrimer technologies. The company is developing a pandemic flu vaccine against the H5N1, H9N2 and other avian influenza viruses and a season flu vaccine against human influenza strains using its VLP and Novasome adjuvant technologies. Novavax's drug delivery technologies include the micellar nanoparticle (MNP) technology which is the basis for the development of its first FDA-approved product, ESTRASORB(R). In addition to MNP, Novavax drug delivery technologies include Novasomes(R) and Sterisomes(R), solvent and oil free emulsions for subcutaneous depot injection. The company has several products utilizing the MNP technology in various stages of development.

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, 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  http://www.sec.gov/.






 

 

mit 8,39$. Bin mal gespannt wie das weiter geht. Ich hab ja immer mit einer Korrektur gerechnet, die aber nicht eintrat. Zum richtigen Zeitpunkt gab es auch immer gute news, die den Kurs weiter in die Höhe treiben.  

gesorgt und dürfte für noch mehr Potenzial gut sein.

Nachrichten · Ausland
USA stufen Vogelgrippe als Sicherheitsbedrohung ein
Freitag, 17. März 2006

Washington - Die Vogelgrippe ist von den USA offiziell als Risiko für die nationale Sicherheit eingestuft worden. In einem am Donnerstag vom Weißen Haus veröffentlichten Strategiepapier zur Sicherheitspolitik werden neben militärischen und ideologischen Bedrohungen auch Epidemien und Naturkatastrophen als Risiken genannt.

Neben Aids wird dabei auch die Vogelgrippe aufgeführt, obwohl in den USA bislang noch kein Infektionsfall mit dem H5N1-Erreger bekannt geworden ist. Die US-Regierung gab zugleich bekannt, dass sie internationale Partnerschaften zur Eindämmung der Vogelgrippe eingehen wolle.

http://www.aerzteblatt.de/v4/news/news.asp?id=23482  

Kurs für eine Kapitalerhöhung.

21.03.2006 13:52
Novavax Executes Definitive Agreement for $38 Million Public Offering

MALVERN, Pa., March 21 /PRNewswire-FirstCall/ -- Novavax, (Nachrichten) Inc. today announced that it has entered into a definitive agreement for a $38 million registered direct offering of 5,205,479 shares of its common stock at a price of $7.30 per share. The shares of common stock will be issued pursuant to an effective shelf registration statement.

Rodman&Renshaw, LLC acted as the exclusive placement agent for the offering. Novavax plans to use the net proceeds from the offering for general corporate purposes, including but not limited to i) clinical development of virus-like particles (VLP) based avian and seasonal influenza vaccines, including the development of appropriate adjuvants, and demonstration of large-scale production capabilities, for such vaccines; ii) internal research and development programs, such as preclinical and clinical testing and studies of our product candidates and the development of new technologies; iii) expansion of and investment in the Company's research and development facilities, including compliance with CGMP (Current General Manufacturing Practices) and GLP (Good Laboratory Practices) rules and regulations and iv) other general corporate purposes. A copy of the final prospectus relating to the offering may be obtained from Dennis Genge, Vice President and Chief Financial Officer, Novavax, Inc., 508 Lapp Road, Malvern, PA 19355, when available.

About Novavax, Inc.

Novavax is focused on creating differentiated, value-added pharmaceutical and vaccine products and technologies. The company's technology platforms include the virus-like particle (VLP) manufacturing technology utilizing the baculovirus expression system in insect cells, as well as novel vaccine adjuvants based on Novasome(R) non-phospholipid vesicles and dendrimer technologies. The company is developing a pandemic flu vaccine against H5N1, H9N2 and other avian influenza viruses and a seasonal flu vaccine against human influenza strains using its VLP and Novasome adjuvant technologies. Novavax's drug delivery technologies include the micellar nanoparticle (MNP) technology which is the basis for the development of its first FDA-approved product, ESTRASORB(R). In addition to MNP, Novavax drug delivery technologies include Novasomes and Sterisome(R) solvent and oil free emulsions for subcutaneous depot injection. The company has several products utilizing the MNP technology in various stages of development.

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, 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 http://www.sec.gov/.