Wer rennt schneller ? VICL XOMA DVAX HEB ?
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_bbb_ : Wer rennt schneller ? VICL XOMA DVAX HEB ?
Vier Biotechs welche einen netten run die nächsten Monate / Jahre hinlegen könnten.
Company Name: Vical, Incorporated
Ticker Symbol: VICL
WWW Address: www.vical.com
Company Name: XOMA Ltd. Bermuda
Ticker Symbol: XOMA
WWW Address: www.xoma.com
Company Name: Dynavax Technologies Corporation
Ticker Symbol: DVAX
WWW Address: www.dynavax.com
Company Name: Hemispherx Biopharma, Inc.
Ticker Symbol: HEB
WWW Address: www.hemispherx.net
_bbb_ : HEB
_bbb_ : HEB Chart
_bbb_ : HEB Post...gute Info
_bbb_ : :-)
Jun 30, 2009, 6:42 a.m. EST
Vical says swine flu vaccine works in mice
Influenza A(H1N1) - update 55
Laboratory-confirmed cases of new influenza A(H1N1) as officially reported to WHO by States Parties to the International Health Regulations (2005)
_bbb_ : Press Release
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June 30, 2009
Vical Inc. (NASDAQ: VICL) showed promising swine flu test data in its animal model today and was one of the top rising stocks. A pact from Novavax, Inc. (NASDAQ: NVAX) with the government of Spain and ROVI Pharmaceuticals sent its shares even higher on a percentage basis.
Vical Incorporated (NASDAQ: VICL) said tests in its vaccine against A/H1N1 pandemic influenza, the swine flu, produced robust immune responses that were “well above the accepted protection threshold in 100% of vaccinated mice and rabbits” after a standard two-dose vaccine regimen. The company said that at least 75% of vaccinated animals achieved or exceeded the protection threshold after a single dose of vaccine. Vical went so far as saying that it is ready to advance directly to large-scale cGMP manufacturing of the vaccine for human clinical trials, subject to securing external funding for this program.
Novavax, Inc. (NASDAQ: NVAX) signed a deal with Spain’s health ministry and ROVI Pharma, a specialty drug maker in Spain, to license its genetically engineered technology to produce pandemic and seasonal flu vaccines and build that country’s first vaccine-making plant.
While exact terms are outstanding, this could easily bring in tens of millions of dollars in future royalty and milestone payments if and after the vaccines are approved and marketed. The target here is to get both pandemic flu vaccines and seasonal flu vaccines by 2012.
ROVI has committed to make a $3 million equity investment in Novavax at $2.74, a 10% premium to yesterday’s close. The Spanish government is forming a foundation and will invest in a 60 million facility and a non-profit foundation will be formed will be formed and initially funded with a 25 million euro credit line from the Spanish government.
This was a huge boom for both companies today. Vical Inc. (NASDAQ: VICL) rose over 22% to $2.70, on over 8 million shares. Novavax, Inc. (NASDAQ: NVAX) shares closed up 31% at $3.28, on over 32 million shares. As far as how high that volume is, that is about 14-times average on Vical and nearly 8-times average volume on Novavax.
Jon C. Ogg
Tags: NVAX, VICL
RobinW : NVAX awaiting approval of FDA, too
The FDA has fallen weeks behind schedule in responding to select NDA's and PDUFA's. While people across the globe continue to fall ill, suffer and die from disease and debilitations, American drug research and development companies such as Cell Therapeutics (NASDAQ:CTIC), Hemispherx Biopharma (AMEX:HEB), BioDelivery Sciences International (NASDAQ:BDSI), Discovery Laboratories (NASDAQ:DSCO), Acura Phamaceuticals (NASDAQ:ACUR), King Pharmaceuticals (NYSE:KG) and Genta (OTC:GNTA) sit by anxiously awaiting word from the FDA on their medical discoveries - drugs that have demonstrated themselves to be paramount in effectiveness to combat many of these diseases and debilitations.
Stock investors have become impatient with the constant stalling of the FDA. They have set out to try to find answers, to now understand why it is that an agency of the government of the United States, charged with the approval of new drugs for the American marketplace, is withholding drugs such as Ampligen and Genasense from the people.
In their search for the reasons why, many investors have theorized that the hold-ups by the FDA are due to FDA chief Margaret Hamburg and her husband Peter Fitzhugh Brown. On May 26, 2009 The Wall Street Journal reported that Margaret Hamburg and Peter Fitzhugh Brown were heavily invested, both directly and indirectly, in drug company stocks and that they were being required to divest themselves of their holdings due to underlying conflict of interest issues.
Adequate time has lapsed since that article was published for the FDA chief and her husband to comply with the requirement that they divest themselves of their drug stock holdings and associations. Still, weeks have come and gone and no further word has been reported in the media (that I am aware of) as to the compliance of Margaret Hamburg and her husband.
There are other theories as well. Some of them ludicrous and some worthy of contemplation. One theory argues that the FDA is simply overworked and that the additional duties and responsibilities imposed upon them by the new Family Smoking Prevention and Tobacco Control Act only add to the workload and slow down the wheels of progress even further.
The FDA was already behind schedule with NDA responses prior to the Family Smoking Prevention and Tobacco Control Act. To argue that the FDA has fallen behind in their duties to the people due to this Act adding to their workload is, in itself, a ludicrous argument.
It would be more believable to claim that drugs developed by U.S. companies aren't being approved by the U.S. Food and Drug Administration in a timely manner because the U.S. government is indirectly outsourcing drug development to foreign companies in lieu of American companies through the drug approval process.
According to records returned by the FDA's search engine at accessdata.fda.gov, the FDA approved a total of 123 drugs during the three month period of April to June, 2009. Of those 123 drug approvals -
79 of those drugs (64.2%) were developed by companies either located outside of the United States or which are wholly owned subsidiaries of companies located outside of the United States, and
Nearly half (36, or 45.6%) of those drugs were developed by companies either located in India or which are wholly owned subsidiaries of companies located in India.
With only 44 of the drugs approved during that time period being developed by American companies, it would appear as though the FDA's preference for Indian drug research and development companies have become a viable threat to the success of American drug companies.
And what of those 44 American drug research and development companies? As a sideline, it's interesting to note that 27 (61.4%) of the American drugs approved by the U.S. FDA were developed by companies that are privately held (they do not have stocks that trade on the public markets). How this tidbit of information fits into the grand scheme of things is anybody's guess, but it certainly leaves room for more conspiracy theories.
_bbb_ : VICL News
_bbb_ : XOMA News
XOMA Announces Conference Call and Webcast On July 14 to Review Top Line Multi-dose and Other Results of Its Phase 1 Clinical Trial of XOMA 052 in Type 2 Diabetes
Source: XOMA Ltd.
On Tuesday July 7, 2009, 7:00 am EDT
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Conference Call and Webcast Scheduled for 11 a.m. ET
Source: Vical Incorporated
On Wednesday July 8, 2009, 6:30 am EDT
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July 8, 2009 · Filed Under vaccine
Vical Inc. (Nasdaq: VICL) on Wednesday announced a positive four-month interim analysis for what is arguably its second-largest market opportunity, taking potentially another small step toward the goal of attracting a partner for its herpes vaccine program.
The results jump the gun a bit, as detailed endpoints were not provided. Vical expects the trial to be completed in the fourth quarter of 2009, and to have final data available in the first half of 2010.
But the company said its TransVax cytomegalovirus herpes vaccine provided promising results compared with placebo across a broad range of clinical efficacy endpoints. Vical said the vaccine demonstrated a clear viral reduction compared with placebo in the percentage of recipients experiencing herpes virus reactivation. The vaccine also showed a decrease in peak and cumulative viral loads. TransVax also provided an overall increase in cellular immune responses compared with placebo.
The TransVax vaccine appears to be Vical’s No. 2 market opportunity in its pipeline. The No. 1 appears to be Allovectin-7, which is in a Phase III trial to treat metastatic melanoma.
The cytomegalovirus infects more than half of all adults in the U.S. by age 40, and is even more widespread in developing countries. A healthy immune system can fight off the irus, but it can severely affect those with a weak immune system, including transplant patients, pregnant mothers and newborns. — Mike Tarsala
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_bbb_ : XOMA Announces Positive Results ...
Nassie : Gute News für VICAL
Nassie : News
SAN DIEGO, Sept. 10, 2009 (GLOBE NEWSWIRE) -- Vical Incorporated (Nasdaq:VICL) announced today that the company's DNA vaccine against A/H1N1 pandemic influenza (swine flu) has demonstrated robust immune responses in 100% of vaccinated animals against virus strains isolated from recent outbreaks in three distinct geographic locations -- California, Texas and Mexico.
Vical's plasmid DNA vaccine contains the H1 hemagglutinin gene sequence provided by the U.S. Centers for Disease Control and Prevention (CDC) for the swine-origin A/California/04/09 pandemic influenza virus, and after two doses produced immune responses well above the accepted protection threshold in 100% of vaccinated mice and rabbits using HI assays against the swine-origin A/California/07/09 x-179a, A/Texas/15/09 and A/Mexico/4108/09 influenza viruses. Hemagglutination inhibition (HI) titers were well above the protection threshold of 40, ranging from 320 to 2,560 in mice, and from 640 to 2,560 in rabbits against the California strain. Results against the Texas and Mexico strains were essentially equivalent, ranging from 640 to 2,560 in both mice and rabbits. Vical's vaccine would also be expected to provide similar robust immune responses against other swine-origin A/H1N1 influenza virus subtypes, supporting selection of a single A/H1N1 virus strain as the basis for the vaccine.
"Cross-reactivity is consistent with previous CDC reports that circulating strains of swine-origin A/H1N1 pandemic influenza have remained antigenically homogeneous," said Vijay B. Samant, President and Chief Executive Officer of Vical, "but future viral changes are unpredictable and could be far more substantial. The inherent speed of our DNA vaccine platform both in initial development and manufacturing could be extremely important in addressing the potential shortfalls of conventional vaccine approaches."
Vical has entered into a Cooperative Research and Development Agreement (CRADA) with the U.S. Naval Medical Research Center (NMRC), a biomedical research organization within the U.S. Navy, to develop a vaccine against H1N1 influenza.
"We are working with the U.S. Navy to secure funding to advance our H1 vaccine into human clinical testing," added Mr. Samant. "Based on the sustained threat from the ongoing H1N1 pandemic, we have initiated critical-path manufacturing activities to allow initiation of a Phase 1 trial in as little as four to six weeks after funding is secured."
Vical researches and develops biopharmaceutical products based on its patented DNA delivery technologies for the prevention and treatment of serious or life-threatening diseases. Potential applications of the company's DNA delivery technology include DNA vaccines for infectious diseases or cancer, in which the expressed protein is an immunogen; cancer immunotherapeutics, in which the expressed protein is an immune system stimulant; and cardiovascular therapies, in which the expressed protein is an angiogenic growth factor. The company is developing certain infectious disease vaccines and cancer therapeutics internally. In addition, the company collaborates with major pharmaceutical companies and biotechnology companies that give it access to complementary technologies or greater resources. These strategic partnerships provide the company with mutually beneficial opportunities to expand its product pipeline and address significant unmet medical needs. Additional information on Vical is available at www.vical.com.
The Vical Incorporated logo is available at http://www.globenewswire.com/newsroom/prs/?pkgid=5768
This press release contains forward-looking statements subject to risks and uncertainties that could cause actual results to differ materially from those projected. Forward-looking statements include statements about Vical's vaccine technologies and their potential application in a vaccine against H1N1 influenza, potential human clinical testing of such a vaccine, the Vical/NMRC CRADA, potential changes in circulating strains of influenza, potential government regulatory and procurement activities, as well as the company's focus, collaborative partners, and product candidates. Risks and uncertainties include whether the company's technologies will be successfully applied for the development of an H1 DNA vaccine; whether such vaccine will advance to clinical testing quickly, if at all; whether funding will be secured to support a Phase 1 trial; whether Vical, NMRC or others will continue development of any influenza DNA vaccine candidates; whether Vical and/or NMRC will terminate the CRADA before achievement of its objectives; whether the company's DNA vaccine candidate will be effective in protecting humans against H1N1 or any other strains of influenza; whether H1N1 pandemic influenza will undergo substantial strain changes; whether Vical's pandemic influenza vaccine will advance sufficiently to be considered for licensure during future pandemics; whether results in animal testing will be predictive of results in human testing; whether any product candidates will be shown to be safe and effective; the timing, nature and cost of clinical trials; whether Vical or its collaborative partners will seek or gain approval to market any product candidates; whether Vical or its collaborative partners will succeed in marketing any product candidates; and additional risks set forth in the company's filings with the Securities and Exchange Commission. These forward-looking statements represent the company's judgment as of the date of this release. The company disclaims, however, any intent or obligation to update these forward-looking statements.
CONTACT: Vical IncorporatedAlan R. Engbring
Nassie : Schau doch nach
Tiger : Das Volumen vorbörslich ist schon viermal so hoch,
Nassie : News
_bbb_ : News !
Dec 09, 2009 01:00 ETDynavax's European Manufacturing Facility Approved for Commercial Production of HEPLISAV Hepatitis B Surface Antigen