Post by Hot Christian Stocks on Feb 19, 2013 7:51:16 GMT -5
Today's Profile is on Dynavax Technologies Corporation (DVAX)
DVAX has Heplisav review from the FDA -target date Feb 24, 2013.
About HEPLISAV
HEPLISAV is an investigational adult hepatitis B vaccine for which a U.S. BLA has been accepted for review by the FDA and a MAA has been accepted for review by the EMA. In Phase 3 trials, HEPLISAV demonstrated higher and earlier protection with fewer doses than currently licensed vaccines. Dynavax has worldwide commercial rights to HEPLISAV. HEPLISAV combines hepatitis B surface antigen with a proprietary Toll-like Receptor 9 agonist to enhance the immune response.
About Dynavax
Dynavax Technologies Corporation, a clinical-stage biopharmaceutical company, discovers and develops novel products to prevent and treat infectious and inflammatory diseases. The Company's lead product candidate is HEPLISAV, a Phase 3 investigational adult hepatitis B vaccine designed to provide higher and earlier protection with fewer doses than currently licensed vaccines.
For more information visit www.dynavax.com
DVAX Key Company Management
Dino Dina, M.D. – Chief Executive Officer and Director
Dr. Dina has been our President from May 1997 until July 2010, a member of our Board of Directors since May 1997 and our Chief Executive Officer since May 1998. From 1982 until he joined us in 1997, Dr. Dina was an employee of Chiron Corporation, a biopharmaceutical company. At Chiron, Dr. Dina held a series of positions with increasing responsibility. He ultimately served as president of Chiron Vaccines (formerly Biocine Company), which he directed from its inception in 1987. Under Dr. Dina's direction, Chiron Vaccines received the first-ever approval of an adjuvanted influenza vaccine in Italy, successfully completed development of the first genetically engineered pertussis vaccine, and conducted clinical trials for vaccines to prevent HIV, herpes simplex type II, cytomegalovirus, and hepatitis B infections. The virology group he directed was responsible for several key scientific findings, including the discovery, cloning, and sequencing of the hepatitis C virus, and the cloning and sequencing of the viral genomes for HIV and hepatitis A viruses. Prior to joining Chiron, Dr. Dina was employed at Albert Einstein College of Medicine in Bronx, New York, as an assistant professor of genetics from 1977 to 1982. He received his M.D. from the University of Genoa Medical School in Italy.
J. Tyler Martin, M.D. – President, Chief Medical Officer, and Director
Dr. Martin is the President, Chief Medical Officer and a member of our Board of Directors. Dr. Martin has nearly 20 years of drug development experience. Before joining Dynavax in 2009, Dr. Martin was President of Humabs LLC. Previously, Dr. Martin worked at Chiron as the Vice President, Development from 2004 until 2006 and the Director, Clinical Research from 1994 until 1997. In his 7 years at Chiron, Dr. Martin led the team responsible for the development of the novel vaccine adjuvant MF59, the first vaccine adjuvant licensed by regulatory agencies since alum, and approved as FLUAD influenza vaccine in Europe. He has also held senior development and research positions at Sangamo, Inc., Valentis, Inc. and SyStemix/GTI. Dr. Martin received a B.S. in Chemistry and an M.D. from the University of Nebraska. He completed his fellowship in pediatric infectious diseases and molecular microbiology at Washington University in St. Louis, Missouri.
Brant Biehn – Vice President
Mr. Biehn joined Dynavax in January 2010. Prior to joining Dynavax, Mr. Biehn held increasingly senior sales and marketing positions during his 21 year tenure at Merck. Since 2005, he has had responsibility for many adult vaccine products, including Merck's hepatitis A, hepatitis B and pneumococcal vaccines. Most recently, he served as International Market Lead for ZOSTAVAX®, a vaccine launched in the US in 2005 for the prevention of herpes zoster, or shingles as well as Merck's other adult vaccines. Prior to 2009, in his role as a global brand leader, he designed and managed marketing and sales programs, including distribution channels; targeted marketing to customer groups, payers, healthcare professionals, and consumers; and led country-specific marketing for ex-US markets. Over the past two years he worked with countries worldwide to supply pneumococcal polysaccharide vaccine to help prevent secondary bacterial infections that may result from pandemic flu infection. This program extended to both large public health programs as well as private health groups, with an emphasis on prevention of pandemic flu impacts. Earlier in his career Mr. Biehn created and led national sales organizations and directed multiple marketing efforts aimed at commercialization planning for new vaccine and human health products. Mr. Biehn earned a Bachelor of Science in Computer Science from the Memorial University of Newfoundland.
(ZOSTAVAX is a registered trademark of Merck & Co., Inc.)
Other beneficial management:
www.dynavax.com/management.html
$DVAX Contact Info
Dynavax Technologies
2929 Seventh Street, Suite 100
Berkeley, CA 94710
Phone: +1.510.848.5100
Toll Free: +1.877.848.5100
Fax: +1.510.848.1327
contact@dynavax.com
Rhein Biotech GmbH
(Dynavax Europe)
Eichsfelder Strasse 11
D-40595 Düsseldorf
Phone: +49.0.211.7.58.45.0
Fax: +49.0.211.7.5.45.130
info@rheinbiotech.de
Investor Relations
Phone: +1.510.665.7205
IR@dynavax.com
DVAX Recent Developments
1) $DVAX is a clinical stage company with no products on the market yet.
2) $DVAX has Heplisav for FDA review on Feb 24, 2013. They also have two other items in their pipeline – (a) DV1179 for multiple autoimmune and inflammatory diseases including lupus, psoriasis, and rheumatoid arthritis partnered with GSK (b) AZD1419 for Asthma & and chronic obstructive pulmonary disorder partnered with AZN. While the pipeline items other than Heplisav have a large market potential, they are still early stage & should not be factored heavily in its valuation. Heplisav on the other hand, has a decent market potential o f$450-$600 million in US & Europe (according to William Blair analysts) but this entirely depends on what label restrictions are placed on it.
3) $DVAX had an FDA Panel in Nov, 2012 which resulted in 13-1 positive for efficacy and 8-5 negative for efficacy. The stock fell immediately after the panel due to the safety concerns raised by the panel.
4) $DVAX’s PDUFA in Feb is still important despite panel’s negative votes because the panel’s safety concerns might not be enough to convince the FDA to issue a CRL and request new clinical trials. The company’s management believes that FDA will probably not request a large trial but might restrict the label & request post-marketing studies.
5) $DVAX has $148M as of Sep 2012 with a burn rate of about $15M per quarter. They have $34M Options and Warrants Outstanding. It looks like $DVAX has plenty of cash but additional study requests from FDA might lead to a dilution after the decision.
Competitors to watch during approval period. Some stocks follow the trend.
finance.yahoo.com/q/co?s=DVAX+Competitors
finance.yahoo.com/q/in?s=DVAX+Industry
finance.yahoo.com/q/sec?s=DVAX+SEC+Filings
finance.yahoo.com/q/it?s=DVAX+Insider+Transactions
finance.yahoo.com/q/mh?s=DVAX+Major+Holders
$DVAX Headlines
investors.dynavax.com/newsevents.cfm
As always, we encourage you to do further research. Also, remember when you are in a position to profit it is often wise to do so.
Remember, sometimes everything can seem to be in line for a perfect situation and still go against you. So be smart, use the stops to protect your position and follow your rules.
Kind Regards,
-Staff from PennyPlayoftheday.com
*Forward & Share to be entered to win one of three $250 gift cards of your choice. The more you share, the more entries you will receive towards the contest. Please no spam, if we receive reports of unsolicited forwarded emails you will be automatically disqualified from the contest. Contest runs through 5/5 and is subject to change without notice. Employees and their immediate families are not allowed to participate.
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Full disclaimer can be read at: pennyplayoftheday.com/disclaimer
DO NOT BASE ANY INVESTMENT DECISION UPON ANY MATERIALS FOUND IN THIS REPORT. We are not registered as a securities broker-dealer of an investment advisor either with the US Securities and Exchange Commission (the "SEC") or with any state securities regulatory authority. We are neither licensed nor qualified to provide financial advice. Many of the companies communicated in our emails or website are developmental stage companies with little or no operating or trading history. The information contained in our alerts should be viewed as commercial advertisement and is not intended to be investment opinion. The report is not provided to any particular individual with a view toward their investment circumstances. The information contained in our alerts is not an offer to buy or sell securities. We distribute opinions, comments and information free of charge to individuals who wish to receive them. Our advertisements and website have been prepared for informational purposes only and are not intended to be used as a complete source of information on any particular company. An individual should never invest in the securities of any of the companies profiles based solely on information contained in our report. Individuals should assume that all information contained in the alerts about profiled companies is not trust worthy unless verified by their own independent research. Any individual who chooses to invest in any securities should do so with caution. Investing in securities is speculative and carries a high degree of risk; you may lose some of all of the money that is invested. Always research your own investments and consult with a registered investment advisor or licensed stock broker before investing.
The profiles are a service of PennyPlayoftheDay a marketing and advertising firm that may have been compensated. All direct and third party compensation received will be disclosed within each individual alert in accordance with section 17(b) of the nineteen thirty three Securities Act. Any compensation constitutes a conflict of interest as to our ability to remain objective in our communication regarding the profiled companies. We were not compensated for this profile.
PPOTD and /or its affiliated may buy, hold, and sell securities in the companies profiled. When compensated in shares, all readers should be aware that it is our policy to liquidate all shares immediately. We reserve the right to buy or sell the shares of any of the companies mentioned in any materials we produce at any time. This compensation constitutes a conflict of interest as to our ability to remain objective in our communication regarding the profiled companies. .
Forward-Looking Statements, Certain statements in this communication that are not historical facts are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements may be identified by the use of words such as "anticipate," "believe," "expect," "future," "may," "will," "would," "should," "plan," "projected," "potential," "intend," and similar expressions. Such forward-looking statements, involve known and unknown risks, uncertainties and other factors that may cause the actual results, performance or achievements of (the "Company") to be materially different from those expressed or implied by such forward-looking statements.
The Company's future operating results are dependent upon many factors, including risk factors discussed in the Company's periodic filings with the Securities and Exchange Commission, which are available for review at www.sec.gov. We undertake no obligation to update any forward-looking statement, whether as a result of new information, future events or otherwise. Information contained in our advertisement will contain "forward looking statements" as defined under 27A of the Securities act 1933 and Section twenty one B of the Securities Exchange's Thirty Four Act. Subscribers are cautioned not to place undue reliance upon these forward looking statements. These "forward looking statements" are subject to a number of known and unknown risks and uncertainties outside our control that could cause actual operations or results to differ materially from those anticipated. Factors that could affect performance include, but are not limited to, those factors that are discussed in each profiled company's most recent reports or registration statements filed with the SEC. You should consider these factors in evaluating these forward looking statements included in the advertisement and not place undue reliance upon such statements.
We are committed to providing factual information on the companies that are profiled. However, we do not provide any assurances as to the accuracy or completeness of the information provided, including information regarding a profiled company's plans or ability to effect any planned or proposed actions. We have no first-hand knowledge of any profiled company's operations and therefore cannot comment on their capabilities, intent, resources, nor experience and we make no attempt to do so. Statistical information, dollar amounts, and market size data was provided by the subject company and related sources which we believe to be reliable. To the fullest extent of the law, we will not be liable to any person or entity for the quality, accuracy, completeness, reliability, or timeliness of the information provided in the alert, or for any direct, indirect, consequential, incidental, special or punitive damages that may arise out of the use of information we provide to any person or entity (including, but not limited to ,lost profits, loss of opportunities, trading losses, and damages that may result from any inaccuracy or incompleteness of this information).
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We encourage you to invest carefully and read investment information available at the websites of the SEC at www.sec.gov and FINRA at www.finra.org.
DVAX has Heplisav review from the FDA -target date Feb 24, 2013.
About HEPLISAV
HEPLISAV is an investigational adult hepatitis B vaccine for which a U.S. BLA has been accepted for review by the FDA and a MAA has been accepted for review by the EMA. In Phase 3 trials, HEPLISAV demonstrated higher and earlier protection with fewer doses than currently licensed vaccines. Dynavax has worldwide commercial rights to HEPLISAV. HEPLISAV combines hepatitis B surface antigen with a proprietary Toll-like Receptor 9 agonist to enhance the immune response.
About Dynavax
Dynavax Technologies Corporation, a clinical-stage biopharmaceutical company, discovers and develops novel products to prevent and treat infectious and inflammatory diseases. The Company's lead product candidate is HEPLISAV, a Phase 3 investigational adult hepatitis B vaccine designed to provide higher and earlier protection with fewer doses than currently licensed vaccines.
For more information visit www.dynavax.com
DVAX Key Company Management
Dino Dina, M.D. – Chief Executive Officer and Director
Dr. Dina has been our President from May 1997 until July 2010, a member of our Board of Directors since May 1997 and our Chief Executive Officer since May 1998. From 1982 until he joined us in 1997, Dr. Dina was an employee of Chiron Corporation, a biopharmaceutical company. At Chiron, Dr. Dina held a series of positions with increasing responsibility. He ultimately served as president of Chiron Vaccines (formerly Biocine Company), which he directed from its inception in 1987. Under Dr. Dina's direction, Chiron Vaccines received the first-ever approval of an adjuvanted influenza vaccine in Italy, successfully completed development of the first genetically engineered pertussis vaccine, and conducted clinical trials for vaccines to prevent HIV, herpes simplex type II, cytomegalovirus, and hepatitis B infections. The virology group he directed was responsible for several key scientific findings, including the discovery, cloning, and sequencing of the hepatitis C virus, and the cloning and sequencing of the viral genomes for HIV and hepatitis A viruses. Prior to joining Chiron, Dr. Dina was employed at Albert Einstein College of Medicine in Bronx, New York, as an assistant professor of genetics from 1977 to 1982. He received his M.D. from the University of Genoa Medical School in Italy.
J. Tyler Martin, M.D. – President, Chief Medical Officer, and Director
Dr. Martin is the President, Chief Medical Officer and a member of our Board of Directors. Dr. Martin has nearly 20 years of drug development experience. Before joining Dynavax in 2009, Dr. Martin was President of Humabs LLC. Previously, Dr. Martin worked at Chiron as the Vice President, Development from 2004 until 2006 and the Director, Clinical Research from 1994 until 1997. In his 7 years at Chiron, Dr. Martin led the team responsible for the development of the novel vaccine adjuvant MF59, the first vaccine adjuvant licensed by regulatory agencies since alum, and approved as FLUAD influenza vaccine in Europe. He has also held senior development and research positions at Sangamo, Inc., Valentis, Inc. and SyStemix/GTI. Dr. Martin received a B.S. in Chemistry and an M.D. from the University of Nebraska. He completed his fellowship in pediatric infectious diseases and molecular microbiology at Washington University in St. Louis, Missouri.
Brant Biehn – Vice President
Mr. Biehn joined Dynavax in January 2010. Prior to joining Dynavax, Mr. Biehn held increasingly senior sales and marketing positions during his 21 year tenure at Merck. Since 2005, he has had responsibility for many adult vaccine products, including Merck's hepatitis A, hepatitis B and pneumococcal vaccines. Most recently, he served as International Market Lead for ZOSTAVAX®, a vaccine launched in the US in 2005 for the prevention of herpes zoster, or shingles as well as Merck's other adult vaccines. Prior to 2009, in his role as a global brand leader, he designed and managed marketing and sales programs, including distribution channels; targeted marketing to customer groups, payers, healthcare professionals, and consumers; and led country-specific marketing for ex-US markets. Over the past two years he worked with countries worldwide to supply pneumococcal polysaccharide vaccine to help prevent secondary bacterial infections that may result from pandemic flu infection. This program extended to both large public health programs as well as private health groups, with an emphasis on prevention of pandemic flu impacts. Earlier in his career Mr. Biehn created and led national sales organizations and directed multiple marketing efforts aimed at commercialization planning for new vaccine and human health products. Mr. Biehn earned a Bachelor of Science in Computer Science from the Memorial University of Newfoundland.
(ZOSTAVAX is a registered trademark of Merck & Co., Inc.)
Other beneficial management:
www.dynavax.com/management.html
$DVAX Contact Info
Dynavax Technologies
2929 Seventh Street, Suite 100
Berkeley, CA 94710
Phone: +1.510.848.5100
Toll Free: +1.877.848.5100
Fax: +1.510.848.1327
contact@dynavax.com
Rhein Biotech GmbH
(Dynavax Europe)
Eichsfelder Strasse 11
D-40595 Düsseldorf
Phone: +49.0.211.7.58.45.0
Fax: +49.0.211.7.5.45.130
info@rheinbiotech.de
Investor Relations
Phone: +1.510.665.7205
IR@dynavax.com
DVAX Recent Developments
1) $DVAX is a clinical stage company with no products on the market yet.
2) $DVAX has Heplisav for FDA review on Feb 24, 2013. They also have two other items in their pipeline – (a) DV1179 for multiple autoimmune and inflammatory diseases including lupus, psoriasis, and rheumatoid arthritis partnered with GSK (b) AZD1419 for Asthma & and chronic obstructive pulmonary disorder partnered with AZN. While the pipeline items other than Heplisav have a large market potential, they are still early stage & should not be factored heavily in its valuation. Heplisav on the other hand, has a decent market potential o f$450-$600 million in US & Europe (according to William Blair analysts) but this entirely depends on what label restrictions are placed on it.
3) $DVAX had an FDA Panel in Nov, 2012 which resulted in 13-1 positive for efficacy and 8-5 negative for efficacy. The stock fell immediately after the panel due to the safety concerns raised by the panel.
4) $DVAX’s PDUFA in Feb is still important despite panel’s negative votes because the panel’s safety concerns might not be enough to convince the FDA to issue a CRL and request new clinical trials. The company’s management believes that FDA will probably not request a large trial but might restrict the label & request post-marketing studies.
5) $DVAX has $148M as of Sep 2012 with a burn rate of about $15M per quarter. They have $34M Options and Warrants Outstanding. It looks like $DVAX has plenty of cash but additional study requests from FDA might lead to a dilution after the decision.
Competitors to watch during approval period. Some stocks follow the trend.
finance.yahoo.com/q/co?s=DVAX+Competitors
finance.yahoo.com/q/in?s=DVAX+Industry
finance.yahoo.com/q/sec?s=DVAX+SEC+Filings
finance.yahoo.com/q/it?s=DVAX+Insider+Transactions
finance.yahoo.com/q/mh?s=DVAX+Major+Holders
$DVAX Headlines
investors.dynavax.com/newsevents.cfm
As always, we encourage you to do further research. Also, remember when you are in a position to profit it is often wise to do so.
Remember, sometimes everything can seem to be in line for a perfect situation and still go against you. So be smart, use the stops to protect your position and follow your rules.
Kind Regards,
-Staff from PennyPlayoftheday.com
*Forward & Share to be entered to win one of three $250 gift cards of your choice. The more you share, the more entries you will receive towards the contest. Please no spam, if we receive reports of unsolicited forwarded emails you will be automatically disqualified from the contest. Contest runs through 5/5 and is subject to change without notice. Employees and their immediate families are not allowed to participate.
Never invest in any stock featured on our site or emails unless you can afford to lose your entire investment. Disclaimer& Risk Disclosure: The disclaimer is to be read and fully understood before using our site, or joining our email list.
Please note well: PennyPlayoftheDay.com employees are not registered as an Investment Advisor in any jurisdiction whatsoever. This is a Paid Advertisement.
Full disclaimer can be read at: pennyplayoftheday.com/disclaimer
DO NOT BASE ANY INVESTMENT DECISION UPON ANY MATERIALS FOUND IN THIS REPORT. We are not registered as a securities broker-dealer of an investment advisor either with the US Securities and Exchange Commission (the "SEC") or with any state securities regulatory authority. We are neither licensed nor qualified to provide financial advice. Many of the companies communicated in our emails or website are developmental stage companies with little or no operating or trading history. The information contained in our alerts should be viewed as commercial advertisement and is not intended to be investment opinion. The report is not provided to any particular individual with a view toward their investment circumstances. The information contained in our alerts is not an offer to buy or sell securities. We distribute opinions, comments and information free of charge to individuals who wish to receive them. Our advertisements and website have been prepared for informational purposes only and are not intended to be used as a complete source of information on any particular company. An individual should never invest in the securities of any of the companies profiles based solely on information contained in our report. Individuals should assume that all information contained in the alerts about profiled companies is not trust worthy unless verified by their own independent research. Any individual who chooses to invest in any securities should do so with caution. Investing in securities is speculative and carries a high degree of risk; you may lose some of all of the money that is invested. Always research your own investments and consult with a registered investment advisor or licensed stock broker before investing.
The profiles are a service of PennyPlayoftheDay a marketing and advertising firm that may have been compensated. All direct and third party compensation received will be disclosed within each individual alert in accordance with section 17(b) of the nineteen thirty three Securities Act. Any compensation constitutes a conflict of interest as to our ability to remain objective in our communication regarding the profiled companies. We were not compensated for this profile.
PPOTD and /or its affiliated may buy, hold, and sell securities in the companies profiled. When compensated in shares, all readers should be aware that it is our policy to liquidate all shares immediately. We reserve the right to buy or sell the shares of any of the companies mentioned in any materials we produce at any time. This compensation constitutes a conflict of interest as to our ability to remain objective in our communication regarding the profiled companies. .
Forward-Looking Statements, Certain statements in this communication that are not historical facts are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements may be identified by the use of words such as "anticipate," "believe," "expect," "future," "may," "will," "would," "should," "plan," "projected," "potential," "intend," and similar expressions. Such forward-looking statements, involve known and unknown risks, uncertainties and other factors that may cause the actual results, performance or achievements of (the "Company") to be materially different from those expressed or implied by such forward-looking statements.
The Company's future operating results are dependent upon many factors, including risk factors discussed in the Company's periodic filings with the Securities and Exchange Commission, which are available for review at www.sec.gov. We undertake no obligation to update any forward-looking statement, whether as a result of new information, future events or otherwise. Information contained in our advertisement will contain "forward looking statements" as defined under 27A of the Securities act 1933 and Section twenty one B of the Securities Exchange's Thirty Four Act. Subscribers are cautioned not to place undue reliance upon these forward looking statements. These "forward looking statements" are subject to a number of known and unknown risks and uncertainties outside our control that could cause actual operations or results to differ materially from those anticipated. Factors that could affect performance include, but are not limited to, those factors that are discussed in each profiled company's most recent reports or registration statements filed with the SEC. You should consider these factors in evaluating these forward looking statements included in the advertisement and not place undue reliance upon such statements.
We are committed to providing factual information on the companies that are profiled. However, we do not provide any assurances as to the accuracy or completeness of the information provided, including information regarding a profiled company's plans or ability to effect any planned or proposed actions. We have no first-hand knowledge of any profiled company's operations and therefore cannot comment on their capabilities, intent, resources, nor experience and we make no attempt to do so. Statistical information, dollar amounts, and market size data was provided by the subject company and related sources which we believe to be reliable. To the fullest extent of the law, we will not be liable to any person or entity for the quality, accuracy, completeness, reliability, or timeliness of the information provided in the alert, or for any direct, indirect, consequential, incidental, special or punitive damages that may arise out of the use of information we provide to any person or entity (including, but not limited to ,lost profits, loss of opportunities, trading losses, and damages that may result from any inaccuracy or incompleteness of this information).
Third Party Web Sites and Information
PennyPlayoftheDay.com and newsletter may provide hyperlinks to third party websites or access to third party content. PPOTD does not control, endorse, or guarantee content found in such sites. You agree that PPOTD is not responsible for any content, associated links, resources, or services associated with a third party site. You further agree that PPOTD shall not be liable for any loss or damage of any sort associated with your use of third party content. Links and access to these sites are provided for your convenience only.
We encourage you to invest carefully and read investment information available at the websites of the SEC at www.sec.gov and FINRA at www.finra.org.