About Us > Overview Overview Dynavax is a clinical-stage biopharmaceutical company committed to developing innovative products for the treatment of infectious diseases, respiratory diseases, and cancer. Our novel Toll-like Receptor 9 (TLR9) agonist products are based on our proprietary immunostimulatory sequences (ISS), which are short DNA sequences that stimulate the innate immune response to fight disease and control chronic inflammation. Our clinical product candidates include: HEPLISAV ™ hepatitis B vaccine partnered with Merck & Co., Inc. Hepatitis B therapy owned by Dynavax Cancer and hepatitis C therapies funded by Symphony Dynamo, Inc. Our preclinical pipeline includes: Asthma and COPD therapies partnered with AstraZeneca Universal Flu vaccine funded by the NIH and under supply agreement with Novartis
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GlaxoSmithKline and Dynavax Announce Worldwide Strategic Alliance
- Developing First-in-Class Endosomal TLR Inhibitors for Autoimmune and
Inflammatory Diseases -
LONDON & PHILADELPHIA & BERKELEY, Calif., Dec 17, 2008 (BUSINESS WIRE) --
GlaxoSmithKline (LSE:GSK) (NYSE:GSK) and Dynavax Technologies Corporation (NASDAQ:DVAX) today announced a worldwide strategic alliance to discover, develop and commercialize novel inhibitors of endosomal Toll-like Receptors (TLRs) for the treatment of immuno-inflammatory diseases. TLRs are key receptors of the innate immune system that can induce strong inflammatory responses.
Under the terms of the alliance, Dynavax will receive an initial payment of $10 million for which GSK will receive an exclusive option over four programs targeting autoimmune and inflammatory diseases such as lupus, psoriasis, and rheumatoid arthritis.
"Our alliance with GSK provides an opportunity to create an entirely new product franchise for Dynavax," commented Dino Dina, M.D., President and Chief Executive Officer of Dynavax. "Our TLR inhibitors have the potential to create significant value for our newest collaborator GSK as well as for our stockholders. Alliances with major pharmaceutical companies have enabled Dynavax to establish a diverse pipeline of innovative products, while contributing valuable cash for our programs."
Dynavax is to conduct research and early clinical development in up to four programs and is eligible to receive future potential development and commercialization milestones totaling approximately $200 million per program. GSK can exercise its exclusive option to license each program upon achievement of proof-of-concept or earlier upon certain circumstances. After exercising its option, GSK will carry out further development and commercialization of these products. Dynavax will receive tiered, up to double-digit royalties on sales and has retained an option to co-develop and co-promote one specified product.
Dynavax has pioneered a new approach to treating autoimmune and inflammatory diseases with its first-in-class oligonucleotide-based endosomal TLR inhibitors, called immunoregulatory sequences (IRS). Dynavax's lead inhibitor drug candidate, DV1079, is a bifunctional inhibitor of TLR7 and TLR9, and is expected to enter clinical development in the fourth quarter of 2009.
"We are committed to using our expertise, in collaboration with Dynavax, to research and develop new therapeutics that can improve the lives of patients with conditions like systemic lupus erythematosus, psoriasis and rheumatoid arthritis," commented Jose Carlos Gutierrez-Ramos, Ph.D., Senior Vice President and Head of the Immuno-Inflammation Centre of Excellence for Drug Discovery at GSK. "Dynavax is a recognized pioneer in the scientific community for its innovation of endosomal TLR inhibitors which prevent immune signaling in autoimmune and inflammatory diseases."
Dynavax Conference Call
Dynavax will webcast a conference call today at 9:00 a.m. ET (6:00 a.m. PT) to discuss this alliance. The live and archived webcast can be accessed by visiting the investor relations section of the Company's Web site at investors.dynavax.com/events.cfm.
About TLR Inhibitors
Dynavax's endosomal TLR inhibitors are a novel class of oligonucleotides, called immunoregulatory sequences (IRS), that specifically inhibit the TLR-induced inflammatory response associated with autoimmune and inflammatory diseases. Preclinical data from animal model studies show Dynavax's TLR inhibitors block IFN-alpha and also reduce symptoms in multiple autoimmune diseases models, such as lupus, inflammatory skin disorders, and rheumatoid arthritis.
About Dynavax
Dynavax Technologies Corporation, a clinical-stage biopharmaceutical company, discovers and develops a diversified, well-funded pipeline of novel Toll-like Receptor (TLR) product candidates. Based on Dynavax's proprietary technology platform, these products specifically modify the innate immune response to infectious, respiratory, autoimmune, and inflammatory diseases. Dynavax's product programs are supported by global partnerships with leading pharmaceutical companies such as Merck & Co., Inc., GlaxoSmithKline, and AstraZeneca AB, as well as funding from Symphony Dynamo, Inc. and the National Institutes of Health. For more information visit www.dynavax.com.
Dynavax Forward-Looking Statement
This press release contains "forward-looking statements," including statements related to the potential value of payments that may be received under our collaboration with GSK, the anticipated development of our inhibitors of endosomal TLRs, the future responsibilities of the parties under the collaboration agreement and Dynavax's ability to perform under the terms of the collaboration agreement. Actual results may differ materially from those set forth in this press release due to the risks and uncertainties inherent in our business, including difficulties or delays in discovery or development, initiation and completion of preclinical or clinical studies, the results of those studies and the impact of those results on the initiation and completion of subsequent studies and issues arising in the regulatory process; achieving our GSK collaborative agreement objectives; our ability to obtain additional financing to support our operations; and other risks detailed in the "Risk Factors" section of our Quarterly Report on Form 10-Q. We undertake no obligation to revise or update information herein to reflect events or circumstances in the future, even if new information becomes available.
About GlaxoSmithKline
GlaxoSmithKline - one of the world's leading research-based pharmaceutical and healthcare companies - is committed to improving the quality of human life by enabling people to do more, feel better and live longer. For company information, visit GlaxoSmithKline at www.gsk.com.
GlaxoSmithKline Forward-Looking Statement
Under the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995, GSK cautions investors that any forward-looking statements or projections made by GSK, including those made in this announcement, are subject to risks and uncertainties that may cause actual results to differ materially from those projected. Factors that may affect GSK's operations are described under 'Risk Factors' in the 'Business Review' in the company's Annual Report on Form 20-F for 2007.
SOURCE: Dynavax Technologies Corporation
DynavaxMichael Ostrach, 1-510-665-7257VP and Chief Business Officermostrach@dynavax.comAmy Figueroa, 1-510-665-7211Investor Relations and Corporate Communicationsafigueroa@dynavax.comorGSKUK Media enquiries:Philip Thomson, (020) 8047 5502Stephen Rae, (020) 8047 5502Alice Hunt, (020) 8047 5502Gwenan White, (020) 8047 5502US Media enquiries:Nancy Pekarek, 215-751-7709Mary Anne Rhyne, 919-483-2839Sarah Alspach, 215-751-7709European Analyst/Investor enquiries:David Mawdsley, (020) 8047 5564Sally Ferguson, (020) 8047 5543Gary Davies, (020) 8047 5503US Analyst/Investor enquiries:Tom Curry, 215-751-5419
Copyright Business Wire 2008
News Provided by COMTEX
- Developing First-in-Class Endosomal TLR Inhibitors for Autoimmune and
Inflammatory Diseases -
LONDON & PHILADELPHIA & BERKELEY, Calif., Dec 17, 2008 (BUSINESS WIRE) --
GlaxoSmithKline (LSE:GSK) (NYSE:GSK) and Dynavax Technologies Corporation (NASDAQ:DVAX) today announced a worldwide strategic alliance to discover, develop and commercialize novel inhibitors of endosomal Toll-like Receptors (TLRs) for the treatment of immuno-inflammatory diseases. TLRs are key receptors of the innate immune system that can induce strong inflammatory responses.
Under the terms of the alliance, Dynavax will receive an initial payment of $10 million for which GSK will receive an exclusive option over four programs targeting autoimmune and inflammatory diseases such as lupus, psoriasis, and rheumatoid arthritis.
"Our alliance with GSK provides an opportunity to create an entirely new product franchise for Dynavax," commented Dino Dina, M.D., President and Chief Executive Officer of Dynavax. "Our TLR inhibitors have the potential to create significant value for our newest collaborator GSK as well as for our stockholders. Alliances with major pharmaceutical companies have enabled Dynavax to establish a diverse pipeline of innovative products, while contributing valuable cash for our programs."
Dynavax is to conduct research and early clinical development in up to four programs and is eligible to receive future potential development and commercialization milestones totaling approximately $200 million per program. GSK can exercise its exclusive option to license each program upon achievement of proof-of-concept or earlier upon certain circumstances. After exercising its option, GSK will carry out further development and commercialization of these products. Dynavax will receive tiered, up to double-digit royalties on sales and has retained an option to co-develop and co-promote one specified product.
Dynavax has pioneered a new approach to treating autoimmune and inflammatory diseases with its first-in-class oligonucleotide-based endosomal TLR inhibitors, called immunoregulatory sequences (IRS). Dynavax's lead inhibitor drug candidate, DV1079, is a bifunctional inhibitor of TLR7 and TLR9, and is expected to enter clinical development in the fourth quarter of 2009.
"We are committed to using our expertise, in collaboration with Dynavax, to research and develop new therapeutics that can improve the lives of patients with conditions like systemic lupus erythematosus, psoriasis and rheumatoid arthritis," commented Jose Carlos Gutierrez-Ramos, Ph.D., Senior Vice President and Head of the Immuno-Inflammation Centre of Excellence for Drug Discovery at GSK. "Dynavax is a recognized pioneer in the scientific community for its innovation of endosomal TLR inhibitors which prevent immune signaling in autoimmune and inflammatory diseases."
Dynavax Conference Call
Dynavax will webcast a conference call today at 9:00 a.m. ET (6:00 a.m. PT) to discuss this alliance. The live and archived webcast can be accessed by visiting the investor relations section of the Company's Web site at investors.dynavax.com/events.cfm.
About TLR Inhibitors
Dynavax's endosomal TLR inhibitors are a novel class of oligonucleotides, called immunoregulatory sequences (IRS), that specifically inhibit the TLR-induced inflammatory response associated with autoimmune and inflammatory diseases. Preclinical data from animal model studies show Dynavax's TLR inhibitors block IFN-alpha and also reduce symptoms in multiple autoimmune diseases models, such as lupus, inflammatory skin disorders, and rheumatoid arthritis.
About Dynavax
Dynavax Technologies Corporation, a clinical-stage biopharmaceutical company, discovers and develops a diversified, well-funded pipeline of novel Toll-like Receptor (TLR) product candidates. Based on Dynavax's proprietary technology platform, these products specifically modify the innate immune response to infectious, respiratory, autoimmune, and inflammatory diseases. Dynavax's product programs are supported by global partnerships with leading pharmaceutical companies such as Merck & Co., Inc., GlaxoSmithKline, and AstraZeneca AB, as well as funding from Symphony Dynamo, Inc. and the National Institutes of Health. For more information visit www.dynavax.com.
Dynavax Forward-Looking Statement
This press release contains "forward-looking statements," including statements related to the potential value of payments that may be received under our collaboration with GSK, the anticipated development of our inhibitors of endosomal TLRs, the future responsibilities of the parties under the collaboration agreement and Dynavax's ability to perform under the terms of the collaboration agreement. Actual results may differ materially from those set forth in this press release due to the risks and uncertainties inherent in our business, including difficulties or delays in discovery or development, initiation and completion of preclinical or clinical studies, the results of those studies and the impact of those results on the initiation and completion of subsequent studies and issues arising in the regulatory process; achieving our GSK collaborative agreement objectives; our ability to obtain additional financing to support our operations; and other risks detailed in the "Risk Factors" section of our Quarterly Report on Form 10-Q. We undertake no obligation to revise or update information herein to reflect events or circumstances in the future, even if new information becomes available.
About GlaxoSmithKline
GlaxoSmithKline - one of the world's leading research-based pharmaceutical and healthcare companies - is committed to improving the quality of human life by enabling people to do more, feel better and live longer. For company information, visit GlaxoSmithKline at www.gsk.com.
GlaxoSmithKline Forward-Looking Statement
Under the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995, GSK cautions investors that any forward-looking statements or projections made by GSK, including those made in this announcement, are subject to risks and uncertainties that may cause actual results to differ materially from those projected. Factors that may affect GSK's operations are described under 'Risk Factors' in the 'Business Review' in the company's Annual Report on Form 20-F for 2007.
SOURCE: Dynavax Technologies Corporation
DynavaxMichael Ostrach, 1-510-665-7257VP and Chief Business Officermostrach@dynavax.comAmy Figueroa, 1-510-665-7211Investor Relations and Corporate Communicationsafigueroa@dynavax.comorGSKUK Media enquiries:Philip Thomson, (020) 8047 5502Stephen Rae, (020) 8047 5502Alice Hunt, (020) 8047 5502Gwenan White, (020) 8047 5502US Media enquiries:Nancy Pekarek, 215-751-7709Mary Anne Rhyne, 919-483-2839Sarah Alspach, 215-751-7709European Analyst/Investor enquiries:David Mawdsley, (020) 8047 5564Sally Ferguson, (020) 8047 5543Gary Davies, (020) 8047 5503US Analyst/Investor enquiries:Tom Curry, 215-751-5419
Copyright Business Wire 2008
News Provided by COMTEX
Meine English-Kenntnisse sind leider nicht mehr die Besten, kann mal wer dien vorigen Text kurz zusammen fassen?
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Die Firma hat nu CASH um zu entwickeln...
Hab 1/3 verkauft bei 200%gewin...der rest ist bleibt im depot als freebies !!!!!!!!!!!!! :-)
Bei 500% +++++war ein retrace von XX % drin...morgen bzw..die nächtren monate gehts hier ab ohne ende IMO !!!!
Die Firma hat nu CASH um zu entwickeln...
Hab 1/3 verkauft bei 200%gewin...der rest ist bleibt im depot als freebies !!!!!!!!!!!!! :-)
Bei 500% +++++war ein retrace von XX % drin...morgen bzw..die nächtren monate gehts hier ab ohne ende IMO !!!!
Press Release Source: Dynavax Technologies Corporation
Dynavax Announces Termination of Partnership With Merck for HEPLISAV Hepatitis B Vaccine
Friday December 19, 6:45 am ET
All Rights Revert to Dynavax
BERKELEY, Calif.--(BUSINESS WIRE)--Dynavax Technologies Corporation (Nasdaq:DVAX - News) today announced the termination of a global license and development collaboration agreement with Merck & Co., Inc. for HEPLISAVTM, a Phase 3 hepatitis B virus (HBV) vaccine. All rights to develop and commercialize HEPLISAV revert to Dynavax.
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Dynavax will continue to evaluate regulatory options for the development of HEPLISAV indicated for adults outside of the United States and for the global end-stage renal disease markets, which the Company estimates represent approximately 70% of the total market opportunity for this vaccine. If the regulatory feedback is favorable, Dynavax plans to pursue a new partner or financing arrangement to support the completion of HEPLISAV’s development for these markets.
“We believe the economics for HEPLISAV, which has been shown to be clinically superior in our trials, favor identifying an appropriate regulatory path in the U.S. and Europe,” commented Dino Dina, M.D., President and Chief Executive Officer of Dynavax. “In the first quarter of 2009, we expect to gain additional insight into the regulatory path for HEPLISAV that will enable us to evaluate further development and pursue partnering agreements with potential collaborators or investors. Independently of HEPLISAV, with our current cash position and strong pharmaceutical partnerships, we have the ability to continue to advance our diversified, well-funded pipeline of products to position Dynavax for future success.”
Update to 2008 Cash Outlook
Dynavax’s consolidated cash, cash equivalents, marketable securities and investments held by Symphony Dynamo, Inc., or total cash, is projected to be over $65 million at December 31, 2008, an increase from the previous guidance of over $50 million. This increase is due to the $10 million initial payment under Dynavax’s worldwide strategic alliance with GlaxoSmithKline as well as the Company’s conservatively managed cash burn rate. Due to the termination of the Merck partnership, Dynavax anticipates that it will accelerate the recognition of approximately $31 million of non-cash revenue previously reported as deferred revenue.
About HEPLISAV
HEPLISAV is a Phase 3 hepatitis B vaccine that combines HBV surface antigen (HBsAg) with Dynavax’s proprietary immunostimulatory sequences (ISS), which specifically target Toll-Like Receptor 9 (TLR9) to stimulate an innate immune response. Clinical data demonstrate HEPLISAV’s highly effective protection against HBV with a more rapid onset of protection, superior 2-dose regimen, and longer lasting seroprotection compared to current vaccines. In a recent Phase 3 trial, 95% of subjects receiving 2 doses of HEPLISAV were seroprotected compared to 81% of subjects receiving 3 doses of Engerix-B. In 9 clinical trials conducted over a period of nearly 10 years, a total of approximately 2,500 individuals have been vaccinated with more than 5,000 doses of HEPLISAV.
In October 2008, the U.S. Food and Drug Administration (FDA) requested additional information prior to considering further development of HEPLISAV in end-stage renal disease patients but advised that the balance of risk versus potential benefit no longer favors continued clinical evaluation of HEPLISAV in healthy adults and children. The clinical hold on the two U.S. IND Applications for HEPLISAV has been in effect since March 2008 following the FDA’s request for a complete review of safety data, including all available information about a single case of Wegener's granulomatosis reported in a Phase 3 clinical trial.
HEPLISAV is not on clinical hold in any market outside of the U.S.
About Dynavax
Dynavax Technologies Corporation, a clinical-stage biopharmaceutical company, discovers and develops a diversified, well-funded pipeline of novel Toll-like Receptor (TLR) product candidates. Based on Dynavax’s proprietary technology platform, these products specifically modify the innate immune response to infectious, respiratory, autoimmune, and inflammatory diseases. Dynavax’s product programs are supported by global partnerships with leading pharmaceutical companies such as GlaxoSmithKline, AstraZeneca AB, and Novartis as well as funding from Symphony Dynamo, Inc. and the National Institutes of Health. For more information visit www.dynavax.com.
Dynavax Forward-Looking Statement
This press release contains “forward-looking statements,” including statements related to our plans to evaluate regulatory options for HEPLISAV and the timing of that evaluation, the prospects for HEPLISAV and the determination of whether further clinical development of HEPLISAV will be undertaken, and if undertaken, whether further development can be partnered or financed; and our projected year end cash position. Actual results may differ materially from those set forth in this press release due to the risks and uncertainties inherent in our business, including difficulties or delays in development, initiation and completion of clinical trials, the results of clinical trials and the impact of those results on the initiation and completion of subsequent trials and issues arising in the regulatory process; the scope and validity of patent protection and the possibility of claims against us based on the patent rights of others; our ability to obtain additional financing to support our operations; and other risks detailed in the “Risk Factors” section of our Quarterly Report on Form 10-Q. We undertake no obligation to revise or update information herein to reflect events or circumstances in the future, even if new information becomes available.
Contact:
Dynavax Technologies Corporation
Dino Dina, M.D., 510-665-4601
President & Chief Executive Officer
ddina@dynavax.com
Amy Figueroa, 510-665-7211
Investor Relations & Corporate Communications
afigueroa@dynavax.com
--------------------------------------------------
Source: Dynavax Technologies Corporation
Dynavax Announces Termination of Partnership With Merck for HEPLISAV Hepatitis B Vaccine
Friday December 19, 6:45 am ET
All Rights Revert to Dynavax
BERKELEY, Calif.--(BUSINESS WIRE)--Dynavax Technologies Corporation (Nasdaq:DVAX - News) today announced the termination of a global license and development collaboration agreement with Merck & Co., Inc. for HEPLISAVTM, a Phase 3 hepatitis B virus (HBV) vaccine. All rights to develop and commercialize HEPLISAV revert to Dynavax.
ADVERTISEMENT
Dynavax will continue to evaluate regulatory options for the development of HEPLISAV indicated for adults outside of the United States and for the global end-stage renal disease markets, which the Company estimates represent approximately 70% of the total market opportunity for this vaccine. If the regulatory feedback is favorable, Dynavax plans to pursue a new partner or financing arrangement to support the completion of HEPLISAV’s development for these markets.
“We believe the economics for HEPLISAV, which has been shown to be clinically superior in our trials, favor identifying an appropriate regulatory path in the U.S. and Europe,” commented Dino Dina, M.D., President and Chief Executive Officer of Dynavax. “In the first quarter of 2009, we expect to gain additional insight into the regulatory path for HEPLISAV that will enable us to evaluate further development and pursue partnering agreements with potential collaborators or investors. Independently of HEPLISAV, with our current cash position and strong pharmaceutical partnerships, we have the ability to continue to advance our diversified, well-funded pipeline of products to position Dynavax for future success.”
Update to 2008 Cash Outlook
Dynavax’s consolidated cash, cash equivalents, marketable securities and investments held by Symphony Dynamo, Inc., or total cash, is projected to be over $65 million at December 31, 2008, an increase from the previous guidance of over $50 million. This increase is due to the $10 million initial payment under Dynavax’s worldwide strategic alliance with GlaxoSmithKline as well as the Company’s conservatively managed cash burn rate. Due to the termination of the Merck partnership, Dynavax anticipates that it will accelerate the recognition of approximately $31 million of non-cash revenue previously reported as deferred revenue.
About HEPLISAV
HEPLISAV is a Phase 3 hepatitis B vaccine that combines HBV surface antigen (HBsAg) with Dynavax’s proprietary immunostimulatory sequences (ISS), which specifically target Toll-Like Receptor 9 (TLR9) to stimulate an innate immune response. Clinical data demonstrate HEPLISAV’s highly effective protection against HBV with a more rapid onset of protection, superior 2-dose regimen, and longer lasting seroprotection compared to current vaccines. In a recent Phase 3 trial, 95% of subjects receiving 2 doses of HEPLISAV were seroprotected compared to 81% of subjects receiving 3 doses of Engerix-B. In 9 clinical trials conducted over a period of nearly 10 years, a total of approximately 2,500 individuals have been vaccinated with more than 5,000 doses of HEPLISAV.
In October 2008, the U.S. Food and Drug Administration (FDA) requested additional information prior to considering further development of HEPLISAV in end-stage renal disease patients but advised that the balance of risk versus potential benefit no longer favors continued clinical evaluation of HEPLISAV in healthy adults and children. The clinical hold on the two U.S. IND Applications for HEPLISAV has been in effect since March 2008 following the FDA’s request for a complete review of safety data, including all available information about a single case of Wegener's granulomatosis reported in a Phase 3 clinical trial.
HEPLISAV is not on clinical hold in any market outside of the U.S.
About Dynavax
Dynavax Technologies Corporation, a clinical-stage biopharmaceutical company, discovers and develops a diversified, well-funded pipeline of novel Toll-like Receptor (TLR) product candidates. Based on Dynavax’s proprietary technology platform, these products specifically modify the innate immune response to infectious, respiratory, autoimmune, and inflammatory diseases. Dynavax’s product programs are supported by global partnerships with leading pharmaceutical companies such as GlaxoSmithKline, AstraZeneca AB, and Novartis as well as funding from Symphony Dynamo, Inc. and the National Institutes of Health. For more information visit www.dynavax.com.
Dynavax Forward-Looking Statement
This press release contains “forward-looking statements,” including statements related to our plans to evaluate regulatory options for HEPLISAV and the timing of that evaluation, the prospects for HEPLISAV and the determination of whether further clinical development of HEPLISAV will be undertaken, and if undertaken, whether further development can be partnered or financed; and our projected year end cash position. Actual results may differ materially from those set forth in this press release due to the risks and uncertainties inherent in our business, including difficulties or delays in development, initiation and completion of clinical trials, the results of clinical trials and the impact of those results on the initiation and completion of subsequent trials and issues arising in the regulatory process; the scope and validity of patent protection and the possibility of claims against us based on the patent rights of others; our ability to obtain additional financing to support our operations; and other risks detailed in the “Risk Factors” section of our Quarterly Report on Form 10-Q. We undertake no obligation to revise or update information herein to reflect events or circumstances in the future, even if new information becomes available.
Contact:
Dynavax Technologies Corporation
Dino Dina, M.D., 510-665-4601
President & Chief Executive Officer
ddina@dynavax.com
Amy Figueroa, 510-665-7211
Investor Relations & Corporate Communications
afigueroa@dynavax.com
--------------------------------------------------
Source: Dynavax Technologies Corporation
nachdem ich mehr als die hälfte für 1.83€ verkauft habe und seitdem auf freebies sitze habe ich am Freitag nochmal für den Einstiegskurs die gleiche menge nachgeladen...denn die 2.60 werden wir sicherlich widersehen...hehehehehhee :-)
Dynavax Announces Fourth Quarter and Year-End 2008 Financial Results
ih.advfn.com/...cb=1235996408&article=36463285&symbol=N%5EDVAX
ih.advfn.com/...cb=1235996408&article=36463285&symbol=N%5EDVAX
Dynavax Appoints Chief Medical Officer
Date : 03/04/2009 @ 3:30AM
Source : Business Wire
Stock : Dynavax Technologies Corporation (DVAX)
Quote : 0.59 0.0 (0.00%) @ 8:54AM
Dynavax Appoints Chief Medical Officer
Dynavax Technologies (Nasdaq:DVAX) today announced the appointment of J. Tyler Martin, M.D. as Chief Medical Officer. Dr. Martin will manage Dynavax’s clinical affairs, including the development of Dynavax’s three current clinical-stage product candidates and three preclinical candidates, which are expected to enter clinical development within the next year.
“Tyler’s experience in infectious diseases and his demonstrated record of driving products through clinical development to support regulatory and commercial success will be instrumental as we advance our pipeline of products,” said Dino Dina, M.D., President and Chief Executive Officer.
Dr. Martin has close to 20 years of experience in the biotechnology industry and has led development activities to support Investigational New Drug (IND) Applications, New Drug Applications (NDAs), and marketed drugs. Most recently, Dr. Martin was President of Humabs LCC, and before that Vice President, Development at Chiron. In his total of 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.
About Dynavax
Dynavax Technologies Corporation, a clinical-stage biopharmaceutical company, discovers and develops a diversified pipeline of novel Toll-like Receptor (TLR) based product candidates. Based on Dynavax’s proprietary technologies, these products specifically modify the innate immune response to infectious, respiratory, autoimmune, and inflammatory diseases. Dynavax has partnerships with leading pharmaceutical companies such as GlaxoSmithKline, AstraZeneca AB, and Novartis as well as funding from Symphony Dynamo, Inc. and the National Institutes of Health. For more information visit www.dynavax.com.
Date : 03/04/2009 @ 3:30AM
Source : Business Wire
Stock : Dynavax Technologies Corporation (DVAX)
Quote : 0.59 0.0 (0.00%) @ 8:54AM
Dynavax Appoints Chief Medical Officer
Dynavax Technologies (Nasdaq:DVAX) today announced the appointment of J. Tyler Martin, M.D. as Chief Medical Officer. Dr. Martin will manage Dynavax’s clinical affairs, including the development of Dynavax’s three current clinical-stage product candidates and three preclinical candidates, which are expected to enter clinical development within the next year.
“Tyler’s experience in infectious diseases and his demonstrated record of driving products through clinical development to support regulatory and commercial success will be instrumental as we advance our pipeline of products,” said Dino Dina, M.D., President and Chief Executive Officer.
Dr. Martin has close to 20 years of experience in the biotechnology industry and has led development activities to support Investigational New Drug (IND) Applications, New Drug Applications (NDAs), and marketed drugs. Most recently, Dr. Martin was President of Humabs LCC, and before that Vice President, Development at Chiron. In his total of 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.
About Dynavax
Dynavax Technologies Corporation, a clinical-stage biopharmaceutical company, discovers and develops a diversified pipeline of novel Toll-like Receptor (TLR) based product candidates. Based on Dynavax’s proprietary technologies, these products specifically modify the innate immune response to infectious, respiratory, autoimmune, and inflammatory diseases. Dynavax has partnerships with leading pharmaceutical companies such as GlaxoSmithKline, AstraZeneca AB, and Novartis as well as funding from Symphony Dynamo, Inc. and the National Institutes of Health. For more information visit www.dynavax.com.
Dynavax Announces Extension of AstraZeneca Research Collaboration
Date : 03/11/2009 @ 6:45AM
Source : Business Wire
Stock : Dynavax Technologies Corporation (DVAX)
Quote : 0.582 0.042 (7.78%) @ 12:25PM
Dynavax Announces Extension of AstraZeneca Research Collaboration
Dynavax Technologies Corporation (Nasdaq:DVAX) today announced an extension of the term of its research collaboration with its pharmaceutical partner AstraZeneca until July 2010. Under this collaboration, the companies are developing novel therapies for the treatment of asthma and chronic obstructive pulmonary disease (COPD). After nominating the first candidate drug AZD1419, expected to enter Phase 1 clinical development in the second half of 2009, Dynavax and AstraZeneca currently are working on a second candidate drug and this extension includes research funding for a third candidate drug.
The first candidate drug AZD1419 utilizes Dynavax’s proprietary immunostimulatory sequences (ISS) technology and represents a new strategy for the treatment of allergic respiratory diseases such as asthma. This therapy is designed to modify the course of these diseases by changing the basic immune response to environmental allergens, such as house dust and pollens, leading to a prolonged reduction in asthma symptoms.
About the Collaboration
In September 2006, Dynavax and AstraZeneca entered into a potential $136 million research and license agreement to discover, develop, and commercialize novel therapies for the treatment of asthma and COPD. Dynavax’s Toll-like Receptor 9 (TLR9) agonist products are based on its proprietary ISS, which are short DNA sequences that specifically target TLR9 to stimulate the innate immune response.
AstraZeneca is responsible for the development and worldwide commercialization of any products arising out of the research program. Dynavax is eligible to receive a total of $136 million in payments and, upon commercialization of these products, royalties based on product sales and the opportunity to co-promote in the United States.
About Dynavax
Dynavax Technologies Corporation, a clinical-stage biopharmaceutical company, discovers and develops a diversified pipeline of novel Toll-like Receptor (TLR) based product candidates. Based on Dynavax’s proprietary technologies, these products specifically modify the innate immune response to infectious, respiratory, autoimmune, and inflammatory diseases. Dynavax has partnerships with leading pharmaceutical companies such as GlaxoSmithKline, AstraZeneca, and Novartis as well as funding from Symphony Dynamo, Inc. and the National Institutes of Health. For more information visit www.dynavax.com.
Forward Looking Statements
This press release contains "forward-looking statements," including statements about planned initiation of clinical trials and the potential for ISS to treat respiratory diseases and for Dynavax to receive payments. Actual results may differ materially from those set forth in this press release due to the risks and uncertainties inherent in our business, including the ability to successfully discover, develop, obtain regulatory approval and commercialize innovative ISS-based drug candidates to treat respiratory disease; the therapeutic potential of our ISS technology to treat asthma and COPD; the ability to continue the collaboration in effect and earn milestones under the agreement with AstraZeneca; difficulties or delays in developing, testing and manufacturing products to support clinical development plans; the scope and validity of patent protection for product candidates; competition from other companies working with ISS technologies and products; the ability to obtain additional financing to support operations; and other risks detailed in the "Risk Factors" section of our Annual Report on Form 10-K. We undertake no obligation to revise or update information herein to reflect events or circumstances in the future, even if new information becomes available.
About AstraZeneca
AstraZeneca is a major international healthcare business engaged in the research, development, manufacturing and marketing of meaningful prescription medicines and supplier for healthcare services. AstraZeneca is one of the world's leading pharmaceutical companies with healthcare sales of US$ 31.6 billion and is a leader in gastrointestinal, cardiovascular, neuroscience, respiratory, oncology and infectious disease medicines. For more information about AstraZeneca, please visit: www.astrazeneca.com.
Date : 03/11/2009 @ 6:45AM
Source : Business Wire
Stock : Dynavax Technologies Corporation (DVAX)
Quote : 0.582 0.042 (7.78%) @ 12:25PM
Dynavax Announces Extension of AstraZeneca Research Collaboration
Dynavax Technologies Corporation (Nasdaq:DVAX) today announced an extension of the term of its research collaboration with its pharmaceutical partner AstraZeneca until July 2010. Under this collaboration, the companies are developing novel therapies for the treatment of asthma and chronic obstructive pulmonary disease (COPD). After nominating the first candidate drug AZD1419, expected to enter Phase 1 clinical development in the second half of 2009, Dynavax and AstraZeneca currently are working on a second candidate drug and this extension includes research funding for a third candidate drug.
The first candidate drug AZD1419 utilizes Dynavax’s proprietary immunostimulatory sequences (ISS) technology and represents a new strategy for the treatment of allergic respiratory diseases such as asthma. This therapy is designed to modify the course of these diseases by changing the basic immune response to environmental allergens, such as house dust and pollens, leading to a prolonged reduction in asthma symptoms.
About the Collaboration
In September 2006, Dynavax and AstraZeneca entered into a potential $136 million research and license agreement to discover, develop, and commercialize novel therapies for the treatment of asthma and COPD. Dynavax’s Toll-like Receptor 9 (TLR9) agonist products are based on its proprietary ISS, which are short DNA sequences that specifically target TLR9 to stimulate the innate immune response.
AstraZeneca is responsible for the development and worldwide commercialization of any products arising out of the research program. Dynavax is eligible to receive a total of $136 million in payments and, upon commercialization of these products, royalties based on product sales and the opportunity to co-promote in the United States.
About Dynavax
Dynavax Technologies Corporation, a clinical-stage biopharmaceutical company, discovers and develops a diversified pipeline of novel Toll-like Receptor (TLR) based product candidates. Based on Dynavax’s proprietary technologies, these products specifically modify the innate immune response to infectious, respiratory, autoimmune, and inflammatory diseases. Dynavax has partnerships with leading pharmaceutical companies such as GlaxoSmithKline, AstraZeneca, and Novartis as well as funding from Symphony Dynamo, Inc. and the National Institutes of Health. For more information visit www.dynavax.com.
Forward Looking Statements
This press release contains "forward-looking statements," including statements about planned initiation of clinical trials and the potential for ISS to treat respiratory diseases and for Dynavax to receive payments. Actual results may differ materially from those set forth in this press release due to the risks and uncertainties inherent in our business, including the ability to successfully discover, develop, obtain regulatory approval and commercialize innovative ISS-based drug candidates to treat respiratory disease; the therapeutic potential of our ISS technology to treat asthma and COPD; the ability to continue the collaboration in effect and earn milestones under the agreement with AstraZeneca; difficulties or delays in developing, testing and manufacturing products to support clinical development plans; the scope and validity of patent protection for product candidates; competition from other companies working with ISS technologies and products; the ability to obtain additional financing to support operations; and other risks detailed in the "Risk Factors" section of our Annual Report on Form 10-K. We undertake no obligation to revise or update information herein to reflect events or circumstances in the future, even if new information becomes available.
About AstraZeneca
AstraZeneca is a major international healthcare business engaged in the research, development, manufacturing and marketing of meaningful prescription medicines and supplier for healthcare services. AstraZeneca is one of the world's leading pharmaceutical companies with healthcare sales of US$ 31.6 billion and is a leader in gastrointestinal, cardiovascular, neuroscience, respiratory, oncology and infectious disease medicines. For more information about AstraZeneca, please visit: www.astrazeneca.com.
DYNAVAX TECHNOLOGIES CORP Financials
EDGAR Online Financials(Thu 9:04am)
finance.yahoo.com/q/is?s=dvax
EDGAR Online Financials(Thu 9:04am)
finance.yahoo.com/q/is?s=dvax
DVAX mentioned in this Video !
Stocks Under $1
www.thestreet.com/_yahoo/video/10474051/...p;cm_ite=NA&s=1
:-)
Stocks Under $1
www.thestreet.com/_yahoo/video/10474051/...p;cm_ite=NA&s=1
:-)
Bald zündet diese Rakete....
Sehr gutes DD posting von "knulp" (ihub)
investorshub.advfn.com/boards/read_msg.aspx?message_id=36716761
Sehr gutes DD posting von "knulp" (ihub)
investorshub.advfn.com/boards/read_msg.aspx?message_id=36716761
Man wird nicht reich, durch das, was man verdient, sondern durch das, was man nicht ausgibt
"
":-))
Man wird nicht reich, durch das, was man verdient, sondern durch das, was man nicht ausgibt"
"was denkst du wenn die (siehe dezember news) verkünden dass sie eine der 4x200millionen Zahlungen für weitere projekte von Glaxo erhalten ????? :-)
lala ??? oder lalalalalala ???
:-)
lol
bbb
lala ??? oder lalalalalala ???
:-)
lol
bbb
stockcharts.com/c-sc/...10!uc15!lp5,5][j20444984,y]&r=3555
(Verkleinert auf 71%) 
Man wird nicht reich, durch das, was man verdient, sondern durch das, was man nicht ausgibt"
"Das ist noch "Schritt" warts mal ab ! ;-)
ýTrab zwischen 2-3 €
ýGalopp 4-XX€ ????
ýTrab zwischen 2-3 €
ýGalopp 4-XX€ ????
DVAX NEWS !
www.businesswire.com/portal/site/home/...05272&newsLang=en
April 27, 2009 06:45 AM Eastern Daylight Time
Dynavax Presents Additional Phase 3 Data for HEPLISAV™ Hepatitis B Vaccine at EASL Medical Conference
BERKELEY, Calif.--(BUSINESS WIRE)--Dynavax Technologies Corporation (Nasdaq:DVAX)
............
www.businesswire.com/portal/site/home/...05272&newsLang=en
April 27, 2009 06:45 AM Eastern Daylight Time
Dynavax Presents Additional Phase 3 Data for HEPLISAV™ Hepatitis B Vaccine at EASL Medical Conference
BERKELEY, Calif.--(BUSINESS WIRE)--Dynavax Technologies Corporation (Nasdaq:DVAX)
............
Dynavax Announces First Quarter 2009 Financial Results
BERKELEY, Calif., Apr 28, 2009 (BUSINESS WIRE) -- Dynavax Technologies Corporation (Nasdaq: DVAX) today reported financial results for the first quarter ended March 31, 2009.
investors.dynavax.com/releasedetail.cfm?ReleaseID=380318
lala...
BERKELEY, Calif., Apr 28, 2009 (BUSINESS WIRE) -- Dynavax Technologies Corporation (Nasdaq: DVAX) today reported financial results for the first quarter ended March 31, 2009.
investors.dynavax.com/releasedetail.cfm?ReleaseID=380318
lala...
April 30, 2009 06:00 AM Eastern Daylight Time
Dynavax Presents Data From Novel Universal Flu Vaccine Candidate
Proprietary Approach for Protection Against Influenza
www.businesswire.com/portal/site/home/...05250&newsLang=en
lala...
Dynavax Presents Data From Novel Universal Flu Vaccine Candidate
Proprietary Approach for Protection Against Influenza
www.businesswire.com/portal/site/home/...05250&newsLang=en
lala...
Posted by: knulp Date: Friday, May 08, 2009 3:51:14 AM
In reply to: _bbb_ who wrote msg# 212538 Post # of 212539
10x DVAX truth moment is due in a month...
files.shareholder.com/downloads/DVAX/...09%20-%20FINAL_4pm.pdf
This study successfully demonstrated that a short, 2 dose
regimen of HEPLISAV is superior to the current 3 dose
regimen of Engerix-B
• HEPLISAV demonstrated earlier protection and greater rate
of seroprotection at all time points in the study
• It is expected that the shorter schedule in association with
early protection will result in increased compliance and
better protection against Hepatitis B infection
• In the subjects evaluated to date, HEPLISAV has a safety
profile similar to Engerix-B
ANCA-Associated Vasculitis
• Two cases of ANCA-associated vasculitis occurred during
subject participation in this clinical trial, one in each treatment
group (1/1,820 vs. 1/608, p=0.4382)
• One subject developed p-ANCA vasculitis (MPA) in the
Engerix-B treatment group (0/1,820 vs. 1/608, p=0.2504)
• One subject developed c-ANCA vasculitis (WG) in the
HEPLISAV treatment group (1/1,820 vs. 0/608, p=1.0000)
• There is no apparent difference in the occurrence of ANCAassociated
vasculitis, MPA or WG, between treatment groups
phast study demonstrates that heplisav (dvax hepatitis b drug) is better than current lead drug, engerix b of glaxo.
if fda will lift clinical hold on heplisav, dvax will follow vnda trend...first for the approval of drug, then the sale of commercial rights to a major pharma...will glaxo buy dvax or heplisav right if it will confirmed that heplisav is better than engerix b?
fda will make its response at any time in the second quarter, june 30 is day after day closer...
dvax will end 2009 with at least 50 millions cash, or 1,26, it's trading below cash. If drug approved, 5/10 $ will be the trading range of dvax for
In reply to: _bbb_ who wrote msg# 212538 Post # of 212539
10x DVAX truth moment is due in a month...
files.shareholder.com/downloads/DVAX/...09%20-%20FINAL_4pm.pdf
This study successfully demonstrated that a short, 2 dose
regimen of HEPLISAV is superior to the current 3 dose
regimen of Engerix-B
• HEPLISAV demonstrated earlier protection and greater rate
of seroprotection at all time points in the study
• It is expected that the shorter schedule in association with
early protection will result in increased compliance and
better protection against Hepatitis B infection
• In the subjects evaluated to date, HEPLISAV has a safety
profile similar to Engerix-B
ANCA-Associated Vasculitis
• Two cases of ANCA-associated vasculitis occurred during
subject participation in this clinical trial, one in each treatment
group (1/1,820 vs. 1/608, p=0.4382)
• One subject developed p-ANCA vasculitis (MPA) in the
Engerix-B treatment group (0/1,820 vs. 1/608, p=0.2504)
• One subject developed c-ANCA vasculitis (WG) in the
HEPLISAV treatment group (1/1,820 vs. 0/608, p=1.0000)
• There is no apparent difference in the occurrence of ANCAassociated
vasculitis, MPA or WG, between treatment groups
phast study demonstrates that heplisav (dvax hepatitis b drug) is better than current lead drug, engerix b of glaxo.
if fda will lift clinical hold on heplisav, dvax will follow vnda trend...first for the approval of drug, then the sale of commercial rights to a major pharma...will glaxo buy dvax or heplisav right if it will confirmed that heplisav is better than engerix b?
fda will make its response at any time in the second quarter, june 30 is day after day closer...
dvax will end 2009 with at least 50 millions cash, or 1,26, it's trading below cash. If drug approved, 5/10 $ will be the trading range of dvax for
Posted by: knulp Date: Saturday, May 09, 2009 6:18:46 AM
In reply to: _bbb_ who wrote msg# 418 Post # of 423
DVAX READ PHAST CONCLUSIONS...FDA WILL SOON REMOVE CLINICAL HOLD AND IF DRUG APPROVED, I SMELL BUYOUT BY GLAXO OR OTHER COMPETITOR, FDA APPROVED VNDA ILOPERIDONE (NO HOPE AND NO ADDITIONAL DATA) WHY DON'T APPROVE HEPLISAV THAT COULD BE BETTER OF ENGERIX B?
LINK HERE
files.shareholder.com/downloads/DVAX/...09%20-%20FINAL_4pm.pdf
In reply to: _bbb_ who wrote msg# 418 Post # of 423
DVAX READ PHAST CONCLUSIONS...FDA WILL SOON REMOVE CLINICAL HOLD AND IF DRUG APPROVED, I SMELL BUYOUT BY GLAXO OR OTHER COMPETITOR, FDA APPROVED VNDA ILOPERIDONE (NO HOPE AND NO ADDITIONAL DATA) WHY DON'T APPROVE HEPLISAV THAT COULD BE BETTER OF ENGERIX B?
LINK HERE
files.shareholder.com/downloads/DVAX/...09%20-%20FINAL_4pm.pdf
www.businesswire.com/portal/site/home/...05224&newsLang=en
May 13, 2009 06:45 AM Eastern Daylight Time
Dynavax Awarded Grant to Support Development of TLR Inhibitors in Skin Diseases
May 13, 2009 06:45 AM Eastern Daylight Time
Dynavax Awarded Grant to Support Development of TLR Inhibitors in Skin Diseases
Dynavax Announces Data Presentations at American Thoracic Society Medical Conference
ih.advfn.com/...50930&article=37769493&symbol=N%5EDVAX
ih.advfn.com/...50930&article=37769493&symbol=N%5EDVAX
"Ultimately, the best results might come from combining the techniques. Dynavax, a California biotechnology company, hopes to begin trials next year of a vaccine designed to spur antibodies against M2 and T cells against nucleoprotein."
www.nytimes.com/2009/05/19/science/...wanted=2&ref=science
www.nytimes.com/2009/05/19/science/...wanted=2&ref=science
May 21, 2009, 1:20 p.m. EST
As flu fears loom, will niche vaccine makers cash in?
H1N1 scare gives stocks a sharp boost, but companies face challenges
www.marketwatch.com/story/...boost-from-flu-scare?siteid=yhoof
As flu fears loom, will niche vaccine makers cash in?
H1N1 scare gives stocks a sharp boost, but companies face challenges
www.marketwatch.com/story/...boost-from-flu-scare?siteid=yhoof
Charts stehen sehr gut...wer jetzt noch nicht dabei ist hats dann bald verpasst....tschüssiii
:-)
:-)
www.finviz.com/chart.ashx?t=DVAX&ta=1&p=d&s=l" style="max-width:560px" />
June 03, 2009 09:00 AM Eastern Daylight Time
Dynavax Presents Additional Phase 3 Data for HEPLISAVTM Hepatitis B Vaccine at DDW Medical Conference
HEPLISAV Demonstrates Rapid, Increased Protection for Adults
Digestive Disease Week
BERKELEY, Calif.--(BUSINESS WIRE)--Dynavax Technologies Corporation (Nasdaq:DVAX) today presented additional Phase 3 clinical data for HEPLISAVTM hepatitis B vaccine in a poster session at the Digestive Disease Week (DDW) medical conference in Chicago. In addition to meeting its primary endpoint in this Phase 3 trial as previously reported, HEPLISAV provided more rapid and increased seroprotection against hepatitis B viral infection and with fewer doses than the licensed vaccine. The data show the differences to be particularly significant in the subset of subjects over 40 years of age who are usually less likely to respond to immunization.
“Vaccination is critical for the prevention of hepatitis B viral infection and its spread, but the lengthy dosing regimen of current vaccines leaves many unprotected,” commented Scott A. Halperin, M.D., Director Clinical Trials Research Center, Dalhousie University, IWK Heath Centre of Halifax, Nova Scotia and Lead Investigator in the Phase 3 trial. “The Phase 3 data demonstrate HEPLISAV’s superior immunogenicity and similar safety profile versus the licensed vaccine, particularly for adults over 40 who are more difficult to protect against this preventable viral infection.”
This Phase 3 trial referred to as PHAST (Phase 3 HeplisAv Short-regimen Trial) evaluated more than 2,400 adults. The seroprotection rate at the primary endpoint was 95% in subjects receiving 2 doses of HEPLISAV at 0 and 1 month, compared to 81% in subjects receiving 3 doses of licensed vaccine Engerix-B® at 0, 1, and 6 months.
In a subanalysis of subjects over 40 years of age, at each time point during the trial there was a statistically significant (p < 0.0001) difference in the seroprotection rate for subjects receiving HEPLISAV or Engerix-B.
Ages 40-55
Dosing Regimen
Seroprotection Rate (1)
Treatment Group
at Month
1 2 3 6 7
HEPLISAV 2 doses (0, 1 month) 18% 84% 92%(2) 97% 97%
Engerix-B 3 doses (0, 1, 6 months) 3% 21% 17% 27% 75%(2)
(1) Seroprotection rate – percentage of subjects with anti-HBsAg antibodies ≥ 10 mlU/mL
(2) Primary endpoint
A copy of the poster is available at investors.dynavax.com/newsevents.cfm. Dynavax’s abstract #587659 is titled “A Phase 3 Safety and Efficacy Study to Compare Immune Responses following Either Two Doses of Hepatitis B Surface Antigen Combined with Immunostimulatory Phosphorothioate Oligonucleotide (HBsAg-ISS) or Three Doses of Conventional Hepatitis B Vaccine.”
As previously reported, safety results from this trial demonstrated the safety profile of HEPLISAV and Engerix-B appeared similar. Subjects were randomized 3 to 1 to receive HEPLISAV or Engerix-B and one case of vasculitis was reported in each of the treatment groups. Following the report of the severe adverse event of Wegener's granulomatosis, an uncommon form of vasculitis, HEPLISAV was placed and remains on clinical hold by the U.S. Food and Drug Administration (FDA). Dynavax is in active discussions with regulatory agencies to resolve the FDA’s clinical hold on HEPLISAV and identify an appropriate path for its further development and approval in the United States, Europe, and the rest of the world.
About HEPLISAV
HEPLISAV is a Phase 3 hepatitis B vaccine aimed at unmet medical needs in the vaccination of adults and end-stage renal disease patients by providing rapid and increased protection with fewer doses. HEPLISAV combines a proprietary immunostimulatory sequence (ISS), which targets Toll-like Receptor 9, with hepatitis B surface antigen (HBsAg).
About Hepatitis B
Hepatitis B is a chronic disease which can lead to cirrhosis of the liver and hepatocellular carcinoma. There is no cure for hepatitis B and disease prevention through effective vaccines is critical to reducing the spread of the disease. Current hepatitis B vaccines for adults usually require 3 doses given over 6 months to provide seroprotection of approximately 30%, 75%, and 90% after the first, second, and third doses respectively. The effectiveness of current vaccines is further compromised because only 30% of people receive all 3 doses.
About Dynavax
Dynavax Technologies Corporation, a clinical-stage biopharmaceutical company, discovers and develops a diversified pipeline of novel Toll-like Receptor (TLR) based product candidates. Based on Dynavax’s proprietary technologies, these products specifically modify the innate immune response to infectious, respiratory, autoimmune, and inflammatory diseases. Dynavax has partnerships with leading pharmaceutical companies such as GlaxoSmithKline, AstraZeneca, and Novartis as well as funding from Symphony Dynamo, Inc. and the National Institutes of Health. For more information visit www.dynavax.com.
About DDW
DDW is the largest international gathering of physicians, researchers and academics in the fields of gastroenterology, hepatology, endoscopy and gastrointestinal surgery. Jointly sponsored by the American Association for the Study of Liver Diseases, the American Gastroenterological Association (AGA) Institute, the American Society for Gastrointestinal Endoscopy and the Society for Surgery of the Alimentary Tract, DDW takes place May 30 – June 4, 2009, at the McCormick Place, Chicago, IL. The meeting showcases approximately 5,000 abstracts and hundreds of lectures on the latest advances in GI research, medicine and technology. For more information, visit www.ddw.org.
Forward Looking Statements
This press release contains “forward-looking statements,” that are subject to a number of risks and uncertainties, including statements related to the nature of communications with regulatory agencies regarding HEPLISAV. Actual results may differ materially from those set forth in this press release due to the risks and uncertainties inherent in our business, including whether the FDA will remove the clinical hold for HEPLISAV, whether HEPLISAV can be further developed, financed or commercialized, or even if further development is permitted, that successful clinical development and regulatory approval can occur in a timely manner or without significant additional studies and difficulties or delays in development, the Company's ability to obtain additional financing to support its operations; and other risks detailed in the "Risk Factors" section of our current periodic reports with the SEC. We undertake no obligation to revise or update information herein to reflect events or circumstances in the future, even if new information becomes available.
Engerix-B® is a registered trademark of GlaxoSmithKline
Contacts
Dynavax Technologies Corporation
Amy Figueroa, 510-665-7211
Investor Relations and Corporate Communications
afigueroa@dynavax.com
Permalink: www.businesswire.com/news/home/20090603005196
Dynavax Presents Additional Phase 3 Data for HEPLISAVTM Hepatitis B Vaccine at DDW Medical Conference
HEPLISAV Demonstrates Rapid, Increased Protection for Adults
Digestive Disease Week
BERKELEY, Calif.--(BUSINESS WIRE)--Dynavax Technologies Corporation (Nasdaq:DVAX) today presented additional Phase 3 clinical data for HEPLISAVTM hepatitis B vaccine in a poster session at the Digestive Disease Week (DDW) medical conference in Chicago. In addition to meeting its primary endpoint in this Phase 3 trial as previously reported, HEPLISAV provided more rapid and increased seroprotection against hepatitis B viral infection and with fewer doses than the licensed vaccine. The data show the differences to be particularly significant in the subset of subjects over 40 years of age who are usually less likely to respond to immunization.
“Vaccination is critical for the prevention of hepatitis B viral infection and its spread, but the lengthy dosing regimen of current vaccines leaves many unprotected,” commented Scott A. Halperin, M.D., Director Clinical Trials Research Center, Dalhousie University, IWK Heath Centre of Halifax, Nova Scotia and Lead Investigator in the Phase 3 trial. “The Phase 3 data demonstrate HEPLISAV’s superior immunogenicity and similar safety profile versus the licensed vaccine, particularly for adults over 40 who are more difficult to protect against this preventable viral infection.”
This Phase 3 trial referred to as PHAST (Phase 3 HeplisAv Short-regimen Trial) evaluated more than 2,400 adults. The seroprotection rate at the primary endpoint was 95% in subjects receiving 2 doses of HEPLISAV at 0 and 1 month, compared to 81% in subjects receiving 3 doses of licensed vaccine Engerix-B® at 0, 1, and 6 months.
In a subanalysis of subjects over 40 years of age, at each time point during the trial there was a statistically significant (p < 0.0001) difference in the seroprotection rate for subjects receiving HEPLISAV or Engerix-B.
Ages 40-55
Dosing Regimen
Seroprotection Rate (1)
Treatment Group
at Month
1 2 3 6 7
HEPLISAV 2 doses (0, 1 month) 18% 84% 92%(2) 97% 97%
Engerix-B 3 doses (0, 1, 6 months) 3% 21% 17% 27% 75%(2)
(1) Seroprotection rate – percentage of subjects with anti-HBsAg antibodies ≥ 10 mlU/mL
(2) Primary endpoint
A copy of the poster is available at investors.dynavax.com/newsevents.cfm. Dynavax’s abstract #587659 is titled “A Phase 3 Safety and Efficacy Study to Compare Immune Responses following Either Two Doses of Hepatitis B Surface Antigen Combined with Immunostimulatory Phosphorothioate Oligonucleotide (HBsAg-ISS) or Three Doses of Conventional Hepatitis B Vaccine.”
As previously reported, safety results from this trial demonstrated the safety profile of HEPLISAV and Engerix-B appeared similar. Subjects were randomized 3 to 1 to receive HEPLISAV or Engerix-B and one case of vasculitis was reported in each of the treatment groups. Following the report of the severe adverse event of Wegener's granulomatosis, an uncommon form of vasculitis, HEPLISAV was placed and remains on clinical hold by the U.S. Food and Drug Administration (FDA). Dynavax is in active discussions with regulatory agencies to resolve the FDA’s clinical hold on HEPLISAV and identify an appropriate path for its further development and approval in the United States, Europe, and the rest of the world.
About HEPLISAV
HEPLISAV is a Phase 3 hepatitis B vaccine aimed at unmet medical needs in the vaccination of adults and end-stage renal disease patients by providing rapid and increased protection with fewer doses. HEPLISAV combines a proprietary immunostimulatory sequence (ISS), which targets Toll-like Receptor 9, with hepatitis B surface antigen (HBsAg).
About Hepatitis B
Hepatitis B is a chronic disease which can lead to cirrhosis of the liver and hepatocellular carcinoma. There is no cure for hepatitis B and disease prevention through effective vaccines is critical to reducing the spread of the disease. Current hepatitis B vaccines for adults usually require 3 doses given over 6 months to provide seroprotection of approximately 30%, 75%, and 90% after the first, second, and third doses respectively. The effectiveness of current vaccines is further compromised because only 30% of people receive all 3 doses.
About Dynavax
Dynavax Technologies Corporation, a clinical-stage biopharmaceutical company, discovers and develops a diversified pipeline of novel Toll-like Receptor (TLR) based product candidates. Based on Dynavax’s proprietary technologies, these products specifically modify the innate immune response to infectious, respiratory, autoimmune, and inflammatory diseases. Dynavax has partnerships with leading pharmaceutical companies such as GlaxoSmithKline, AstraZeneca, and Novartis as well as funding from Symphony Dynamo, Inc. and the National Institutes of Health. For more information visit www.dynavax.com.
About DDW
DDW is the largest international gathering of physicians, researchers and academics in the fields of gastroenterology, hepatology, endoscopy and gastrointestinal surgery. Jointly sponsored by the American Association for the Study of Liver Diseases, the American Gastroenterological Association (AGA) Institute, the American Society for Gastrointestinal Endoscopy and the Society for Surgery of the Alimentary Tract, DDW takes place May 30 – June 4, 2009, at the McCormick Place, Chicago, IL. The meeting showcases approximately 5,000 abstracts and hundreds of lectures on the latest advances in GI research, medicine and technology. For more information, visit www.ddw.org.
Forward Looking Statements
This press release contains “forward-looking statements,” that are subject to a number of risks and uncertainties, including statements related to the nature of communications with regulatory agencies regarding HEPLISAV. Actual results may differ materially from those set forth in this press release due to the risks and uncertainties inherent in our business, including whether the FDA will remove the clinical hold for HEPLISAV, whether HEPLISAV can be further developed, financed or commercialized, or even if further development is permitted, that successful clinical development and regulatory approval can occur in a timely manner or without significant additional studies and difficulties or delays in development, the Company's ability to obtain additional financing to support its operations; and other risks detailed in the "Risk Factors" section of our current periodic reports with the SEC. We undertake no obligation to revise or update information herein to reflect events or circumstances in the future, even if new information becomes available.
Engerix-B® is a registered trademark of GlaxoSmithKline
Contacts
Dynavax Technologies Corporation
Amy Figueroa, 510-665-7211
Investor Relations and Corporate Communications
afigueroa@dynavax.com
Permalink: www.businesswire.com/news/home/20090603005196
Sag mal ,bbb, wenn ich das richtig verstehe ist "Hepislav" auf clinical hold,ja ??!! Das hiesse Hepislav wird nicht weiterentwickelt oder worauf wartet man ...?
MFG
Chali
MFG
Chali
Antwort siehe Bio-Renner "Sammelthread" ;-)
Die arbeiten dran das "hold" wegzubekommen...
Die arbeiten dran das "hold" wegzubekommen...
Lasst uns unsere diskussion zu Dynavax doch einfach in diesem thread weiterführen,anstatt in deinem Sammelthread für biotechaktien! Heute bei börseneröffnung in US werde ich fett zuschlagen und mich mit DVAX eindecken !! Wenn du Lust hast,bbb,kannst du auch mal in meinem thread "Flamel Technologies,die neue amylin"vorbeisschauen,Flamel ist meine dickste posi und vical hatte ich mal vor 10 Jahren,allerdings zu ganz anderen Preisen .....
MFG
Chali
MFG
Chali
Etwas älter,aber immer noch aktuell und lesenswert:
BERKELEY, Kalifornien, October 20 /PRNewswire/ --
Präklinische Studien zeigen: mit konservierten Virusproteinen gepaarte
TLR9 Agonisten bieten 30-fach verdünnte Dosierung von
Standardvackzinkomponenten
Dynavax Technologies Corporation (Nasdaq: DVAX) gab heute bekannt, dass
das Unternehmen auf der am morgigen Freitag, dem 20. Oktober in Wien
(Österreich) stattfindenden "Second International Conference on Influenza
Vaccines for the World" seine jüngsten präklinischen Daten vorstellen wird.
Diese zeigen, dass das Influenza (Grippe-) Vakzin des Unternehmens die
Immunisationskraft von Standard-Grippevakzinen verbessern kann. Dynavax liess
verlauten, dass die Daten aus dem Maus- bzw. Primatenmodell zeigten, dass die
gemeinsame Verabreichung des Grippevakzins von Dynavax mit einem
Standard-Vakzin die Immunreaktion des Standardvakzins stärkt, eine
Verringerung der Dosierung des Standardvakzins erlaubt und stammunabhängige
Extra Protection Layer bietet. Das Vakzin von Dynavax basiert auf der
unternehmenseigenen TLR9 Agonisten-basierten ISS-Technologie (ISS,
Immunostimulatory Sequence). Die Finanzierung der Arbeit wurde zu einem Teil
durch einen Zuschuss von 3,0 Mio. USD des National Institute of Allergy and
Infectious Disease (NIAID), eine Abteilung der National Institutes of Health,
für die Erforschung und Entwicklung eines pandemischen Influenza Vakzins
ermöglicht.
Auswirkungen für die Entwicklung von künftigen Grippevakzinen
"Unsere Ergebnisse bei der Grippe machen uns zuversichtlich, dass wir
bald in der Lage sein werden, den Schritt hin zu einem kommerziellen Produkt
zu machen. In den anderen Infektionskrankheits-Vakzinprogrammen von Dynavax,
sagten die präklinischen Daten genau die später in den klinischen
Humanstudien ermittelten Ergebnisse voraus", meint Gary Van Nest, Ph.D., Vice
President of Preclinical Research bei Dynavax.
Van Nest erläutert: "Standard-Grippevakzine bieten Schutz gegen eine
Virusinfektion, indem sie neutralisierende Antikörper gegen die
Virus-Oberflächenproteine (Hämagglutinin bzw. HA und Neuraminidase bzw. NA)
erzeugen. Sobald es zu einer unzulänglichen Antikörperproduktion oder einer
Nichtübereinstimmung zwischen dem Vakzin und dem zirkulieren Virus kommt,
kann die Wirksamkeit des Standardvakzins drastisch abnehmen. Das Dynavax
Universal Flu Vakzin verbessert nicht nur die Blockierung bzw.
Neutralisierung des Virus sowie die Wirkungen des koadministrierten
Standard-Grippevakzins. Es tötet auch auf eine vom Virenstamm unabhängige
Weise alle vom Virus infizierten Zellen und verhindert so dessen Ausbreitung,
was zu Lungenentzündung und oftmals anderen tödlichen Sekundärkrankheiten
führen kann."
"Unsere aufregenden Ergebnisse," fügt Van Nest hinzu, "werden produziert,
indem unsere TLR9 Agonisten (ISS) an die hochgradig konservierten
Virusproteine, Nucleoprotein (NP) und extrazelluläre Domain-of-Matrix Protein
2 (M2e), gekoppelt werden. NP-ISS induziert starke T-Helfer 1 (Th1) und
zytotoxische T-Zellen-Reaktionen (CTL), die die vom Virus infizierten Zellen
töten. M2e-ISS induziert starke zytotoxische Antikörperreaktionen, was
ebenfalls infizierte Zellen tötet und somit die Krankheitsschwere beschränkt.
Es ist tatsächlich so, dass - auch wenn ein Standard-Grippevakzin nicht mit
dem jahreszeitlichen Virus übereinstimmt - unser universelles Grippevakzin
potenziellen Schutz gegen Viruserkrankungen bietet, wenn es gleichzeitig mit
einem beliebigen Standardgrippevakzin angewendet wird."
Daten aus Wien
In der Präsentation in Wien mit dem Titel "Induction of Broadly
Protective Cellular Immune Responses Using an ISS Conjugate Vaccine"
beschreibt Debbie Higgins, Senior Manager, Preclinical Programs bei Dynavax,
die Arbeit von Dynavax und von deren Mitarbeitern am Influenza Research
Center am Baylor College of Medicine.
Die Studien lassen vermuten, dass durch Anfügen von ISS-gekoppelten
konservierten Antigenen an Standardvakzine es möglich ist, die Wirksamkeit
von beliebigen trivalenten Standard-Influenza-Vakzinen zu erhöhen bzw. die
Dosierung von Standardvakzinen bei gleichzeitiger Wirksamkeitssteigerung zu
verringern. Die Daten zeigen die Verbesserung von funktionalen
Antikörperreaktionen gegen die Vakzinstämme. Im Einzelnen:
Bei Mäusen ergab NP-ISS gemeinsam mit Standardvakzin (Fluzone(R),
sanofi-aventis) verabreicht, signifikant gestiegene
Antikörperreaktionen bei 30- fach weniger Fluzone.
Primate (Paviane), die mit NP-ISS und Standardvakzin immunisiert
wurden, entwickelten bessere Fluzone-specifische Antiköperreaktionen,
gemessen durch Analyse der Hämagglutination Inhibition und der
Viralneutralisation.
Die ISS-Koppelung an ein kurzes M2e-Peptid (M2e-ISS) generierte eine
starke M2e-spezifische Antikörperreaktion.
Im August 2006 präsentierte Dynavax auf der "Novel Vaccines: Bridging
Research, Development and Production" Konferenz in Cambridge, Massachusetts
(USA), Daten, die sowohl die Fähigkeit des Grippevakzins des Unternehmens zur
Verleihung von ´cross-protective´ Zellimmunität gegen grösstenteils
divergente Grippestämme bei Mäusen als auch dessen Potenzial als universelles
Grippevakzin, belegten. Die Daten liessen vermuten, dass das Vakzin das
Potenzial besitzt, jährliche Impfungen überflüssig zu machen und dass die
Bevorratung des Vakzins für den Pandemiefall möglich sein könnte. Es konnte
gezeigt werden, dass das Dynavax Grippevakzin spezifischen Schutz gegen
"Antigendrift" und "Antigenshift" bietet. Mit der NP-ISS-Paarung immunisierte
Mäuse, die anschliessend Drift- und Shift Virusstämmen ausgesetzt wurden,
zeigten statistisch signifikant geringere virale Titer und höhere
Überlebensraten verglichen mit Mäusen, die mit NP alleine oder einem
PBS-Placebo immunisiert waren.
MFG
Chali
BERKELEY, Kalifornien, October 20 /PRNewswire/ --
Präklinische Studien zeigen: mit konservierten Virusproteinen gepaarte
TLR9 Agonisten bieten 30-fach verdünnte Dosierung von
Standardvackzinkomponenten
Dynavax Technologies Corporation (Nasdaq: DVAX) gab heute bekannt, dass
das Unternehmen auf der am morgigen Freitag, dem 20. Oktober in Wien
(Österreich) stattfindenden "Second International Conference on Influenza
Vaccines for the World" seine jüngsten präklinischen Daten vorstellen wird.
Diese zeigen, dass das Influenza (Grippe-) Vakzin des Unternehmens die
Immunisationskraft von Standard-Grippevakzinen verbessern kann. Dynavax liess
verlauten, dass die Daten aus dem Maus- bzw. Primatenmodell zeigten, dass die
gemeinsame Verabreichung des Grippevakzins von Dynavax mit einem
Standard-Vakzin die Immunreaktion des Standardvakzins stärkt, eine
Verringerung der Dosierung des Standardvakzins erlaubt und stammunabhängige
Extra Protection Layer bietet. Das Vakzin von Dynavax basiert auf der
unternehmenseigenen TLR9 Agonisten-basierten ISS-Technologie (ISS,
Immunostimulatory Sequence). Die Finanzierung der Arbeit wurde zu einem Teil
durch einen Zuschuss von 3,0 Mio. USD des National Institute of Allergy and
Infectious Disease (NIAID), eine Abteilung der National Institutes of Health,
für die Erforschung und Entwicklung eines pandemischen Influenza Vakzins
ermöglicht.
Auswirkungen für die Entwicklung von künftigen Grippevakzinen
"Unsere Ergebnisse bei der Grippe machen uns zuversichtlich, dass wir
bald in der Lage sein werden, den Schritt hin zu einem kommerziellen Produkt
zu machen. In den anderen Infektionskrankheits-Vakzinprogrammen von Dynavax,
sagten die präklinischen Daten genau die später in den klinischen
Humanstudien ermittelten Ergebnisse voraus", meint Gary Van Nest, Ph.D., Vice
President of Preclinical Research bei Dynavax.
Van Nest erläutert: "Standard-Grippevakzine bieten Schutz gegen eine
Virusinfektion, indem sie neutralisierende Antikörper gegen die
Virus-Oberflächenproteine (Hämagglutinin bzw. HA und Neuraminidase bzw. NA)
erzeugen. Sobald es zu einer unzulänglichen Antikörperproduktion oder einer
Nichtübereinstimmung zwischen dem Vakzin und dem zirkulieren Virus kommt,
kann die Wirksamkeit des Standardvakzins drastisch abnehmen. Das Dynavax
Universal Flu Vakzin verbessert nicht nur die Blockierung bzw.
Neutralisierung des Virus sowie die Wirkungen des koadministrierten
Standard-Grippevakzins. Es tötet auch auf eine vom Virenstamm unabhängige
Weise alle vom Virus infizierten Zellen und verhindert so dessen Ausbreitung,
was zu Lungenentzündung und oftmals anderen tödlichen Sekundärkrankheiten
führen kann."
"Unsere aufregenden Ergebnisse," fügt Van Nest hinzu, "werden produziert,
indem unsere TLR9 Agonisten (ISS) an die hochgradig konservierten
Virusproteine, Nucleoprotein (NP) und extrazelluläre Domain-of-Matrix Protein
2 (M2e), gekoppelt werden. NP-ISS induziert starke T-Helfer 1 (Th1) und
zytotoxische T-Zellen-Reaktionen (CTL), die die vom Virus infizierten Zellen
töten. M2e-ISS induziert starke zytotoxische Antikörperreaktionen, was
ebenfalls infizierte Zellen tötet und somit die Krankheitsschwere beschränkt.
Es ist tatsächlich so, dass - auch wenn ein Standard-Grippevakzin nicht mit
dem jahreszeitlichen Virus übereinstimmt - unser universelles Grippevakzin
potenziellen Schutz gegen Viruserkrankungen bietet, wenn es gleichzeitig mit
einem beliebigen Standardgrippevakzin angewendet wird."
Daten aus Wien
In der Präsentation in Wien mit dem Titel "Induction of Broadly
Protective Cellular Immune Responses Using an ISS Conjugate Vaccine"
beschreibt Debbie Higgins, Senior Manager, Preclinical Programs bei Dynavax,
die Arbeit von Dynavax und von deren Mitarbeitern am Influenza Research
Center am Baylor College of Medicine.
Die Studien lassen vermuten, dass durch Anfügen von ISS-gekoppelten
konservierten Antigenen an Standardvakzine es möglich ist, die Wirksamkeit
von beliebigen trivalenten Standard-Influenza-Vakzinen zu erhöhen bzw. die
Dosierung von Standardvakzinen bei gleichzeitiger Wirksamkeitssteigerung zu
verringern. Die Daten zeigen die Verbesserung von funktionalen
Antikörperreaktionen gegen die Vakzinstämme. Im Einzelnen:
Bei Mäusen ergab NP-ISS gemeinsam mit Standardvakzin (Fluzone(R),
sanofi-aventis) verabreicht, signifikant gestiegene
Antikörperreaktionen bei 30- fach weniger Fluzone.
Primate (Paviane), die mit NP-ISS und Standardvakzin immunisiert
wurden, entwickelten bessere Fluzone-specifische Antiköperreaktionen,
gemessen durch Analyse der Hämagglutination Inhibition und der
Viralneutralisation.
Die ISS-Koppelung an ein kurzes M2e-Peptid (M2e-ISS) generierte eine
starke M2e-spezifische Antikörperreaktion.
Im August 2006 präsentierte Dynavax auf der "Novel Vaccines: Bridging
Research, Development and Production" Konferenz in Cambridge, Massachusetts
(USA), Daten, die sowohl die Fähigkeit des Grippevakzins des Unternehmens zur
Verleihung von ´cross-protective´ Zellimmunität gegen grösstenteils
divergente Grippestämme bei Mäusen als auch dessen Potenzial als universelles
Grippevakzin, belegten. Die Daten liessen vermuten, dass das Vakzin das
Potenzial besitzt, jährliche Impfungen überflüssig zu machen und dass die
Bevorratung des Vakzins für den Pandemiefall möglich sein könnte. Es konnte
gezeigt werden, dass das Dynavax Grippevakzin spezifischen Schutz gegen
"Antigendrift" und "Antigenshift" bietet. Mit der NP-ISS-Paarung immunisierte
Mäuse, die anschliessend Drift- und Shift Virusstämmen ausgesetzt wurden,
zeigten statistisch signifikant geringere virale Titer und höhere
Überlebensraten verglichen mit Mäusen, die mit NP alleine oder einem
PBS-Placebo immunisiert waren.
MFG
Chali
hadda chalif hier jekauf
isser jetze nimmer so gut drauf
hat die aktie schon verlust
isses krass auch mit drm frust ;)
Von ehrgeiz,statt von Poesie beseelt,
der long sich durch die reime qüält.
Der chalif,schlau,und das kein flachs,
kauft fett ein bei Dynavax.
Ferrari,Porsche ,Jaguar,
welch schöner traum,bald isser wahr'!
Für'n Lifetrust bald wird chalif spenden,
sonst jämmerlich der Long wird enden.
Der gentalong hat keine wahl,
schon bald für ihn wirds eine qual,
Mit Macht und reichtum wollt er blenden,
doch bald wird er beim sozi enden.
Ein Penny noch für dies Papierchen,
das reicht ja nicht mal für ein bierchen
Es hälft ka puda,hälft ka schminke,
Genda dud noch Pleite stinke' .!
Chalif chukle
P.S. Immer cool bleiben ,sipan,mitte 2010
haben wir 2-stellige kurse,wetten ??!!
der long sich durch die reime qüält.
Der chalif,schlau,und das kein flachs,
kauft fett ein bei Dynavax.
Ferrari,Porsche ,Jaguar,
welch schöner traum,bald isser wahr'!
Für'n Lifetrust bald wird chalif spenden,
sonst jämmerlich der Long wird enden.
Der gentalong hat keine wahl,
schon bald für ihn wirds eine qual,
Mit Macht und reichtum wollt er blenden,
doch bald wird er beim sozi enden.
Ein Penny noch für dies Papierchen,
das reicht ja nicht mal für ein bierchen
Es hälft ka puda,hälft ka schminke,
Genda dud noch Pleite stinke' .!
Chalif chukle
P.S. Immer cool bleiben ,sipan,mitte 2010
haben wir 2-stellige kurse,wetten ??!!
...das du mit dabei bist ,sipan,da erkennt man gleich den echten Biotechfreak!
Wenn du News zu Heplisav brauchst,dann ruf doch einfach mal bei der Rhein biotech
GMBH (gehört komplett Dynavax) in Düsseldorf an,zur not kriegste die
Telefonnummer von mir per BM ... sag Bescheid .!
MFG
Chali
Wenn du News zu Heplisav brauchst,dann ruf doch einfach mal bei der Rhein biotech
GMBH (gehört komplett Dynavax) in Düsseldorf an,zur not kriegste die
Telefonnummer von mir per BM ... sag Bescheid .!
MFG
Chali
momentan im ausland...
sonst könnte man da vorbei fahren :-) Betriebsbesichtigung...
ich denk mal das wird schon mit der Aktie....
sonst könnte man da vorbei fahren :-) Betriebsbesichtigung...
ich denk mal das wird schon mit der Aktie....
"Dynavax Technologies Corp. said Friday its partnership with Merck & Co. to develop Heplisav, a hepatitis B vaccine candidate that has been stalled in the U.S. by safety issues, is over.
Dynavax retains all the rights to develop and bring Heplisav to market, and it said it will continue to evaluate its options in bringing Heplisav to markets outside the U.S. According to Dynavax, foreign markets offer 70 percent of the potential market for the drug.
In premarket trading, Dynavax shares fell 29 cents, or 18.8 percent, to $1.25.
In March, the Food and Drug Administration halted all studies of Heplisav after one trial patient was diagnosed with Wegener's granulomatosis, a rare disease that causes blood vessels to inflame. In October, the FDA told Dynavax and Merck that the risks of testing Heplisav on healthy patients outweigh the benefits, although it is willing to consider approving the drug in patients with kidney failure.
There are no holds on Heplisav testing outside the U.S., Dynavax said. The company said it expects to get more insight into regulatory paths for the drug in the first quarter of 2009.
Dynavax and Merck entered their partnership in November 2007. Merck paid Dynavax $31.5 million upfront, and Dynavax could have received up to $105 million in payments as the drug, already in late stage testing, advanced through development and sales milestones. Dynavax was also set to receive double-digit royalties on worldwide sales."
Dynavax retains all the rights to develop and bring Heplisav to market, and it said it will continue to evaluate its options in bringing Heplisav to markets outside the U.S. According to Dynavax, foreign markets offer 70 percent of the potential market for the drug.
In premarket trading, Dynavax shares fell 29 cents, or 18.8 percent, to $1.25.
In March, the Food and Drug Administration halted all studies of Heplisav after one trial patient was diagnosed with Wegener's granulomatosis, a rare disease that causes blood vessels to inflame. In October, the FDA told Dynavax and Merck that the risks of testing Heplisav on healthy patients outweigh the benefits, although it is willing to consider approving the drug in patients with kidney failure.
There are no holds on Heplisav testing outside the U.S., Dynavax said. The company said it expects to get more insight into regulatory paths for the drug in the first quarter of 2009.
Dynavax and Merck entered their partnership in November 2007. Merck paid Dynavax $31.5 million upfront, and Dynavax could have received up to $105 million in payments as the drug, already in late stage testing, advanced through development and sales milestones. Dynavax was also set to receive double-digit royalties on worldwide sales."
du bist sehr überzeugt von dieser aktie. Kannst du bitte mal die wichtigsten facts darstellen,
warum ein investment hier lohnt!
Vielen Dank!
warum ein investment hier lohnt!
Vielen Dank!
Im moment bin ich nicht investiert,da ich ein Investment gefunden zu haben glaube,von dem ich noch mehr überzeugt bin,aber bei Kursen um 1 $/Share werde ich mit sicherheit zu Dynavax zurückkehren,hier geht es erstmal um Heplisav,die von allen erwartete News der FDA zur aufhebung des clinical hold,sollte die News kommen,wird der kurs an dem Tag explodieren ... !
MFG
Chali
MFG
Chali
bin wieder "on board",die einstiegskurse waren einfach zu verlockend für mich, ......... lets hope for something to come here ......
MFG
Chali
MFG
Chali
Kaum hat der Chalif investiert,
der Kurs auch mächtig schon krepiert.
:-)
der Kurs auch mächtig schon krepiert.
:-)
Scheinst ja mächtig neidisch zu sein auf die Performance von Dynavax,wenn ich mir deine mickrige genta so anschaue,wie wäre es denn,wenn du hier bei uns mit einsteigst ... ??!!?? Du würdest es nicht bereuen ....
MFG
Chali
P.s. Dem winnie tuts bald machtig Leid,
es kam nur vom Performance-Neid.
Bald isser wech von Genta,mal kein flachs,
und kauft fett ein bei Dynavax ......
MFG
Chali
P.s. Dem winnie tuts bald machtig Leid,
es kam nur vom Performance-Neid.
Bald isser wech von Genta,mal kein flachs,
und kauft fett ein bei Dynavax ......
www.marketwire.com/press-release/...s-NASDAQ-DVAX-1087838.html
Dec 09, 2009 01:00 ETDynavax's European Manufacturing Facility Approved for Commercial Production of HEPLISAV Hepatitis B Surface Antigen
Dec 09, 2009 01:00 ETDynavax's European Manufacturing Facility Approved for Commercial Production of HEPLISAV Hepatitis B Surface Antigen
realtime.bigcharts.com/...tyle=2003&size=1&mocktick=1" style="max-width:560px" />
:-)
DVAX/ Wednesday, December 9, 2009, 9:42am PST
Dynavax gets OK at German factory for hepatitis vaccine work
Dynavax Technologies Corp. got approval from European regulators to make part of its hepatitis B vaccine at a German factory.
The license from the European Union lets Berkeley-based Dynavax (NASDAQ: DVAX) make hepatitis B surface antigen for commercial use at the factory in Düsseldorf, in the west central part of Germany.
Rhein Biotech GmbH, a German unit of Dynavax, used the factory to make the same antigen — part of the company’s Heplisav vaccine — for clinical trials starting in 2006. Since then the factory has been upgraded.
Heplisav has finished a Phase III clinical trial. The company hopes to market the vaccine to people who don’t respond well to current vaccines — people with chronic kidney disease, for example.
Zbigniew Janowicz is CEO of Rhein Biotech and Dino Dina, M.D., is CEO of Dynavax.
sanfrancisco.bizjournals.com/sanfrancisco/...32.html?ana=yfcpc
Dynavax gets OK at German factory for hepatitis vaccine work
Dynavax Technologies Corp. got approval from European regulators to make part of its hepatitis B vaccine at a German factory.
The license from the European Union lets Berkeley-based Dynavax (NASDAQ: DVAX) make hepatitis B surface antigen for commercial use at the factory in Düsseldorf, in the west central part of Germany.
Rhein Biotech GmbH, a German unit of Dynavax, used the factory to make the same antigen — part of the company’s Heplisav vaccine — for clinical trials starting in 2006. Since then the factory has been upgraded.
Heplisav has finished a Phase III clinical trial. The company hopes to market the vaccine to people who don’t respond well to current vaccines — people with chronic kidney disease, for example.
Zbigniew Janowicz is CEO of Rhein Biotech and Dino Dina, M.D., is CEO of Dynavax.
sanfrancisco.bizjournals.com/sanfrancisco/...32.html?ana=yfcpc
finviz.com/chart.ashx?t=DVAX&ty=c&ta=1&p=d&s=l" style="max-width:560px" />
UPDATE 1-Dynavax hep B vaccine shows promise in kidney disease
Wed Apr 14, 2010 5:17pm EDTStocks
Dynavax Technologies Corporation
* Heplisav protects kidney disease patients in Ph II study
* Shares up 35 pct in after-hours trade
April 14 (Reuters) - Dynavax Technologies Corp (DVAX.O) said a mid-stage study of its experimental hepatitis B vaccine showed that it protected patients with chronic kidney disease from the virus, when measured at week 24.
The vaccine, Heplisav, protected all dialysis and pre-dialysis patients with chronic kidney disease, the company said in a statement.
The study compared two Heplisav regimens -- a single-dose vaccine and a double-dose vaccine -- and enrolled 41 subjects between 40 and 70 years with progressive loss of renal function.
Chronic kidney disease patients undergoing dialysis are at high risk of hepatitis B infection, the company said.
In March 2008, U.S. Food and Drug Administration had put a clinical hold on the vaccine. It is currently in late-stage trials, after the FDA removed the hold last September.
Shares of the company were up 35 percent to $1.95 in trading after the bell. They closed at $1.45 Wednesday on Nasdaq. (Reporting by Esha Dey in Bangalore; Editing by Unnikrishnan Nair)
MFG
Chali
Wed Apr 14, 2010 5:17pm EDTStocks
Dynavax Technologies Corporation
* Heplisav protects kidney disease patients in Ph II study
* Shares up 35 pct in after-hours trade
April 14 (Reuters) - Dynavax Technologies Corp (DVAX.O) said a mid-stage study of its experimental hepatitis B vaccine showed that it protected patients with chronic kidney disease from the virus, when measured at week 24.
The vaccine, Heplisav, protected all dialysis and pre-dialysis patients with chronic kidney disease, the company said in a statement.
The study compared two Heplisav regimens -- a single-dose vaccine and a double-dose vaccine -- and enrolled 41 subjects between 40 and 70 years with progressive loss of renal function.
Chronic kidney disease patients undergoing dialysis are at high risk of hepatitis B infection, the company said.
In March 2008, U.S. Food and Drug Administration had put a clinical hold on the vaccine. It is currently in late-stage trials, after the FDA removed the hold last September.
Shares of the company were up 35 percent to $1.95 in trading after the bell. They closed at $1.45 Wednesday on Nasdaq. (Reporting by Esha Dey in Bangalore; Editing by Unnikrishnan Nair)
MFG
Chali
Meine Dax-Zertis sind heute auch fantastisch gelaufen.
Du lagst mit Dynavax heute auch gut, weiter so :-) .....
Gruß
Du lagst mit Dynavax heute auch gut, weiter so :-) .....
Gruß
"An der Börse sind 2 mal 2 niemals 4, sondern 5 minus 1.
Man muß nur die Nerven haben, das minus 1 auszuhalten."
Man muß nur die Nerven haben, das minus 1 auszuhalten."
ist es. Ein Megawert mit 3 Mega Downdraws. Das ist schon mal die erste Hoffnung. Die Wahrscheinlichkeit auf einen Vierten sit eher gering. Wäre da nicht die Unsicherheit bezüglich der anstehenden Klagen wegen irreführenden Infos bezüglich der Entwicklungsstand von Hepadingsbums. Hier könnte man zu größeren zahlungen verdonnert werden. Man kennt ja die amerikanischen Gerichte. Und das ist die zweite Hoffnung. Die US Gerichtsbarkeit :-) Der nächste Schwachpunkt steckt im Management. Hier rollten Köpfe. Die nächste Hoffnung. Man hat einen ausgedienten Pfizer-Veteran an Bord geholt. Möglicherweise hat der noch alte Beziehungen, die bei der Fortführung der Einführungsbemühungen der Hepadings vielleicht doch noch zum Erfolg führen können oder eine Übernahme einleiten. Beides würde der Aktie neuen Schub verleihen.
Egal ob ARIA, CNDO oder DVAX. Ich denke jetzt sollte man in diesen Werten drin sein...
Gestern mehrere Widerstände nach oben angetestet und durchbrochen. Für die kommende Woche sollte es weiter bergauf gehen. Meine Meinung: 2,50$ als Gap Close.
Wünsche allen Investierten viel Glück. biotech
Wünsche allen Investierten viel Glück. biotech
wäre für alle das Beste. Es gab auch einen Artikel, der dies behandelt (nur wo?).
DVAX hat mit AstraZeneca und GlaxoSmithKline zwei starke Partner an der Seite. Es würde daher nicht verwundern, wenn diese beiden ein Angebot unterbreiten.
Optimal wäre ein drittes U, welches die beiden aussticht.
biotech
DVAX hat mit AstraZeneca und GlaxoSmithKline zwei starke Partner an der Seite. Es würde daher nicht verwundern, wenn diese beiden ein Angebot unterbreiten.
Optimal wäre ein drittes U, welches die beiden aussticht.
biotech
Hör dir mal bitte den webcast an. Partnerships sind von essentieller Bedeutung und sie sind weiter auf der Suche nach geeigneten Kooperationen. Dies sagt er mehrmals, das erste (?) mal jedoch bei 16:35.
Ab 17:00 EMA 120-Questions;
ab 20:22 dann wieder Heplisav - das interessante Zeug.
-> 21:19 "final draft protocol is in with the fda and they are due to have that back to us before the end of this month"
(entschuldigt die möglichen Fehler, bin kein Muttersprachler);
ab 22:00 partnerships with AZ and GSK moving forward;
LG, biotech
Ab 17:00 EMA 120-Questions;
ab 20:22 dann wieder Heplisav - das interessante Zeug.
-> 21:19 "final draft protocol is in with the fda and they are due to have that back to us before the end of this month"
(entschuldigt die möglichen Fehler, bin kein Muttersprachler);
ab 22:00 partnerships with AZ and GSK moving forward;
LG, biotech
Also sind in diesem Monat noch News fällig, passend zur technischen Aufwärtsbewegung.
seekingalpha.com/article/...n-healthcare-for-2014?source=yahoo
biotech
biotech
Von heute:
seekingalpha.com/article/...s-for-under-3-a-share?source=yahoo
biotech
seekingalpha.com/article/...s-for-under-3-a-share?source=yahoo
biotech
Merck may eye vaccine makers
Merck is no stranger to making huge deals to acquire intriguing pipelines, and it is currently bleeding money from lost patent protections. So I fully expect them to be aggressive in going after ways to stop the bleeding.
The good news is that there are some very compelling buyout possibilities in the vaccine space for Merck this year. One of Merck's core businesses is vaccines, and as such, I think there are three companies that could fit the bill.
1. Dynavax (DVAX) - Heplisav is an experimental Hep B vaccine that could be approved in Europe this year and in the U.S. in 2016. Merck already has a recombinant Hep B vaccine, so they are no strangers to this market opportunity.
2. Inovio Pharmaceuticals (INO) - VGX-3100 is a cervical dysplasia vaccine candidate set to report mid-stage results by mid-2014. Merck is the maker of the infamous Gardasil, so there would be an interesting synergy created with a merger.
3. Novavax (NVAX) - developing state-of-the-art influenza vaccines that would compete directly against Merck's Afluria.
Merck is no stranger to making huge deals to acquire intriguing pipelines, and it is currently bleeding money from lost patent protections. So I fully expect them to be aggressive in going after ways to stop the bleeding.
The good news is that there are some very compelling buyout possibilities in the vaccine space for Merck this year. One of Merck's core businesses is vaccines, and as such, I think there are three companies that could fit the bill.
1. Dynavax (DVAX) - Heplisav is an experimental Hep B vaccine that could be approved in Europe this year and in the U.S. in 2016. Merck already has a recombinant Hep B vaccine, so they are no strangers to this market opportunity.
2. Inovio Pharmaceuticals (INO) - VGX-3100 is a cervical dysplasia vaccine candidate set to report mid-stage results by mid-2014. Merck is the maker of the infamous Gardasil, so there would be an interesting synergy created with a merger.
3. Novavax (NVAX) - developing state-of-the-art influenza vaccines that would compete directly against Merck's Afluria.
Dynavax Technologies (DVAX) is a clinical-stage biopharmaceutical company that discovers and develops novel products to prevent and treat infectious and inflammatory diseases. Its main product is Heplisav which is meant to treat Hepatitis B and is in Phase III trials.
DVAX has risen more than 70% since its lows in November but is still selling for less than half its levels earlier in 2013. Not surprisingly for a biotech concern, three insiders bought over $300K worth of new shares at the end of October almost exactly at the stock's recent bottom.
Analysts are high on this ~$2 a share stock. The four analysts that cover the stock have a $4.50 median price target on DVAX. Price targets range from $3 to $6 a share. Dynavax has partnerships with GlaxoSmithKline (GSK) and AstraZeneca (AZN) for the development of its candidates, and will receive milestone payments.
The company has five candidates in its pipeline, where three are currently running clinical trials. Dynavax has over $75mm of net cash on the balance sheet and has a market capitalization just a tad over $500mm.
DVAX has risen more than 70% since its lows in November but is still selling for less than half its levels earlier in 2013. Not surprisingly for a biotech concern, three insiders bought over $300K worth of new shares at the end of October almost exactly at the stock's recent bottom.
Analysts are high on this ~$2 a share stock. The four analysts that cover the stock have a $4.50 median price target on DVAX. Price targets range from $3 to $6 a share. Dynavax has partnerships with GlaxoSmithKline (GSK) and AstraZeneca (AZN) for the development of its candidates, and will receive milestone payments.
The company has five candidates in its pipeline, where three are currently running clinical trials. Dynavax has over $75mm of net cash on the balance sheet and has a market capitalization just a tad over $500mm.
Es gab laut SA-Artikel 3 Insider Buys und siehe da, Yahoo Finance listet sie nicht unter Insider Transactions, sondern Insider Roster:
1.
KISNER DANIEL L
Director§Purchase
Oct 30, 2013 15,000
2.
ORONSKY ARNOLD L
Director§Purchase
Oct 30, 2013 375,055
3.
PHILLIPS PEGGY V
Director§Purchase
Oct 30, 2013 138,023
Alles in allem 528078 Aktien zum Preis von etwa 1.27 USD (30.10.2013). Macht dann etwa 670659,06 USD! Das nenne ich einen dicken batzen zum Schnäppchenpreis.
biotech
1.
KISNER DANIEL L
Director§Purchase
Oct 30, 2013 15,000
2.
ORONSKY ARNOLD L
Director§Purchase
Oct 30, 2013 375,055
3.
PHILLIPS PEGGY V
Director§Purchase
Oct 30, 2013 138,023
Alles in allem 528078 Aktien zum Preis von etwa 1.27 USD (30.10.2013). Macht dann etwa 670659,06 USD! Das nenne ich einen dicken batzen zum Schnäppchenpreis.
biotech
finance.yahoo.com/q/ao?s=DVAX+Analyst+Opinion
Auch unter Analyst Rating Network nachzulesen (gute Quelle):
www.analystratings.net/stocks/NASDAQ/DVAX/
Mir würde am Anfang ne glatte drei reichen, aber würd bei 4,5,6 auch nicht meckern...
Auch unter Analyst Rating Network nachzulesen (gute Quelle):
www.analystratings.net/stocks/NASDAQ/DVAX/
Mir würde am Anfang ne glatte drei reichen, aber würd bei 4,5,6 auch nicht meckern...
www.nasdaq.com/symbol/dvax/recommendations
www.nasdaq.com/symbol/dvax/analyst-research
biotech
www.nasdaq.com/symbol/dvax/analyst-research
biotech
Warten wir eben auf die morgige Eröffnung in den USA. Ich erwarte was schönes... (Nur meine Meinung)
LG, biotech
LG, biotech
zwar zugegebenermaßen sehr langsam aber ab morgen wird's in den usa wohl weiter abgehen. ask ist dort 2.19
nicht nur der kleine sprung vom freitag lässt aufhorchen, sondern auch das volumen
Die Aktie ist doch zumindest etwas ins Bewusstsein gerückt.
Auf YaFi's Market Pulse schreibt ein User, daß er am Freitag ein "stock halted" auf dem Nasdaq Bookviewer (?) gesehen hat. Aber noch mehr bewegen das gesteigerte Aktienvolumen und die positiven Chartanalysen die Gemüter. Es könnte wirklich was im Busch sein. Hoffen wir das Beste. biotech
Auf YaFi's Market Pulse schreibt ein User, daß er am Freitag ein "stock halted" auf dem Nasdaq Bookviewer (?) gesehen hat. Aber noch mehr bewegen das gesteigerte Aktienvolumen und die positiven Chartanalysen die Gemüter. Es könnte wirklich was im Busch sein. Hoffen wir das Beste. biotech
Viele meiner Favoriten im Keller. Dynavax habe ich verkauft und bin komplett bei NWBO rein. Keine Amarin (puh, schwitz), keine Ariad, keine Galena, keine Mannkind, keine Merrimack, keine Chelsea und (leider) keine Cytrix. Ich denke, für eine lange Position sind die DAVX immer noch super zu haben. Es hätte ja ich etwas kommen können über das Wochenende. Die Zeichen standen ja gut. Ansonsten immer noch bei MNKD ein Auge drauf. Und nicht zu vergessen: Novavax. Steht im DVAX Artikel von Seeking Alpha mit drin. Diese Woche eventuell noch eine Meldung von PharmAthene, da wird eine FDA-Antwort zum Trial-Stop erwartet. Außerdem für diese/nächste Woche: IntelGenx PDUFA-Date. biotech
www.nasdaq.com/press-release/...llion-milestone-20140303-01204
www.wallstreet-online.de/nachricht/...f-collaboration-with-gsk
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