Dynavax 17.12.2008 zu 0.6€ gekauft
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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
- 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 http://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
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Meine English-Kenntnisse sind leider nicht mehr die Besten, kann mal wer dien vorigen Text kurz zusammen fassen?
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Bei 500% +++++war ein retrace von XX % drin...morgen bzw..die nächtren monate gehts hier ab ohne ende IMO !!!!
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
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Source: Dynavax Technologies Corporation
http://ih.advfn.com/...cb=1235996408&article=36463285&symbol=N%5EDVAX
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 : 03/11/2009 @ 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.
EDGAR Online Financials(Thu 9:04am)
http://finance.yahoo.com/q/is?s=dvax
Stocks Under $1
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Sehr gutes DD posting von "knulp" (ihub)
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bbb
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Genau...und vor allem mit viel LALA !!! :-)
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