BERKELEY, CA--(Marketwire - July 10, 2012) - Dynavax Technologies Corporation (NASDAQ: DVAX) today announced the appointment of David Happel to the position of Vice President of Global Sales and Marketing. Mr. Happel has more than 25 years of experience in the biotech and pharmaceutical industry, including senior level leadership roles in global marketing, sales, product management and commercial operations. Mr. Happel will direct the execution of Dynavax's commercialization strategy, market development and sales and distribution. In addition, Mr. Happel will oversee the company's commercial organization including Vice President, Brant Biehn, a 20-year veteran in the adult vaccine industry, who will focus on developing the commercial opportunity in Europe and the rest of world as well as continuing to help prepare for the U.S. launch of HEPLISAV™.
"Now that the BLA for HEPLISAV is filed and our February 2013 PDUFA date has been assigned, we are excited to have Dave join the Dynavax team," said President and Chief Medical Officer, Tyler Martin, M.D. "His extensive experience launching new products in a biotech environment and his proven track record leading sales and marketing organizations will be critical as we work to bring HEPLISAV to the market."
Said Mr. Happel, "I look forward to leading the team to commercialize HEPLISAV, an important product candidate with a significant market opportunity. In addition, the MAA submission planned for the third quarter of 2012 demonstrates our commitment to develop the markets beyond the U.S. and explore potential strategic partnerships to launch HEPLISAV in Europe and the rest of world."
Mr. Happel joins Dynavax from Dr. Reddy's, where he focused on building a proprietary products business for North America. Prior to Dr. Reddy's, Mr. Happel served as the Executive Vice President and Chief Commercial Officer at Aerovance. Previously at Chiron Corporation, he held leadership positions as Vice President and Global Commercial Director in the pulmonary business unit of the biopharmaceuticals division overseeing the commercialization of TOBI®. Mr. Happel was also with InterMune, Inc. as Senior Director, Sales and Marketing where he built the commercial organization from the ground up and directed all aspects of a start-up biotech company for the commercial development of Actimmune®. Earlier in his career he held positions with Parke-Davis/Pfizer (Warner-Lambert). Mr. Happel received his B.A. in Chemistry from Indiana University and an M.B.A. in Marketing from Indiana State University.
HEPLISAV is an investigational adult hepatitis B vaccine for which a U.S. BLA has been accepted for review by the FDA and a European Marketing Authorization Application (MAA) is expected to be submitted in the third quarter of 2012. In Phase 3 trials, HEPLISAV demonstrated higher and earlier protection with fewer doses than currently licensed vaccines. Dynavax has worldwide commercial rights to HEPLISAV. HEPLISAV combines hepatitis B surface antigen with a proprietary Toll-like Receptor 9 agonist to enhance the immune response.
Dynavax Technologies Corporation, a clinical-stage biopharmaceutical company, discovers and develops novel products to prevent and treat infectious and inflammatory diseases. The Company's lead product candidate is HEPLISAV, a Phase 3 investigational adult hepatitis B vaccine designed to provide higher and earlier protection with fewer doses than currently licensed vaccines. For more information visit www.dynavax.com.
This press release contains "forward-looking statements," including those relating to the HEPLISAV MAA submission, that are subject to a number of risks and uncertainties. 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 successful clinical and regulatory development and review and approval of HEPLISAV and our process for its manufacture can occur in a timely manner or without significant additional studies or difficulties or delays; whether our studies can support registration for commercialization of HEPLISAV; 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, including whether the BLA will be approved and the timely filing of the MAA; our ability to obtain additional financing to support the development and commercialization of HEPLISAV and our other operations; our ability to successfully transition to a commercial operation and execute on our commercial strategy; possible claims against us, including enjoining sales of HEPLISAV, based on the patent rights of others; 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. Information on Dynavax's website at www.dynavax.com is not incorporated by reference in our current periodic reports with the SEC.