Dynavax Technologies Corporation, a clinical-stage biopharmaceutical company, discovers and develops novel products to prevent and treat infectious and inflammatory diseases, has announced that following the recent submission of the Biologics Licence Application (BLA) to the US Food and Drug Administration (FDA), the company intends to begin developing a commercial operation capable of independently launching Heplisav in the US. The company believes that being able to bring Heplisav to the market successfully will ultimately help maximize long-term value for its shareholders.
With the goal of laying the foundation for long-term success, Dynavax plans to strengthen its senior team with the addition of experienced commercial leadership. Subsequent to a recommendation from Dino Dina, the company's chief executive officer, the company's board of directors has agreed to initiate a process that they anticipate will include his succession. Dr Dina plans to continue in his role as CEO through this process and will support the transition to his eventual successor. He will also continue as a member of the company's Board thereafter.
Dr Dina joined Dynavax in May 1997 and has led the transformation of the Company from its early days through the research and development phase. Dr Dina, said, “I believe now is the right time to prepare Dynavax to effectively capitalize on the significant market opportunity we have ahead of us when we are able to bring the benefits of Heplisav to the public. I am committed to working with our Board to plan for the success of Dynavax.”
“Dino's leadership and vision have been critical in making Dynavax what it is today, a diversified company with an important product candidate in Heplisav and a maturing pipeline. We fully endorse the strategic direction for Dynavax that Dino has set and appreciate Dino's commitment to a smooth and seamless transition process,” said Arnold Oronsky, PhD, chairman of the board. “We are confident that Dino and the leadership team will remain focused on Dynavax's success and building value for shareholders in the years ahead.”
Heplisav is an investigational adult hepatitis B vaccine for which a US BLA has been submitted to the FDA and a European Marketing Authorization Application (MAA) is expected to be submitted in the third quarter of 2012. Heplisav may not be marketed in the US unless and until a BLA is approved and may not be marketed in Europe unless and until a MAA is approved. In phase III trials, Heplisav demonstrated higher and earlier protection with fewer doses than currently licensed vaccines. Dynavax has worldwide commercial rights to Heplisav. It combines hepatitis B surface antigen with a proprietary Toll-like Receptor 9 agonist to enhance the immune response.