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Dynavax Technologies Corporation (DVAX)
Discussion of the Complete Response Letter from the FDA regarding BLA for HEPLISAV
February 25, 2013 9:00 am ET
Jennifer Lew - Principal Accounting Officer and Vice President of Finance
Dino Dina - Chief Executive Officer and Executive Director
J. Tyler Martin - President, Chief Medical Officer and Director
Philip Nadeau - Cowen and Company, LLC, Research Division
Thomas Wei - Jefferies & Company, Inc., Research Division
Geoffrey C. Meacham - JP Morgan Chase & Co, Research Division
Liisa A. Bayko - JMP Securities LLC, Research Division
Y. Katherine Xu - William Blair & Company L.L.C., Research Division
Megan McCloskey - MLV & Co LLC, Research Division
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Good morning. I'm Jennifer Lew, Vice President of Finance, and I'd like to thank you for joining us today to discuss the complete response letter to Dynavax received from the FDA regarding its BLA for HEPLISAV.
Participating with me on the call today are Dr. Dino Dina, CEO; Doctor Tyler Martin, President and Chief Medical Officer; and Michael Ostrach, Vice President and Chief Business Officer.
Before discussing today's topics, we need to advise that we will use forward-looking statements that are subject to a number of risks and uncertainties. Actual results may differ materially due to the risks and uncertainties inherent in our business. Examples of these forward-looking statements include, but are not limited to, the timing of the company's meeting with the FDA; the FDA's feedback and related company plans to respond to the FDA Complete Response Letter for the BLA for HEPLISAV; whether or not additional clinical or nonclinical studies will be required to obtain FDA approval; the resources plan to be devoted to the BLA for HEPLISAV; sufficiency of data to be submitted and data that may be generated and submitted to FDA; timing and potential outcome of data-generating activities; regulatory submissions and decisions by the FDA on the BLA for HEPLISAV; and other difficulties or delays in clinical development, manufacturing, regulatory approval, market acceptance, and commercialization of HEPLISAV. These forward-looking statements are based on the information available to us today. We may not actually achieve the plan, carry out our intention or meet the expectations disclosed in our forward-looking statements, and you should not place undue reliance on our forward-looking statement. Actual results or events could differ materially. We assume no obligation to update these statements as circumstances change, except as required by law. For additional information, please see the forward-looking statement section in today's press release and the Risk Factors section of our quarterly report on Form 10-Q. I'd now like to turn the call over to Dino Dina, our CEO.
Thank you, Jennifer. As we disclosed in the press release we issued this morning, we received a complete response letter from the FDA regarding our BLA for HEPLISAV. In the complete response letter, the FDA specified that the BLA we submitted, seeking an indication for adults aged 18- to 70-year-old, cannot be approved without additional safety data, and the FDA outlined their reasons for this response.
Our comments on this call will be based on our current understanding of these issues and the steps that may be necessary to address them. Please keep in mind that we've only just received the letter, and we have not been yet in the right discussion with the FDA for clarification.
In the complete response letter, the FDA expressed 2 primary concerns. First, sufficient data has not -- safety data has not been established to support the proposed indication of HEPLISAV in adults aged 18 to 70 years old. As a result, the agency indicated that further clinical evaluation of safety in this broad age group will be necessary prior to licensure and -- excuse me, I'm sorry. This broad age group will be necessary prior to licensure and the design and size of an additional safety study will be required -- will require discussion with the FDA.
Second, the need for additional data from our process validation program and pertaining to a -- from our manufacturing controls and facilities. Let me briefly touch on each of these matters.
The FDA has told us that additional safety information will be required for us to reach approval for a broad indication. In part, we believe this is driven by their expressed ongoing concern that novel adjuvants may cause rare autoimmune events, of course, in addition to the vote at VRBPAC meeting.
However, we believe the door remains open for a more focused label for HEPLISAV with the safety data that we currently have. Specifically, FDA has expressed their willingness and interest in continuing the discussion about what information is needed to support a more focused use of HEPLISAV, stating that the safety data required to support licensure will depend on the indication of HEPLISAV and a favorable risk-benefit determination associated with that specific indication.
We will request a meeting with the FDA to discuss the CRL, and we believe the meeting can take place within the next 6 weeks. Our attack is to gain a better understanding of the specific issues and implement plans to address them. We intend to seek a path forward towards approval in a more focused population, which may be achievable without an additional clinical study. And these may include, once we gain clarity from FDA, pursuit of the chronic kidney disease population, adults over age of 40, and other groups that who have not responded well to currently available HBV vaccines, where HEPLISAV have been shown to provide significant benefit.