November 14, 2016
By Alex Keown, BioSpace.com Breaking News Staff
BERKELEY, Calif. – Shares of Dynavax Technologies Corporation are down nearly 70 percent this morning after the U.S. Food and Drug Administration (FDA) rejected the company’s bid for approval of Heplisav-B, its hepatitis B vaccine for adults. This continues the struggle for Dynavax to gain approval of the troubled vaccine, which has already been rejected once.
The FDA sent the company a Complete Response Letter saying the regulatory agency is seeking additional information before it can move forward in the approval process, Dynavax said in a statement this morning. The FDA is seeking clarification “regarding specific adverse events of special interest (AESIs), a numerical imbalance in a small number of cardiac events in a single study (HBV-23), new analyses of the integrated safety data base across different time periods, and post-marketing commitments,” Dynavax said. The FDA did not request additional trials, nor did it suggest there were any safety concerns. But, the FDA’s letter said it needed more time to review the data and those clarifications must be made before the FDA will clear Heplisav-B.
But, clarifying those questions is not something Dynavax will likely be able to do on its own. Eddie Gray, chief executive officer of Dynavax, said the necessary time and resources needed to answer the FDA’s questions and gain approval is something the company may not have. In a statement this morning, Gray said Dynavax will have to consider taking on a partner, either another pharmaceutical company or a financial partner, to advance Heplisav-B. Although it seems the company will need assistance to reach the finish line, Gray said the FDA’s CRL is consistent with the company’s position that Heplisav-B is something that can gain regulatory approval.
“We will maintain our efforts on the oncology programs, including our lead cancer immunotherapy candidate, SD-101, for which we recently announced encouraging early clinical data in metastatic melanoma,” Gray said in a statement.
Heplisav-B is an investigational adult hepatitis B vaccine that combines hepatitis B surface antigen with a proprietary Toll-like receptor 9 agonist to enhance the immune response. The medicine is administered twice per month, according to Dynavax. Dynavax’s Phase III data showed Heplisav-B demonstrated higher and earlier protection with fewer doses than a GlaxoSmithKline’s Engerix-B.
Heplisav-B was originally up for review by the FDA in September, but that timeline had been pushed back as the FDA wanted more time to review the Biologics License Application. That’s on top of the FDA rejecting Heplisav-B three years ago over safety concerns.
Dynavax expects a Class 2 designation for a resubmission of the BLA, which would result in a target review period of six months, the company said.
Shares of Dynavax hit a morning low of $3.20, plunging from Friday’s close of $11.60.
