About a month after launching Heplisav-B in the U.S., Dynavax is putting big money behind the hepatitis B vaccine, just as it secured backing from a CDC expert panel. In an agreement with investment firm CRG LP, Dynavax could receive up to $175 million in a loan to support the vaccine’s commercialization.
The loan is divided into two parts, with $100 million made immediately available to Dynavax. The rest, $75 million, can be claimed in increments of $25 million before the end of next June.
Dynavax plans to use the loan and the $192 million in cash left at the end of 2017 to support the launch of a Heplisav-B sales team next week and the clinical trials of SD-101, its lead immuno-oncology program, said company CFO Michael Ostrach. During an interview with FiercePharma at this year’s J.P. Morgan Healthcare Conference, Dynavax CEO Eddie Gray said the sales team will consist of about 60 people initially.
Dynavax nabbed the hard-fought FDA approval for Heplisav-B in November 2017 after two failed attempts, and now it has received unanimous recommendation from experts on a CDC’s Advisory Committee on Immunization Practices (ACIP) panel Wednesday. ACIP’s recommendation to add a vaccine to its list is crucial because it means easier and wider coverage from payers.
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Even prior to the ACIP presentation, Dynavax expressed confidence that it has an upper hand against GlaxoSmithKline’s established Engerix-B, even though Heplisav-B’s $115-per-dose wholesale price is much higher than the Glaxo shot’s $22.40 tag. Dynavax’s vaccine only requires two doses one month apart, and compared with three doses over a six-month period required by Engerix-B, it could mean better completion rate.
ACIP's vote in favor of Heplisav-B reinforces the company's belief that the “two-dose vaccine with demonstrated higher rates of protection versus Engerix-B, and a safety profile similar to three-dose vaccines, will become the new standard of care for adults,” said Dynavax CEO Eddie Gray in a statement.
Other than the Heplisav-B marketing in the U.S., Dynavax will also use the loan to advance its immuno-oncology programs.
A phase 2 trial combining its TLR9 agonist, called SD-101, with Merck’s Keytruda in patients with metastatic melanoma and those with head and neck squamous cell cancer have yielded data and have been submitted to upcoming medical conferences, the company said in a release. The phase 3 trial of the therapy and additional phase 2 studies are expected to start later this year, CFO Ostrach added.
Editor's Note: This story has been updated to reflect that CDC's ACIP has voted in favor of including Heplisav-B on its list of recommended products.