Biovest International (BVTI), a majority-owned subsidiary of Accentia Biopharmaceuticals, Inc. (ABPI), announced on Tuesday that the company will file with the Canadian health authorities for the approval of BiovaxID for the treatment of follicular non-Hodgkin’s lymphoma, an incurable cancer of the immune system.
The filing in Canada is part of an international strategy for seeking marketing approvals, which includes the planned filing with the US FDA later this year, and also follows a formal pre-filing advisory meeting with Health Canada's Biologics and Genetic Therapies Directorate (BGTD).
According to comments made in a Tuesday press release, discussions with the BGTD regarding the BiovaxID submission for approval after presenting long term data from already-completed clinical trials were encouraging enough to convince Biovest to move forward with the marketing request.
"At the meeting, the BGTD supported the filing of an NDS with Health Canada seeking marketing approval for BiovaxID, thus validating more than 15-years of committed, diligent work conducted by Biovest and the [U.S. National Cancer Institute] NCI," noted Carlos F. Santos, Ph.D., Biovest’s Senior Vice President, Product Development & Regulatory Affairs.
Biovest’s President & CEO, Samuel S. Duffey, added, “Based on the feedback from Health Canada, we have confidence in our ongoing worldwide regulatory strategy to seek marketing approvals in multiple countries, supported by a compelling body of evidence demonstrating the safety and efficacy of BiovaxID.”
It has been a couple of years since BiovaxID came out of Phase III trials with results that were deemed positive at the time, but while many questioned whether the initial results bore the strength to carry to treatment to approval, the encouraging follow-up and long term data review looks to be the basis of the renewed push to see BiovaxID gain the regulatory green light.
Volume flowed into both Biovest and Accentia following the news on Tuesday. BVTI was down ten percent following the news while Accential remained relatively unchanged. Using recent trading patterns as a guide, shares of both Biovest and Accentia were entering into the lower ends of their respective trading ranges before the news hit.
With the ASCO conference also on the horizon, cancer immunotherapy stocks could start gaining more headlines over the coming months.
Disclosure: May purchase shares of BVTI and/or ABPI within 72-hours.
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