Biovest International's ($BVTI) stock has risen by 15% on two pieces of news about its personalized cancer vaccine for the treatment of follicular non-Hodgkin lymphoma, BiovaxID. The company will seek marketing approval in the EU for the vaccine, based on patients' own cancer cells, and will keep Ferghana Partners on board as strategic transaction adviser to evaluate and implement financings and partnering opportunities.
Biovest has already met with EU-member national regulatory agencies to discuss the vaccine's clinical data in pre-filing clinical advisory meetings. The European Medicines Agency (EMA) centralized procedure means that the company can seek approval with all EU member countries simultaneously. According to the company, there are around 23,000 patients in the EU with follicular lymphoma, which is equivalent to the potential market in the U.S.
Biovest's EU regulatory advisor, Adriaan Fruijtier, stated: "We are pleased with the guidance provided in our pre-filing regulatory advisory meetings with the EU-member national medicines regulatory agencies we met with. I believe this feedback will facilitate the approval process."
BiovaxID has orphan drug designation in the EU for mantle cell lymphoma and follicular lymphoma, and the EMA could make a decision on approval within 12 months. In April 2012, Biovest announced plans for marketing submission in Canada for BiovaxID--the next step will be to meet with the U.S. FDA to review the vaccine's clinical data and discuss the company's approach in what could be a very significant market. The company has come a long way since its brush with bankruptcy in 2008.
- read the press release about EU submission
- see the press release about Ferghana Partners