Danish biotechnology firm Bavarian Nordic (OMX: BAVA, OTC: BVNRY) has gotten a big piece of the ongoing biotech deal frenzy. Bristol-Myers Squibb (NYSE: BMY) has signed an exclusive deal for Prostvac worth up to 975 million USD. An upfront fee of 60 million USD is already coming their way. The cancer immunotherapy and infectious disease vaccine maker already has one approved drug and several others in early clinical development. Its stock market price is up by 50% following the news.
Prostvac cancer immunotherapy candidate is currently in pivotal phase 3 trials under an SPA protocol from the FDA for asymptomatic or minimally symptomatic metastatic castration-resistant prostate cancer (mCRPC). Target enrolment was reached last December and a total of 1298 patients are on the trial. The three arm-study has a stand-alone, combination treatment arm with adjuvant dose of GM-CSF (Granulocyte-Macrophage Colony Stimulating Factor, used as an immunostimulator) and Placebo control group.
Bristol-Myers Squibb has an option to exercise the deal once phase 3 results are available. Upside fof 50 million to 230 million plus on top of the 80 million exercise milestone hinges on median OS data exceeding results from phase 2 study [in combination phase 2 study with GM-CSF the overall survival for the treatment arm was 8.5 months longer than the in the control group (25.1 vs 16.6 months]. Regulatory milestone are a maximum of 110 million and sales milestones of a maximum of 495 million plus double-digit royalties could come on top of all that. Here is the summarized agreement:
60 million upfront
80 million after phase 3 fs BMS exercises option
230 million max based on phase 3 data
110 million max in regulatory milestones
495 million max plus royalties from sales
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For a maximum total of 975 million plus royalties
BRISTOL-MYERS SQUIBB is going to further research combination with its monoclonal antibody Yervoy (Ipilimumab), that is already on the market in melanoma and is in phase 3 for mCRPC. About a week ago Bavarian reported promising Phase 1 trial results for Prostvac- Ipilimumab combination. An investigator sponsored trial combining the drugs has already been in the works. Bavarian's US subsidiary is called BN ImmunoTherapeutics
Target enrolment was reached last December and a total of 1298 patients are on the trial
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