BioMarin Pharmaceutical Inc. (Nasdaq:BMRN) today announced that the Company earned a $15 million milestone payment from Pfizer, Inc. This milestone payment was triggered by the European Commission (EC) approval of TALZENNA® (talazoparib) as monotherapy for the treatment of adult patients with germline breast cancer susceptibility gene (gBRCA) 1/2-mutations, who have human epidermal growth factor receptor 2-negative (HER2-) locally advanced (LA) or metastatic breast cancer (MBC). Patients should have been previously treated with an anthracycline and/or a taxane in the (neo)adjuvant, locally advanced or metastatic setting unless patients were not suitable for these treatments. Patients with hormone receptor-positive (HR+) breast cancer should have been treated with a prior endocrine-based therapy, or be considered unsuitable for endocrine-based therapy. This milestone payment is part of an agreement made with Medivation, Inc. when Medivation purchased talazoparib. Medivation was acquired by Pfizer in September 2016.
In August 2015, Medivation, Inc. and BioMarin Pharmaceutical Inc. entered into an asset purchase agreement under which Medivation acquired all worldwide rights to talazoparib, a once-daily, oral poly (ADP-ribose) polymerase (PARP) inhibitor. Under the agreement, Medivation, acquired by Pfizer, is responsible for all research, development, regulatory and commercialization activities for all indications on a global basis.
Under the terms of the agreement, Medivation paid BioMarin $410 million upfront, and BioMarin is entitled to receive up to an additional $160 million (in aggregate) upon the achievement of regulatory and sales-based milestones, of which $50 millionhas been earned to date, as well as mid-single digit royalties for talazoparib.
