On June 21, 2019 BioMarin Pharmaceutical Inc. (Nasdaq:BMRN) reported that the Company earned a $15 million milestone payment from Pfizer, Inc (Press release, BioMarin, JUN 21, 2019, View Source [SID1234537213]). 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.
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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 million has been earned to date, as well as mid-single digit royalties for talazoparib.