BioMarin Earns Milestone Payments from Pfizer for TALZENNA® (talazoparib) for Metastatic Breast Cancer Patients with an Inherited BRCA Mutation

European Commission Approval Triggers $15 Million Payment

BioMarin Entitled to Earn Mid-Single Digit Royalties on Future Sales

News provided by

BioMarin Pharmaceutical Inc.

Jun 21, 2019, 11:30 ET

SAN RAFAEL, Calif., June 21, 2019 /PRNewswire/ -- 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 million has been earned to date, as well as mid-single digit royalties for talazoparib.

About BioMarin

BioMarin is a global biotechnology company that develops and commercializes innovative therapies for people with serious and life-threatening rare disorders. The company's portfolio consists of seven commercialized products and multiple clinical and pre-clinical product candidates.

For additional information, please visit www.BMRN.com. Information on BioMarin's website is not incorporated by reference into this press release

BioMarin® is a registered trademark of BioMarin Pharmaceutical Inc.

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BioMarin Pharmaceutical Inc.

BioMarin Pharmaceutical Inc.

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SOURCE BioMarin Pharmaceutical Inc.

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