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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

SAN RAFAEL, Calif., June 21, 2019 /PRNewswire/ -- BioMarin Pharmaceutical Inc. (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.

BioMarin Pharmaceutical logo (PRNewsfoto/BioMarin Pharmaceutical Inc.)

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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Traci McCarty

Debra Charlesworth

BioMarin Pharmaceutical Inc.

BioMarin Pharmaceutical Inc.

(415) 455-7558

(415) 455-7451

 

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