BioMarin Receives Milestone Payments from Pfizer for Talzenna® (Talazoparib) for Metastatic Breast Cancer Patients with an Inherited BRCA Mutation

SAN RAFAEL, Calif., Oct. 16, 2018 /PRNewswire/ -- BioMarin Pharmaceutical Inc. (Nasdaq:BMRN) today announced that the Company earned $15 million in milestone payments from Pfizer Inc. These milestone payments were triggered by the U.S. Food and Drug Administration (FDA) approval of Talzenna® (talazoparib) for the treatment of adult patients with deleterious or suspected deleterious germline BRCA (gBRCA)-mutated, HER2-negative locally advanced (LA) or metastatic breast cancer (MBC). Patients are selected for therapy based on an FDA-approved companion diagnostic. These milestone payments are part of an agreement made with Medivation, Inc. when Medivation purchased talazoparib.  Medivation was acquired by Pfizer.

In August 2015, Medivation, Inc. and BioMarin Pharmaceutical Inc. entered into an asset purchase agreement under which Medivation acquired all worldwide rights to Talzenna (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 was entitled to receive up to an additional $160 million (in aggregate) upon the achievement of regulatory and sales-based milestones, of which $35 million has been earned to date, as well as mid-single digit royalties for Talzenna (talazoparib). In June of this year, the European Medicines Agency accepted the Marketing Application for talazoparib for this patient population and is currently reviewing the application.

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.

SOURCE BioMarin Pharmaceutical Inc.