Agreements

Date: 2018-10-16

Type of information: Milestone

Compound: talazoparib (BMN 673)

Company: Biomarin Pharmaceutical (USA - CA) Medivation (USA - CA), now Pfizer (USA - NY)

Therapeutic area: Cancer - Oncology

Type agreement: product acquisition

Action mechanism:

enzyme inhibitor/poly-ADP-Ribose polymerase inhibitor. Talazoparib is a orally available poly ADP ribosse polymerase (PARP) inhibitor, a class of molecules that has shown clinical activity against cancers involving defects in DNA repair, under investigation for the treatment of certain cancers. Talazoparib is currently in the Phase 3 EMBRACA trial in patients with germline BRCA mutated breast cancer (NCT01945775). The pivotal study is a two-arm study randomizing patients with germline BRCA mutated locally advanced and/or metastatic breast cancer 2:1 to talazoparib or the protocol-specified physicians' choice of chemotherapy. Talazoparib is also being studied in a single arm Phase 2 ABRAZO trial evaluating overall response rates in patients with germline BRCA mutated breast cancer, and in multiple investigator-sponsored trials across multiple tumor types (NCT02034916).

Disease: metastatic breast cancer.

Details:

• On August 24, 2015, Medivation and BioMarin Pharmaceutical announced that they have entered into an asset purchase agreement under which Medivation will acquire all worldwide rights to talazoparib (formerly referred to as BMN 673), a highly-potent, orally-available poly ADP ribose polymerase (PARP) inhibitor currently in a Phase 3 study for the treatment of patients with deleterious germline BRCA 1 or BRCA 2 mutations and locally advanced and/or metastatic breast cancer. Under the agreement, Medivation will be responsible for all research, development, regulatory and commercialization activities for all indications on a global basis. The closing of the transaction is conditioned on the expiration or termination of the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act. The transaction is anticipated to close in 2015.

Financial terms:

Under the terms of the agreement, Medivation will pay BioMarin $410 million upfront, up to an additional $160 million upon the achievement of regulatory and sales-based milestones and mid-single digit royalties for talazoparib. At the closing of the transaction, Medivation will assume all financial obligations associated with the development and commercialization of talazoparib.

Latest news:

• On October 16, 2018, BioMarin Pharmaceutical announced that the company earned $15 million in milestone payments from Pfizer. These milestone payments were triggered by the 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.
• On June 7, 2018, BioMarin Pharmaceutical announced that the company received $20 million in milestone payments from Pfizer. These milestone payments were triggered by the FDA acceptance of Pfizer's New Drug Application (NDA) submission for talazoparib and by the European Medicines Agency (EMA) acceptance of Pfizer's submission of a Marketing Authorization Application (MAA) for talazoparib. These milestone payments are part of an agreement made with Medivation when the company purchased talazoparib.