On August 24, 2015 Medivation, Inc. (Nasdaq:MDVN) and BioMarin Pharmaceutical Inc. (Nasdaq:BMRN) reported 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 (Press release, BioMarin, AUG 24, 2015, View Source [SID:1234507320]). Schedule your 30 min Free 1stOncology Demo! Under the agreement, Medivation will be responsible for all research, development, regulatory and commercialization activities for all indications on a global basis.
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"Acquiring all worldwide rights to talazoparib provides Medivation with a transformational opportunity to diversify and expand our proprietary portfolio and global oncology franchise. PARP inhibitors are an exciting class of oncology therapeutics that have been associated with promising activity across multiple tumor types, including breast and prostate cancer. These latter two disease indications are areas in which Medivation has proven expertise and development capabilities and in the case of prostate cancer, an established and successful commercial presence," said David Hung, M.D., President and Chief Executive Officer of Medivation. "Talazoparib’s potential to act alone or augment the effects of a wide array of tumor DNA-damaging oncology therapies and its high potency and level of activity in various cancers make talazoparib a great strategic fit for Medivation’s oncology portfolio, building on existing strengths as well as potentially allowing Medivation to expand into new oncology indications."
"We believe that Medivation is an outstanding company to drive the future development of talazoparib and ensure it reaches its full therapeutic potential," said Hank Fuchs, M.D., Chief Medical Officer at BioMarin. "Medivation’s expertise and track record in oncology clinical development and commercialization has been well demonstrated by the Company’s success to date. Placing talazoparib in their capable hands allows us to optimize our portfolio and focus our resources on established areas of expertise – developing novel products to treat rare and ultra-rare genetic diseases."
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.
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.
About Talazoparib
Talazoparib is a highly-potent, orally available 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. 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. Patients may have received no more than two prior chemotherapy regimens for metastatic disease. The primary objective of the study is to compare progression-free survival of patients treated with monotherapy talazoparib relative to those treated with protocol-specified physicians’ choice single-agent chemotherapy. Radiographic progression will be determined by blinded independent central radiology review. 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.