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In the half-billion range for BioMarin PARP inhibitor
SAN FRANCISCO and SAN RAFAEL, Calif.—Medivation Inc. announced Aug. 24 that it had entered into an asset purchase agreement with BioMarin Pharmaceutical Inc. under which Medivation will acquire all worldwide rights to talazoparib, which is an 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. While the deal means a pipeline boost for Medivation, it seems to be for BioMarin another step toward focusing on rare and ultra-rare diseases.
The deal sets a transaction price of $410 million upfront, plus as much as $160 million in milestones and mid-single digit royalties. Under the agreement, Medivation will be responsible for all research, development, regulatory and commercialization activities for all indications on a global basis with regard to talazoparib, formerly referred to as BMN 673.
“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 Dr. David Hung, president and CEO 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.”
The closing of the transaction currently waits upon expiration or termination of the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act, but the deal is anticipated to close in this calendar year.
“We believe that Medivation is an outstanding company to drive the future development of talazoparib and ensure it reaches its full therapeutic potential,” said Dr. Hank Fuchs, 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.”
Analyst chatter online hasn’t been all that heavy with regard to the deal, though John Carroll at FierceBiotech.com noted Medivation has “enjoyed considerable success with its prostate cancer pill Xtandi” (despite some strong competition from Johnson & Johnson’s Zytiga), adding that “Now Medivation has a shot at a near-term add-on to the portfolio—but faces a small gang of competitors.”
Carroll also noted that the transaction price “is likely to raise a few eyebrows in the cancer field. Late-stage cancer assets in particular can often snag a bigger set of milestones than this these days, with a number of big players competing for programs.”
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.