Medivation will acquire all worldwide rights to the Phase III breast cancer treatment talazoparib (formerly BMN 673) from BioMarin Pharmaceutical for up to $570 million-plus, the companies said today.
Talazoparib is an oral poly ADP ribose polymerase (PARP) inhibitor now under study in the Phase III EMBRACA trial in patients with germline BRCA mutated breast cancer. EMBRACA is a pivotal study comparing talazoparib to chemotherapy in the progression-free survival of patients with germline BRCA mutated locally advanced and/or metastatic breast cancer.
Talazoparib is also being studied in the Phase II ABRAZO trial, intended to evaluate overall response rates in patients with germline BRCA mutated breast cancer, and in multiple investigator-sponsored trials across multiple tumor types.
Under the deal, Medivation will oversee all talazoparib research, development, regulatory and commercialization activities for all indications worldwide.
“Acquiring all worldwide rights to talazoparib provides Medivation with a transformational opportunity to diversify and expand our proprietary portfolio and global oncology franchise,” Medivation president and CEO David Hung, M.D., said in a statement. “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.”
Medivation co-markets the androgen receptor inhibitor Xtandi (enzalutamide) for metastatic castration-resistant prostate cancer in collaboration with Astellas Pharma. The companies are also developing Xtandi for additional stages of prostate cancer as well as breast cancer.
“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,” stated Hank Fuchs, M.D., BioMarin’s CMO.
BioMarin’s marketed drugs include Aldurazyme® (laronidase) for Mucopolysaccharidosis I (MPS I), developed through a 50/50 joint venture with Genzyme; Naglazyme® (galsulfase) for MPS VI; Kuvan® (sapropterin) for phenylketonuria (PKU), developed in partnership with Merck Serono; the enzyme replacement therapy Vimizim® (elosulfase) for Mucopolysaccharidosis type IVA (MPS IVA; Morquio A syndrome); and Firdapse® (amifampridine), approved in Europe for Lambert-Eaton Myasthenic Syndrome (LEMS) in adults.
Furthest along in BioMarin’s pipeline is Duchenne muscular dystrophy (DMD) candidate Drisapersen, an exon skipping oligonucleotide, for which a marketing application has been submitted to FDA and the European Medicines Agency for treating DMD patients with mutations in the dystrophin gene that are amenable to treatment with exon 51 skipping.
On Wednesday, the FDA granted its rare pediatric disease designation for Drisapersen, which BioMarin acquired when it bought Prosensa Holding for up to $840 million, in a deal designed to expand its rare-disease pipeline and completed in January.
Medivation agreed to pay BioMarin $410 million upfront, up to an additional $160 million in payments tied to achieving regulatory and sales-based milestones, and mid-single digit royalties.
Medivation agreed to take on all financial obligations associated with talazoparib’s development and commercialization from BioMarin at the closing of the transaction, the companies said.
The deal is expected to close later this year, subject to expiration or termination of the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act.