Neurocrine Biosciences is paying Portuguese firm BIAL $30 million up front for exclusive rights to develop the latter’s EU-approved Parkinson’s disease drug Ongentys® (opicapone) in North America. Neurocrine says that when technology transfer has been completed it anticipates meeting with FDA to discuss a potential NDA.
Under terms of the deal, Neurocrine will take over development and commercialization of opicapone in the U.S. and Canada. BIAL could receive an additional $115 million from Neurocrine in development, regulator, and commercial milestones, plus a percentage of net sales, in exchange for the manufacture and supply of opicapone.
“Securing the commercial rights to opicapone in the United States and Canada is another important step in expanding our movement disorders franchise,” said Kevin C. Gorman, Ph.D., CEO of Neurocrine Biosciences. “Opicapone is a significant late-stage asset with outstanding clinical data and a long period of exclusivity.”
Opicapone is a once-daily, peripherally acting catechol-O-methyltransferase (COMT) inhibitor, developed as adjunctive therapy to levodopa. Ongentys was cleared by the European Commission in June 2016 for use in adult Parkinson’s disease patients who have end-of-dose motor fluctuations that cannot be stabilized using levodopa/DOPA decarboxylase inhibitor combination therapy. Approval in Europe was based on data from more than 28 clinical studies, including the pivotal BIPARK-I and BIPARK-II trials, which together enrolled about 1000 patients. The two studies confirmed that once-daily opicapone therapy led to statistically significant decreases in off-time periods for Parkinson’s patients. The Phase III results also showed that opicapone therapy improved motor fluctuations in levodopa-treated patients regardless of concomitant dopamine agonist or monoamine oxidase type B inhibitor therapy.
The deal with Neurocrine Biosciences comes less than a fortnight after BIAL reported that it was selling its allergic immunotherapy business, BIAL Aristegui, to Germany’s Roxall. The Spanish-origin BIAL Aristegui operation, which BIAL bought in 1998, represented 7% of the firm’s global turnover in 2016. BIAL said selling off the business will allow it to focus on its key therapeutic areas of central nervous and cardiovascular systems and reinforce its international expansion, particularly in Europe. BIAL also said it will retain its pharma business unit in Spain, which has a range of neurology, internal medicine, cardiology, and women's health products.
Neurocrine is exploiting its R&D platform to develop treatments for neurological and endocrine diseases and disorders. The company’s late-stage clinical programs include elagolix, a gonadotropin-releasing hormone antagonist for that is partnered with AbbVie, and Ingrezza™ (valbenazine), a vesicular monoamine transporter 2 (VMAT2) inhibitor for the treatment of movement disorders. Ingrezza™ is currently undergoing FDA priority review for the treatment of tardive dyskinesia, with a planned Prescription Drug User Fee Act (PDUFA) target date of April 11, 2017.