Mitsubishi Tanabe Pharma (MTPC) is to acquire NeuroDerm for $39 per share in cash, in a deal that values the Israeli pharma firm at $1.1 billion. MTPC said the acquisition will fit its medium-term strategy for U.S. growth, through which it plans to achieve U.S. sales of ¥80 billion (about $721 million) by FY2020. The Japanese drugs giant previously stated that it has also earmarked more than ¥200.0 billion (about $1.8 billion) for investment, including M&As, “to build a business foundation in the U.S.”
The $39 per share deal for NeuroDerm is a premium of about 17% over the price at close of trading on Friday, and a 79% premium on NeuroDerm’s stock price on June 9, 2017. The NeuroDerm board has unanimously approved the deal, which is expected to close in the final quarter of 2017, subject to shareholder approval and customary regulatory conditions. On completion, NeuroDerm will be a wholly owned subsidiary of MTPC.
“We believe that this transaction will yield important benefits for NeuroDerm’s shareholders and the Parkinson’s disease patients that urgently need new therapies,” stated Oded S. Lieberman, Ph.D., CEO of NeuroDerm. “MTPC has demonstrated development and commercialization expertise in the field of neurology, and we are confident that the combination of their resources and the robust data supporting ND0612, our Phase III Parkinson’s disease product candidate, will help make this important new therapy available as broadly and rapidly as possible. The transaction also provides our shareholders with a significant return on their investment in NeuroDerm, reflecting the value that we have created with our pipeline and technologies.”
NeuroDerm claims to be the first company to have developed a liquid formulation of levodopa/carbidopa (LD/CD). The firm is progressing a pipeline of candidates that can be administered subcutaneously via continuous delivery belt- or patch-pump systems, for treating patients who no longer respond to oral levodopa therapy.
Lead LD/CD candidate ND0612 is undergoing Phase III trials in the U.S. and Europe and is projected to launch in 2019. Two subcutaneously administered ND0612 products are in development. ND0612L is expected to treat moderately severe Parkinson’s disease. ND0612H is in development for treating severe-stage Parkinson’s disease, as what the firm hopes will be a more effective alternative to existing treatment such as surgery, deep brain stimulation, or LD/CD intestinal gel.
In previous Phase I and II studies, Parkinson’s disease patients who received continuous subcutaneous ND0612L achieved therapeutic steady-state plasma levodopa levels and demonstrated reduced fluctuations in plasma levodopa concentrations, reductions in “off” time, improved sleep, better quality of life, and global clinical improvements, but without increases in dyskinesia. ND0612H has successfully completed a Phase IIa dose-finding trial that achieved high average plasma levodopa concentrations, which NeuroDerm says indicate that the treatment may offer a viable alternative to surgical procedures for advanced Parkinson’s disease.
NeuroDerm is separately developing ND0701 as a next-generation alternative to current continuous apomorphine therapy. ND0701 is administered via patch pump and is in development for treating Parkinson’s disease patients who don’t respond well to LD/CD.
NeuroDerm’s ND0801 program is a patented reformulation of approved drugs, which is being developed as a nonaddictive nicotine-based combination therapy administered via a transdermal patch, for treating cognitive disorders associated with central nervous system disorders, including attention deficit disorder/attention deficit hyperactivity disorder (ADD/ADHD), Alzheimer’s disease, Parkinson’s disease, and schizophrenia. A Phase IIa, open-label dose escalation study is ongoing in Israel.
MTPC’s “Medium-Term Management Plan 16–20: Open Up the Future” includes building a solid foundation for growth in the U.S., based on in-house sales. The first step will be the U.S. launch next month of Radicava™ (edaravone), a treatment for amyotrophic lateral sclerosis (ALS) therapy that won FDA approval in May. The free-radical scavenger was first approved in Japan in 2001 as a treatment for the acute stage of cerebral infarction and was cleared by the country’s regulator for the ALS indication in June 2015.
MTPC also aims to develop additional products for the U.S. market, both through in-house R&D and through drug acquisitions and collaborations with academia, venture companies, and the established industry.