Sunovion Pharmaceuticals has agreed to acquire Cynapsus Therapeutics for approximately $624 million, the companies said, in a deal that expands the buyer’s central nervous system drug portfolio.
Through the deal, Sunovion would acquire Cynapsus’ Phase III Parkinson’s disease (PD) candidate APL-130277. This sublingual therapy is designed to be a fast-acting, easy-to-use, on-demand treatment option for managing “off” episodes associated with the disease.
The deal, announced yesterday, came just 2 days after APL-130277 won the FDA’s Fast Track Designation. At the time, Cynapsus said its Phase III clinical program is nearing completion, with the company planning to submit an NDA to the FDA in the first half of 2017.
Last year, Cynapsus launched the first pivotal trial for APL-130277, called CTH-300, for which data is expected in mid-to-late fourth quarter. The trial aims to evaluate the efficacy, safety, and tolerability of APL-130277 versus placebo in patients with PD over a 12-week period. The primary endpoint is the mean change in the Movement Disorder Society’s Unified Parkinson’s Disease Rating Scale Part III (MDS-UPDRS III) score at 30 minutes after dosing.
Cynapsus is also carrying out a second Phase III trial, CTH-301, focused on assessing the safety and tolerability of APL-130277 in patients with PD over a 6-month period. An estimated 226 patients will be enrolled—up to 126 who were enrolled in CTH-300, plus an additional 100 new patients. Topline data is expected in the first half of 2017.
During the fourth quarter, the company plans to launch a European Registration Study, CTH-302, comparing APL-130277 with subcutaneous apomorphine in up to 80 patients randomized in the 4-week open label crossover study. Endpoints will include the duration of “on” episodes, use of patient diaries, as well as preference, ease-of-use, and tolerability of APL-130277.
Following what the company called a full consideration of alternatives aimed at optimizing shareholder value, Cynapsus’ board unanimously recommended that shareholders and warrantholders vote for the deal at a special meeting expected to be held on or about October 13.
The deal is set to close in the fourth quarter—Sunovion’s third fiscal quarter—subject to securityholder, court, and regulatory approvals and satisfaction of other customary closing conditions.
At $40.50 a share, the deal price reflects a 120% premium over Cynapsus’ closing price yesterday of $18.36 a share on NASDAQ.
“The acquisition of Cynapsus is well-aligned with Sunovion’s focus on the innovative application of science and medicine to help people with serious medical conditions and complements our robust product pipeline,” Sunovion Chairman and CEO Nobuhiko Tamura said in a statement.
Added Cynapsus President and CEO Anthony J. Giovinazzo: “With its leadership in therapies for central nervous system disorders and commercial experience specific to neurology, we believe Sunovion is best suited to advance APL-130277 in the United States and other key markets.”