Cynapsus Therapeutics and MonoSol Rx announced that they have signed a global licensing agreement for select intellectual property, including existing and future patents and patent applications, covering all oral films containing apomorphine for the treatment of “off” episodes in patients with Parkinson’s disease (PD).
According to the Michael J. Fox Foundation for Parkinson’s Research, off episodes are motor fluctuations resulting from a diminishing effectiveness of levodopa, the gold standard for PD treatment, over its long-term use. The drug’s effects wear off before another dose can be taken.
APL-130277 is a “turning on” PD medication, developed by Cynapsus, that contains apomorphine in a quick-acting and easy-to-use sublingual thin film. The investigational medicine and its use in PD is covered in Cynapsus’ patent portfolio, and in issued and pending patent applications in the U.S. and elsewhere. MonoSol Rx also has a series of issued and pending patent applications, as well as expertise in film technology, further strengthening APL-130277’s protection, MonoSol said in a company press release.
Under the licensing agreement, MonoSol Rx is eligible to receive upfront and contingent milestone payments, as well as single-digit royalty payments, on net sales of APL-130277. Cynapsus holds worldwide commercialization rights for the treatment.
Cynapsus completed a Phase 2 clinical trial (NCT02228590) examining the safety, efficacy, and tolerability APL-130277 in 19 Parkinson’s patients. The study reported positive results in converting patients from “off” to “on” states, without complications typically associated with the subcutaneous administration of apomorphine. The drug candidate is designed to convert all manifestations of “off” episodes, including morning episodes, often thought as being the most difficult to treat. The company has began a Phase 3 clinical trial program (NCT02469090 and NCT02542696) in the U.S., and announced that it plans to submit a New Drug Application (NDA) for APL-130277 to the U.S. Food and Drug Administration (FDA) in late 2016 or early 2017.
Apomorphine (Apokyn) is an FDA-approved non-ergoline dopamine agonist, delivered through subcutaneous injection, to treat acute, intermittent treatment of “off” episodes in advanced Parkinson’s patients.
“We are delighted to have signed the agreement with MonoSol Rx for their intellectual property portfolio covering pharmaceutical films which will broaden our IP [intellectual property] protection for APL-130277 as we move closer to commercialization. Cynapsus aims to provide patients suffering with PD a patient-friendly way to treat their often debilitating OFF episodes,” said Anthony Giovinazzo, Cynapsus’ president and chief executive officer. “We continue to focus on completing our Phase 3 clinical trials and filing our NDA.”