Cynapsus is a specialty central nervous system, or CNS, pharmaceutical company developing a fast-acting, easy-to-use, sublingual thin film for the potential treatment for on-demand management of debilitating OFF episodes associated with Parkinson’s disease (PD). The Company successfully completed a Phase 2 clinical trial for its product candidate, APL-130277, a sublingual formulation of apomorphine hydrochloride, or apomorphine. Apomorphine is the only molecule approved for acute, intermittent treatment of OFF episodes for advanced PD patients, but is currently only approved as a subcutaneous injection in the United States. APL-130277 is a “turning ON” medication designed to rapidly, safely and reliably convert a PD patient from the OFF to the ON state while avoiding many of the issues associated with subcutaneous delivery of apomorphine. It is designed to convert all types of OFF episodes, including morning OFF episodes, often considered the most difficult to treat. Cynapsus has initiated its pivotal Phase 3 clinical program for APL-130277, and will rely on the abbreviated Section 505(b)(2) regulatory pathway in the United States. The Company intends to submit a new drug application, or NDA, near the end of 2016 or in early 2017.
Our Phase 2 study demonstrated that APL-130277 provided rapid, clinically meaningful improvement in motor function for PD patients in the OFF state and provided clinically meaningful changes in Movement Disorder Society’s Unified Parkinson’s Disease Rating Scale Part III (MDS-UPDRS Part III) scores. In addition, much of the benefit was sustained through 90 minutes. These results showed that APL-130277 was safe and well-tolerated in PD patients with OFF episodes. The most common adverse events (AE’s) were mild to moderate, and are commonly associated with dopaminergic medications.
We retain global commercialization rights to APL-130277. In the United States, we expect to build sales and marketing infrastructure to commercialize APL-130277 ourselves. We believe that a targeted sales effort of approximately 100 sales representatives will enable us to effectively market APL-130277 to high-prescribing general neurologists and approximately 1,200 movement disorder specialists in the United States. We believe a sales force of this size can reach these physicians to provide for a robust commercial adoption of APL-130277. In addition, we intend to invest in education of both doctors and patients to foster widespread adoption of APL-130277. Outside the United States, we may choose to partner with companies that have the necessary expertise to develop and commercialize APL-130277.
We have a substantial patent portfolio, including issued and pending patent applications in the United States and certain other jurisdictions that cover APL-130277 and its use in the treatment of PD. We also rely on significant know-how for the creation of an optimal and functional sublingual apomorphine strip system that combines key mechanical, chemical reaction and pharmacokinetic, or PK, attributes.