Cynapsus Therapeutics Inc.
TSX VENTURE : CTH
OTCQX : CYNAF

Cynapsus Therapeutics Inc.

October 14, 2014 06:00 ET

Cynapsus Therapeutics' Phase 2 Drug Candidate for Parkinson's Chosen as One of the Top Ten Neurology Projects to Watch

TORONTO, CANADA--(Marketwired - Oct. 14, 2014) - Cynapsus Therapeutics Inc. (TSX VENTURE:CTH)(OTCQX:CYNAF) today announced that its APL-130277 for Parkinson's was recognized as one of the Top Ten Neurology Projects to Watch by a joint selection committee including Dr. Harry Tracy, a noted authority on pharmacological interventions for diseases of the brain. Dr. Tracy is also the editor of the respected biotechnology publication NeuroPerspective, which is utilized by pharmaceutical companies and investors around the world. Cynapsus has been invited to present the APL-130277 project at the Therapeutic Area Partnerships Meeting taking place on November 19 to 21, 2014, at the Hyatt Regency Boston.

Criteria for selection of the Top 10 Neurology Projects to Watch are:

  • Large market, large unmet need, with increasing opportunity
  • History of the molecule and drug
  • Strong science
  • Strong company
  • Diversity of indications
  • Potential for new opportunities beyond the initial indications
  • Multi-level partnering opportunities, i.e., biotech to biotech as well as pharma to biotech

Over one million people in the U.S. and an estimated 4 to 6 million people globally suffer from Parkinson's disease. Parkinson's disease is a chronic and progressive neurodegenerative disease that impacts motor activity, and its prevalence is increasing with the aging of the population. OFF episodes are a complication of Parkinson's disease that leave patients rigid and unable to move and communicate. Approximately 25% to 50% of Parkinson's patients experience OFF episodes, which can occur 1 to 6 times daily and last between 30 and 120 minutes.

Today, apomorphine is the only drug that can rapidly convert a patient from OFF (unable to move) to ON (fully functional). Unfortunately for Parkinson's patients, apomorphine is primarily only available as a needle injection, which can be painful and difficult to administer.

Cynapsus' APL-130277 drug candidate is the only oral formulation of apomorphine for the treatment of OFF episodes. APL-130277 is a thin film strip that a Parkinson's patient can place under their tongue when an OFF episode is starting. If approved, APL‐130277 will provide patients with a convenient and more tolerable alternative to multiple daily injections. As a new means of delivering an approved drug, this clinical stage project is expected to follow a 505(b)(2) regulatory and clinical path which is expected to culminate in a New Drug Approval application in 2016.

"We are honored to be recognized from among the hundreds of worthy neuroscience projects, worldwide. This nomination provides further independent validation of the potential of APL-130277, and comes only a few months after receiving a second grant from The Michael J. Fox Foundation for Parkinson's Research. We are now focused on completing efficacy and safety studies in Parkinson's patients over the next 12 to 18 months," said Mr. Anthony Giovinazzo, President and Chief Executive Officer of Cynapsus.

About Therapeutics Area Partnerships

The 8th Annual Therapeutic Area Partnerships is one of the industry's most targeted and efficient partnering meeting for life science companies seeking partnerships in the top therapeutic areas: Neuroscience, Oncology, Cardiovascular/Metabolic, Infectious, Inflammatory Diseases and other hot therapeutic areas. Decision-makers focusing on these therapeutic categories can meet to develop strategic alliances in a personal and interactive setting that combines company presentations, 1:1 meetings and networking functions. More information is available at http://www.iirusa.com/therapeuticareapartnership/home.xml.

About Cynapsus Therapeutics

Cynapsus is a specialty pharmaceutical company developing a convenient and easy to use sublingual (oral) thin film strip for the acute rescue of OFF motor symptoms of Parkinson's disease. Cynapsus' drug candidate, APL-130277, is an easy-to-administer, fast-acting reformulation of apomorphine, which is the only approved drug (in the United States, Europe, Japan and other countries) to rescue patients from OFF episodes. Cynapsus is focused on maximizing the value of APL-130277 by completing pivotal studies in advance of a New Drug Application (NDA) expected to be submitted in 2016.

Over one million people in the U.S. and an estimated 4 to 6 million people globally suffer from Parkinson's disease. Parkinson's disease is a chronic and progressive neurodegenerative disease that impacts motor activity, and its prevalence is increasing with the aging of the population. Based on a recent study and the results of the Corporation's Global 500 Neurologists Survey, it is estimated that between 25 percent and 50 percent of patients experience OFF episodes in which they have impaired movement or speaking capabilities. Current medications only control the disease's symptoms, and most drugs become less effective over time as the disease progresses.

More information about Cynapsus (TSX VENTURE:CTH)(OTCQX:CYNAF) is available at www.cynapsus.ca and at the System for Electronic Document Analysis and Retrieval (SEDAR) at www.sedar.com.

Forward Looking Statements

This announcement contains "forward-looking statements" within the meaning of applicable securities laws. Generally, these forward-looking statements can be identified by the use of forward-looking terminology such as "plans", "expects" or "does not expect", "is expected", "budget", "scheduled", "estimates", "forecasts", "intends", "anticipates" or "does not anticipate", or "believes" or variations of such words and phrases or state that certain actions, events or results "may", "could", "would", "might" or "will be taken", "occur" or "be achieved". Forward-looking statements are subject to known and unknown risks, uncertainties and other factors that may cause the actual results, level of activity, performance or achievements of Cynapsus to be materially different from those expressed or implied by such forward-looking statements, including but not limited to those risks and uncertainties relating to Cynapsus' business disclosed under the heading "Risk Factors" in its March 26, 2014, Annual Information Form and its other filings with the various Canadian securities regulators which are available online at www.sedar.com. Although Cynapsus has attempted to identify important factors that could cause actual results to differ materially from those contained in forward-looking statements, there may be other factors that cause results not to be as anticipated, estimated or intended. There can be no assurance that such statements will prove to be accurate, as actual results and future events could differ materially from those anticipated in such statements. Accordingly, readers should not place undue reliance on forward-looking statements. Cynapsus does not undertake to update any forward-looking statements, except in accordance with applicable securities laws.

Neither the TSX Venture Exchange nor the OTCQX International has approved or disapproved of the contents of this press release.

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