Cynapsus Therapeutics Inc.

TSX VENTURE : CTH


Cynapsus Therapeutics Inc.

October 29, 2012 08:06 ET

Cynapsus Therapeutics' APL 130277 for Parkinson's Chosen As One Of The Top Ten Neurology Projects To Watch For 2012

-Independent Committee Selects Cynapsus' Novel Sublingual formulation of Apomorphine, as One of the Most Promising CNS Candidates-

TORONTO, ONTARIO--(Marketwire - Oct. 29, 2012) - Cynapsus Therapeutics Inc. (TSX VENTURE:CTH) today announced that its APL-130277 for Parkinson's was recognized as one of the Top Ten Neurology Projects to Watch in 2012 by a joint selection committee including Dr. Harry Tracy, a noted authority on pharmacological interventions for diseases of the brain and editor of the highly respected biotechnology publication NeuroPerspective, as well as with Elsevier Business Intelligence, the publishers of In Vivo, Startup and The Pink Sheet. Cynapsus has been invited to present the APL-130277 Project at Elsevier's Therapeutic Area Partnerships Meeting taking place on November 28-30, 2012 at the Westin Copley in Boston.

Criteria for selection of the Top 10 Neurology Projects to Watch in 2012 were:

  • 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

APL‐130277 is a unique and innovative, sublingual thin film strip formulation of apomorphine. Apomorphine is an approved drug prescribed in the US, Europe and several other countries. It is administered as a subcutaneous injection or infusion to Parkinson's patients experiencing daily "OFF" or motor fluctuation episodes. APL‐130277 would 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 bioequivalence regulatory and clinical path which would culminate in a New Drug Approval application in 2015.

"We are humbled to be recognized from among several hundred worthy neuroscience projects, worldwide. This is a significant honor and further independent validation of the potential of APL-130277. This comes only a few months after receiving a significant grant from The Michael J. Fox Foundation for Parkinson's Research (MJFF) to help support our next clinical study (CTH103). The MJFF Clinical Intervention Award was provided through the Edmond J. Safra Core Programs for Parkinson's Research," said Mr. Anthony Giovinazzo, President and Chief Executive Officer of Cynapsus. "Since we started this project, we determined that there are a large number of Parkinson's patients who would benefit from needle-free delivery of the drug. This includes patients who want a convenient alternative to a very painful injection regimen, patients who have resisted initiating therapy because of the needle issues, and the increase in PD population as a result of the growing aging baby boomer generation. These factors combined indicate that the number of Parkinson's patients worldwide could potentially increase 2-to-3 fold over the next 8 to 10 years. This significant potential unmet medical need coupled with a short and lower risk clinical pathway would be of interest to many in global and specialty pharma, especially given that our pending patent estate, when approved and granted, would provide protection to 2031 at a minimum."

About Parkinson's Disease

Parkinson's disease is a chronic, degenerative neurological disorder that results from the loss of dopamine‐producing nerve cells in the brain. Current treatments for Parkinson's disease are able to reduce the symptoms of the disease but are not able to treat the underlying neurodegenerative processes that lead to a decline in physical and cognitive functions that affects some patients with Parkinson's disease. It is estimated that over one million people in the United States and 5 million people globally are living with Parkinson's disease. According to the National Institute of Neurodegenerative Disease and Stroke, the average age of onset is 60, although some people are diagnosed at age 40 or younger.

About Cynapsus Therapeutics

Cynapsus is a specialty pharmaceutical company developing the only orally administered convenient (sublingual) delivery of the only approved drug (apomorphine) to treat the motor symptoms of Parkinson's disease. Over one million people in the United States and an estimated 5 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 the IMPACT Registry Study and the results of Cynapsus' Global 500 Neurologists Survey, 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.

Cynapsus' lead drug candidate, APL‐130277, is an easy‐to‐administer, fast‐acting reformulation of an approved drug, apomorphine, used to rescue patients from OFF episodes. Cynapsus is focused on rapidly maximizing the value of APL‐130277 by completing pivotal studies in advance of a New Drug Application expected to be submitted in 2015. Cynapsus anticipates out‐licensing to an appropriate pharmaceutical partner before such an application is submitted.

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

About TA Partnerships

Elsevier's 7th Annual Therapeutic Area Partnerships is the industry's most targeted and efficient partnering meeting for life science companies seeking partnerships in the top therapeutic areas: Oncology, Cardiovascular/Metabolic, Neuroscience, 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.tapartnerships.com/content/Main.aspx

About Elsevier Business Intelligence

Elsevier Business Intelligence, a global leader in the field of healthcare industry information, provides business intelligence on regulatory, business and reimbursement issues that are vital to the healthcare industry. Through a range of products including publications, conferences, e-learning, databases and reports, Elsevier Business Intelligence places biopharma and medical device professionals, and those who focus on these industries, at the forefront of knowledge, by providing the perfect combination of news and information together with penetrating insight and analysis. Our leading publications include PharmAsia News, IN VIVO and "The Pink Sheet." For more information, visit: http://www.ElsevierBi.com

Forward Looking Statements

This announcement contains "forward-looking statements" within the meaning of applicable Canadian securities legislation. 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 and Uncertainties" in "Management's Discussion and Analysis of Operating Results and Financial Condition" for the year ended December 31, 2011, 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.

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