Neurologist Survey Confirms Need for Improved Administration of Parkinson’s Disease Acute Rescue Therapy
Marketwire, December 8, 2011
Cynapsus-sponsored study suggests significant market potential for APL 130277, the Company’s sublingual Apomorphine drug candidate for Parkinson’s disease
TORONTO, CANADA – (Marketwire) – Cynapsus Therapeutics Inc. (CTH: TSX-V) announced today the results of a large survey of neurologists and movement disorder specialists in the United States, Europe, Japan, China and select countries in the Rest of the World. In total, 500 neurologists and movement disorder specialists were surveyed on their treatment of patients with Parkinson’s disease. Collectively, these professionals treat approximately 62,000 Parkinson’s patients per year with approximately 41.4% classified as mild-moderate in severity, 42.2% as moderate-severe, and 16.4% as severe. The results of this survey confirm and expand on the results of the smaller neurologist survey that was completed by the Company in July 2010.
“This comprehensive survey confirms our belief that there is a considerable unmet medical need for APL 130277, a convenient sublingual thin film strip delivery method of Apomorphine. Apomorphine is the drug of choice for acute rescue of Parkinson’s patients that suffer from daily motor freezing episodes,” said Anthony Giovinazzo, President and CEO of Cynapsus. “Given that there are approximately 4 million diagnosed Parkinson’s patients world-wide today, and it is expected that in 15 years this will climb to 10 million, this is a large and growing problem. Further, since approximately one third of these patients have motor fluctuations or “OFF” episodes, the patient need is clearly significant. The data from this survey indicates that the majority of neurologists surveyed believe that a less-invasive, sublingual formulation of Apomorphine would be very useful in the treatment, versus a needle injection, of a significant proportion of these patients. We believe this is very encouraging and supports our strategy going forward.”
Highlights of Survey Results
1. Current use of Apomorphine: Needle injection is a barrier to expanded use. According to the survey, neurologists and movement disorder specialists currently prescribe Apomorphine by needle injection or infusion pump to approximately 5% of all Parkinson’s patients. Among these patients, they describe 6.4% as mild-moderate patients, 40.2% as moderate-severe patients, and 53.4% as severe. In addition, survey respondents reported that “inconvenience”, “difficulty starting therapy” and “injection-site reactions” as the biggest barriers preventing them from expanding use of Apomorphine to a broader spectrum of Parkinson’s patients.
2. Sublingual Apomorphine as adjunct therapy: Fast “ON” in the morning. The majority (75.6%) of surveyed neurologists think that a sublingual solid fast dissolving dosage form would be utilized as an adjunct rescue therapy by a patient to achieve a fast “ON” in the morning, and one or two more times per day.
3. Estimated use of sublingual Apomorphine (such as APL 130277). If a sublingual, solid, fast-dissolving dosage form of Apomorphine was made available (such as APL 130277), respondents would consider using the drug in 15.1% of mild-moderate patients, 38.1% of moderate-severe patients, and 49.5% of severe Parkinson’s patients. Taking into account the classification of patients (i.e. mild-moderate, moderate-severe, severe), these projected uses would represent approximately 30% of all Parkinson’s patients.
4. Neurologists would be willing to prescribe sublingual Apomorphine at launch. One year post launch, respondents reported that they would expect to treat 13.2% of mild-moderate, 22.9% of moderate-severe, and 26.0% of severe patients with sublingual Apomorphine, demonstrating the true need for an alternative to the needle injectable form of delivery. The survey also showed that the United States is particularly ready to accept innovation, as initial adoption rates are shown to be two times higher in the United States than in Europe or the Rest of the World.
*Note: The survey was performed by an independent market research firm. Of the 500 professionals surveyed, 374 were neurologists and 126 were movement disorder specialists. By region, 150 were from the United States, 193 were form Europe, and 157 were from Japan, China and select countries in the Rest of the World (India, Brazil, and Mexico). The survey questionnaire contained 20 primary questions with several containing sub-questions.
About Cynapsus Therapeutics
Cynapsus is a specialty pharmaceutical company developing an improved dosing formulation of an approved drug used to treat the symptoms of 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. 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.
Cynapsus’ lead drug candidate, APL-130277, is an easy-to-administer, fast-acting and oral 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 2013 or 2014. The Company anticipates out-licensing to an appropriate pharmaceutical partner before such an application is submitted.
More information about Cynapsus (CTH: TSX-V) is available at www.cynapsus.ca and at the System for Electronic Document Analysis and Retrieval (SEDAR) at www.sedar.com.
Russo Partners LLC
Robert E. Flamm, Ph.D.
Forward Looking Statements
This press release 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 Factors” in Cynapsus' current 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.