TORONTO, ONTARIO--(Marketwire - March 26, 2012) - Cynapsus Therapeutics Inc. (TSX VENTURE:CTH.V - News), a specialty pharmaceutical company developing an improved dosing formulation of an approved drug used to treat the symptoms of Parkinson's disease, today announced its results for the fourth quarter and fiscal year ended December 31, 2011. Unless specified otherwise, all amounts are in Canadian dollars.
"2011 was a successful year for Cynapsus with achievement of multiple significant milestones. In particular, the year was highlighted by the completion of the first human clinical trial for APL-130277, the announcement of findings from a global neurologist survey confirming market need for APL-130277, and the completion of the acquisition of Adagio Pharmaceuticals," said Anthony Giovinazzo, President and Chief Executive Officer of Cynapsus. "Building on this success, we remain focused on the completion of a dose escalation study in the next 3 to 4 months, as well as preparations for an Investigational New Drug Application to the US FDA for a clinical BioEquivalence study later in the year. The BEQ study is the next critical de-risking milestone that we believe will drive significant shareholder value."
Financial Highlights
Operational Highlights
The following achievements were made during the year:
Cynapsus Completed the First Human Volunteer Pilot Proof-of-Concept Clinical Trial For APL-130277. In the second half of the year, the Company initiated and completed the first human clinical trial for APL-130277. On January 10, 2012, subsequent to the year end, Cynapsus announced positive headline data from its recently completed human volunteer pilot proof-of-concept trial for APL-130277, a sublingual thin film strip formulation of apomorphine. The study showed a pharmacokinetic (PK) profile that compared favorably to injected apomorphine with a mean T-max of 25 minutes and good tolerability, and therefore confirms that APL-130277 has the potential to treat motor fluctuations or "off episodes" in Parkinson's disease. This was a significant milestone and de-risking event for the project.
Cynapsus Completed a Significant Neurologist Survey That Confirms the Need for Improved Administration of Parkinson's Disease Acute Rescue Therapy. On December 8, 2011, the Company announced 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 global neurologist survey was necessary to further support the unmet medical need and calculation of the numbers of patients that would make up the larger target population.
Cynapsus Completed the Acquisition of Adagio Pharmaceuticals Ltd. Beginning in the second quarter, the Company took steps to acquire Adagio. On December 22, 2011, the Company announced the completion of the acquisition of Adagio. The agreement and the issuance of Common shares of Cynapsus as consideration pursuant to the agreement was approved by Cynapsus' shareholders at a Special Shareholder Meeting held on November 30, 2011. The transaction received final approval of the Board of Directors of Cynapsus on December 15, 2011. The acquisition superseded and replaced the License Option Agreement dated July 22, 2010 entered into by Cynapsus and Adagio with respect to the intellectual property owned by Adagio concerning the world-wide APL-130277 patent rights and know-how. The APL-130277 patent rights and know how are critical to the Company's long term objectives and ensures full ownership of those rights by the Company.
In addition, effective March 23, 2012, the Company granted stock options to acquire 4,675,000 common shares. The stock options were granted to officers, directors, employees and consultants of the Company at an exercise price equal to $0.10 per share and with an expiry of 5 years. Of the total, 950,000 stock options will be granted to each of Nathan Bryson (CSO) and Andrew Williams (COO/CFO), 700,000 to Albert Agro (CMO), 400,000 to Rochelle Stenzler (Chairperson), and 200,000 to each of Ronald Hosking (Director), Julia Levy (Director), Alan Torrie (Director) and Alan Ryley (Director).
About Cynapsus Therapeutics
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Cynapsus Therapeutics Reports 2011 Financial Results and Highlights Key Developments
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