Cynapsus Therapeutics Reports First Quarter 2015 Financial Results and Recent Developments
(firmenpresse) - TORONTO, ONTARIO -- (Marketwired) -- 05/08/15 -- Cynapsus Therapeutics Inc. (TSX: CTH)(OTCQX: CYNAF), a specialty Central Nervous System (CNS) pharmaceutical company developing and preparing to commercialize a fast-acting, easy-to-use sublingual thin film for the on-demand management of debilitating OFF episodes associated with Parkinson''s disease (PD), today announced financial results for the three months ended March 31, 2015. Unless specified otherwise, all amounts are in Canadian dollars.
"In the first three months of 2015, we have made significant progress advancing our strategic plan, including work related to the commencement of Phase 3 clinical trials for APL-130277. Importantly, we also raised gross proceeds of approximately $21 million through a private placement, which we expect will fund APL-130277 development through to a New Drug Application (NDA) submission with the U.S. Food and Drug Administration (FDA) in 2016, initial commercialization studies and preparation for a U.S. product launch, as well as planning for clinical studies in the European Union," stated Anthony Giovinazzo, President and Chief Executive Officer of Cynapsus.
Financial Highlights
Operational Highlights
Upcoming Clinical Studies
Following the progress made in the first quarter of 2015, the Company currently plans to complete the following clinical studies:
In parallel, the Company will continue to perform the necessary development activities, including process validation and stability studies as part of the chemistry, manufacturing and controls, or CMC, requirements for the filing of the NDA. The Company expects that all development will be performed according to current Good Manufacturing Practices methodology.
Upon completion of the efficacy and safety studies, as well as the CMC requirements, the Company intends to prepare and submit a Section 505(b)(2) NDA to the FDA in 2016.
About Cynapsus
Cynapsus is a specialty CNS pharmaceutical company developing and preparing to commercialize a Phase 3, fast-acting, easy-to-use, sublingual thin film for the on-demand turning ON of debilitating OFF episodes associated with Parkinson''s disease, or PD. PD is a chronic, progressive neurodegenerative disease characterized by motor symptoms including tremor at rest, rigidity and impaired movement as well as significant non-motor symptoms such as cognitive impairment and mood disorders. The re-emergence of PD symptoms is referred to as an OFF episode. The Company recently 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 to provide rapid turning ON and relief from OFF episodes, but is currently only approved in the United States as a subcutaneous injection, which poses a number of problems. 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 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. The Company has initiated our Phase 3 clinical program for APL-130277, relying on the abbreviated Section 505(b)(2) regulatory pathway in the United States, and intends to submit an NDA in 2016.
PD is the second most common neurodegenerative disease worldwide. Over one million people in the United States and between four and six million people worldwide suffer from PD. There is no known cure or disease modifying treatment currently available for PD. Current medications and treatments only control the major symptoms of the disease, with most drugs becoming less effective over time as the disease progresses. Cells that die in PD produce dopamine, a neurotransmitter critical to the signaling for movement. These current drugs and therapies either aim to supplement dopamine levels in the brain, mimic the effect of dopamine in the brain by stimulating dopamine receptors, referred to as dopamine agonists, or prevent the enzymatic breakdown of dopamine, prolonging its effect. The standard of care for the treatment of symptoms of PD remains oral levodopa, a drug approved nearly 50 years ago. While oral levodopa is efficacious, there are significant challenges for physicians in creating a dosing regimen of oral levodopa that consistently maintains levodopa levels within a patient''s therapeutic range. Over time, the response to levodopa becomes less reliable and predictable and levodopa often cannot turn a patient from the OFF to the ON state. As a result, the majority of PD patients experience OFF episodes despite taking PD medications.
OFF episodes are thought to occur when brain dopamine levels fall below a critical threshold to sustain relatively normal motor function, or ON. It can be a period of time when a patient''s PD medication is not working adequately to alleviate the patient''s PD symptoms, when the medication has a delayed effect or does not work at all. When experiencing an OFF episode, a PD patient is unable to perform simple daily tasks such as eating, bathing and dressing, thus becoming increasingly dependent on caregivers. OFF episodes are considered one of the greatest unmet medical needs facing PD patients. The Company believes the current addressable market for its product candidate, APL-130277, in the United States alone is approximately 400,000 patients.
More information about Cynapsus (TSX: CTH)(OTCQX: CYNAF) is available at and at the System for Electronic Document Analysis and Retrieval (SEDAR) at .
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 Annual Information Form and its other filings with the various Canadian securities regulators which are available online at . 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 nor the OTCQX International has approved or disapproved of the contents of this press release.
Contacts:
Cynapsus Therapeutics Inc.
Anthony Giovinazzo
President and CEO
(416) 703-2449 x225
Andrew Williams
COO & CFO
(416) 703-2449 x253
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Datum: 08.05.2015 - 14:45 Uhr
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