Cynapsus Therapeutics Receives Notice of Allowance from
Cynapsus Therapeutics Receives Notice of Allowance from United States Patent and Trademark Office (USPTO)
Claims Covering APL-130277 Apomorphine Sublingual Thin Film Strip for Parkinson's Patients
TORONTO, ONTARIO -- (Marketwire) -- 12/11/12 --
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Cynapsus Therapeutics Inc. (TSX VENTURE:CTH) is a specialty pharmaceutical company developing the only orally-administered delivery form of apomorphine for the rescue of "off" episodes in Parkinson's disease. The Company announced today that the United States Patent and Trademark Office (USPTO) has issued a Notice of Allowance for the patent application 13/445,656 with critical claims directed to thin film compositions containing apomorphine formulated for sublingual administration. The allowed application will be the first to emerge as a U.S. patent from the company's patent application filings directed to sublingual apomorphine therapies.
Cynapsus' drug candidate, APL-130277, is an easy-to-administer, fast-acting sublingual formulation of apomorphine for use in the rescue of Parkinson's patients from "off" episodes in which the patients have impaired movement or speaking capabilities. The allowed claims cover APL-130277.
"We are very pleased that our intellectual property estate on our sublingual apomorphine project is advancing nicely alongside scientific, clinical and other business developments," said Anthony Giovinazzo, President and Chief Executive Officer at Cynapsus. "The issuance of the patent further strengthens our confidence that APL-130277 will successfully reach the market in 2015."
"We are gratified that the USPTO has allowed these key composition claims covering APL-130277," said Dr. Nathan Bryson, Chief Scientific Officer of Cynapsus. "We are also grateful to have a strong team of experts and partners who have been instrumental in helping us reach this point in our development."
The Cynapsus sublingual apomorphine formulations, including APL-130277, provide a sublingual, dual layer thin film strip system with optimized functional features, including the following:
-- fast acting for quick relief of "off" symptoms in Parkinson's patients; -- a simple solid dosage form with easy administration; -- a dosage form that is fast-dissolving under the tongue for convenience; -- comparable serum profile and therapeutic effects relative to apomorphine injection without the use of a needle; and -- near pH neutral formulation to reduce chances of possible irritation.
Cynapsus' intellectual property position includes other patent applications that seek to further protect additional features of the sublingual apomorphine therapy. Cynapsus has filed patent applications in North America, Europe, Asia, and South America.
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 non-injectable (i.e. sublingual) delivery of the only approved drug (apomorphine) to be used as a rescue therapy for "off" motor symptoms of Parkinson's disease. Over one million people in the U.S. 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 a recent study and the results of the Company'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.
Cynapsus' drug candidate, APL-130277, is an easy-to-administer, fast-acting reformulation of apomorphine, which is approved in an injection formulation 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 expected to be submitted in 2015. Cynapsus anticipates a trade sale or out-licensing to an appropriate global 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.
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 Factors" in its Annual Information Form filed on November 1, 2012 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 ca use 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.
This press release does not constitute an offer to sell or a solicitation to buy any securities in the United States.
The TSXV has neither approved nor disapproved the contents of this press release. Neither the TSXV nor its Regulation Services Provider (as that term is defined in the policies of the TSXV) accepts responsibility for the adequacy or accuracy of this release.
Contacts: Cynapsus Therapeutics Anthony Giovinazzo President and CEO (416) 703-2449 x225 firstname.lastname@example.org
Cynapsus Therapeutics Andrew Williams COO & CFO (416) 703-2449 x253 email@example.com www.cynapsus.ca