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Cynapsus Therapeutics Inc. (CTH:CA)
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Web site:
http://www.cynapsus.ca
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. Despite the use of very effective medications, motor symptoms appear to increase with the progression of Parkinson's disease. A rather debilitating collection of symptoms known as OFF episodes (motor freezing and impaired speech capabilities) can occur in up to 50% of patients. An effective medication for OFF episodes needs to be quick acting, easy to use and readily available for the patient with Parkinson's disease.
Cynapsus' lead drug candidate, APL‐130277, is an easy‐to‐administer, fast‐acting and oral reformulation of existing approved drug (Apomorphine). Apomorphine is currently only available as an injection, used to rescue patients from OFF episodes. Cynapsus is focused on rapidly maximizing the value of APL‐130277 by completing clinical studies in advance of a New Drug Application expected to be submitted in late 2013. The Company anticipates out‐licensing to an appropriate global pharmaceutical partner before such an application is submitted.
Compelling Attributes of APL 130277:
- Reformulation of FDA approved drug with known safety and efficacy
- Existing drug is known as best fast rescue of daily OFF episodes in Parkinson's
- Listerine® strip type solution for convenience, stability and replication of injection parameters
- Ready for new drug approval submission in mid 2013
- Strong patent position with 17 + years coverage
- Growing market due to Baby Boomer generation
- Convenience versus injection, opens large market projected at $300 million to $1 billion per annum by 2023 (WW)
Progress to Date:
- Sourced FDA approved drug manufacturer
- Sourced strip system manufacturer
- Made, tested and optimized clinical lead product
- Completed in‐vivo animal model of absorption to confirm achievement of target FDA parameters
- Completed Neurologist survey to verify unmet medical need
- Completed Payer Survey to confirm reimbursability
- Vetted clinical program during FDA meeting on April 20, 2011
- Clinical program designed with expert input
Next Steps:
- Phase 1 Pilot Study: Proof of human concept trial to demonstrate the pharmacokinetic profile in man is within the FDA 505 b(2) guideline parameters for a bioequivalence NDA filing. (Est. cost: $750,000)
- Bioequivalence Study: Complete an FDA or EMEA sponsored bio equivalence study in healthy volunteers to provide data as per FDA guidelines (i.e. C‐max and AUC within 80% and 125% of reference drug (Apokyn).
- Safety Study: Complete the 120 patient safety study, which FDA requires to demonstrate comparable safety to injection (Apokyn).
Management Team:
Anthony J. Giovinazzo, C.Dir., A.C.C. (President & Chief Executive Officer)
- Appointed President & CEO of Cynapsus November 16, 2009
- Empowered to transition company into high growth CNS specialty pharma company
- Substantial value building changes accomplished in last 22 months
- Over 17 years CNS experience and expertise, including clinical development, licensing, institutional financing and M&A
- Extensive experience and knowledge of the international capital markets and proven team builder
- MBA from IMD (Switzerland), Leadership and Strategy in Pharmaceuticals and Biotech Program (Harvard), and
C.Dir, and A.C.C. from the Directors College.
Dr. Albert Agro, PhD. (Chief Medical Officer)
- Significant large pharma successful CNS clinical development management and new drug approvals
- Held scientific and executive level positions at TransTech Pharma, Axon, Boehringer Ingelheim, and Bayer.
- Ph.D. from the Department of Medicine at McMaster University.
- Assistant professor, Department of Pathology and Molecular Medicine at McMaster University.
Dr. Nathan Bryson, PhD. (Chief Scientific Officer)
- Over 18 years of experience in pharmaceutical development, having held scientific and executive management level positions at Flamel Technologies, Bionisis and Matregen Corp.
- Strong knowledge of early‐stage drug product development and formulation and has co‐authored more than 20 patents.
- BSc in Chemistry from Auburn University and a PhD in Chemistry from M.I.T.
Andrew Williams, MBA (Chief Operating Officer and Chief Financial Officer)
- Co‐founded Cynapsus in 2004; Led go public transaction on Toronto Venture Exchange in 2006
- Held senior management and leadership roles in three other early stage businesses and has several years of experience working as a management consultant, including roles or assignments with: Canadian Tire Corporation, CDI/Corinthian, Global Mentoring, Mellon Bank (US), Ontario Hydro and PNC Bank (US)
- BAH from Queen's University and MBA from Richard Ivey School of Business
World Class Clinical Advisory Board: Dr. Warren Olanow, MD
The Henry P. and Georgette Goldschmidt Professor and Chairman of the Department of Neurology at the Mount
Sinai School of Medicine in New York City and Chief of the Neurology Service at the Mount Sinai Hospital.
Dr. Fabrizio Stocchi, MD, PhD
Professor of Neurology and Director of the Parkinson's Disease and Movement Disorders Research Centre at the
Institute for Research and Medical Care, IRCCS San Raffaele, Rome, Italy.
Dr. Susan Fox, PhD, CCST
Trained in medicine at the University of Manchester, and completed Neurology Specialist training (CCST) in 2001. Consultant Neurologist Nov 2001‐ Sept 2003 at the Walton Centre for Neurology and Neurosurgery, Liverpool UK.
2003, appointed Assistant Professor Division of Neurology, Department of Medicine, University of Toronto and
University Health Network. Member of largest movement disorders clinic in Canada (Toronto Western) with 3,000
Parkinson's patients.
Links:
CTH:CA
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