Cynapsus Therapeutics

Name

Cynapsus Therapeutics

Legal name

Cynapsus Therapeutics Inc.

Website

https://cynapsus.ca

Company type

Public

Founded year

2004

Operating status

Acquired

Headcount range

11–50 employees

Ownership category

akta.pro rank

Headquarters

HQ city

Toronto

HQ country

Canada

HQ region

North America

Offices1 record

Markets served

GTM type

B2B

Offering type

Hardware or Manufacturing

Cost components

Technology or R&D, Personnel, Operations, Marketing or Sales

Revenue model

1. Pharmaceutical Product Sales: Pre-revenue clinical stage company. Revenue expected to come from sales of APL-130277 sublingual thin film if approved by FDA. The product would be commercialized as a prescription pharmaceutical for Parkinson's disease patients experiencing OFF episodes. Acquired by Sunovion Pharmaceuticals in Q4 2016 for US$624 million.

Go-to-market motion1 record

Distribution channels1 record

Marketing channels4 records

Core offering

Cynapsus Therapeutics was developing APL-130277, a sublingual thin film formulation of apomorphine hydrochloride for the acute, on-demand treatment of OFF episodes in Parkinson's disease patients. The sublingual delivery bypasses gastrointestinal and first-pass hepatic metabolism limitations of oral apomorphine, converting patients from OFF to ON state within 15–30 minutes without the need for subcutaneous injection.

Product overview

Cynapsus Therapeutics is a specialty pharmaceutical company developing a single core product: APL-130277, a sublingual thin film formulation of apomorphine hydrochloride. The product is designed for on-demand management of debilitating OFF episodes associated with Parkinson's disease (PD). Apomorphine is an existing dopamine agonist molecule approved for acute treatment of OFF episodes, but only as a subcutaneous injection. APL-130277 provides a non-invasive sublingual alternative that dissolves under the tongue, offering rapid onset (within 15-30 minutes) to convert PD patients from OFF to ON state. The company was developing this product through Phase 3 clinical trials with plans to submit an NDA under the 505(b)(2) regulatory pathway.

Differentiator

Problem solved

Functional benefit

Brands

• APL-130277: A fast-acting, easy-to-use sublingual thin film formulation of apomorphine being developed for the on-demand management of debilitating OFF episodes associated with Parkinson's disease.

Products and services

• APL-130277 A fast-acting, easy-to-administer sublingual thin film formulation of apomorphine hydrochloride for the acute, on-demand treatment of OFF episodes in Parkinson's disease patients. Designed to convert patients from the OFF to the ON state within 15–30 minutes without requiring subcutaneous injection.

Quantifiable outcome

• 78.9% of patients (15 of 19) achieved full ON response in Phase 2 trial
• +5 more outcomes

Segments2 records

Ideal customer profiles2 records

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature1 record

Partnerships

Three partnerships are on record, tiered flagship and core.

• Sunovion Pharmaceuticals Inc.flagshipOthers · 31 August 2016Sunovion acquired Cynapsus for US$40.50 per share in cash, valuing the company at approximately US$624 million (CAN$820 million). Transaction completed Q4 2016. Sunovion is a global biopharmaceutical company focused on CNS disorders and a subsidiary of Sumitomo Dainippon Pharma Co., Ltd.
• Michael J. Fox Foundation for Parkinson's ResearchcoreStrategic or Co-development Partner · 7 January 2016Strategic collaboration on pilot use of wearable device and data science approaches in Phase 3 Parkinson's clinical study. Collaboration builds on MJFF's ongoing data science partnership with Intel Corporation. MJFF has funded earlier phases of clinical development and provided grants for APL-130277 research (August 2012 and July 2014 grants). The Foundation is the world's largest non-profit funder of Parkinson's research with more than $525 million in research funded to date.
• Intel CorporationcoreTechnology or Integration · 1 August 2014Data science collaboration through MJFF partnership to develop platforms for storage of large volumes of patient-generated data and algorithms to glean insights from clinical trial data. Intel developed wearable technology and analytics platform for objective measurement of Parkinson's disease in clinical studies using consumer wearables.

Scale indicators6 records

Recent moves6 records

Expansion highlights4 records

Direct peers

• Lundbeck: Developed and commercialized Onapgo, a continuous subcutaneous apomorphine infusion for Parkinson's disease. Competes in the apomorphine-based OFF episode therapy market and represents another delivery format for the same molecule.
• US WorldMeds (Apokyn): Markets Apokyn, the only FDA-approved subcutaneous apomorphine injection for acute OFF episodes in Parkinson's disease. Directly comparable as it addresses the same indication and patient population with the same active molecule via a different delivery route that APL-130277 was designed to displace.
• Acorda Therapeutics: Developed and commercialized Inbrija, an inhaled levodopa for the on-demand treatment of OFF episodes in Parkinson's disease. Directly competes in the OFF episode rescue therapy space that Cynapsus targeted with APL-130277.
• Adamas Pharmaceuticals: Developed and commercialized Gocovri (amantadine extended-release) for dyskinesia and OFF episodes in Parkinson's disease. Comparable as a specialty CNS company focused on PD motor complications, often prescribed by the same movement disorder specialist channel.
• Mitsubishi Tanabe Pharma (NeuroDerm): Acquired NeuroDerm and developed continuous subcutaneous levodopa/carbidopa delivery for advanced Parkinson's disease. Comparable as a developer of novel delivery technologies targeting OFF episodes and motor fluctuations in PD patients.

Broad incumbents

• Teva Pharmaceutical Industries: Major generic and specialty manufacturer of Parkinson's disease therapies including generic apomorphine and rasagiline. Broad incumbent across PD treatment categories with global commercial scale.
• Amneal Pharmaceuticals: Following combination with Impax, markets a broad Parkinson's disease portfolio including generic and branded PD therapies. Broad incumbent in the PD space with established specialty distribution.
• AbbVie: Markets Duopa/Duodopa (levodopa-carbidopa intestinal gel) for advanced Parkinson's disease. Broad incumbent in PD with established CNS commercial infrastructure and a portfolio approach to managing motor complications in late-stage PD.

Regional players

• Kyowa Kirin: Markets apomorphine products in select international markets for Parkinson's disease OFF episodes. Comparable as a developer/marketer of apomorphine-based therapy in PD, though primarily operating outside North America.
• BIAL Pharmaceuticals: Developed opicapone (Ongentys), a COMT inhibitor adjunct for Parkinson's disease. Comparable as a specialty pharmaceutical company focused on improving PD symptom control, with primary commercial presence in Europe.

Market position

Strengths4 records

Weaknesses4 records

Competitive moat3 records

Key risks5 records

Key highlights6 records

Customer concentration

• LinkedInlinkedin.com/company/cynapsus-therapeutics

Revenue estimate

Valuation estimate

Number of profiles

Profiles4 records

Funding overview

Funding rounds6 records

Investors8 records

Funding detail is available on the Subscription and Enterprise plan.Contact sales →

M&A

Investments

M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

Frequently asked questions about Cynapsus Therapeutics