Company

ACULYS was created to be a catalyst to innovation access for neurology patients and their families in Japan.

Message from CEO

Serving patients as a catalyst for access to innovative medicine

Aculys Pharma, Inc. was founded as Japan’s first biopharma company based on the philosophy of “Catalyst to Access”. Our goal is to become the leading provider of innovations for neuroscience diseases in Japan.

Our company was established to address two critical questions that arose during my time working for global pharmaceutical companies. First, I wondered why more wasn’t being done to help Japanese patients get access to more medications—Japan’s drug lag was a significant challenge for its citizens. And second, I wondered what more could be done to address the true needs of Japanese patients, and what was needed to help them live happier, healthier lives. Because medications alone were not enough.

At ACULYS, we are committed to speeding the pathway for medicines approved in other countries to those in need in Japan as quickly as possible. And to address social issues beyond medication, we are creating comprehensive support programs that go beyond the framework of conventional pharmaceutical companies, building partnerships with health tech companies and working to address the broader social factors that impact patients and their families.

With a focus on the unmet medical needs in neurology, ACULYS is leveraging our team’s expertise and agility as a startup to create positive change for patients, their families, healthcare professionals, and social as a whole. At ACULYS, we are dedicated to building a better world for all of those affected by neuroscience diseases.

Leadership

We are a committed, passionate team focused on bringing new solutions to neurology patients in Japan. Through our expertise and focus on the patient, we aim to change the way sleep disorders are diagnosed, managed and treated.

BOARD OF DIRECTORS

BT Slingsby, MD, PhD, MPH
Co-founder & Executive Chairman

Dr. Slingsby is Founder & Managing Partner at Catalys Pacific. He served as founding CEO during the creation and incubation of Aculys Pharma. Previous to Catalys Pacific, he founded the GHIT Fund – the world’s first public-private fund focused on the development of new medicines for low- and middle-income countries. Dr. Slingsby graduated from Brown University with honors, earned his MPH and PhD from Kyoto University and the University of Tokyo, and received his MD with honors from the George Washington University; he has authored over 50 peer-reviewed articles and currently serves as Invited Professor at the Graduate School of Medicine of Kyoto University and University of Osaka.

Takeshi Takahashi, MBA
Co-founder & Director

Mr. Takahashi is Managing Partner at Catalys Pacific. Prior to Catalys Pacific, he was an investment banker with Morgan Stanley for 12 years and played a significant role in over 30 distinguished transactions with an enterprise value of over US$15.0 billion. Prior to working for Morgan Stanley, Takeshi worked at Merrill Lynch’s asset management division.Takeshi graduated from Waseda University with a degree in Political Science and Economics, and holds an M.B.A. from Kellogg School of Management at Northwestern University. Proficiently bilingual and bicultural.

Nobuo Hanai, PhD
Director

Nobuo currently serves as Industry Advisor to Catalys Pacific. Prior to joining Catalys, he was Representative Director, President and CEO at Kyowa Kirin Co., Ltd. from 2012 to 2018. Thereafter, he served as Representative Director, Chairman and CEO in 2018 and as Director and Chairman in 2019.

As CEO of Kyowa Kirin, he led the development and launch of numerous innovative drugs including mogamulizumab (Potelligent™) and benralizumab (Fasenra™). Nobuo also successfully realized multiple partnerships with Japanese and global pharmaceutical companies along with several M&A transactions of biotech companies outside Japan.

After joining Kyowa Hakko Kogyo in 1976, he led R&D activities of its antibodies. In 2003, he founded BioWa, Inc. in the US in order to license technology related to antibodies, where he served as President and Chief Executive Officer and managed the company. After the inauguration of Kyowa Hakko Kirin, he led the development of various innovative compounds as a global head of R&D.

He received his undergraduate degree from the University of Tokyo and a doctorate degree from Yamaguchi University.

Jay Shepard
Co-founder & Director

Jay brings 35 years’ experience in the pharmaceutical/biotech and drug delivery industries with his extensive corporate leadership and multiple product successes to his role as Operating Partner. In addition to working for Catalys Pacific, he currently serves as Chairman of The Christopher and Dana Reeve Foundation and is on the board of directors of Esperion Therapeutics, Inovio Pharmaceuticals, and Craig Hospital.

Prior to his current positions, he joined Versartis as President and CEO in May 2015. In 2018 when Versartis merged with Aravive, he became CEO of the newly formed company until January of 2020 when he retired. He was an Executive Partner at Sofinnova Ventures until May 2015. Previously, he served as President and CEO of NextWave Pharmaceuticals (acquired by Pfizer), Ilypsa (acquired by Amgen), and interim CEO of Relypsa (Ilypsa’s spin-out company, which was acquired by Galencia). He has participated in or led over 16 product launches by preparing markets and establishing sales and marketing operations, having served as Vice President of Commercial Operations at Telik and Alza Pharmaceuticals (acquired by Johnson & Johnson).

He holds a B.S. in business administration from the University of Arizona.

Ken Haas, JD
Director

Ken Haas has spent 30 years in the management of both early-stage and public high technology and biotechnology companies. He has been with Abingworth since 2004 and currently serves as Partner.

He was part of the founding management team at IntelliGenetics, one of the world’s first bioinformatics companies and, from 1992 to 2001, was CEO of IntelliCorp, a publicly-traded enterprise software company.

At the beginning of his career he practised as an attorney in the business and technology group of Heller, Ehrman, White & McAuliffe, and has been Co-Chair of the Advisory Council to the Neuroscience Institute at Stanford.

He received his BA from Harvard College, an MA from the University of Sussex, a JD from Harvard Law School and attended the Advanced Management Program at Harvard Business School.

Hiroshi Sensaki
Director

SB Investment Advisers (Vision Fund) Vice President. Started the career at Goldman Sachs Asia Special Situations Group and Principal Strategic Investments, experiencing multi asset class investments. Led a corporate turnaround at SBI Japannext as Chief Operating Officer and Managing Director. Became a founding partner of YCP Holdings Ltd (listed on TSE Mothers in 2021), a strategic consulting company, and led the start up of the company and overseas expansion. Afterwards became Director CEO of ABC Cooking Studio Worldwide Ltd, a retail store chain operator, expanded in 8 countries in Asia. Joined Softbank Group in 2019, making investments in US, India and Japan at Principal Investment Department, then moved to Softbank Investment Advisers (Vision Fund) in 2021.

Masao Torii, MBA
Audit & Supervisory Board Member

Obtained BA at Loyola College in USA in 1971 and MBA at Sophia University in Japan in 1975. Also attended Advanced Management Program of Harvard Business School in 1992.

Masao Torii started his career in Nippon Roche K. K., a Japanese affiliate of Swiss pharmaceutical company in 1971 where he assumed increasing responsibilities up to Managing Director.

From 1993 till 2020, he had been President of Japanese affiliates of 4 global pharmaceutical companies, i.e., Rhone-Poulenc Roller, Inc.(French), Schering-Plough K. K.(American), Boehringer Ingelheim Japan (German) and Novartis Holding Japan K. K. (Swiss). He retired from Chairman of Novartis Pharma K.K. in 2021.

Yuko Kanamaru
Audit & Supervisory Board Member

Obtained LL.B. in 2002 and LL.M. in 2005 at Keio University in Japan, LL.M. in 2012 at University of California, Los Angeles, School of Law in the United States. Qualified lawyer in Japan (admitted in 2006) and in the New York, United States (admitted in 2013). With Rajah & Tann LLP, Singapore (2012-2013) and seconded to Sumitomo Electric Industries, Ltd. (2013-2014). Made partner at Mori Hamada & Matsumoto in 2018. Joined GAIEN PARTNERS in 2023.

Yuko is a partner from GAIEN PARTNERS. She is well-versed in advising and representing clients in a wide range of domestic and international disputes, including litigation, arbitration and labor tribunal proceedings. She also regularly advises clients on a range of corporate matters, such as formulation and implementation of internal rules, regulations and systems, and also product liability and personal information matters. Based on her experience at a top Japanese manufacturing company, she communicates and works very closely with clients to find and realize the best solutions for them.

MANAGEMENT


Co-founder & Director

Mr. Takahashi is Managing Partner at Catalys Pacific. Prior to Catalys Pacific, he was an investment banker with Morgan Stanley for 12 years and played a significant role in over 30 distinguished transactions with an enterprise value of over US$15.0 billion. Prior to working for Morgan Stanley, Takeshi worked at Merrill Lynch’s asset management division.Takeshi graduated from Waseda University with a degree in Political Science and Economics, and holds an M.B.A. from Kellogg School of Management at Northwestern University. Proficiently bilingual and bicultural.

Kikuo Tsukahara
Executive Officer, Chief Scientific Officer

Kikuo brings more than 40 years of experience in CNS drug development. From 2016 to 2019, he served as Head of Patient Safety, and from 2013 to 2016, served as Head of Clinical Development at Novartis. Throughout the tenure (2000-2019) at Novartis, Kikuo also served as Head of Clinical Operations as well as Group manager of CNS Clinical Research. Prior to Novartis, Kikuo served as Group Manager of CNS Clinical Research at Bayer. He graduated from Kyushu University with a degree in biology.

Madoka Iwamoto
Executive Officer, Chief Digital Officer

Madoka joined Sanofi (Aventis at the time) in 2004 and experienced various functions including Oncology Medical Affairs to manage post-marketing clinical studies/publication, Oncology Marketing, Business Intelligence, and Sales Force Effectiveness. Then she launched a new advanced analytics team focusing on commercial-related analytics, later expanding her scope to omni-channel marketing.

After moving to Novartis in 2019, she was responsible for the overall digital team, covering both omnichannel marketing and digital health solutions where she partnered with non-pharma companies to co-develop solutions for patients as well as caregivers. Believing in the potential of intersection of Digital and Healthcare, she joined Aculys in 2022 aspiring to deliver values to patients and the society leveraging data & digital.

She received bachelor’s degree in Environment and Information studies from Keio University.

Shinichiro Takeuchi, MS
Head of Regulatory Affairs and Clinical Strategy

Shinichiro brings 18 years’ experience in drug development especially as Project Leader and Regulatory Affairs Manager.

He previously served as Asia Pacific Regional Regulatory Leader at Janssen Pharmaceutical, especially responsible for neuroscience diseases such as Major Depressive Disorder and Multiple Sclerosis (2019-2021).

He developed most of his career in Novartis Pharma Japan. From 2016 to 2019, he served as Group Manager in the Regulatory Affairs Function Department and was responsible for maintaining/obtaining Marketing Authorization Holder, regulatory policy and process improvement. He also served as Regulatory Affairs Compound Responsible from 2013 to 2016 and Project Leader from 2008 to 2013. He worked for more than 30 compounds for these 8 years. Shinichiro also served as Project Manager (2007-2008), Portfolio Manager (2006) as well as Clinical Research Associate (2003-2006) in Novartis Pharma Japan.

He graduated from Graduate School of Bioscience and Biotechnology, Tokyo Institute of Technology with a master degree in bioengineering.

Junichi Onuma
Head of Clinical Development

Junichi brings 26 years’ experience in drug development from planning to operation in various therapeutic areas, such as oncology, cardiology, gynecology, ophthalmology, hematology.

Currently he is leading the clinical operations for Accerise, Chinese Bio-tech company. He is leading the establishment of the clinical operation team by setting up ICCC (In country Clinical Care-taker), forming the Operations Division of Accerise.

Prior to shifting his career to Bio-tech, he worked in clinical development department for Bayer for 25 years. He led the Clinical Trial Team and successfully managed Medical Experts, Data Managers, Statisticians CRAs and CROs and successfully negotiated with regulatory agents through, IND submission, PMDA consultations, NDA submission and registration.

He graduated from Toho University with a degree in molecule biology.

Yasutomo Teshima, MS
Head of Pharmacovigilance and post marketing surveillance

After joining Novartis Pharma K.K. as a new grad, Yasutomo worked in the company’s Safety Information Division; Package Insert Management Group, Regulatory Affairs Division; and Reexamination Division, primarily focusing on pharmacovigilance and post-marketing surveillance operations for ten years.
At the Safety Information Division, Yasutomo was in charge of the central nervous system area, an area which relates to his current work. He was also responsible for preparing and amending package inserts for the primary care, specialty medicines, oncology, and regenerative medicine areas at the Regulatory Affairs Divisions and for a broad range of operations including post-marketing surveillance planning to reexamination applications in the oncology area at the Reexamination Division. During the time, he actively participated in industry-wide initiatives and cross-functional taskforce activities and contributed to numerous achievements with internal and external associates, including authorship of a book.

Graduated Department of Biological Engineering, Graduate School of Basic Engineering, Tokyo University of Science.
A fan of hedgehogs.

Takuya Kumagai, MS
Head of Medical Strategy

Takuya brings 17 years’ commercial experience as Medical representative and Brand manager in various therapeutic area, such as Immunology, Allergy and Respiratory, in Novartis Pharma Japan.

Prior to joining Aculys, he served as a Marketing Group manager, leading the launch of new products and the new indications, as well as team management. Also, in order to meet the unmet medical needs of patients and caregivers, he collaborated with external partners to provide services and solutions which go “beyond the pill”, such as patient support and disease awareness program utilizing digital technology.

He graduated from Graduate School of Agricultural Science, Tokyo University of Agriculture with a master degree in Bioscience.

Shigeyuki Takakura
Head of Medical Promotion

Shigeyuki Takakura has a 30-year experience in the pharmaceutical industry as MR, sales manager, and MSL group manager, including team management experience in primarily commercial and medical divisions.

He has contributed to delivering not only pharmacological therapies but also various treatment options and comprehensive medical solutions by proposing them to physicians and paramedicals in a broad range of departments and therapeutic areas including infectious diseases, allergic diseases, oncology, immunology, organ transplantation, rare diseases, and skin diseases.

Before joining ACULYS, Shigeyuki experienced diverse corporate business models and cultures at major North American and European pharmaceutical companies as well as Japanese and Indian pharmaceutical companies, including Schering-Plough, Novartis Pharma, Bioverativ, and Sun Pharma (where he was temporarily seconded to Pola Pharma).

Shigeyuki graduated Shinshu University. Enjoys a variety of hobbies including particularly cars, with current interests in mountain climbing and amateur radio.

Corporate Overview

Company name
Aculys Pharma, Inc.
Date of establishment
January 22, 2021
Headquarters
the ARGYLE aoyama 6F, 2-14-4 KitaAoyama Minato-ku, Tokyo  Map
Number of employees
16 (as of September 1, 2024)
Representative
Hidemasa Tanigaki (Chief Executive Officer)
Main shareholders
Catalys Pacific, Softbank Vision Fund, HBM Healthcare Investments, GFC, Sumitomo Mitsui Trust Investment, ANRI, JIC Venture Growth Investments, Mitsubishi UFJ Capital, Spiral Capital
Business description
Development, import, manufacturing, and sales of prescription pharmaceuticals

Fund Raising

In March 2022, 14 months after the company was founded, ACULYS procured a cumulative total 9.6 billion yen in funding from venture capitalists in and outside of Japan experienced in the healthcare industry.

History

January 2021
Founded Aculys Pharma, Inc.
July 2021
Entered into a licensing agreement with French Bioprojet SCR on exclusive development and commercialization rights in Japan for the histamine H3 receptor antagonist / inverse agonist pitolisant
October 2021
Series A funding resulted in JPY 6.8B procured
November 2021
Entered into a licensing agreement with US Neurelis on exclusive development and commercialization rights in Japan and Asia-Pacific region for the nasal spray diazepam
January 2022
Initiated Phase 1 clinical trial for pitolisant
March 2022
Series B funding round resulted in JPY 2.8B
September 2022
Initiated Phase 1 clinical trial in Japan for diazepam nasal spray​
November 2022
Initiated Phase 3 clinical trial in Japan for diazepam nasal spray in patients with epileptic seizures, Initiated Phase 3 clinical trial in Japan for pitolisant in patients with narcolepsy
January 2023
Initiated Phase 3 clinical trial in Japan for pitolisant in patients with obstructive sleep apnea syndrome who have excessive daytime sleepiness
August 2024
Filed New Drug Application for Diazepam Nasal Spray in Japan