Company

ACULYS is addressing the drug lag and the tackling social issues on behalf of patients. The following describes the social challenges that ACULYS addresses and features of ACULYS’s business.

Our Vision

Resolving social issues associated with neurological diseases

ACULYS’s corporate purpose is to serve as a catalyst for patient access to innovative medical means in the neurology area and deliver better medicine to patients, their families, workers in healthcare, and the society. We work toward resolving unmet medical needs by delivering to the Japanese market innovative medicines approved outside of Japan.

Social challenges that ACULYS is addressing

Drug lag, faced by patients

Due to Japan’s unique regulatory requirements and approval processes, it can take significantly longer for new drugs to receive approval and become available for use in Japan than in other countries. This delay can be a significant challenge for patients and their families, who may not have access to the latest and most effective treatments for their condition. This gap has been increasing from 2016.

According to a study on new drugs containing new active ingredients approvals in Japan and EU/US, as of 2020, 72% of pharmaceuticals approved in EU and the US in the last five years remain unapproved in Japan, totaling 176 treatments*. This delay can be a significant challenge for patients and their families, who may not have access to the latest and most effective treatments.

* Article on drug lag highlighting domestic unapproved drugs and their characteristics; Office of Pharmaceutical Industry Research News No.63 (July 2021 issue); Office of Pharmaceutical Industry Research

Annual Changes in the number of domestic unapproved drugs and their percentage (total for the last five years)

Drug loss, from the underdevelopment of new drugs in Japan

As of 2020, out of 176 pharmaceutical products that had not been approved in Japan, 33 had gained approval by 2023, leaving 143 products still unapproved. Furthermore, 86 of these unapproved products remain in a state of “drug loss,” with no development having commenced.

Source: https://www.jpma.or.jp/information/evaluation/symposium/ bbh7c90000001esq-att/2023_11_17_02.pdf

Of the 86 drug-loss products, 84% fall into the categories of products either developed by emerging pharmaceutical companies, designated orphan drugs, or indicated for pediatric use. Additionally, as indicated in blue, many of the drug-loss products are highly innovative medications meaning no drugs with the same mechanism of action available for the disease.

Breakdown of 86 drug loss products

Bold font:No drugs with the same mechanism of action available for the disease
(Disease are estimated based on the mechanism of action described in Evaluate and the FDA’s PI.)

Source: https://www.jpma.or.jp/information/evaluation/symposium/
bbh7c90000001esq-att/2023_11_17_02.pdf

Neurology: An Area of Significant Unmet Medical Needs in Japan

In Neurology, the number of pharmaceuticals approved in EU/US but not in Japan has doubled from 11 items in 2016 to 22 items in 2020.¹,and the gap continues to grow. Patient satisfaction and drug efficacy scores remain low ², highlighting further unmet medical needs. Challenges in the disease area include not only a limitation in treatment options but also a broad range of issues that need to be resolved from a socioeconomic perspective, such as the adverse effects on patients’ social lives due to delayed diagnoses and the burden on family members or caregivers.

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

Representative

Sun-A Kim (Chief Executive Officer)

Business description

Development, import, manufacturing, and sales of prescription pharmaceuticals

History

January 2021

Aculys Pharma, Inc. founded by Catalys Pacific

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

March 2025

Series C funding round resulted in JPY 4.4B

June 2025

Received marketing approval for Diazepam Nasal Spray (Spydia® Nasal Spray) in Japan

References: 1. Article on drug lag highlighting whether drugs unapproved in Japan can satisfy unmet medical needs; Office of Pharmaceutical Industry Research News No.66 (July 2022 issue); Office of Pharmaceutical Industry Research 2. 2021 Report on study of domestic base technology (https://u-lab.my-pharm.ac.jp/~soc-pharm/achievements/img/index/r03.pdf); Social Pharmacy, Meiji Pharmaceutical University, and Office of Pharmaceutical Industry Research, Japan Pharmaceutical Manufacturers Association