Innovacell has established a capital and business alliance with Alfresa Corporation with an investment of 1 billion yen and has signed a basic business partnership agreement for the sales of the flagship product ICEF15.

Innovacell K.K. (Head Office: Shinagawa-ku, Tokyo; Representatives: Colin Lee Novick, CEO, and Jason David Sieger, COO; hereafter “Innovacell”), a company aiming to improve people’s health and quality of life (QOL) by developing regenerative medicine products to treat diseases with significant unmet medical needs, has entered into a capital and business alliance with Alfresa Corporation (Head Office: Chiyoda-ku, Tokyo; CEO: Yusuke Fukujin; hereafter “Alfresa”), a subsidiary of Alfresa Holdings Corporation. This alliance includes a 1-billion-yen investment.

Innovacell is currently conducting a Phase III Japan-Europe international joint clinical trial for its regenerative medicine product “ICEF15,” which targets the treatment of urgent fecal incontinence. In parallel, the company is building a framework for launching and selling ICEF15 in Japan, the U.S., and Europe. Innovacell is also in the process of Series D fundraising with the goal of an early close, actively negotiating with domestic and international investors.

Meanwhile, the Alfresa Group has formulated its mid-to-long-term business and financial strategy, “Alfresa Group Mid-to-Long-Term Vision,” aiming to strengthen its core businesses, foster growth industries, and develop new businesses. As the core company of the Alfresa Group, Alfresa Corporation operates a pharmaceutical wholesale business. Within its new business initiatives, the group is working on building a “regenerative medicine supply chain,” including the establishment of Cell Resources Inc., which provides domestically produced cell raw materials (master cells) and manufactures processed cell products for both autologous and allogeneic use. For storage and transportation, Alfresa has set up two regenerative medicine distribution stations and ten product storage facilities, creating an environment capable of handling distribution and continuously improving logistics expertise.

On November 19, 2024, Innovacell signed a basic business partnership agreement with Alfresa Corporation, granting Alfresa exclusive wholesale distribution rights for ICEF15 in Japan. This agreement enables Innovacell to steadily prepare for the domestic launch of ICEF15, which is in its final development stage, and deliver this innovative treatment to patients as soon as possible. Through this partnership, the companies will also explore collaboration on the commercialization of ICEF15 in Japan and the manufacturing and distribution of other pipeline products.

As part of the Series D fundraising, Innovacell will issue 1,176,471 common shares to Alfresa (equivalent to 4.2% of the total shares issued immediately after the transaction), raising 1 billion yen. Innovacell plans to use these funds to advance the Phase III Japan-Europe trial of ICEF15, prepare for the U.S. Phase III trial, build a manufacturing system for ICEF15 in Japan, conduct R&D for other pipeline products, and accelerate preparations for going public.

“With the development of our flagship product ICEF15 entering its final stage, we are now at a critical point where we are beginning to build the infrastructure needed to deliver ICEF15 to patients. At this important juncture, we are deeply grateful and pleased to have formed a capital and business alliance with Alfresa Corporation, a company that is actively investing and leading infrastructure development under a strong commitment to advancing Japan’s regenerative medicine market. As a company that shares Alfresa’s vision, we look forward to exploring further collaboration opportunities and are excited about what lies ahead.”

The Alfresa Group, led by its pure holding company Alfresa Holdings Corporation, operates businesses ranging from the development and manufacturing of pharmaceuticals to distribution and pharmacy management. With consolidated sales exceeding 2.8 trillion yen, it is Japan’s No.1 pharmaceutical wholesaler. The group’s philosophy is “Delivering vibrant lives to everyone,” and its more than 15,000 employees in Japan and abroad support the entire pharmaceutical supply chain, contributing to a wide range of medical needs.

Note: The Alfresa Group refers to its employees as “people working together.”

Alfresa Holdings Corporation Overview
Name: Alfresa Holdings Corporation
President & CEO: Takaharu Arakawa
Business: Management of subsidiaries engaged in wholesale, manufacturing, import/export, and pharmacy operations related to pharmaceuticals, medical devices, and health products
Established: September 2003
Capital: ¥18.454 billion
Employees: 15,557 (as of March 31, 2024, consolidated)
Headquarters: 1-1-3 Otemachi, Chiyoda-ku, Tokyo
URL: http://www.alfresa.com

Since its founding in 2004, Alfresa has been supplying medical pharmaceuticals to hospitals and pharmacies for 20 years, contributing to public health through various services. In addition to pharmaceuticals, it procures medical devices, diagnostic reagents, and nutritional products from around 1,000 domestic and international manufacturers, delivering them safely and reliably to healthcare institutions. Leveraging its network of approximately 170 locations nationwide, Alfresa supports the development of community-based integrated care systems tailored to regional needs. It also provides information services and solution tools to improve operational efficiency and healthcare quality.

Name: Alfresa Corporation
President & CEO: Yusuke Fukujin
Business: Wholesale of medical pharmaceuticals, medical devices, diagnostic reagents, nursing care products, health foods, and OTC drugs
Established: August 1949
Capital: ¥4 billion
Employees: 5,834 (as of March 31, 2024)
Headquarters: 7 Kanda-Mitoshirocho, Chiyoda-ku, Tokyo
URL: http://www.alfresa.co.jp

Innovacell originated as a regenerative medicine startup spun out from the Medical University of Innsbruck in Austria (now Innovacell GmbH). Innovacell Inc. was established in Japan in 2021 as the parent company of the Austrian entity.

The Innovacell Group aims to improve health and QOL through the commercialization of regenerative medicine. It is currently engaged in R&D and commercialization of products to treat urgent fecal incontinence, passive fecal incontinence, and stress urinary incontinence.

The group’s flagship product, ICEF15, is designed to cure urgent fecal incontinence by locally injecting myoblasts prepared from the patient’s own skeletal muscle tissue to regenerate muscle. ICEF15 is the most advanced product in the group’s pipeline and is currently undergoing the Fidelia Phase III international joint trial in Japan and ten European countries. Additionally, Innovacell GmbH has completed multiple clinical trials in Europe, including two late Phase II trials for ICEF15 and ICES13 (targeting stress urinary incontinence).

URL: https://www.innovacell.co.jp