Rakuten Medical Announces Acquisition of Medlight SA

Strategic Acquisition Assures Reliable Supply of High-Quality Fiber Optic Diffusers for the Illuminox™ Platform

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Aug 19, 2020, 09:30 ET

SAN MATEO, Calif., Aug. 19, 2020 /PRNewswire/ -- Rakuten Medical, Inc. announced today the acquisition of Medlight SA. Medlight produces and commercializes a large range of catheters and diffusers for optical light delivery. The terms of the deal were not disclosed.

The acquisition of Medlight provides Rakuten Medical with a strategic partner, including resources and its network of well-qualified subcontractors to facilitate rapid development of new optical devices under the European and US medical regulatory standards. This acquisition also ensures Rakuten Medical has access to and more comprehensive oversight of a supply chain vital to the development of the company's diagnostics and therapeutic light technologies.

Previously Medlight served as a contract manufacturer for Rakuten Medical's device finishing facility in Germany. Medlight was also a labeler for clinical trial materials and provided QA oversight for upstream manufacturing activities.

Founded in 1997, Medlight technologies have been used by more than 35 biotech companies in over 70 different diagnostic and therapeutic applications. Though cancer is the primary therapeutic indication, Medlight's technologies have also been applied to treat cardiovascular diseases, Parkinson's disease, ophthalmic, dermatologic, and dental diseases.

Medlight has a strong track record of working cooperatively with health care professionals, industrial partners, academic institutions, and pharmaceutical companies to develop specific medical devices for therapeutic light delivery. Headquartered just outside of Lausanne, Switzerland, Medlight's proximity to Rakuten Medical's device development group in Sinn-Fleisbach, Germany provides additional logistic benefits.

"Medlight is an ideal acquisition, as they are global leaders in the development of light dosimetry technologies for a variety of diseases," said Hiroshi Mikitani, Chairman and CEO of Rakuten Medical. "This acquisition secures our supply chain, ensuring the needs of patients are met by optimizing and managing continuous improvement of our delivery system."

Founder and CEO, Medlight SA, Roland Bays commented, "Our agreement with Rakuten Medical is a strategic and operational fit. We are very excited to combine our innovative technologies to yield the maximum benefit to the medical community, the patients, and families that are battling cancer."

About Rakuten Medical, Inc.

Rakuten Medical, Inc. is a global biotechnology company developing precision, cell-targeting investigational therapies on its Illuminox^TM platform, which, in preclinical studies have shown to lead to rapid and selective cell killing and tumor necrosis. Illuminox therapies have not yet been approved by any regulatory authority. Rakuten Medical is committed to its mission to conquer cancer and aims to realize a society where cancer patients can lead fulfilling lives. Headquartered in the United States, Rakuten Medical has 6 locations in 5 countries, including Japan, the Netherlands, Germany and Taiwan. For more information, visit www.rakuten-med.com.

About ASP-1929

Since 2013, Rakuten Medical, Inc. has been using technology exclusively licensed from the National Cancer Institute (NCI) to develop new cancer therapies based on its Illuminox^TM technology platform. Rakuten Medical's first pipeline drug developed on Illuminox is ASP-1929, an antibody-drug conjugate comprised of the antibody cetuximab and IRDye® 700DX, a light activatable dye. ASP-1929 binds to epidermal growth factor receptors (EGFR), a cancer antigen expressed in multiple types of solid tumors, including head and neck cancer, esophageal cancer, lung cancer, colon cancer, and pancreatic cancer. After binding to cancer cells, ASP-1929 is locally activated by non-thermal red light (690 nm) illumination emitted by an investigational laser device system. Pre-clinical data indicate that Illuminox technology induces a biophysical process that compromises cell membrane integrity, leading to cancer cell death and tumor necrosis. ASP-1929, has achieved Fast Track designation from the FDA and Sakigake Designation from the Japanese Ministry of Health, Labour, and Welfare and is currently under investigation in a global phase 3 clinical trial for recurrent head and neck cancer. Rakuten Medical, Inc. is moving forward with product development by conducting clinical trials of monotherapy and combination therapy with other drugs. ASP-1929 has not yet been approved by any regulatory authority.

About Illuminox^TM

The Illuminox platform is an investigational platform based on a cancer therapy called photoimmunotherapy, which was developed by Dr. Hisataka Kobayashi and team from the National Cancer Institute in the United States. Rakuten Medical is developing the Illuminox platform as a technology consisting of a drug, device and other related components. The drug component of the platform consists of a targeting moiety conjugated with one or more dyes leading to selective cell surface binding. The device component consists of a light source that locally illuminates the targeted cells with non-thermal light to transiently activate the drug. Pre-clinical data have shown that this activation elicits rapid and selective necrosis of targeted cells through a biophysical process that compromises the membrane integrity of the targeted cells. Therapies developed on Illuminox may also result in local and systemic innate and adaptive immune activation due to immunogenic cell death of the targeted cells and/or the removal of immunosuppressive elements within the tumor microenvironment. Illuminox therapies have not yet been approved as safe or effective by any regulatory authority.

Forward Looking Statements

This press release contains forward looking statements that correspond to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. These statements include various risks, uncertainties, and assumptions that may cause Rakuten Medical's business plans and results to differ from the anticipated results and expectations expressed in these statements. These "forward looking statements" contain information about the status and development of our products, including ASP-1929, and other regulatory and marketing authorization efforts. The approval and commercial success of the product may not be achieved. Forward looking statements relate to the potential benefits, efficacy, and safety of ASP-1929, and the status of regulatory filings. Such statements may include words such as "expect," "believe," "hope," "estimate," "looks as though," "anticipate," "intend," "may," "suggest," "plan," "strategy," "will," and "do", and are based on our current beliefs. In addition, this press release uses terms such as "important," "notable," and "abnormal" to express opinions about clinical trial data. Ongoing clinical trial studies include various risks and uncertainties, in particular, problems that arise during the manufacturing stage of ASP-1929, the occurrence of adverse safety events, situations in failure to demonstrate therapeutic benefits, and other various risks and uncertainties, both reasonable and unreasonable. For this reason, actual results, including regulatory approvals and uncertainties in the commercialization process of ASP-1929, may differ from published information. Except to the extent required by applicable law, we undertake no obligation to publicly update this or any other forward-looking statement, whether because of new information, future developments or events, changes in assumptions, changes in the factors affecting forward-looking statements. If one or more forward-looking statement(s) is updated, no inference should be drawn that additional updates will be made to those or other forward-looking statements.

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SOURCE Rakuten Medical, Inc.