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Biopharmaceuticals Oncology Regulatory

 News Release - September 25, 2020

Rakuten Medical Japan Announces Marketing Approval of Akalux(R) IV Infusion 250mg and BioBlade(R) Laser System from the Ministry of Labour, Health and Welfare in Japan for Locoregional Cancer Treatment

SAN MATEO, Calif., Sept. 25, 2020 -- (Healthcare Sales & Marketing Network) -- Rakuten Medical Inc. is proud to announce that its wholly owned subsidiary Rakuten Medical Japan K.K. has received marketing approval in Japan from the Ministry of Health, Labour and Welfare for Akalux® IV Infusion 250mg (cetuximab saratolacan sodium) to treat unresectable locally advanced or recurrent head and neck cancer. BioBlade® Laser System, the medical device used in the combination with Akalux, was also approved on September 2nd. This combination was developed under the Rakuten Medical Illuminox™ platform. Akalux received Sakigake Designation in April 2019, and application for approval under the Conditional Early Approval System was made in March 2020. Outside of Japan, Rakuten Medical does not have approval of its investigational therapies and is currently running a global Phase 3 trial.

Hiroshi Mikitani, Representative Director and Chairman of Rakuten Medical Japan K.K. commented, "In my search for a treatment for my father who was diagnosed with cancer, I encountered a treatment developed by a Japanese researcher. Now, we are moving forth to deliver this treatment to patients fighting with cancer, as soon as possible. Today, we are deeply moved to receive approval in Japan ahead of the world. However, this is just the beginning of Rakuten Medical's mission. We are dedicated to contribute to cancer treatment and improving the quality of life of as many patients as possible around the world. By bringing everyone together, we will continue to aspire to achieve our corporate mission 'to conquer cancer.'"

About Rakuten Medical

Rakuten Medical, Inc. is a global biotechnology company developing precision, cell-targeting investigational therapies on its Illuminox™ platform, which, in pre-clinical studies have shown to lead to rapid and selective cell killing and tumor necrosis. Outside of Japan, the therapies based on Illuminox platform have not yet been approved as safe or effective by any other regulatory authority. Rakuten Medical is committed to its corporate mission to conquer cancer. Headquartered in the United States, Rakuten Medical has 7 locations in 6 countries, including Japan, the Netherlands, Germany, Taiwan, and Switzerland. For more information, visit https://rakuten-med.com/us/.

About the Illuminox™ platform

The Illuminox platform is an investigational treatment 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 excite (activate) the drug. Pre-clinical data have shown that this excitation (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 microenvironment.

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.


Source: Rakuten Medical

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