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Solasia Announces Approval of episil® oral liquid in South Korea

2019年10月21日 PM08:23
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TOKYO

Solasia Pharma K.K. (TSE: 4597, Headquarters: Tokyo, Japan, President & CEO: Yoshihiro Arai, hereinafter “Solasia”), a specialty pharmaceutical company based in Asia, today officially announced that episil® oral liquid (SP-03, hereinafter “episil®”) which intended use is to protect the oral wounds by forming a protective film, has been approved by the National Institute of Medical Device Safety Information (NIDS) in South Korea.

episil® has a mechanical action indicated for the management of pain and relief of pain in the oral cavity caused by chemotherapy and/or radiotherapy, and is the only ready-to-use, pocket-sized medical device for such indication. episil® is to provide a new pain relief treatment option for patients with oral mucositis also in South Korea.

In 2015, Solasia obtained the exclusive licenses to develop and commercialize episil® in Japan and China from Camurus AB (STO:CAMX). In 2018, Solasia obtained the right for South Korea. In July 2017, episil® was approved in Japan by the Ministry of Health, Labour and Welfare, with newly indication for the management of pain and relief of pain, soothing oral lesions including oral mucositis caused by chemotherapy and/or radiotherapy. Following approval, episil® was launched in Japan in May 2018. In China, episil® was approved by the National Medical Products Administration (NMPA, formerly CFDA) in February 2019, and launched in July 2019.

For the commercialization of episil® in South Korea, Solasia will launch it through a commercial partner. Solasia is currently negotiating with some Korean companies and plans to make a formal announcement upon its decision.

About episil®
episil® uses the patented FluidCrystal® technology from Camurus AB (STO:CAMX), Sweden. It is a lipid-based, preservative-free liquid that adhere to the oral mucosa. Clinically demonstrated, episil® has been shown to rapidly (within minutes) and effectively reduce oral pain for up to 8 hours. It provides physical protection to the oral sensitive and ulcerated epithelium. episil® is the only ready-to-use, pocket-sized medical device that manages and relieves oral mucositis, expected helping patients suffering from oral pain to improve the quality of life (QOL). episil® was first registered in Europe in 2009 and is now launched in the United States, Europe, Japan and other countries. episil® oral liquid is registered as Class I medical device in Europe, 510(k) medical device in the United States, and approved as Class II medical device in Japan and China.

For more information about episil®, please access Camurus AB, episil® website: https://www.episil.net/

About Solasia
Solasia is a specialty pharmaceutical company based in Asia, with a mission of “Better Medicine for a Brighter Tomorrow”. In order to address the unmet medical needs within the oncology area, we develop innovative medicines to contribute to the patient’s healthy living and to provide treatment options for the healthcare providers.

For more information about the company, please visit www.solasia.co.jp/en/

View source version on businesswire.com: https://www.businesswire.com/news/home/20191021005339/en/

CONTACT

Solasia Pharma K.K.

Rie Toyoda, Public Relations and Investor Relations

Tel: +81 3 5843 8049 (Japan)

info@solasia.co.jp

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