Solasia Files New Medical Device Application for episil® in South Korea

TOKYO–(BUSINESS WIRE)–lt;a href="https://twitter.com/hashtag/OM?src=hash" target="_blank"gt;#OMlt;/agt;–Solasia Pharma K.K. (TOKYO:4597, Headquarters:Tokyo, Japan, President &
CEO:Yoshihiro Arai, hereinafter “Solasia”), a specialty pharmaceutical
company based in Asia, today officially announced that the Company has
filed a New Medical Device Application for episil® oral liquid (SP-03,
hereinafter “episil®”) to the Regulatory Authority in South Korea.

episil® has a mechanical action indicated for the management of pain and
relief of pain in the oral cavity, and is the only ready-to-use,
pocket-sized medical device for such indication. As there are currently
no standard treatment for oral mucositis which may be caused by
chemotherapy and/or radiotherapy, episil® is expected to provide a new
pain relief treatment option for patients with oral mucositis in South
Korea.

In 2015, Solasia obtained an exclusive license 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 the 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® has been approved by the National Medical
Products Administration (NMPA, formerly CFDA) in February 2019.

Yoshihiro Arai, President and Chief Executive Officer, Solasia, said:
“Solasia company mission is ‘Better Medicine for a Brighter Tomorrow’.
We have always focused on the patients, and striven to develop
innovative products to treat cancer and support cancer treatment. We
continue to bring ‘quality medicines’ to the market, to benefit more
patients in Asian countries. The filing of episil® will help Solasia to
deliver its unwavering commitment to South Korean patients. All of team
members will continue to work hard to meet the needs of patients and
healthcare professionals and embrace new challenges going forward.”

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, helping
patients improve the quality of their daily lives during cancer
treatment. 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/

Contacts

Solasia Pharma K.K.
Rie Toyoda, Public Relations and
Investor Relations
Tel: +81 3 5843 8049 (Japan)
[email protected]