Solasia Announces Approval of episil® (oral liquid) in Japan
2017年7月7日 - 08:32PM
ビジネスワイヤ(英語)
Solasia Pharma K.K. (TSE: 4597, Headquarters: Tokyo, Japan,
President & CEO: Yoshihiro Arai, hereinafter “Solasia”)
announced today that episil® (SP-03) has been approved for the
management of pain and relief of pain, soothing oral lesions
including oral mucositis/stomatitis caused by chemotherapy and/or
radio therapy by the Ministry of Health, Labour and Welfare.
Solasia will target to obtain reimbursement of episil® and
thereafter be commercialized, distributed and promoted by its
partner, Meiji Seika Pharma K.K.
episil® oral liquid is the first approved product in Japan for
local treatment of pain associated with oral mucositis (OM) for
cancer patients undergoing chemotherapy and radiotherapy. In 2016,
Solasia has obtained an exclusive license to develop and
commercialize episil® in Japan and China from Camurus AB
(“Camurus”) (STO: CAMX). In May 2016, Solasia filed for New Medical
Device Application for episil® in China.
About episil®:
episil® was developed using Camurus’s proprietary
technology FluidCrystal®. episil® is administered as
a lipid-based liquid that spreads on the intra-oral mucosal
surfaces and transforms to a strongly bioadhesive film that
mechanically protects the sensitized and sore mucosa of the oral
cavity. Clinically demonstrated, episil® has been shown to
rapidly (within minutes) and effectively reduce oral pain for up to
8 hours. episil® oral liquid is the only product for OM that
is supplied as a ready-to-use, pocket-sized device helping patients
maintain their quality of life while undergoing cancer therapy.
episil® was first launched in Europe in 2009 and is today
commercially available in a number of countries, including the U.S.
where it was launched by key global pharmaceutical players.
episil® oral liquid is a medical device class 1 in Europe
and a 510(k) registered medical device in the U.S.
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.
Additional information is available at
http://www.solasia.co.jp/en/
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version on businesswire.com: http://www.businesswire.com/news/home/20170707005258/en/
For Solasia Pharma K.K.Rie Toyoda,
+81-3-6721-8317Investor Relationsinfo@solasia.co.jporAnnes
AssociatesShari Annes,
+1-650-888-0902sannes@annesassociates.com