RHEINFELDEN, Switzerland, December 14, 2016 /PRNewswire/ --
Zeria Pharmaceutical Co., Ltd launched Zentacort(R) 3mg capsules (generic name: Budesonide) in Japan on November 29, 2016. Zentacort(R) is sold as Entocort(TM) in more than 40 countries and recommended as first line therapy for treatment in Crohn's Disease (CD) in various international guidelines. Zentacort(R) has an indication for the treatment of mild to moderate active CD and is now listed on the NHI drug reimbursement price list in Japan.
The Study Group on Unapproved and Off-label Drugs of High Medical Need, operating under the Japanese Ministry of Labour, Health and Welfare (MHLW), concluded that there was a substantial need to make Zentacort(R) available for use in treatment in Crohn's disease in Japan. Responding to a request from the MHLW, AstraZeneca started the development of Zentacort(R) in December 2010. Following the acquisition of the worldwide rights to Entocort(TM) (except the USA) by Tillotts Pharma (a wholly-owned subsidiary of Zeria Pharmaceutical) in July 2015, Zeria submitted the new drug application in October 2015 and received the approval in September 2016.
Product name in Japan: Zentacort(R) 3mg capsules
Generic name: Budesonide
Indication: Mild to moderate active Crohn's Disease
Dosage and administration: Usually for adults, 9mg is orally administered once a day in the morning.
Package Zentacort(R) 3mg capsules: 100 capsules/bottle
Date of approval: 28 September 2016
Date of listing price：18 November 2016
Date of launch 29 November 2016
Drug price: Zentacort(R) 3mg Capsules 256.90 yen
Approval holder: Zeria Pharmaceutical Co., Ltd.
Tillotts Pharma AG, part of the Japanese Zeria Group, is a fast-growing specialty pharma company with over 250 employees in Switzerland and abroad. Tillotts is dedicated to the development, in/out-licensing and commercialisation of innovative pharmaceutical products for the digestive system. Tillotts successfully markets its own products Asacol (TM) and Entocort(TM), as well as in-licensed products, in over 65 countries through its affiliates within Europe and a network of gastroenterology-focused partners throughout the world.
All trademarks used or mentioned here are protected by law. The trademark Entocort(TM) is registered in over 45 countries as Entocort(TM) and as Entocir(R), Entocord(R), Budecol (R), and Zentacort(R) in Italy, Spain, Greece, and Japan, respectively (transfer of registrations to Tillotts pending in certain countries). The rights to Entocort, including the rights to the trademark, are owned by Tillotts Pharma AG in various countries (transfer of market authorisations to Tillotts Pharma in process) except for the USA.
Product information in this release is limited, with the aim of providing a summary for general information purposes for a wide audience regarding the activities of Tillotts. More information may be available from local regulatory authorities, but not all products are available in each country. Please consult a healthcare professional for further information.
Zeria Pharmaceutical Co., Ltd., founded in 1955, based in Tokyo, Japan, focuses on R&D, manufacturing and sales of prescription drugs as well as OTC products. The company is listed on the First Section of Tokyo Stock Exchange (Stock code: 4559). Zeria holds a leading position within the gastroenterology field in Japan and operates internationally through a number of subsidiaries.
For more information about Zeria please visit http://www.zeria.co.jp.
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