Publicado 06/10/2016 14:04:09CET
RHEINFELDEN, Switzerland, October 6, 2016 /PRNewswire/ --
Zeria Pharmaceutical Co., Ltd. has received the approval for a new drug application for Zentacort 3mg capsules from the Ministry of Health, Labour and Welfare (MHLW) in Japan for the indication of the improvement of Crohn's Disease (CD). Following the acquisition of the worldwide rights to Entocort(TM) except the USA from AstraZeneca in July 2015, Zeria submitted the new drug application in October 2015 in Japan. Zentacort is sold as Entocort (generic name: budesonide) by Tillotts in more than 40 countries and recommended as first line therapy for treatment in CD in many international guidelines.
Zentacort was submitted in Japan after a special committee for the use of unapproved and off-label drugs with high unmet medical needs, operating under the Japanese MHLW, highlighted that there was a substantial need to make Zentacort available for the treatment in CD. AstraZeneca responded to the request from the Japanese MHLW and started the development of Zentacort in December 2010.
Zentacort is an enteric-coated sustained release formulation designated to release budesonide in the small intestine and the proximal colon. It is indicated for the treatment of mild to moderate active CD and, in some markets, ulcerative colitis (UC).
Zentacort is sold by Tillotts as Entocort in more than 40 countries for CD and, in some markets, ulcerative colitis (UC). CD and UC are types of inflammatory bowel diseases (IBD), one of the most prevalent gastrointestinal (GI) diseases, affecting over 2.2 million people in Europe and 5 million worldwide.
Tillotts CEO Thomas Toth von Kisker commented: "Tillotts is pleased that Zentacort will be introduced in Japan through Zeria. This approval further reinforces Tillotts' commitment as a leading specialist in the field of gastroenterology on a European and worldwide basis, offering patients a broad range of treatments for GI diseases."
Zeria expects that the approval of this new drug will make a significant contribution to treatment of mild to moderate CD in Japan. Sachiaki Ibe, Chairman of Tillotts and CEO of Zeria, declared: "We are extremely happy to introduce a product such as Zentacort in Japan, where the prevalence of CD is increasing, and to offer patients a well-established treatment."
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. Tillotts Pharma AG's trademarks include Tillotts(R), Asacol(TM), Octasa(TM), Fivasa(TM), Lixacol(TM), Asacolon (TM), Colpermin(TM), VistaPrep(TM), Entocort(TM), Entocir(TM), Entocord(TM) and Budecol(TM) and are either registered or applied for in up to 70 countries (transfer of registrations to Tillotts pending in certain countries). The rights to Asacol, including the rights to the trademark, are owned by Tillotts in various countries except for the following: Belgium, Canada, Italy, Luxembourg, the Netherlands, Switzerland, United Kingdom and USA. The rights to Colpermin, including the rights to the trademark, are owned by Tillotts in various countries except for the following: Ireland and United Kingdom. The rights to Entocort, including the rights to the trademark, are owned by Tillotts in various countries (transfer of market authorisations to Tillotts Pharma in process) except for the USA. Simtomax is distributed by Tillotts in Denmark, Finland, Germany, Ireland, Norway, Spain, Sweden and the UK.
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, and could contain product details or information not accessible or valid in your country. Tillotts disclaims responsibility for access of information which may not comply with any regulation or standard in any particular country.
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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