Tillotts Pharma AG's Parent Company Zeria Pharmaceutical Receives Approval for Zentacort(R) 3mg Capsules in Japan

PR66046

RHEINFELDEN, Switzerland, Oct 6, 2016 /PRNewswire=KYODO JBN/ --

      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."

    About Tillotts

    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.

    About Zeria

    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.

    (c) Copyright Tillotts Pharma AG. All rights reserved.

     Tillotts Pharma AG media contact:

     Suzanne Rouden

     Corporate Communications Manager a.i.

     Phone: +41(0)61-935-2749

     Email: srouden@tillotts.com

     http://www.tillotts.com

SOURCE: Tillotts Pharma AG