Tillotts Pharma AG's Parent Company Zeria Pharmaceutical Launches Zentacort(R) 3mg Capsules in Japan for Treatment in Crohn's Disease

PR66887

RHEINFELDEN, Switzerland, Dec 14, 2016 /PRNewswire=KYODO JBN/ --

      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 Summary

    Product name in Japan: Zentacort(R) 3mg capsules

    Generic name: Budesonide

    Formulation: Capsules

    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.

    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. 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.

    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: Tillots Phama AG