| Prioritized Areas |
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| Developing World-Class Drugs |
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Central Research Laboratories
(Kumagaya-shi, Saitama) |
Arecent trend in R&D Ractivities for new drugs is the growing importance of basic research due to advances in drug discovery technologies based on genome information and progress in molecular medicine. Concurrently, the development process has also evolved, becoming more sophisticated and globalized.
To achieve world-class drugs, Zeria concentrates its drug discovery activities in the Research and Development Division, which includes the Central Research Laboratories. We are also engaged in carrying out international clinical trials for our own original drugs as well as strengthening our new drug pipeline by seeking opportunities for in-licensing drugs that have sales track records in overseas markets.
Determined to enhance our range of candidates for original, safe and effective new drugs, we are conducting collaborative research with universities, research facilities and medical institutions from the earliest stages.
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| Focusing on Gastrointestinal Diseases |
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Our targets in R&D initiatives for ethical drugs are high-needs gastrointestinal diseases, such as functional dyspepsia (FD), inflammatory bowel disease (IBD) and irritable bowel syndrome (IBS). Of particular note, simultaneous clinical development is currently being conducted in Japan, the United States and Europe for Zeria’s own original product, Z-338 (a drug for functional dyspepsia). In tandem, we are in-licensing ethical drugs that are well established overseas and conducting domestic development. In addition, we pursue life cycle management such as the addition of new dosage forms and indications to existing drugs.
For cultivating subsequent national brands to Chondroitin ZS Tablets, our leading product in the Consumer Healthcare business, we are dedicated to conducting development centered on our OTC drugs are dedicated to conducting development centered on our OTC drugs supplements, cosmetics and beauty supplements.
Efforts in developing and commercializing OTC drugs entail certain challenges, such as Rx-to-OTC switched drugs and direct OTC drugs that contain novel ingredients that have never been used not only for OTC products but also for ethical drugs in Japan, such as herbal medicines. |
| Top Level Achievements and Valuation Recognized in the Gastrointestinal
Field |
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| Pushing Forward with International Clinical Trials of Our Own Original Products and In-licensing Drugs with Solid Track Records in Overseas Markets |
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During the fiscal year ending March 2012, we plan to gain approval as quickly as possible for Z-338 (predetermined product name: Acofide®), for which Zeria submitted an application for marketing authorization in Japan in September 2010. At the same time, in Europe and the United States, we will select our partners and progress with development.
We will undertake the development of Asacol® as planned for the treatment of Crohn’s disease in Japan and ulcerative colitis in China. In collaboration with Tillotts, we will also reinforce the Asacol® lineup, giving consideration to lifecycle management.
We will also focus on the development of therapeutic agents in the field of cancer treatment. This is a key therapy area for Zeria, second to the gastrointestinal field.
In consumer healthcare products, we will actively develop new products that include Rx-to-OTC switched products and European traditional herbal medicines. |
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| UP DATE 16-May-13 |
| 1. Domestic |
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| 1).Gastrointestinal field |
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| Stage |
Development Code/ Generic Name |
Development |
Indications |
Classsification |
Notes |
| Approved |
Z-338
Acotiamide |
Co-development
(Astellas) |
Functional dyspepsia
Acofide® |
Upper gastrointestinal motility modulator |
Original
Co-promotion
(Astellas Pharma) |
| Phase III |
Z-103
Polaprezinc |
Zeria |
Taste disorder
Promac®
additional indication |
Zinc replacement |
In-licensed |
| Phase II |
Z-206
Mesalazine |
Co-development
(Kyowa Hakko Kirin) |
Crohn's disease Asacol®
additional indication |
pH dependent controlled-release formulation |
Original (Tillotts Pharma) |
| Phase I |
Z-360 |
Zeria |
Pancreatic cancer |
Gastrin CCK2
receptor antagonist |
Original
Asia Global
Development |
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| 2).Other fields |
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| Stage |
Development Code/ Generic Name |
Development |
Indications |
Classsification |
Note |
Phase III
completed |
Z-100 |
Zeria |
Cervical cancer
|
Immunomodulator |
Original |
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| 2. Overseas |
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| Stage |
Development Code/ Generic Name |
Development |
Indications |
Classsification |
Note |
NDA filed
(China) |
Z-206
Mesalazine |
Co-development
(Tillotts Pharma) |
Ulcerative colitis
Asacol® |
pH dependent controlled-release formulation |
Original (Tillotts Pharma) |
Phase III
in
preparation
(Europe) |
Z-338
Acotiamide |
Zeria |
Functional dyspepsia |
Upper gastrointestinal motility modulator |
Original |
Phase II
completed
(North America) |
Zeria |
Original |
Phase II in preparation
(Europe,Asia) |
Z-360 |
Zeria |
Pancreatic cancer |
Gastrin CCK2 receptor antagonist |
Original |
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