| 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 activities 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 for 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 and other products that include food for specified health uses, dietary 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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In October 2009, we have obtained approval for manufacturing and sales of Asacol®, our most important challenge in the current fiscal year. We are strengthening the lineup of Asacol® products in terms of life cycle manegement in collaboration with Tillotts, which has just become a member of the Zeria Group in September 2009, and from which Zeria in-licensed the product in 2004.
Regarding Z-338, we have announced the results of a clinical pharmacological trial at the Digestive Disease Week Conference of the American Gastroenterological Association held in June 2009 in Chicago in the United States. There are high hopes for Z-338 as the first therapeutic drug in the world for the treatment of functional dyspepsia and we are moving forward to the next phase.
In Consumer Healthcare products as well, we intend to pursue the challenges of developing new OTC drugs containing western herbs, such as Colpermin®, a treatment for irritable bowel syndrome (IBS) owned by Tillotts. |
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| UP DATE 06-Aug-10 |
| 1. Domestic |
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| 1).Gastrointestinal field |
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| Stage |
Development Code/ Generic Name |
Development |
Indications |
Classsification |
Notes |
| Filed |
Z-209 |
Zeria |
Bowel cleansing for colonoscopy |
Tablet form bowel preparation |
In-licensed
Visiclear® new formulation |
| NDA in preparation |
Z-338
Acotiamide |
Co-development
(Astellas) |
Functional dyspepsia |
Upper gastrointestinal motility modulator |
Original |
| Phase III |
Z-103
Polaprezinc |
Zeria |
Taste disorder |
Zinc replacement |
In-licensed
Promac® Additional Indication |
| Phase I/II |
Z-208
Tamibarotene |
Co-development
(TMRC) |
Hepatocellular carcinoma |
Retinoic acid RAR alpha receptor agonist |
In-licensed |
| Phase I |
Z-206
Mesalazine |
Co-development
(Kyowa Hakko Kirin) |
Crohn's disease |
pH dependent controlled-release formulation |
Original (Tillotts)
Asacol® additional indication |
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| 2).Other fields |
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| Stage |
Development Code/ Generic Name |
Development |
Indications |
Classsification |
Note |
| Phase III |
Z-100 |
Zeria |
Cervical cancer |
Immunomodulator |
Original
Ancer® Additional Indication |
| Phase II in preparation |
Z-207 |
Zeria |
Allergic rhinitis |
Chemical ablation
ethanol / steroid mixture |
In-licensed |
| Clinical Development
in preparation |
Z-521 |
Zeria |
Hypophosphatemic rickets |
Phosphate replacement |
Original |
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| 2. Overseas |
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| Stage |
Development Code/ Generic Name |
Development |
Indications |
Classsification |
Note |
Approved
(Korea) |
Z-103
Polaprezinc |
SK Chemicals
(Out-licensed) |
Gastritis, Gastric ulcer |
Cytoprotective antiulcer |
In-licensed
Promac® |
Phase III in preparation
(China) |
Z-206
Mesalazine |
Co-development
(Tillotts Pharma) |
Ulcerative colitis |
pH dependent controlled-release formulation |
Original (Tillotts)
Asacol® |
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) |
Z-360 |
Zeria |
Pancreatic cancer |
Gastrin CCK2 receptor antagonist |
Original |
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