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Shionogi, Inc. Announces Positive Outcome To The Decentralized Procedure For The European Approval Of Twinject(R) (Epinephrine Auto-Injector)


8/31/2010 12:44:36 PM

Florham Park, NJ (August 31, 2010) – Shionogi Inc., a U.S.-based group company of Shionogi & Co., Ltd., today announced a positive outcome to the European Decentralized Procedure for the approval of Twinject® (epinephrine auto-injector) following a communication from the UK Regulatory Authority (MHRA) as Reference Member State and the agreement of all the Concerned Member States that the product is approvable, a notification which has been conveyed to the company’s Shionogi Ireland subsidiary.

Twinject®, available in 0.15mg/0.15ml and 0.30mg/0.30ml Solution for Injection in a pre-filled auto-injector syringe, is indicated for the emergency treatment of severe allergic reaction (type I) including anaphylaxis to stinging insects and biting insects, allergen immunotherapy, food, drugs, diagnostic testing substances, and other allergens, as well as anaphylaxis to unknown substance or exercise-induced anaphylaxis.

“We are very pleased to announce that Shionogi has received a positive outcome to the Decentralized Procedure supporting European approval for Twinject ®,” said Dr. Sapan Shah, President and Chief Executive Officer of Shionogi Inc. “With the achievement of this positive milestone, we are looking forward to securing partnerships that will allow Shionogi to maximize the potential for Twinject® in the very important European market.”

About Shionogi Inc.

Shionogi Inc. is a US-based company of Shionogi & Co., Ltd. Headquartered in Osaka, Japan, Shionogi & Co., Ltd. is a major research-driven pharmaceutical company dedicated to placing the highest value on patients. Shionogi’s Research and Development currently targets three therapeutic areas: Infectious Diseases, Pain, and Metabolic Syndrome. The Company has provided such innovative medicines as Crestor and Doripenem, which have been successfully delivered to millions of patients. In addition, Shionogi is engaged in new research areas such as allergy and cancer. Contributing to the health of patients around the world through development in these therapeutic areas is Shionogi’s primary goal. For more details, please visit www.shionogi.co.jp. For more information on Shionogi Inc., headquartered in Florham Park, NJ, please visit www.shionogi-inc.com.

Shionogi Announces Positive Outcome to the DCP for the European Approval of Twinject®

Forward Looking Statements This announcement contains forward-looking statements. These statements are based on expectations in light of the information currently available, assumptions that are subject to risks and uncertainties which could cause actual results to differ materially from these statements. Risks and uncertainties include general domestic and international economic conditions such as general industry and market conditions, and changes of interest rate and currency exchange rate. These risks and uncertainties particularly apply with respect to product-related forward-looking statements. Product risks and uncertainties include, but are not limited to, completion and discontinuation of clinical trials; obtaining regulatory approvals; claims and concerns about product safety and efficacy; technological advances; adverse outcome of important litigation; domestic and foreign healthcare reforms and changes of laws and regulations. Also for existing products, there are manufacturing and marketing risks, which include, but are not limited to, inability to build production capacity to meet demand, unavailability of raw materials and entry of competitive products. The company disclaims any intention or obligation to update or revise any forward-looking statements whether as a result of new information, future events or otherwise.

Contact: Shionogi Inc. Yoshimasa Kyokawa Telephone: +1-678-459-1558 ir@shionogipharma.com



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