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