Shionogi & Co Ltd : Shionogi Files a Patent Infringement Action to Protect Intellectual Property Covering Crystal Form of Doribax® in the US

Shionogi Files a Patent Infringement Action to Protect Intellectual Property Covering Crystal Form of Doribax® in the US

Osaka, Japan, January 8, 2013 - Shionogi & Co., Ltd. (Head Office: Osaka; President & CEO: Isao Teshirogi, Ph.D.; hereafter "Shionogi") today announced that Shionogi filed a patent infringement action in the U.S. District Court in New Jersey on December 28, 2012, against Sandoz, Inc. (hereafter "Sandoz") regarding Sandoz's submission of an Abbreviated New Drug Application with the Food and Drug Administration seeking approval for a generic version of Doribax® (generic name: doripenem hydrate, product name in Japan: Finibax®) before the expiration of Shionogi's intellectual property for the crystal form of Doribax® on March 30, 2021. Shionogi has licensed the commercial rights to Doribax® to Peninsula Pharmaceuticals, Inc., currently a subsidiary of Johnson & Johnson (Head Office: New Jersey, USA; Chairman & CEO: William C. Weldon) in the United States.

Doripenem hydrate is an antibiotic discovered by Shionogi which has already been approved in 87 countries as Finibax®/Doribax®.

Shionogi intends to continue to vigorously defend our rights in this and any other challenges to our intellectual property.

About Another Patent Infringement Action Regarding Doribax®

Shionogi also have been in litigation with Sandoz in the U.S. District Court in New Jersey regarding the substance patent of Doribax® since December 2011 with Janssen Pharmaceuticals Inc. and Peninsula Pharmaceuticals Inc. The substance patent will expire on June 5, 2015.

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.

For further infonnation, contact: Corporate Communications Department Shionogi & Co., Ltd

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