Shionogi & Co Ltd : Shionogi Receives Approval of Injectable Analgesics for Cancer Pain,·gOxiFast® Injection 10mg·h and ·gOxiFast® Injection 50mg·h

Shionogi Receives Approval of Injectable Analgesics for Cancer Pain, "OxiFast® Injection 10mg" and "OxiFast® Injection 50mg"

Osaka, Japan, January 18, 2012 - Shionogi & Co., Ltd. (Head Office: Osaka; President & CEO: Isao Teshirogi, Ph.D.; hereafter "Shionogi") today announced that it has received manufacturing and marketing approval of "OxiFast® Injection 10mg" and "OxiFast® Injection 50mg" (generic name: oxycodone hydrochloride hydrate) for the treatment of cancer pain in Japan on January 18,
2012.
Shionogi has been providing two oral oxycodone products, OxyContin® tablets (oxycodone hydrochloride extended release tablet) since 2003 and OxiNorm® powder (oxycodone hydrochloride powder) since 2007, for the relief of a moderate to severe pain on the patients suffering from many types of cancer. In case of the difficulty of oral administration, however, patients who have been treated by those oxycodone products have to change their therapy to other opioid analgesics. Therefore, the Japanese Society for Palliative Medicine requested a development of injectable oxycodone product to the Ministry of Health, Labor and Welfare (hereafter "MHLW") in 2007. The Investigational Committee for Usage of Unapproved Drugs established by the MHLW agreed with the need for the development of injectable oxycodone product, and Shionogi decided to develop OxiFast® injection. After the launch of OxiFast® injection, patients with a moderate to severe cancer pain will be able to have an oxycodone treatment by OxiFast® injection, which includes the same ingredient as OxyContin® tablets and OxiNorm® powder, even though they cannot be treated with the oral administration.
Shionogi continues to be dedicated to providing an appropriate information of three oxycodone products, "OxyContin® tablets," "OxiNorm® powder" and "OxiFast® injection", so that all patients suffering from cancer pain with the "Oxycodone family" could have a relaxed life without any pain.

OxiFast® Injection Product Overview

Product Name: OxiFast® Injection 10mg, OxiFast® Injection 50mg

Generic Name: Oxycodone hydrochloride hydrate

Indications: Moderate to severe pain associated with all types of cancer

Dosage and Administration: Generally to adults, continuous intravenous administration or continuous subcutaneous administration of 7.5-250mg/day oxycodone hydrochloride (anhydride). Arbitrarily, dosage to be increased or decreased depending on

age or symptoms

Acquisition of Manufacturing

and Marketing Approval: January 18, 2012

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 information, contact: Corporate Communications Department Shionogi & Co., Ltd.

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