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Shire press releasePress Release
Shire Announces the Establishment of Shire Japan KK
Tokyo, Japan – April 8, 2013 – Shire plc (LSE: SHP, NASDAQ: SHPGY) today officially announces
the establishment of Shire Japan KK. The new Shire Japan KK office is located in the Kita-Shinjuku
area of Tokyo and is represented by Vice President and Representative Director, Steve Engen.
First established in the United Kingdom in 1986, Shire develops and provides healthcare treatments in
the areas of behavioral health and gastrointestinal conditions, rare diseases, regenerative medicine and other symptomatic conditions treated by specialist physicians. With major operations in the US, UK, Switzerland and centers of excellence throughout Europe, South America, Canada and the Pacific Rim, Shire employs over 5,300 people in 29 countries around the world. The establishment of Shire Japan KK underscores the company’s commitment to patients in Japan. “We are very pleased to be strengthening our presence in Japan,” says Angus Russell, Chief Executive Officer. “We look forward to being able to help more patients and provide value to the Japanese healthcare system.” While Shire established its first physical presence in Japan in 2008, many of Shire’s products have been available for several years via partnering arrangements: ELAPRASE®, a treatment for Hunter syndrome (MPS II), is marketed by Genzyme Japan KK. FOSRENOL®, a treatment for hyperphosphatemia is marketed by Bayer Yakuhin, Ltd. REMINYL®, a treatment for Alzheimer’s disease is marketed by Janssen Pharmaceutical KK REPLAGAL® a treatment for Fabry disease, is marketed by Dainippon Sumitomo Pharma Co. In January 2009, Shire entered into a License Agreement with Mochida Pharmaceutical Co., Ltd. to develop and commercialise LIALDA® (once-daily oral formulation of mesalazine), a therapeutic agent for the treatment of ulcerative colitis. This product is currently under development in Japan. In November 2011, Shire entered into a strategic partnership with Shionogi & Co., Ltd. to co-develop and co-commercialize VYVANSE® (once-daily lisdexamfetamine capsules) and INTUNIV® (guanfacine extended release tablets),1 in Japan for the treatment of Attention Deficit Hyperactivity Disorder (ADHD). Both products are currently under development in Japan by Shionogi and Shire. In addition, two of Shire’s products, VPRIV® (velaglucerase alfa for the treatment of Gaucher disease) and XAGRID® (anagrelide for the treatment of essential thrombocythemia), are currently in late-stage development in Japan. Shire Japan KK is planning to commercialize these products in Japan following The announcement of the establishment of Shire Japan KK follows the appointment of Vice President and Representative Director, Steve Engen, in February. “With our knowledge of unmet medical needs and deep expertise from other countries around the world, we seek to bring more healthcare solutions to Japan – treatments to enable better lives for patients with life-altering conditions,” he says. Dr. Flemming Ornskov, Shire’s CEO Designate who assumes his role at the end of April adds, “We welcome the establishment of Shire Japan KK and recognize that this is the next natural step in the 1 Product names in the US
Registered in Jersey, No. 99854, 22 Grenville Street, St Helier, Jersey JE4 8PX
evolution of Shire’s business in Japan. By further committing to the patients and families in Japan that will benefit from our products and services, we are confident that we will deliver value to Japanese society and are seeking to propel our business forward in the future in this very important country." For more detailed information about Shire Japan KK, please visit Not all products are available in all countries and prescribing information may differ. Please consult your local physician for specific prescribing information. For further information please contact:
Jessica Cotrone (Human Genetic Therapies) NOTES TO EDITORS
Shire enables people with life-altering conditions to lead better lives.
Through our deep understanding of patients’ needs, we develop and provide healthcare in the areas of: Behavioral Health and Gastro Intestinal conditions Rare as well as other symptomatic conditions treated by specialist physicians. We aspire to imagine and lead the future of healthcare, creating value for patients, physicians, policymakers, payors and our shareholders. FORWARD - LOOKING STATEMENTS - "SAFE HARBOR" STATEMENT UNDER THE PRIVATE
SECURITIES LITIGATION REFORM ACT OF 1995
Statements included in this announcement that are not historical facts are forward-looking statements.
Forward-looking statements involve a number of risks and uncertainties and are subject to change at
any time. In the event such risks or uncertainties materialize, Shire’s results could be materially
adversely affected. The risks and uncertainties include, but are not limited to, that:
Shire’s products may not be a commercial success; revenues from ADDERALL XR are subject to generic erosion; the failure to obtain and maintain reimbursement, or an adequate level of reimbursement, by third-party payors in a timely manner for Shire's products may impact future revenues and earnings; Shire relies on a single source for manufacture of certain of its products and a disruption to the supply chain for those products may result in Shire being unable to continue marketing or developing a product or may result in Shire being unable to do so on a commercially viable basis; Shire uses third party manufacturers to manufacture many of its products and is reliant upon third party contractors for certain goods and services, and any inability of these third party manufacturers to manufacture products, or any failure of these third party contractors to provide these goods and services, in each case in accordance with its respective contractual obligations, could adversely affect Shire’s ability to manage its manufacturing processes or to operate its business; the development, approval and manufacturing of Shire’s products is subject to extensive oversight by various regulatory agencies and regulatory approvals or interventions associated with changes to manufacturing sites, ingredients or manufacturing processes could lead to significant delays, increase in operating costs, lost product sales, an interruption of research activities or the delay of new product launches; the actions of certain customers could affect Shire 's ability to sell or market products profitably and fluctuations in buying or distribution patterns by such customers could adversely impact Shire’s revenues, financial conditions or results of operations; investigations or enforcement action by regulatory authorities or law enforcement agencies relating to Shire’s activities in the highly regulated markets in which it operates may result in the distraction of senior management, significant legal costs and the payment of substantial compensation or fines; adverse outcomes in legal matters and other disputes, including Shire’s ability to obtain, maintain, enforce and defend patents and other intellectual property rights required for its business, could have a material adverse effect on Shire’s revenues, financial condition or results of operations; and other risks and uncertainties detailed from time to time in Shire’s filings with the U.S. Securities and Exchange Commission, including its most recent Annual Report on Form 10-K.
List of Publications (Dr. Imran Ali) Books: 1. Imran Ali and Hassan Y. Aboul-Enein (Edts.), Advances in Chromatography for Petroleum Industry, E. Book, Bentham Science Publishers, USA (2010), Under Preparation. 2. Imran Ali, Hassan Y. Aboul-Enein and V.K. Gupta, Nano Chromatography and Capillary Electrophoresis: Pharmaceutical and Environmental Analyses, Wile