Otsuka Obtains Marketing Approval in Japan for Onglyza Tablets to Treat Type 2 Diabetes; Transferred Rights to Kyowa Hakko Kirin®

Tokyo, Japan, March 29, 2013--Otsuka Pharmaceutical Co., Ltd. (Otsuka) and Kyowa Hakko Kirin Co., Ltd.(Kyowa Hakko Kirin) today announced that Otsuka has obtained marketing approval for Onglyza Tablets 2.5mg and 5mg(generic name: saxagliptin hydrate) to treat type 2 diabetes. Otsuka signed an agreement with Kyowa Hakko Kirin in June 2012, transferring to Kyowa Hakko Kirin the exclusive development and marketing rights for Onglyza in Japan. Onglyza was originated by Bristol-Myers Squibb. This oral hypoglycemic agent for diabetes acts by selectively inhibiting dipeptidyl peptidase-4 (DPP-4), an enzyme that breaks down glucagon-like peptide-1 (GLP-1) and gastric inhibitory peptide (GIP). Once-daily dosing with Onglyza produces a blood glucose-dependent reduction in blood sugar levels. The efficacy and safety of Onglyza were confirmed in accordance with the Guideline for Clinical Evaluation of Oral Hypoglycemic Agents (PFSB/ELD Notification No. 0709-1, July 9, 2010). Onglyza has been approved in 85 countries, including the US and EU (as of February 2013).®® ®*1® ® ® Otsuka Pharmaceutical is to transfer marketing rights in Japan for Onglyza to Kyowa Hakko Kirin, based on the 2012 agreement signed by the two companies. Otsuka will receive ¥8.2 billion from Kyowa Hakko Kirin upon approval, in addition to the initial payment of ¥3.0 billion. Moreover, Otsuka will receive running royalties after the launch of the drug in proportion to its revenue. The approval of Onglyza provides a new option in the treatment of type 2 diabetes and is therefore expected to help healthcare professionals and patients to manage type 2 diabetes.® ® GLP-1 is secreted soon after eating, stimulating the pancreatic beta-cells and increasing insulin secretion. When DPP-4 is inhibited, blood levels of GLP-1 are maintained and rising blood sugar levels can be curbed.*1： Onglyza product overview®

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