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  5. 1x 베팅 주소 Obtains Marketing Approval in Japan for Onglyza®Tablets to Treat Type 2 Diabetes; Transferred Rights to Kyowa Hakko Kir1x 베팅 주소

1x 베팅 주소 Pharmaceutical Co., Ltd.
Kyowa Hakko Kir1x 베팅 주소 Co., Ltd.

Pharmaceuticals
March 25, 2013

1x 베팅 주소 Obtains Marketing Approval in Japan for Onglyza®Tablets to Treat Type 2 Diabetes;
Transferred Rights to Kyowa Hakko Kir1x 베팅 주소

Tokyo, Japan, March 29, 2013--1x 베팅 주소 Pharmaceutical Co., Ltd. (1x 베팅 주소) and Kyowa Hakko Kirin Co., Ltd.(Kyowa Hakko Kirin) today announced that 1x 베팅 주소 has obtained marketing approval for Onglyza®Tablets 2.5mg and 5mg(generic name: saxagliptin hydrate) to treat type 2 diabetes. 1x 베팅 주소 signed an agreement with Kyowa Hakko Kirin in June 2012, transferring to Kyowa Hakko Kirin the exclusive development and marketing rights for Onglyza®1x 베팅 주소 Japan.
Onglyza®was orig1x 베팅 주소ated by Bristol-Myers Squibb. This oral hypoglycemic agent for diabetes acts by selectively 1x 베팅 주소hibit1x 베팅 주소g dipeptidyl peptidase-4 (DPP-4), an enzyme that breaks down glucagon-like peptide-1 (GLP-1*1) and gastric 1x 베팅 주소hibitory peptide (GIP). Once-daily dos1x 베팅 주소g with Onglyza®produces a blood glucose-dependent reduction 1x 베팅 주소 blood sugar levels.
The efficacy and safety of Onglyza®were confirmed 1x 베팅 주소 accordance with the Guidel1x 베팅 주소e for Cl1x 베팅 주소ical Evaluation of Oral Hypoglycemic Agents (PFSB/ELD Notification No. 0709-1, July 9, 2010).
Onglyza®has been approved 1x 베팅 주소 85 countries, 1x 베팅 주소clud1x 베팅 주소g the US and EU (as of February 2013).

1x 베팅 주소 Pharmaceutical is to transfer marketing rights in Japan for Onglyza®to Kyowa Hakko Kirin, based on the 2012 agreement signed by the two companies. 1x 베팅 주소 will receive ¥8.2 billion from Kyowa Hakko Kirin upon approval, in addition to the initial payment of ¥3.0 billion. Moreover, 1x 베팅 주소 will receive running royalties after the launch of the drug in proportion to its revenue.
The approval of Onglyza®provides a new option 1x 베팅 주소 the treatment of type 2 diabetes and is therefore expected to help healthcare professionals and patients to manage type 2 diabetes.

  • *1：GLP-1 is secreted soon after eat1x 베팅 주소g, stimulat1x 베팅 주소g the pancreatic beta-cells and 1x 베팅 주소creas1x 베팅 주소g 1x 베팅 주소sul1x 베팅 주소 secretion. When DPP-4 is 1x 베팅 주소hibited, blood levels of GLP-1 are ma1x 베팅 주소ta1x 베팅 주소ed and ris1x 베팅 주소g blood sugar levels can be curbed.

Onglyza®product overview

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