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Jun. 05, 2012Print(PDF/40KB)Licensing

Dainippon Sumitomo Pharma and Shionogi to Sign a License Agreement for the Co-marketing of “DSP-8153”, Combination Product of Anti-hypertension Drugs irbesartan and amlodipine besilate

Dainippon Sumitomo Pharma Co., Ltd. (Headquarters: Osaka; President & CEO: Masayo Tada; hereafter "DSP") and Shionogi & Co., Ltd. (Headquarters: Osaka; President & CEO: Isao Teshirogi, Ph.D.; hereafter "Shionogi") today announced that they have entered into a license agreement for the co-marketing in Japan of "DSP-8153" (product code), a combination product of anti-hypertension drugs irbesartan and amlodipine besilate, of which DSP has submitted an application for manufacturing and marketing approval to the Ministry of Health, Labor and Welfare in Japan.

DSP-8153 is a combination product of irbesartan with evidence for renoprotective effects and amlodipine besilate with evidence for cerebroprotective and cardioprotective effects in addition to a stable and sustained hypotensive effect. DSP submitted an application for manufacturing and marketing approval for "DSP-8153" in November, 2011. In clinical trials in Japan, DSP-8153 was shown to be effective for patients with essential hypertension uncontrolled by irbesartan or amlodipine besilate alone. Moreover, two doses are included in the application for this combination product, irbesartan 100mg/amlodipine 5mg and irbesartan 100mg/amlodipine 10mg. If approved, this will be the first combination product in Japan including 10mg of amlodipine.

"DSP sells irbesartan (DSP's brand name: AVAPRO®) as one of its strategic products and amlodipine besilate (brand name: AMLODIN®) as one of its focus products in the domestic market, and now we have combined them to develop DSP-8153. I am very pleased to enter into an agreement with Shionogi with a strong sales network in Japan who also commercialize irbesartan. Both companies will conduct activities to provide information to medical institutions to ensure this combination product is delivered to more patients who need it." said Masayo Tada, President & CEO, Dainippon Sumitomo Pharma Co., Ltd.
Isao Teshirogi, President & CEO, Shionogi & Co., Ltd. said, "The company positions irbesartan (Shionogi's brand name: Irbetan®) as one of its most important strategic products in the domestic market in its Third Medium-Term Business Plan. Irbetan® is highly evaluated globally, and we are working on delivering it to more patients in Japan. This license agreement for the co-marketing of a combination product including irbesartan with DSP is a great chance for us to provide a new treatment option for hypertensive patients. Both companies will actively conduct detailing/promotional activities to maximize the value of this product."

By expanding the combination product for more patients in Japan, DSP and Shionogi will do our best to further contribute to therapy for hypertension.

About irbesartan
Irbesartan is a long-acting ARB (angiotensin Ⅱ receptor antagonist) originally created by Sanofi (France) with a long half-life in blood and a 24-hour-lasting blood pressure-lowering effect, having high anti-hypertensive effect in mild to severe hypertension. Based on the large-scale clinical trials, IDNT and IRMA2, which are often cited in the major international guidelines, this drug is also recognized as the only one ARB with evidence for its renoprotective effect in hypertensive type 2 diabetic patients covering both early-stage and overt nephropathy. Irbesartan is now commercialized overseas since it was launched globally in 1997, and highly regarded as one of the top ARB brands. In the domestic market, Irbesartan has been commercialized since July 2008, as DSP's brand name: AVAPRO® and Shionogi's brand name: Irbetan®.

About amlodipine besilate
Amlodipine besilate is a calcium antagonist with a strong, stable and sustained hypotensive effect and is highly acclaimed in Japan and overseas. It has made the wider treatment for early to severe patients with hypertension possible since the prescription by 10mg of amlodipine was approved in February 2009 in Japan, which is a standard dosage in global markets. Based on results from large-scale clinical trials carried out overseas such as ASCOT-BPLA and CAMELOT, evidence for cerebroprotection and cardioprotection have been reported and prescriptions are widely written with the expectation of an improved prognosis for patients with hypertension.