Dainippon Sumitomo Pharma and Shionogi to co-market antihypertensive DSP-8153

Dainippon Sumitomo Pharma (DSP; TYO: 4506) has entered into a license accord with fellow Japanese drugmaker Shionogi (TYO: 4507) for the co-marketing in Japan of DSP-8153, a combination product of the anti-hypertension drugs irbesartan and amlodipine besilate, for which DSP submitted an application for manufacturing and marketing approval to the Ministry of Health, Labor and Welfare in Japan last November.

DSP-8153 is a combination product of irbesartan (Sanofi’s now off-patent Avapro) with evidence for renoprotective effects and amlodipine besilate (also off-patent) with evidence for cerebroprotective and cardioprotective effects in addition to a stable and sustained hypotensive effect.

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.