OREANDA-NEWS. July 01, 2011. Daiichi Sankyo Co., Ltd. (hereafter, Daiichi Sankyo) and AstraZeneca KK today announced that AstraZeneca has received approval from the Japanese Ministry of Health, Labour and Welfare for the manufacture and marketing of the proton pump inhibitor, NEXIUM® Capsule (esomeprazole magnesium) 10mg and NEXIUM® Capsule 20mg.

The active ingredient in NEXIUM® Capsules, esomeprazole magnesium, is one of the two isomers in omeprazole, the active substance in Omepral®. Esomeprazole selectively inhibits the activity of the enzyme H+/K+- ATPase, the acid pump. Esomeprazole thus inhibits the final step in the regulation of acid secretion and thereby provides effective control of acid related disease.

NEXIUM® Capsules received an indication for prevention of recurrence of gastric ulcer and duodenal ulcer in patients treated with non-steroidal anti-inflammatory drugs (NSAIDs), in addition to other therapeutic indications Omepral® has already received in Japan, including reflux esophagitis and non-erosive reflux disease (NERD).

NEXIUM® Capsules has been globally approved and is currently sold in more than 120 countries and regions backed up by rich and robust clinical evidence/experience. In the phase III clinical studies for reflux esophagitis patients in Japan, NEXIUM® Capsules demonstrated a quick relief of symptoms, endoscopic healing, patient tolerability and a good safety profile.

Under the terms of this agreement AstraZeneca and Daiichi Sankyo will co-promote this product in Japan. AstraZeneca will manufacture and develop the product and Daiichi Sankyo will be responsible for its sales and distribution.

Daiichi Sankyo and AstraZeneca are determined to contribute to the needs of patients with acid related disease in Japan by maximizing the value of NEXIUM® Capsules through their strong collaboration.