AstraZeneca’s NEXIUM receives first regulatory approval in Japan for the treatment of acid-related diseases

AstraZeneca today announced that NEXIUM (esomeprazole magnesium) 10 mg and 20 mg capsules have received regulatory approval in Japan for the treatment of acid-related conditions including non-erosive reflux disease (NERD), reflux esophagitis, and peptic ulcer disease (PUD). NEXIUM also received regulatory approval for prevention of recurrence of gastric ulcer and duodenal ulcer in patients treated with non-steroidal anti-inflammatory drugs (NSAIDs).

NEXIUM is currently available in more than 120 countries and is the world’s leading proton pump inhibitor (PPI) with annual sales of almost $5 billion in 2010. AstraZeneca plans to launch NEXIUM in Japan in the second half of 2011. The PPI market in Japan was $2 billion in 2010.

In a previously announced co-promotion agreement, AstraZeneca will manufacture and develop NEXIUM and Daiichi Sankyo will be responsible for its distribution in Japan.

The regulatory approval of NEXIUM was based on eight clinical studies conducted in Japan, including two large comparative efficacy and safety studies of patients with reflux esophagitis and two comparative efficacy and safety studies in patients taking Non Steroidal Anti-Inflammatory Drugs (NSAIDs).

Tony Zook, Executive Vice President of AstraZeneca’s Global Commercial Organisation said, “The availability of NEXIUM in Japan provides patients with a world-leading treatment option for acid-related conditions, which can have a significant impact on patient quality of life. We are pleased to be able to add NEXIUM to our portfolio of medicines in Japan, our second largest market, and strengthen our leadership in the global gastrointestinal sector.”