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

Friday, 1 July 2011

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.”



NEXIUM is a prescription only drug used to treat patients with acid-related symptoms and diseases. NEXIUM can provide relief for a range of patients, including those who are frustrated by the disruption that the condition causes to their life. NEXIUM works by binding to and inhibiting the acid pumps of a particular type of cells in the lining the stomach wall to stop the production of stomach acid. In doing so, it lowers the level of acidity in the stomach and helps to heal erosions in the esophagus or ulcers in the stomach and duodenum.

About AstraZeneca in Japan

As its second largest market globally, Japan is of strategic importance to AstraZeneca. Revenue grew by 4% in 2010 to $2,617 million in 2010. AstraZeneca has steadily built a significant presence in Japan with 3,100 employees, an R&D centre in Osaka and a leadership position in the oncology market.

CRESTOR™ and LOSEC®, as well as the launch of SYMBICORT® TURBUHALER® in 2010, contributed to continued growth.

About AstraZeneca

AstraZeneca is a global, innovation-driven biopharmaceutical business with a primary focus on the discovery, development and commercialisation of prescription medicines for gastrointestinal, cardiovascular, neuroscience, respiratory and inflammation, oncology and infectious disease. AstraZeneca operates in over 100 countries and its innovative medicines are used by millions of patients worldwide. For more information please visit:


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