For Immediate Release

2011.09.15

AstraZeneca K.K.
Daiichi Sankyo Company, Limited

Daiichi Sankyo and AstraZeneca Launch NEXIUM(R) 10mg and 20mg Capsules in Japan

TOKYO, Japan (September 15, 2011) − Daiichi Sankyo Co., Ltd. (hereafter, Daiichi Sankyo) and AstraZeneca KK (hereafter, AstraZeneca) today announced the launch of NEXIUM® Capsule (esomeprazole magnesium) 10mg and NEXIUM® Capsule 20mg following the NHI (National Health Insurance) drug price listing received on September 12, 2011.

 

The NHI reimbursement price is 96.70 yen for NEXIUM® Capsule 10mg, and 168.90 yen for NEXIUM® Capsule 20mg. (Approval for manufacture and marketing: July 1, 2011; NHI drug price listing: September 12, 2011)

 

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 conditions.

 

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 NEXIUM® Capsules 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 conditions in Japan by maximizing the value of NEXIUM® Capsules through their strong collaboration.

 

Product outline

Product name

NEXIUM® Capsules 10mg, NEXIUM® Capsules 20mg

Generic name (JAN)

Esomeprazole magnesium

Indications

○Gastric ulcer, duodenal ulcer, anastomotic ulcer, reflux esophagitis, non-erosive reflux disease (NEXIUM® Capsules 10mg only), Zollinger-Ellison syndrome, and prevention of recurrence of gastric ulcer and duodenal ulcer in patients treated with non-steroidal anti-inflammatory drugs

○Adjunct for eradication of Helicobacter pylori in the following diseases

Gastric ulcer, duodenal ulcer, gastric MALT lymphoma, idiopathic thrombocytopenic purpura and metachronous development of gastric cancer after endoscopic resection of early gastric cancer

Dosage

○Gastric ulcer, duodenal ulcer, anastomotic ulcer and Zollinger-Ellison syndrome

The usual adult dosage is 20 mg of esomeprazole given orally once daily. The usual duration of administration is up to 8 weeks for gastric and anastomotic ulcers, and up to 6 weeks for duodenal ulcer.

○Reflux esophagitis

Usually the adult dosage is 20 mg of esomeprazole given orally once daily. The usual duration of administration is up to 8 weeks. The dosage for maintenance therapy of repeatedly recurring or relapsing reflux esophagitis is 10 - 20 mg given orally once daily.

○Non-erosive reflux disease

Usually the adult dosage is 10 mg of esomeprazole given orally once daily. The usual duration of administration is up to 4 weeks.

○Prevention of recurrence of gastric ulcer and duodenal ulcer in patients treated with non-steroidal anti-inflammatory drugs

Usually the adult dosage is 20 mg of esomeprazole given orally once daily.

○Adjunct for eradication of Helicobacter pylori

Usually to adults, 20 mg of esomeprazole, 750 mg (potency) of amoxicillin hydrate and 200 mg (potency) of clarithromycin should be given concomitantly via oral route all twice a day for 7 days, provided that the dose of clarithromycin can be increased up to 400 mg (potency) twice a day according to the need.

If the triple therapy with proton pump inhibitor, amoxicillin hydrate and clarithromycin for eradication of Helicobacter pylori failed, usually to adults, 20 mg of esomeprazole, 750 mg (potency) of amoxicillin hydrate and 250 mg of metronidazole should be given concomitantly via oral route all twice a day for 7 days as an alternative therapy.

Approval for manufacture and marketing

July 1, 2011

NHI drug price listing

September 12, 2011

Product launch

September 15, 2011

Manufacture and marketing

AstraZeneca KK

Sales and distribution

Daiichi Sankyo Co., Ltd.

For inquiries:

AstraZeneca K.K.

Corporate Communications

Telephone: +81-6-6453-8011

http://www.astrazeneca.co.jp/ 

Daiichi Sankyo Co., Ltd.

Corporate Communications Department

Telephone : +81-3-6225-1126

http://www.daiichisankyo.com 

 

 

This press release is an English-language translation of the original Japanese-language version. To the extent that there are discrepancies between this translation and the original version, the original version shall be definitive.

End