Dexlansoprazole, a new dual-delayed release technology for the treatment of reflux disease, accepted for national approvals within the European Union

Zurich Switzerland (ots) - Takeda Pharmaceuticals International
GmbH ("Takeda") announced that the European decentralised procedure
(DCP) was positively concluded for dexlansoprazole, a proton pump
inhibitor (PPI) with a new dual- delayed release technology for the
treatment of reflux disease. The regulatory process has now entered
into the national phase in which the involved member states can adopt
a national decision and grant national marketing authorization.
Sweden was the first country to approve dexlansoprazole in the EU,
followed by Lithuania, Belgium, Germany and Ireland. Takeda
anticipates further national approvals and market launches from Q4
FY13.

The application for marketing authorization in 16 countries
through the DCP was submitted in March 2012 with Portugal serving as
its Reference Member State (RMS). Following its evaluation, the RMS
and all Concerned Member States (CMS) reached consensus that
dexlansoprazole is approvable.

Common symptoms of reflux disease are persistent heartburn and
regurgitation, i.e. pain or burning in the chest, stomach acid rising
into the esophagus, sour taste in the mouth and burning in the
throat. The prevalence of reflux disease has been increasing in the
last 20 years[1] and affects up to 25% of people in Europe.[2]

Dexlansoprazole is the first and only currently approved PPI with
a dual-delayed release formulation and that relieves GERD symptoms
for up to 24 hours.[3], [4] The PPI can be taken without regard to
food intake[5] or the timing of meals. [6], [7]

Dexlansoprazole has been approved in adults for the treatment of
erosive reflux esophagitis, the maintenance of healed erosive reflux
esophagitis and maintenance of relief of heartburn as well as for
short-term treatment of heartburn and acid regurgitation associated
with symptomatic non-erosive gastroesophageal reflux disease
(GERD).[7] The most frequently reported side effects include
diarrhoea, abdominal pain, headache, feeling sick (nausea), abdominal
discomfort, gas (flatulence) and constipation.[7]

Dexilant® was approved by the FDA (Food and Drug Administration)
in the US in 2009 for the management of erosive esophagitis and non-
erosive reflux disease. It is also marketed in Canada, Mexico and
several countries in Asia.

With the approval of dexlansoprazole in Europe, Takeda expands its
profile in the Gastrointestinal area as an innovative and ethical
company producing medicine that improves people's lives.

Other PPIs marketed by the Takeda Group include: pantoprazole,
marking more than 15 years of experience and over one billion
treatment courses.[8] Pantoprazole is marketed in more than 90
countries under a variety of brand names, including Pantozol®. Takeda
also markets Tecta®, the improved pantoprazole magnesium formulation
and lansoprazole, a well-known PPI in around 90 markets.

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About Takeda Pharmaceuticals International GmbH

Headquartered in Zurich as a wholly owned subsidiary of Takeda
Pharmaceutical Company Limited, Osaka, Japan, the company has a
commercial presence covering more than 70 countries, with particular
strength in Asia, North America, Europe and fast-growing emerging
markets including Latin America, Russia-CIS and China. Areas of focus
include cardiovascular and metabolic, oncology, respiratory and
immunology, central nervous system, general medicine, and vaccines.

Takeda is a research-based global company with its main focus on
pharmaceuticals. As the largest pharmaceutical company in Japan and
one of the global leaders of the industry, Takeda is committed to
strive towards better health for people worldwide through leading
innovation in medicine. Through the integration of Millennium
Pharmaceuticals and Nycomed, Takeda has been transforming itself,
broadening its therapeutic expertise and geographic outreach.

Additional information about Takeda is available through its
corporate website, www.takeda.com.

References:
1. El-Serag HB. Clin Gastroenterol Hepatol 2007; 5: 17-26
2. El-Serag HB et al. Gut Published Online 13 July 2013; doi:
10.1136/gutjnl-2012-304269
3. Metz DC, et al. Aliment Pharmacol Ther 2009;29:742-54;
4. Howden CW, et al. Aliment Pharmacol Ther 2009;30:895-907.
5. Lee RD, et al. Aliment Pharmacol Ther 2009;29:824-33.
6. Lee RD, et al. Aliment Pharmacol Ther 2010;31:1001-11.
7. EU Summary of Product Characteristics, Dexilant®, September 2013
8. Periodic Safety Update Report (PSUR) No. 34 - pantoprazole,
October 2012

This press release has been issued by Takeda Pharmaceuticals
International GmbH, Thurgauerstrasse 130, CH-8152 Glattpark-Opfikon,
Zurich, Switzerland.

Contacts:
Danny Stepto
Takeda Pharmaceuticals International GmbH
+41 (0)44 555 1504 danny.stepto@takeda.com