New Study Results Analyzed the Use of KAPIDEX(TM) (dexlansoprazole) for Nighttime Heartburn in Adults with Non-Erosive GERD

New Study Results Analyzed the Use of KAPIDEX(TM) (dexlansoprazole) for
Nighttime Heartburn in Adults with Non-Erosive GERD
Results Presented at the American College of Gastroenterology 2009 Annual
Scientific Meeting

SAN DIEGO, Oct. 26 /PRNewswire/ -- New data being presented at the American
College of Gastroenterology (ACG) 2009 Annual Scientific Meeting in San Diego
showed that treatment with KAPIDEX(TM) (dexlansoprazole) delayed release
capsules over a four-week period resulted in a statistically significant
greater percentage of nights without heartburn in subjects with non-erosive
gastroesophageal reflux disease (GERD), compared to placebo (p<0.001). In
addition, secondary measures showed that KAPIDEX improved relief of nighttime
heartburn and GERD-related sleep disturbances (p<0.001). KAPIDEX was approved
in January 2009 for the once-daily, oral treatment of heartburn associated
with symptomatic non-erosive GERD, the healing of erosive esophagitis (EE) and
the maintenance of healed EE.

This multicenter, randomized, double-blind, placebo-controlled clinical trial
evaluated the effect of KAPIDEX on subjects with nighttime heartburn symptoms.
The study enrolled 305 subjects (ages 18 to 66) with non-erosive symptomatic
GERD, who reported having moderate-to-severe nighttime heartburn and
GERD-related sleep disturbances on at least three of seven nights. Subjects
were randomized to receive either KAPIDEX 30 mg or placebo orally every
morning for four weeks. Study results showed that treatment with KAPIDEX 30 mg
resulted in a greater percentage of nights without heartburn compared to
placebo (73% vs. 36%, respectively, p<0.001). During the last seven days of
treatment, KAPIDEX 30 mg also provided relief of nighttime heartburn and
GERD-related sleep disturbances in a greater percentage of subjects (48% vs.
20%, and 70% vs. 48%, respectively, p<0.001 for both). Relief was defined as
six of seven days without nighttime heartburn and no more than one night with
mild heartburn, and six of seven days without GERD-related sleep disturbances.

About GERD
GERD, commonly known as acid reflux disease, affects nearly 19 million
Americans. GERD is often characterized by frequent and persistent heartburn
that occurs two or more days a week despite treatment and diet changes. GERD
can affect both men and women, and symptoms are often triggered by certain
foods, stress or pressure on the stomach. Up to 70 percent of GERD patients
have non-erosive GERD, a term used to describe symptoms suggestive of GERD in
patients with no endoscopic evidence of EE.

About KAPIDEX(TM) (dexlansoprazole) delayed release capsules
KAPIDEX (dexlansoprazole) delayed release capsules is a proton pump inhibitor
(PPI), which decreases acid production by turning off many of the acid pumps
in the stomach, thus helping to protect the esophagus from acidic reflux so
that esophageal inflammation can heal. KAPIDEX combines an enantiomer of
lansoprazole with a Dual Delayed Release(TM) (DDR) formulation designed to
provide two separate releases of medication. KAPIDEX, taken once daily, is
approved for the healing of all grades of erosive esophagitis (EE) for up to
eight weeks, maintaining healing of EE for up to six months, and treating
heartburn associated with symptomatic non-erosive gastroesophageal reflux
disease (GERD) for four weeks.

Important Safety Information
KAPIDEX is contraindicated in patients with known hypersensitivity to any
component of the formulation. Hypersensitivity and anaphylaxis have been
reported with KAPIDEX use. Symptomatic response with KAPIDEX does not preclude
the presence of gastric malignancy. The most commonly reported
treatment-emergent adverse reactions (greater than or equal to 2%) include
diarrhea (4.8%), abdominal pain (4.0%), nausea (2.9%), upper respiratory tract
infection (1.9%), vomiting (1.6%), and flatulence (1.6%). KAPIDEX must not be
co-administered with atazanavir because atazanavir systemic concentrations may
be substantially decreased. KAPIDEX may interfere with the absorption of drugs
for which gastric pH is important for bioavailability (e.g., ampicillin
esters, digoxin, iron salts, ketoconazole). Patients taking concomitant
warfarin may require monitoring for increases in international normalized
ratio (INR) and prothrombin time. Increases in INR and prothrombin time may
lead to abnormal bleeding, which can lead to serious consequences. Concomitant
tacrolimus use may increase tacrolimus whole blood concentrations.

Please see the complete prescribing information and visit the KAPIDEX Web site
at www.kapidex.com.

Takeda Pharmaceuticals North America, Inc. and Takeda Global Research &
Development Center, Inc.
Based in Deerfield, Ill., Takeda Pharmaceuticals North America, Inc. and
Takeda Global Research & Development Center, Inc. are subsidiaries of Takeda
Pharmaceutical Company Limited, the largest pharmaceutical company in Japan.
The respective companies currently market oral diabetes, insomnia,
rheumatology and gastroenterology treatments and seek to bring innovative
products to patients through a pipeline that includes compounds in development
for diabetes, cardiovascular disease, gastroenterology, neurology and other
conditions. Takeda is committed to striving toward better health for
individuals and progress in medicine by developing superior pharmaceutical
products. To learn more about these Takeda companies, visit www.tpna.com.

SOURCE Takeda Pharmaceuticals North America, Inc.

Elissa J. Johnsen, Takeda Pharmaceuticals North America, +1-224-554-3185,
ejohnsen@tpna.com; or Amy Losak, Ketchum, +1-646-935-3917,
amy.losak@ketchum.com