PATIENTS LIVING WITH GERD NOW HAVE A NEW TREATMENT OPTION FOR IMPROVED AND
SUSTAINED SYMPTOM RELIEF

Contacts:
Laurene Redding
Takeda Canada, Inc.
905-814-2329
[email protected]

DEXILANT is the First Proton Pump Inhibitor (PPI) with a
DUAL DELAYED RELEASE (DDR) Technology

MISSISSAUGA, ON, Sept. 22 /CNW/ - Takeda Canada, Inc. is pleased to announce the approval of DEXILANT (dexlansoprazole), the first and only proton pump inhibitor (PPI) with a novel dual delayed release technology, which delivers two separate doses of medication at different times throughout the day providing improved and sustained symptom relief throughout the day and night. DEXILANT delayed release capsules 30 mg and 60 mg are indicated as a once-daily oral treatment of heartburn associated with symptomatic non-erosive Gastroesophageal Reflux Disease (GERD), the healing of erosive esophagitis and the maintenance of healed erosive esophagitis.  GERD, a chronic condition commonly known as acid reflux disease, affects one-third of the Canadian population and is often characterized by frequent and persistent heartburn that occurs two or more days a week¹. 

Persistent heartburn is the most common symptom of GERD; however, other symptoms include regurgitated stomach acid; sour taste in the mouth; burning of the throat; pain or burning in the chest; and night-time awakenings due to heartburn.  Symptoms caused by an increase in acid secretion can be triggered by foods, such as chocolate, fried/fatty foods, alcohol and coffee². 

Aside from heartburn and regurgitation, adults with GERD may also experience atypical symptoms, including persistent sore throat, hoarseness, chronic cough, difficult or painful swallowing, asthma, unexplained chest pain, and the feeling of a lump in the throat. Some may also experience an uncomfortable feeling of fullness after meals.³

GERD also may be associated with serious long-term risks.  Some people experience acid reflux symptoms more frequently than others, but not experiencing symptoms all of the time does not eliminate the risk of serious damage.⁴ 

The persistent symptoms of heartburn and regurgitation can be quite troublesome during the day, but when they keep you from sleeping at night, GERD can seriously interfere with one's ability to work and play," says Gail Attara, President & Chief Executive Officer of the Gastrointestinal Society."  The introduction of a new drug with a different way of delivering the medicine throughout the day is great news and may help those patients who are not currently achieving full symptom relief.

According to a national survey by Leger Marketing, the majority of Canadians view GERD in the following way:

• Nearly three quarters (74%) of those who have spoken to their doctor about their symptoms were given a diagnosis.  Of that, 66% were diagnosed with either GERD or acid reflux;
• Fifty-eight per cent (58%) of respondents who exhibited symptoms of GERD waited up to one year before seeking medical attention.  Of that, 53% delayed seeking medical treatment because they felt symptoms were indicative of food choices;
• More than 50 per cent (55%) of those surveyed indicate that GERD impacts their sleep patterns;
• Less than 20 per cent of respondents (15%) were aware that GERD could lead to serious long-term effects if left untreated.⁵

"While diet and lifestyle changes may be very helpful for some GERD sufferers, they do not relieve symptoms for others. Medications to reduce stomach acid are very effective for those with troublesome GERD symptoms," says Dr. David Armstrong, Gastroenterologist and Associate Professor of Medicine at McMaster University. "By providing two distinct peaks of release, DEXILANT provides better acid reduction and more sustained symptom control over a longer period of time, so GERD will have less of an impact on a person's daily life - this should lead, ultimately, to improvements in our patients' overall quality of life."

Additional findings from the Leger Marketing survey reinforce a need for new innovations in treating GERD.  More than 50 percent of respondents with GERD still have reoccurring symptoms even though they are currently being treated with a prescription medication⁶.

"Takeda is focused on health care solutions that address the unmet medical needs of patients," says Paul Friel, general manager and president, Takeda Canada, Inc.  "We are thrilled that doctors can now prescribe DEXILANT as part of an overall plan to help patients better manage and better control erosive esophagitis and symptoms of GERD."

Health Canada approval of DEXILANT was based on studies conducted in 20 countries in approximately 6,000 patients with erosive and non-erosive GERD. Two double-blind, eight-week, randomized, controlled trials compared treatment with DEXILANT to treatment with lansoprazole in patients with erosive esophagitis (EE). DEXILANT (60 mg) produced high overall healing rates at week eight when compared to lansoprazole (30 mg).  DEXILANT (60 mg) produced high overall healing rates at week eight when compared to lansoprazole (30 mg). DEXILANT healed 92.3% to 93.1% of patients, versus lansoprazole, with overall healing rates from 86.1% to 91.5%.  DEXILANT was generally well tolerated. Results from two double-blind randomized, controlled trials in patients with confirmed healing of erosive esophagitis showed that patients treated with DEXILANT (30 and 60 mg) experienced consistently high overall maintenance of healed erosive esophagitis and heartburn relief versus patients on placebo. In two four-week trials in patients who identified heartburn as their primary GERD symptom and did not have esophageal erosions, DEXILANT demonstrated statistically significant symptom relief.  Patients were heartburn free 99% of nights and 96% of 24-hour periods.

About Takeda Canada, Inc.
Takeda Canada, Inc. is a division of Takeda Pharmaceutical Company Limited, the largest pharmaceutical company in Japan. The Canadian headquarters was established in Mississauga, Ontario, in 2009. Takeda Canada, Inc. currently distributes Actos® for the treatment of type 2 diabetes and Dexilant for the treatment of gastroesophageal reflux disease. The company seeks to enhance the lives of Canadians by providing innovative new products for metabolic, cardiovascular, oncology, central nervous system, and other related conditions. Takeda is committed to striving toward better health for individuals and progress in medicine. To learn more about Takeda Canada, Inc. visit www.takedacanada.com.

Video News Release will be available via satellite on Wednesday, September 22, 2010 at:

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**DEXILANT OR DUAL DELAYED RELEASE is a trademark of Takeda Pharmaceuticals North America, Inc. and used under liscense by Takeda Canada.

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¹ Canadian Society of Intestinal Research. GERD. http://www.badgut.com/index.php?contentFile=gerd&title=GERD
Accessed August 25,2010.

² Canadian Digestive Health Foundation. GERD. http://www.cdhf.ca/pdfs/fact-sheets/CDHF_FactSheet_GERD.pdf#zoom=100. Accessed July 23, 2010.

³ Canadian Digestive Health Foundation. GERD. http://www.cdhf.ca/pdfs/fact-sheets/CDHF_FactSheet_GERD.pdf#zoom=100. Accessed July 23, 2010.

⁴ Canadian Digestive Health Foundation. GERD. http://www.cdhf.ca/pdfs/fact-sheets/CDHF_FactSheet_GERD.pdf#zoom=100. Accessed July 23, 2010.

⁵ Leger Marketing Survey completed with 415 people, ages 18 year+ between August 11-18, 2010.

⁶ Leger Marketing Survey completed with 415 people, ages 18 year+ between August 11-18, 2010.

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