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Biopharmaceuticals Gastroenterology

 News Release - January 31, 2007

Procter & Gamble Pharmaceuticals Commemorates 15 Years of Trusted Leadership With Asacol(R) (Mesalamine) Delayed-Release Tablets

Treatment for Mildly to Moderately Active Ulcerative Colitis Continues to Touch Patients' Lives, Delivering a Well-Tolerated, Trusted Therapy

CINCINNATI, Jan. 31 (HSMN NewsFeed) -- Procter & Gamble Pharmaceuticals, Inc. today celebrates the trusted efficacy of Asacol on its 15th anniversary. Asacol is the No. 1 most prescribed 5-ASA therapy for ulcerative colitis (UC), a form of inflammatory bowel disease (IBD).(1) More than 20 million prescriptions have been written for Asacol since it was approved by the U.S. Food and Drug Administration and launched in 1992.(2) Asacol is indicated to treat mildly to moderately active UC and for the maintenance of remission of UC.

"Over the past 15 years, we have worked hard to earn the trust of ulcerative colitis patients and their physicians. Asacol has improved many lives on the basis of its effectiveness and tolerability enabling it to become the category leader," said Mark A. Collar, president of global pharmaceuticals and personal health. "We take our leadership position seriously. We will work to advance disease understanding and quality of life through ongoing clinical research and patient education based on the insights we have gained."

Over the years, P&G has demonstrated a continued commitment to improving the lives of patients with UC. Dedicated to UC research and education, P&G provides unrestricted grants to support key professional and patient organizations such as the Crohn's & Colitis Foundation of America (CCFA), American College of Gastroenterology (ACG), American Gastroenterological Association (AGA), American Society of Colon and Rectal Surgeons (ASCRS), the Foundation for Clinical Research in IBD, and Women, Educators, Clinicians, and Researchers in IBD (WE CARE).

P&G strives to improve patient outcomes by helping patients better understand their condition and medication through support programs and education. For example, the ScriptAssist® Nurse Call Back program for patients taking Asacol, which began in 2006, offers patients a personalized support service from registered nurses to help improve adherence to therapy. P&G also publishes "Insights & Answers," a patient newsletter aimed at increasing awareness about UC and its treatment. In addition, patients can receive from their physician an Asacol "Patient Support Kit" which includes product samples, educational brochures on Asacol and UC, as well as other materials to help patients cope with their condition. P&G offers a Patient Assistance Program which in 2006 provided qualified patients a total of over $5 million worth of Asacol at no cost to the patient.

"I rely on Asacol not only because I am a person living with UC, but also because I am a husband and father, graduate student and triathlete living with the condition," said Asacol patient, Josh Reineke of Providence, R.I., a Ph.D. student in biotechnology and a competitive triathlete for the past three years. "As you can well imagine, I need to be in control of my UC to live my life the way I want."

About Ulcerative Colitis

UC involves inflammation of the lining of the colon and rectum. It varies in clinical severity with patients having mild, moderate or severe disease. Treatment depends on the extent and severity of disease.

UC causes flares followed by periods of remission. During a flare, in which the rectum or colon become inflamed, people experience symptoms such as diarrhea, rectal bleeding, abdominal cramping and an urgent need to go to the bathroom. Flares can vary in duration and intensity. While UC is a lifelong condition, medication may help control flares.

UC affects people of all ages, but is often diagnosed during early adulthood. The causes of this condition are unknown, but may involve heredity, infection or the immune system.

About Asacol

For 15 years, Asacol has been making a difference in the lives of patients with mildly to moderately active UC. It is the No. 1 most prescribed 5-ASA therapy, with more than 20 million prescriptions written.(1),(2)

Asacol is indicated for the treatment of mildly to moderately active UC (the indicated dosage is two 400 mg tablets tid for 6 weeks) and for the maintenance of remission of UC (the indicated dosage is 1.6 g/day in divided doses).

Asacol was well-tolerated in clinical studies. Overall, the incidence of adverse events with Asacol was comparable to placebo. In pivotal clinical studies of mildly to moderately active UC, the most frequent adverse events reported for Asacol and placebo, respectively, were headache (35% vs. 36%), abdominal pain (18% vs. 14%), eructation (16% vs. 15%), pain (14% vs. 8%) and nausea (13% vs. 15%); for the maintenance of remission of UC, the most frequent adverse events were headache (50% vs. 50%), rhinitis (42% vs. 36%), diarrhea (35% vs. 50%), abdominal pain (32% vs. 44%) and flatulence (24% vs. 30%).

Asacol is contraindicated in patients with hypersensitivity to salicylates. Caution should be exercised when using Asacol in patients with known renal dysfunction or history of renal disease. It is recommended that all patients have an evaluation of renal function prior to initiation of Asacol tablets and periodically while on Asacol therapy. Serious adverse events may occur with Asacol. Please see accompanying full prescribing information or visit http://www.pgpharma.com/pi/US-Asacol.pdf .

About Procter & Gamble (NYSE: PG )

Three billion times a day, P&G brands touch the lives of people around the world. The company has one of the strongest portfolios of trusted, quality, leadership brands, including Actonel®, Asacol®, Enablex®, Prilosec OTC®, Metamucil®, Fibersure®, Align®, Pepto-Bismol®, Vicks®, ThermaCare®, PUR®, Crest® and Oral-B®. The P&G community consists of over 135,000 employees working in over 80 countries worldwide. Please visit http://www.pg.com for the latest news and in-depth information about P&G and its brands.

(1) Data on file: IMS National Prescription Audit, 12 months ending May 2006.

(2) Data on file: IMS National Prescription Audit, 1992 - July 2006.


Source: Procter & Gamble

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