Procter & Gamble Pharmaceuticals Launches Asacol(R) HD (mesalamine) Delayed-Release...

Procter & Gamble Pharmaceuticals Launches Asacol(R) HD (mesalamine)
Delayed-Release Tablets
Asacol HD offers moderately active UC patients a new treatment option for
managing their flares

CINCINNATI, July 7 /PRNewswire/ -- Procter & Gamble Pharmaceuticals (P&GP)
announced today the availability of Asacol HD (mesalamine) delayed-release
tablets, which are indicated for the treatment of moderately active ulcerative
colitis (UC), a form of inflammatory bowel disease. UC involves inflammation
of the lining of the colon and rectum and is typically characterized by flares
followed by periods of remission. Moderately active UC is characterized by
tougher symptoms than mildly active UC. Asacol HD is proven to help treat
these tougher flares of moderately active UC. Asacol HD was approved by the
U.S. Food and Drug Administration (FDA) based on evaluations from the ASCEND
studies [Assessing the Safety and Clinical Efficacy of a New Dose of 5-ASA
(4.8 g/day 800 mg tablet)].

In six-week clinical studies of moderately active UC flares, Asacol HD at 4.8
g/day helped many patients reduce their UC symptoms, including number of bowel
movements and rectal bleeding, for some as early as three weeks. Asacol HD
decreased the number of trips to the bathroom (i.e., number of bowel
movements) in approximately three out of four of patients by six weeks and
decreased rectal bleeding for approximately 80 percent of patients by six
weeks. Patients should discuss their experiences with Asacol HD with a
physician, as their individual results may vary.

"In six-week clinical trials of moderately active UC, Asacol HD helped reduce
rectal bleeding and stool frequency, without the use of steroids. These
encouraging results help support Asacol HD as an effective therapy in patients
with moderately active UC," said Stephen B. Hanauer, M.D., Chief of
Gastroenterology, Hepatology and Nutrition at the University of Chicago
Medical Center. "Every patient's disease is different and requires a personal
approach to treatment. A course of treatment that is right for one patient may
not be right for another. Patients should speak with their doctors to
determine the course of therapy that is best for them."

P&GP has been a leader in UC research and education through support of
professional UC programs and research grants. P&GP is also the maker of
Asacol(R) (mesalamine) 400 mg delayed-release tablets, the number one
most-prescribed oral 5-aminosalicylic acid (5-ASA) therapy.* More than 20
million prescriptions have been written for Asacol since its FDA approval and
U.S. launch in 1992.** Physicians have relied on Asacol as a trusted UC
therapy for more than 17 years. Asacol HD is the newest addition to P&GP's GI
portfolio.

"Procter & Gamble is delighted to introduce Asacol HD to the Asacol franchise.
This new addition will further help UC patients get their symptoms under
control so that their lives can be more predictable," said Dan Hecht, General
Manager for P&G Pharmaceuticals, North America. "This addition to P&G's robust
portfolio of gastrointestinal therapies underscores P&G's continued commitment
to developing innovative ways to improve the lives of millions of people that
struggle with GI conditions every day."

If for any reason a patient is dissatisfied with the first course of therapy,
P&GP will refund the receipted cost of the original prescription. Receipted
cost includes only the amount actually paid by the patient. P&GP will not
refund costs covered by third party payers, including Medicaid. Call
1-800-448-4878 for more information.

Detailed Clinical Data for Asacol HD in Moderately Active UC
The efficacy and safety of Asacol HD was evaluated in the ASCEND studies.

The primary endpoint of the ASCEND II and III studies was overall improvement
at six weeks, which was determined by the Physician's Global Assessment (PGA)
which encompassed the clinical assessments of rectal bleeding, stool frequency
and sigmoidoscopy findings. The Patient's Functional Assessment (PFA) was also
included in ASCEND II.

In ASCEND III, 70 percent of patients (n=273/389) achieved overall improvement
with Asacol HD at 4.8 g/day as compared to 66 percent of patients (n=251/383)
who took Asacol 400 mg tablets at 2.4 g/day.(1) In ASCEND II, 72 percent of
patients (n=89/124) achieved overall improvement with Asacol HD at 4.8 g/day
at six weeks, as compared to 59 percent of patients (n=77/130) who took Asacol
400 mg tablets at 2.4 g/day.(1,2) One Asacol HD 800 mg tablet has not been
shown to be bioequivalent to two Asacol 400 mg tablets.

In addition, Asacol HD at 4.8 g/day demonstrated rapid improvement in rectal
bleeding and stool frequency. At three weeks, rectal bleeding improved in 78
percent and 75 percent of the patients in the ASCEND III and ASCEND II
studies, respectively. At six weeks, 84 percent of the patients taking Asacol
HD at 4.8 g/day in ASCEND III and 79 percent of patients in ASCEND II
experienced improvements in rectal bleeding.(1,2)

At three weeks, improvement of stool frequency was achieved by 76 percent and
64 percent of patients taking Asacol HD at 4.8 g/day in the ASCEND III and
ASCEND II studies, respectively. At six weeks, the percentage of patients with
improved stool frequency was 79 percent in ASCEND III and 74 percent in ASCEND
II. (1,2)

About Ulcerative Colitis (UC)
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
and/or the immune system.

About Asacol and Asacol HD
Asacol is indicated for the treatment of mildly to moderately active UC and
for the maintenance of remission of UC. The recommended dosage for active UC
is two 400 mg tablets TID, with or without food, for a total daily dose of 2.4
g for 6 weeks. For the maintenance of remission of UC, the recommended dosage
is 1.6 g/day in divided doses.

Asacol HD is indicated for the treatment of moderately active UC. The
recommended dose in adults is two 800 mg tablets TID, with or without food,
for a total daily dose of 4.8 g. The safety and effectiveness of Asacol HD
beyond 6 weeks has not been established.

In clinical trials, Asacol and Asacol HD were generally well-tolerated. The
most common adverse reactions reported in patients treated with Asacol and
Asacol HD were nausea, diarrhea, abdominal pain, eructation, flatulence,
exacerbation of UC, headache, rhinitis, nasopharyngitis and pain.

Asacol and Asacol HD are contraindicated in patients with hypersensitivity to
salicylates. Caution should be exercised when using these products 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 and periodically while on Asacol or Asacol HD therapy. Acute
exacerbation of colitis symptoms can also occur. Caution should be exercised
when administering Asacol or Asacol HD to patients with liver disease. Serious
adverse events may occur with Asacol or Asacol HD.

Please visit http://www.asacol.com/pdf/us-asacol.pdf for Asacol Full
Prescribing Information and http://www.AsacolHD.com for Asacol HD Full
Prescribing Information.

About Procter & Gamble (NYSE: PG)
Three billion times a day, P&G brands touch the lives of people around the
world. P&G has one of the strongest portfolios of trusted, quality, leadership
brands, including Actonel(R) (risedronate sodium) tablets, Asacol(R)
(mesalamine) delayed-release tablets, Asacol(R) HD (mesalamine)
delayed-release tablets, Enablex(R) (darifenacin) extended release tablets,
Prilosec OTC(R), Align(R), Metamucil(R), Fibersure(R), Pepto-Bismol(R),
Vicks(R), PUR(R), Crest(R) and Oral-B(R). The P&G community consists of more
than 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.

Media Contacts:
Scott Docherty - P&G Pharmaceuticals, Inc. +1-513-622-0478
Danielle Catapano - MSL Worldwide, PR +1-212-468-3194

* Based on total prescription share data. This information is an estimate
derived from the use of information under license from IMS National
Prescription Data for the 12 month period ending December 2008. IMS expressly
reserves all rights, including rights of copying, distribution and
republication.

** IMS national prescription data from 1992-July 2006.

(1) Asacol HD Package Insert (April 2009)
(2) Hanauer SB et al. Am J Gastroenterol 2005; 100: 2478-2485.

SOURCE Procter & Gamble Pharmaceuticals

Scott Docherty, P&G Pharmaceuticals, Inc., +1-513-622-0478, or Danielle
Catapano, MSL Worldwide, PR, +1-212-468-3194