CREON(R) (pancrelipase) Delayed-Release Capsules Improves Digestive Outcomes In Adults With Chronic Pancreatitis

CREON(R) (pancrelipase) Delayed-Release Capsules Improves Digestive Outcomes
In Adults With Chronic Pancreatitis
- NEW DATA SUPPORT SAFE AND EFFECTIVE USE OF CREON TO TREAT EXOCRINE
PANCREATIC INSUFFICIENCY DUE TO CHRONIC PANCREATITIS OR PANCREATIC SURGERY -

MARIETTA, Ga., Oct. 26 /PRNewswire/ -- Solvay Pharmaceuticals, Inc. announced
today that new data demonstrate that CREON®( )(pancrelipase) Delayed-Release
Capsules significantly improves a key measure of fat absorption in adults with
exocrine pancreatic insufficiency (EPI) due to chronic pancreatitis (CP) or
pancreatic surgery. EPI is a condition resulting from a deficiency in the
production and/or secretion of pancreatic enzymes that are necessary to digest
nutrients in food and, if untreated, can lead to diarrhea, weight loss and
ultimately malnutrition.

Findings from this Phase III study, which have been submitted to the FDA, were
presented at the American College of Gastroenterology Annual Scientific
Meeting in San Diego, California, on Sunday, October 25th, by Dr. David C.
Whitcomb, in a poster titled "Efficacy and safety of pancrelipase
delayed-release capsules (CREON®) in patients with pancreatic insufficiency
due to chronic pancreatitis or pancreatic surgery," poster number P101. Among
FDA-approved pancreatic enzyme replacement therapies (PERTs), this study
provides important new data to evaluate PERT dosing specifically in patients
with EPI due to CP or pancreatic surgery.

"The maldigestion associated with EPI due to chronic pancreatitis and
pancreatic surgeries can result in malnutrition as well as debilitating pain
and GI symptoms that negatively impact quality of life for these patients,"
said David C. Whitcomb, M.D., Ph.D., University of Pittsburgh Medical Center.
"These data support the use of PERT to improve the absorption of fat in
patients receiving diets of at least 100 g of fat per day, which serves as an
important demonstration to clinicians that EPI can be effectively treated
without restricting patients' diets to be very low in fat."

According to the study results, adults with CP or who have undergone
pancreatic surgery, who took CREON®, had an improved coefficient of fat
absorption (CFA) as compared to the placebo group. CFA is calculated based on
measures of fat ingestion and fat excretion; assessing the CFA of a patient is
another way to measure the absorption of fat as a percentage of fat intake in
patients being tested for EPI. The primary efficacy endpoint was the change
in CFA from baseline to the end of the double-blind treatment period. The CFA
improved by 32.1% in the CREON® group compared to 8.8% in the placebo group,
representing a statistically significant difference between CREON® and placebo
(P<0.0001).

"These data add to the growing body of evidence supporting the efficacy and
safety profile of CREON® across multiple conditions while also providing
clarity around the appropriate dosing of pancreatic enzyme replacement therapy
in these patients," said Elizabeth M. Mutisya, M.D., Vice President of U.S.
Medical Affairs and Chief Medical Officer at Solvay Pharmaceuticals, Inc.
"These CREON® study results are encouraging as dosing of pancreatic enzymes
for patients with EPI due to CP or pancreatic surgery has not previously been
well defined."

Study Details
The double-blind, randomized, placebo-controlled, two-arm, parallel-group
study conducted in the United States, Eastern and Central Europe, examined the
efficacy and safety of CREON® 12,000-lipase unit capsules in 52 adults aged 18
years or older with EPI due to CP or pancreatic surgery. Patients were
randomized to receive CREON® 12,000-lipase unit capsules at a dose of 72,000
lipase units per main meal and 36,000 lipase units per snack or matching
placebo. EPI was confirmed in all subjects through direct pancreatic function
testing such as, secretin tests or fecal elastase (< 100 micrograms/g),
72-hour fecal fat determination (> 15 g/day) or pancreatectomy more than 180
days prior to study enrollment.

Upon analysis of the primary efficacy results, the mean CFA increased by 32.1%
in the CREON® group and 8.8% in the placebo group, with a statistically
significant difference between CREON® and placebo (p < 0.0001). Thus, the
study met its primary objective, showing a superior efficacy of CREON® over
placebo on the key measure of CFA. Overall symptoms of maldigestion improved
from baseline to a greater extent in CREON®-treated patients compared with
placebo, with significantly greater improvements in stool characteristics,
flatulence, and stool consistency. CREON® was well-tolerated and had a
similar adverse event profile to that of placebo. A low number of
treatment-emergent adverse events were reported; primarily gastrointestinal
events and metabolic/nutritional disorders.

About Exocrine Pancreatic Insufficiency and Pancreatic Enzyme Replacement
Therapy
Exocrine pancreatic insufficiency (EPI) is a condition resulting from a
deficiency in the production and/or secretion of pancreatic enzymes that are
necessary to digest nutrients in food. The safety and efficacy of prior
formulations of pancrelipase in pediatric patients with EPI due to CF have
been described in the medical literature. Prior formulations of pancrelipase
have also demonstrated clinical efficacy in those patients through years of
clinical experience. PERTs work in patients with EPI by delivering pancreatic
enzymes to the small intestine to help break down fats, proteins and
carbohydrates in food, thereby acting as a replacement for digestive enzymes
physiologically secreted by the pancreas. EPI can occur as a complication of
a variety of diseases or conditions, including CF, pancreatic cancer,
gastrointestinal surgery and chronic pancreatitis. Statistics show that more
than 80% of CF patients have EPI, which usually develops during the first year
of life.

The original products in the pancreatic enzyme drug class pre-date modern FDA
regulatory requirements. Over the past two decades, products in this class
have been allowed to be marketed as prescription drugs without formal NDA
approval. In 2004, the FDA required manufacturers to submit New Drug
Applications (NDAs) for all pancreatic enzyme replacement therapies in order
to remain on the market. By April 2010, all pancreatic enzyme replacement
therapies are required to have approved NDAs and must be manufactured under
the new guidelines.

Important Safety Information
Warnings and precautions include fibrosing colonopathy, a rare, serious
adverse reaction that has been described in association with high-dose use of
pancreatic enzyme replacement therapy in the treatment of cystic fibrosis
patients. Caution should be exercised when doses of CREON®( )exceed 2,500
lipase units/kg of body weight per meal (or greater than 10,000 lipase
units/kg of body weight per day). Care should be taken to ensure that CREON®(
)is not chewed or retained in the mouth to avoid irritation of oral mucosa.
Caution should be exercised when prescribing CREON®( )to patients with gout,
renal impairment, or hyperuricemia. There is theoretical risk of viral
transmission with all pancreatic enzyme products, including CREON®. Caution
should be exercised when administering pancrelipase to a patient with a known
allergy to proteins of porcine origin.

In the clinical study used to demonstrate the efficacy and safety of
FDA-approved CREON®, the incidence of adverse events (regardless of causality)
was higher during placebo treatment (71%) than during CREON®( )treatment
(50%). Treatment-emergent adverse events occurring in at least two patients
(greater than or equal to 6%) receiving CREON®( )or placebo were abdominal
pain, abdominal pain upper, abnormal feces, cough, dizziness, flatulence,
headache, and weight decreased.

CREON®( )has been approved with a Risk Evaluation and Mitigation Strategy
(REMS) to ensure that the benefits of the drug outweigh its risks. As part of
the REMS, a Medication Guide with important dosing and safety information
applicable to this class of products, including CREON®, is provided for
patients and caregivers, with an emphasis on understanding the risk of
fibrosing colonopathy as well as the importance of not over- or under-dosing.
The FDA requires that the Medication Guide be handed out with every
prescription for the drug dispensed.

For full safety and Prescribing Information about the FDA-approved formulation
of CREON®, visit www.CREON.com.

Solvay Pharmaceuticals, Inc., of Marietta, Georgia, is the U.S. subsidiary of
Solvay Pharmaceuticals. For more information, visit
www.solvaypharmaceuticals-us.com.

Solvay Pharmaceuticals is a research driven group of companies that
constitutes the global pharmaceutical business of the Solvay Group. These
companies seek to fulfill carefully selected, unmet medical needs in the
therapeutic areas of neuroscience, cardiometabolic, influenza vaccines,
gastroenterology and men's and women's health. Its 2008 sales were EUR 2.7
billion and it employs more than 9,000 people worldwide. For more information,
visit www.solvaypharmaceuticals.com.

Solvay is an international Chemicals and Pharmaceuticals Group with
headquarters in Brussels. It employs some 28,300 people in 50 countries. In
2008, its sales amounted to EUR 9.5 billion generated by its three activity
sectors: Chemicals, Plastics and Pharmaceuticals. Solvay (NYSE-Euronext:
SOLB.BE - Bloomberg: SOLB.BB - Reuters: SOLBt.BR) is listed on NYSE-Euronext
at Brussels. Details are available at www.solvay.com.

CONTACTS:
Jessica Riley Aaron Estrada
Solvay Pharmaceuticals, Inc. Ruder Finn
(770) 578-5637 (212) 715-1568
jessica.riley@solvay.com estradaa@ruderfinn.com

SOURCE Solvay Pharmaceuticals, Inc.

Jessica Riley, Solvay Pharmaceuticals, Inc., +1-770-578-5637,
jessica.riley@solvay.com; Aaron Estrada, Ruder Finn, +1-212-715-1568,
estradaa@ruderfinn.com