Solvay Pharmaceuticals, Inc. Announces Commercial Availability of CREON(R) (Pancrelipase)...

Solvay Pharmaceuticals, Inc. Announces Commercial Availability of CREON(R)
(Pancrelipase) Delayed-Release Capsules
- First and only FDA-approved therapy for exocrine pancreatic insufficiency is
now available through pharmacies and requires new prescriptions reflecting new
dosage strengths -

MARIETTA, Ga., July 7 /PRNewswire/ -- Solvay Pharmaceuticals, Inc. today
announced the commercial availability of CREON(R) (pancrelipase)
Delayed-Release Capsules. Now available to be filled at pharmacies
nationwide, CREON(R) was approved by the Food and Drug Administration (FDA) on
April 30, 2009, for the treatment of exocrine pancreatic insufficiency (EPI)
due to cystic fibrosis (CF) or other conditions. CREON(R) is the first and
only pancreatic enzyme product (PEP) to receive FDA approval under new
manufacturing guidelines for the class.

The new formulation of CREON(R) has new Prescribing Information, a new dosing
schedule, and a Medication Guide to provide important dosing and safety
information to patients. CREON(R) also has new dosage strengths and --
effective immediately -- requires new prescriptions for all patients who have
previously been prescribed CREON(R).

CREON(R) is available in three prescription strengths dosed by lipase units.
As of today, the new FDA-approved dosage strengths are CREON(R) 6,000 lipase
units, CREON(R) 12,000 lipase units, and CREON(R) 24,000 lipase units.
Patients already taking CREON can be transitioned to the FDA-approved CREON(R)
dosage strengths on a capsule-to-capsule basis as follows.
Former Dosage Strength FDA-approved Dosage Strength
CREON(R) 5 Creon(R) 6,000 units 19,000 units 30,000 units
Lipase Protease Amylase
CREON(R) 10 Creon(R) 12,000 units 38,000 units 60,000 units
Lipase Protease Amylase
CREON(R) 20 Creon(R) 24,000 units 76,000 units 120,000 units
Lipase Protease Amylase

The FDA-approved formulation of CREON(R) includes several changes of which
prescribers and pharmacists should take note. CREON(R) is the first
"zero-overfill" pancreatic enzyme product, meaning that the capsules target
100% of the lipase amount indicated on the product labeling. Mineral oil has
also been removed from the product, which may lead to increased absorption of
fat-soluble vitamins. Additionally, the product has new trade dress and
capsule imprints to distinguish the former dosage strength capsules from this
new FDA-approved formulation.

To ensure that patient access to CREON(R) is not disrupted, the former dosage
strengths of CREON(R) will continue to be commercially available during a
brief transitional period while Solvay Pharmaceuticals educates healthcare
professionals, patients and caregivers about the transition to FDA-approved
CREON(R). Effective July 7th, however, prescribers and pharmacists should
begin writing and filling CREON(R) prescriptions reflecting the new,
FDA-approved dosage strengths as CREON(R) 5, 10 and 20 will no longer be sold
to wholesale distributors. Additional information about the new formulation
of CREON(R) can be found at www.CREON.com.

"We are proud that CREON(R) is the first and only pancreatic enzyme product to
receive FDA approval and to meet the FDA's standards of quality, safety,
effectiveness and labeling," said Elizabeth Mutisya, M.D., Vice President of
Medical Affairs and Chief Medical Officer, Solvay Pharmaceuticals. "Solvay
Pharmaceuticals is committed to helping healthcare professionals, patients and
their caregivers transition to the FDA-approved formulation of CREON(R) and to
continuing our more than 20 years of support for patients with EPI."

Solvay Pharmaceuticals offers a Patient Assistance Program through which
certain patients can obtain CREON(R) at no cost if they meet financial
eligibility criteria. Solvay Pharmaceuticals also offers a CF-specific
support program, SolvayCARES(SM), which provides nutritional, educational and
financial resources to those touched by CF. For more information about
SolvayCARES(SM), contact your local CF healthcare provider or visit
www.SolvayCARES.com.

About Exocrine Pancreatic Insufficiency and Pancreatic Enzyme Products
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. For patients with EPI, pancreatic
enzymes are essential to ensure adequate nutrition and health. Pancreatic
enzyme products 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 NDAs for all
pancreatic enzyme products in order to remain on the market. By April 2010,
all pancreatic enzymes are required to have approved NDAs and must be
manufactured under the new guidelines.

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

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(R) 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(R) is not chewed or retained in the mouth to avoid irritation of oral
mucosa. Caution should be exercised when prescribing CREON(R) to patients
with gout, renal impairment, or hyperuricemia. There is theoretical risk of
viral transmission with all pancreatic enzyme products, including CREON(R).
Caution should be exercised when administering pancrelipase to a patient with
a known allergy to proteins of porcine origin.

CREON(R) 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(R), 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(R), 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.

CONTACT:
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; or Aaron Estrada, Ruder Finn, +1-212-715-1568,
estradaa@ruderfinn.com