chenodeoxycholic acid - Sigma-Tau Pharmaceuticals

For Immediate Release
Sigma-Tau Pharmaceuticals Completes Acquisition of Chenix ® (chenodeoxycholic acid) from
Solvay Pharmaceuticals, Inc.
Jan 30, 2009, Gaithersburg, MD – Sigma-Tau Pharmaceuticals, Inc. announced today that it has
completed the acquisition of Chenix ® (chenodeoxycholic acid) from Solvay Pharmaceuticals, Inc.
The agreement transfers the marketing authorization and all related regulatory, manufacturing and
clinical data to Sigma-Tau.
Chenix ® was originally approved in 1983 for the dissolution of gallstones in a certain subset of
gallstone patients. The product is not currently marketed in the United States.
Sigma-Tau is pursuing US Food and Drug Administration (FDA) approval for the use of
chenodeoxycholic acid (CDCA) in patients with a disease called Cerebrotendinous Xanthomatosis
(CTX). CTX is a very rare genetic disease which is believed to affect fewer than one hundred
people in the U.S. While CDCA is widely accepted by the scientific community as the first line
treatment for CTX, the product is currently unavailable as an approved drug in the United States,
necessitating its importation from other countries.
“At Sigma-Tau we are dedicated to developing medicines for the unmet needs of patients with rare
diseases, even if there are only a few hundred patients,” said Gregg Lapointe, Chief Executive
Officer of Sigma-Tau Pharmaceuticals. “The acquisition of this marketing authorization is an
important asset which supports our effort to make CDCA available in the U.S., and we are very
grateful for Solvay’s collaboration and support towards this objective.”
Sigma-Tau has received an Orphan Drug Designation from the FDA for the use of CDCA and also
has acquired the German approved chenodeoxycholic acid product called Chenofalk ® . Chenofalk ®
is distributed in Europe through Sigma-Tau’s German affiliate: Sigma-Tau Arzeneimittel GmbH.
Sigma-Tau is also working closely with the United Leukodystrophy Foundation (ULF) to better
understand the needs of CTX patients and to develop a newborn screening program for the disease.
About Cerebrotendinous Xanthomatosis (CTX)
Cerebrotendinous Xanthomatosis (CTX) is a rare, autosomal recessive metabolic disorder caused
by mutations in a gene called CYP27A1, which produces an enzyme called sterol 27-hydroxylase.
Sterol 27-hydroxylase is required to turn cholesterol into bile acids, which are important in the
absorption of fat in the intestine. In addition, when sterol-27 hydroxylase is not working properly,
cholesterol and precursors of bile acids will accumulate in tissues throughout the body causing a
variety of physiologic and neurological problems.

About Sigma-Tau Pharmaceuticals, Inc.
Sigma-Tau Pharmaceuticals, Inc. is a U.S. based, wholly owned subsidiary of the Sigma-Tau
Group, and is dedicated solely to the global development and commercialization of medicines for
patients with rare diseases. Sigma-Tau Pharmaceuticals, Inc. is based in Gaithersburg, Maryland.
Since 1989, the company’s products have been focused on rare diseases, kidney disease, and
cancer. With more than 6,000 identified rare diseases that affect approximately 25 million patients
in the Unites States, Sigma-Tau places its considerable scientific resources behind the development
and commercialization of compounds that benefit the few. The company has a substantial
development program focused on transplant, cancer, inherited genetic disorders, malaria, and other
areas of unmet medical need. For more information about the company, visit www.sigmatau.com
About Solvay Pharmaceuticals
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 constitute the global
pharmaceutical business of the Solvay Group. The company seeks to fulfill carefully selected,
unmet medical needs in the therapeutic areas of neuroscience, cardio-metabolic, influenza
vaccines, gastroenterology, and men’s and women’s health. Its 2007 sales were EUR 2.6 billion
and it employs more than 9,000 people worldwide. For more information, visit
www.solvaypharmaceuticals.com.
SOLVAY is an international chemical and pharmaceutical Group with headquarters in Brussels. It
employs more than 28,000 people in 50 countries. In 2007, its consolidated sales amounted to
EUR 9.6 billion, generated by its three sectors of activity: Chemicals, Plastics and
Pharmaceuticals. Solvay (NYSE Euronext: SOLB.BE - Bloomberg: SOLB.BB - Reuters:
SOLBt.BR) is listed on the NYSE Euronext stock exchange in Brussels. Details are available at
www.solvay.com
About United Leukodystrophy Foundation (ULF)
The United Leukodystrophy Foundation (ULF) is dedicated to helping patients and family
members afflicted with various types of leukodystrophies including CTX. The ULF is committed
to the identification, treatment and cure of all leukodystrophies through programs of education,
advocacy, research and service.
For more information, please contact:
Marc Tewey
Vice President of Commercial Operations
Phone: 301-670-1518
Email: Marc.Tewey@sigmatau.com C002 01/09