Sigma-Tau Pharmaceuticals and Danisco BioActives Announce Partnership Agreement to...

Sigma-Tau Pharmaceuticals and Danisco BioActives Announce Partnership
Agreement to Develop Drug Candidate for Prevention of Necrotizing
Enterocolitis

GAITHERSBURG, Md., April 7 /PRNewswire/ -- Sigma-Tau Pharmaceuticals, Inc. and
Danisco BioActives announced today that they have signed a partnering
agreement for the development of a new biologic drug candidate, which may help
to prevent a deadly disease called necrotizing enterocolitis (NEC).

NEC is a rare, life-threatening gastrointestinal disorder in infants that
affects very low birth weight (VLBW) premature infants (babies less than 1,500
grams or 3 pounds, five ounces). There are approximately 60,000 VLBW babies
born each year in the United States, of which 5 percent to 15 percent will
acquire NEC. Treatment options for this condition are extremely limited and
mortality rates of 20 percent to 30 percent have gone unchanged in the United
States for more than 30 years.

Under the terms of the agreement, Sigma-Tau and Danisco will collaborate to
develop STP-206, a biologic agent comprised of live bacteria, which may be
effective in preventing the occurrence of NEC. Sigma Tau will manage the
clinical development of the product and, ultimately, will seek the approval of
the Food and Drug Administration (FDA) and the European Medicines Agency
(EMEA) to market the drug for the prevention of NEC. Human clinical trials
are scheduled to start later this year.

"We have had a very longstanding and successful relationship with Danisco and
we are very pleased to move forward with this agreement," said Gregg Lapointe,
chief executive officer of Sigma-Tau Pharmaceuticals. "Together, we hope to
provide a new and innovative option to prevent this deadly disease and
ultimately save lives."

"Danisco is excited to collaborate with Sigma-Tau Pharmaceuticals in the
development of an innovative live biotherapeutic solution to this complex and
life-threatening disorder," said Scott Bush, dietary supplements vice
president for Danisco BioActives.

About Necrotizing Enterocolitis (NEC)

NEC is a life-threatening gastrointestinal disorder with significant morbidity
and mortality primarily affecting premature infants under 1500 grams, known as
very low birth weight infants. Every year, thousands of premature babies die
as a result of this disease and more will suffer from abnormal
neurodevelopmental outcomes. While the cause of the disease is unknown, the
pathological findings of infants who died of NEC show intense mucosal
inflammation, hemorrhage and transmural necrosis of the small and large
intestines.

In the United States, more than 300,000 premature babies (less than 2500
grams) are born each year. Of this group, the 60,000 to 70,000 that weigh
less than 1,500 grams at birth are at high risk for acquiring NEC.

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 United States, Sigma-Tau
places its considerable scientific resources behind the development and
commercialization of compounds that benefit the few. The company has
substantial development programs 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 Danisco

With a rich and innovative portfolio, Danisco is a world leader in food
ingredients, enzymes and bio-based solutions. Using nature's own materials,
science and the knowledge of our 7,200 people, we design and deliver bio-based
ingredients that meet market demand for healthier and safer products.
Danisco's ingredients are used globally in a wide range of industries - from
bakery, dairy and beverages to animal feed, laundry detergents and bioethanol
- offering functional, economic and environmental benefits. Headquartered in
Denmark and operating from more than 80 locations, Danisco's key focus is to
become our customers' first choice and a truly market-driven global business.

Danisco BioActives is dedicated to delivering innovative ingredients for
taste, texture, food safety, human health and nutrition. The BioActives offer
includes probiotics, prebiotics, sweeteners, cultures and natural extracts.
Danisco BioActives focuses on offering unique, science-based benefits,
affordable cost-in-use and best-in-class service. To this effect Danisco
BioActives has recently entered multiple partnership agreements for highly
documented, health promoting ingredients.

Find out more at www.danisco.com.

Company Contacts:

Marc Tewey Scott Bush
Sigma-Tau Pharmaceuticals, Inc. Danisco BioActives
VP Commercial Operations VP Dietary Supplements
9841 Washingtonian Blvd, Suite 500 3329 Agriculture Drive
Gaithersburg, MD 20878 Madison, WI 53716
301-948-1041 608-395-2617

SOURCE Sigma-Tau Pharmaceuticals

Marc Tewey of Sigma-Tau Pharmaceuticals, Inc, +1-301-948-1041; or Scott Bush
of Danisco BioActives, +1-608-395-2617