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Sigma-Tau Pharmaceuticals and Danisco BioActives Announce Partnership Agreement to Develop Drug Candidate for Prevention of Necrotizing Enterocolitis
Date:4/7/2009

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


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SOURCE Sigma-Tau Pharmaceuticals
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