Danisco STP Press Release .doc - Sigma-Tau Pharmaceuticals
Danisco STP Press Release .doc - Sigma-Tau Pharmaceuticals
Danisco STP Press Release .doc - Sigma-Tau Pharmaceuticals
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<strong>Sigma</strong>-<strong>Tau</strong> <strong>Pharmaceuticals</strong> and <strong>Danisco</strong> Bioactive Announce Partnership<br />
Agreement to Develop Drug Candidate for Prevention of Necrotizing<br />
Enterocolitis<br />
GAITHERSBURG, Md – April 7, 2009 - <strong>Sigma</strong>-<strong>Tau</strong> <strong>Pharmaceuticals</strong>, Inc and <strong>Danisco</strong><br />
BioActives announced today that they have signed a partnering agreement for the development<br />
of a new biologic drug candidate, which may help to prevent a deadly disease called necrotizing<br />
enterocolitis (NEC).<br />
NEC is a rare, life threatening gastrointestinal disorder in infants that affects very low birth<br />
weight (VLBW) premature infants (babies less than 1,500 grams or 3 pounds, five ounces).<br />
There are approximately 60,000 VLBW babies born each year in the United States, of which 5<br />
percent to 15 percent will acquire NEC. Treatment options for this condition are extremely<br />
limited and mortality rates of 20 percent to 30 percent have gone unchanged in the United States<br />
for more than 30 years.<br />
Under the terms of the agreement, <strong>Sigma</strong>-<strong>Tau</strong> and <strong>Danisco</strong> will collaborate to develop <strong>STP</strong>-206,<br />
a biologic agent comprised of live bacteria, which may be effective in preventing the occurrence<br />
of NEC. <strong>Sigma</strong> <strong>Tau</strong> will manage the clinical development of the product and, ultimately, will<br />
seek the approval of the Food and Drug Administration (FDA) and the European Medicines<br />
Agency (EMEA) to market the drug for the prevention of NEC. Human clinical trials are<br />
scheduled to start later this year.<br />
"We have had a very longstanding and successful relationship with <strong>Danisco</strong> and we are very<br />
pleased to move forward with this agreement,” said Gregg Lapointe, chief executive officer of<br />
<strong>Sigma</strong>-<strong>Tau</strong> <strong>Pharmaceuticals</strong>. “Together, we hope to provide a new and innovative option to<br />
prevent this deadly disease and ultimately save lives.”<br />
“<strong>Danisco</strong> is excited to collaborate with <strong>Sigma</strong>-<strong>Tau</strong> <strong>Pharmaceuticals</strong> in the development of an<br />
innovative live biotherapeutic solution to this complex and life-threatening disorder,” said Scott<br />
Bush, dietary supplements vice president for <strong>Danisco</strong> BioActives.<br />
About Necrotizing Enterocolitis (NEC)<br />
NEC is a life threatening gastrointestinal disorder with significant morbidity and mortality<br />
primarily affecting premature infants under 1500 grams, known as very low birth weight infants.<br />
Every year, thousands of premature babies die as a result of this disease and more will suffer<br />
from abnormal neurodevelopmental outcomes. While the cause of the disease is unknown, the<br />
pathological findings of infants who died of NEC show intense mucosal inflammation,<br />
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<br />
year. Of this group, the 60,000 to 70,000 that weigh less than 1,500 grams at birth are at high<br />
risk for acquiring NEC.<br />
About <strong>Sigma</strong>-<strong>Tau</strong> <strong>Pharmaceuticals</strong>, Inc.<br />
<strong>Sigma</strong>-<strong>Tau</strong> <strong>Pharmaceuticals</strong>, Inc. is a U.S. based, wholly owned subsidiary of the <strong>Sigma</strong>-<strong>Tau</strong><br />
Group, and is dedicated solely to the global development and commercialization of medicines for<br />
patients with rare diseases. <strong>Sigma</strong>-<strong>Tau</strong> <strong>Pharmaceuticals</strong>, Inc. is based in Gaithersburg,<br />
Maryland.<br />
Since 1989, the company’s products have been focused on rare diseases, kidney disease, and<br />
cancer. With more than 6,000 identified rare diseases that affect approximately 25 million<br />
patients in the United States, <strong>Sigma</strong>-<strong>Tau</strong> places its considerable scientific resources behind the<br />
development and commercialization of compounds that benefit the few. The company has<br />
substantial development programs focused on transplant, cancer, inherited genetic disorders,<br />
malaria, and other areas of unmet medical need.<br />
For more information about the company, visit www.sigmatau.com.<br />
About <strong>Danisco</strong><br />
With a rich and innovative portfolio, <strong>Danisco</strong> is a world leader in food ingredients, enzymes and<br />
bio-based solutions. Using nature’s own materials, science and the knowledge of our 7,200<br />
people, we design and deliver bio-based ingredients that meet market demand for healthier and<br />
safer products. <strong>Danisco</strong>’s ingredients are used globally in a wide range of industries – from<br />
bakery, dairy and beverages to animal feed, laundry detergents and bioethanol – offering<br />
functional, economic and environmental benefits. Headquartered in Denmark and operating from<br />
more than 80 locations, <strong>Danisco</strong>’s key focus is to become our customers’ first choice and a truly<br />
market-driven global business.<br />
<strong>Danisco</strong> BioActives is dedicated to delivering innovative ingredients for taste, texture, food<br />
safety, human health and nutrition. The BioActives offer includes probiotics, prebiotics,<br />
sweeteners, cultures and natural extracts. <strong>Danisco</strong> BioActives focuses on offering unique,<br />
science-based benefits, affordable cost-in-use and best-in-class service. To this effect <strong>Danisco</strong><br />
BioActives has recently entered multiple partnership agreements for highly <strong>doc</strong>umented, health<br />
promoting ingredients.<br />
Find out more at www.danisco.com.<br />
Company Contacts:<br />
Marc Tewey Scott Bush<br />
<strong>Sigma</strong>-<strong>Tau</strong> <strong>Pharmaceuticals</strong>, Inc <strong>Danisco</strong> BioActives<br />
VP Commercial Operations VP Dietary Supplements<br />
9841 Washingtonian Blvd, Suite 500 3329 Agriculture Drive<br />
Gaithersburg, MD 20878 Madison, WI 53716<br />
301-948-1041 608-395-2617