Sigma-Tau Pharmaceuticals, Inc and Danisco BioActives announced 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 three pounds, five ounces). There are approximately 60,000 VLBW babies born each year in the United States, of which 5 per cent to 15 per cent will acquire NEC. Treatment options for this condition are extremely limited and mortality rates of 20 per cent to 30 per cent 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.

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.

Sigma-Tau Pharma is a US-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.

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.