| 4.7.2009 Danisco BioActives and Sigma-Tau Pharmaceuticals announce partnership agreement |
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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 in 2009. A step towards human health This demonstrates the focus of Danisco BioActives towards the health and nutrition market and reinforces the interest for our bio-based solutions and scientific expertise in human health. '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. What is NEC? NEC is a rare but life threatening gastrointestinal disorder in infants that primarily affects Very Low Birth Weight (VLBW) premature infants (babies less than 1,500 grams or 3lbs, 5 oz). There are approximately 60,000 VLBW babies born each year in the United States, of which 5- 15% will acquire NEC. Treatment options for this condition are extremely limited and mortality rates of 20-30% have gone unchanged in the U.S. for over 30 years.The partnering agreement has been signed to develop a new biologic drug candidate which may help to prevent a deadly disease called Necrotizing Enterocolitis (NEC). |