ADEZA RECEIVES ORPHAN DRUG DESIGNATION FOR GESTIVA

Adeza announced that the FDA's Office of Orphan Products Development has granted orphan drug designation to Gestiva, the company's therapeutic candidate for the prevention of preterm birth in women with a history of preterm delivery. If Gestiva is approved, orphan drug designation provides the opportunity for seven years of U.S. market exclusivity.

The company submitted a new drug application for Gestiva, a long-acting injectable form of a naturally occurring progesterone, in the second quarter of 2006. In October Adeza recieved an FDA approvable letter for Gestiva requesting an additional rodent study and certain other conditions. The letter also outlined postapproval clinical requirements.

"This is an important milestone," Emory Anderson, president and CEO of Adeza, said. "Gestiva has the potential to significantly reduce preterm birth, improve neonatal outcomes and reduce associated healthcare costs in women with a history of preterm delivery."