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Makena

Generic name: hydroxyprogesterone caproate
Treatment for: Premature Labor

Update: Makena (hydroxyprogesterone caproate) Now FDA Approved - February 3, 2011

FDA Grants Adeza Priority Review for Gestiva to Prevent Preterm Births

Goal of 6 Months Set by FDA to Review NDA for Gestiva

SUNNYVALE, Calif., June 5, 2006 - Adeza today announced that the U.S. Food and Drug Administration (FDA) has granted the company's New Drug Application (NDA) for Gestiva Priority Review status. A Priority Review designation sets a six-month goal for review by the FDA. Priority Review is granted to product candidates that, if approved, would provide a significant improvement in the treatment, diagnosis or prevention of a disease. Pursuant to Prescription Drug User Fee Act (PDUFA) guidelines, the FDA has set a goal to complete its review or otherwise respond to the Gestiva NDA by October 20, 2006. Gestiva, a long-acting form of a naturally occurring progesterone, is Adeza's drug candidate for prevention of preterm birth in women with a history of preterm delivery.

The March of Dimes estimates that over $18 billion in costs were associated with preterm or low-birth-weight infants in 2003. According to the New England Journal of Medicine, preterm birth has historically accounted for up to 85% of all pregnancy related complications and deaths in the U.S.

"A preterm birth occurs nearly every minute in the United States, resulting in tremendous financial and human costs. Women with a history of preterm birth are among the highest risk for future preterm delivery," said Emory V. Anderson, president and chief executive officer. "Treating women with previous preterm birth with Gestiva has the potential to significantly reduce preterm birth costs."

In May 2006, Adeza announced the submission of its NDA to the FDA under Section 505(b)(2) of the Federal Food, Drug, and Cosmetic Act, which allows for FDA approval of new or improved formulations of previously approved products. Adeza's NDA submission for Gestiva includes data from a clinical study conducted by the National Institute of Child Health and Human Development, one of the institutes of the NIH. The NIH studied a long-acting form of a naturally occurring progesterone, 17 alpha-hydroxyprogesterone caproate (17P), in a multi-center, double-blind, placebo-controlled trial that enrolled 463 women with a prior history of preterm birth. Patients were enrolled at 16 to 21 weeks of gestation and randomly assigned to receive weekly injections of 17P or placebo until delivery or 37 weeks of gestation. Treatment with 17P resulted in an overall reduction in the preterm birth rate of 34% and a reduction of 42% in the rate of preterm births prior to 32 weeks. In addition, infants born to women treated with 17P had significantly lower rates of necrotizing enterocolitis, intraventricular hemorrhage, use of supplemental oxygen, and mean number of days of respiratory therapy.

The use of this form of progesterone is recommended by the American College of Obstetricians and Gynecologists (ACOG) in the treatment of women for recurrent preterm birth. If Gestiva receives FDA approval, Adeza will have the only commercially available, NIH-studied, ACOG-recommended and FDA-approved therapeutic for the prevention of recurrent preterm birth.

Posted: June 2006

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