Adeza (NASDAQ:ADZA) today announced that its New Drug Application (NDA) for Gestiva(TM) will be reviewed by the Reproductive Health Drugs Advisory Committee to the U.S. Food and Drug Administration (FDA) on August 29, 2006. Gestiva, a long acting form of a naturally occurring progesterone, is the company's drug candidate to prevent preterm birth in women with a history of preterm delivery.
"The setting of an advisory committee meeting date marks an important next step in the Gestiva NDA review process," said Emory V. Anderson, president and chief executive officer. "A preterm birth occurs nearly every minute and imposes a $26 billion annual cost to the U.S. health care system. For the cases involving women with a prior history of preterm delivery, we believe Gestiva can help reduce costs by prolonging pregnancy and preventing preterm births."
In May 2006, Adeza announced the submission of its Gestiva NDA under Section 505(b)(2) of the Federal Food, Drug, and Cosmetic Act. Adeza was subsequently granted Priority Review for the Gestiva NDA and, pursuant to Prescription Drug User Fee Act (PDUFA) guidelines, the FDA has set a goal to complete its review or otherwise respond to Adeza on the Gestiva NDA by October 20, 2006. Priority Review is granted to product candidates that, if approved, would provide a significant improvement in the treatment, diagnosis or prevention of a disease.
The Gestiva NDA includes positive data from a 463-patient clinical study with 17 alpha-hydroxyprogesterone caproate (17P) in pregnant women with a history of preterm birth conducted by the National Institute of Child Health and Human Development, one of the institutes of the National Institutes of Health (NIH). 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.
In 2003 the American College of Obstetricians and Gynecologists (ACOG) issued a recommendation for the use of progesterone in women with a history of prior preterm birth to help prevent preterm delivery, following publication of NIH study results in the June 2003 New England Journal of Medicine.
Adeza designs, manufactures and markets innovative products for women's health. Adeza's initial focus is on reproductive healthcare using its proprietary technologies to predict preterm birth and assess infertility. Adeza's principal product is a patented diagnostic test, FullTerm(TM), The Fetal Fibronectin Test, which utilizes a single-use, disposable cassette and is analyzed on Adeza's patented TLiIQ(R) System. This product is approved by the FDA for use in assessing the risk of preterm birth. Adeza also markets and sells the E-tegrity(R) Test, an infertility-related test to assess receptivity of the uterus to embryo implantation in women with unexplained infertility. More information is available at www.adeza.com.
Adeza cautions you that statements included in this press release that are not a description of historical facts are forward-looking statements, including for example, statements related to Gestiva's regulatory status and medical potential. The inclusion of forward-looking statements should not be regarded as a representation by Adeza that any of its plans will be achieved. Actual results may differ materially from those set forth in this release due to the risks and uncertainties inherent in Adeza's business including, without limitation, risks related to the anticipated regulatory or commercial path for its product candidates. Further information about these and other risks is included Adeza's Annual Report on Form 10-K and other periodic and current reports filed by Adeza with the Securities Exchange Commission, which are available from the SEC's Web site (www.sec.gov), and also available on the Investor Relations section of Adeza's Web site. All forward-looking statements are qualified in their entirety by this cautionary statement and Adeza undertakes no obligation to revise or update this news release to reflect events or circumstances after the date hereof.