Healthcare Industry News: Hydroxyprogesterone
News Release - August 29, 2006
FDA Advisory Committee Recommends Approval of Adeza's NDA for Gestiva to Prevent Preterm BirthSUNNYVALE, Calif.--(HSMN NewsFeed)--Aug. 29, 2006--Adeza (NASDAQ:ADZA ) today announced that the Reproductive Health Drugs Advisory Committee to the U.S. Food and Drug Administration (FDA) recommended by a majority vote that the data presented by Adeza in its New Drug Application (NDA) for Gestiva(TM) support efficacy in preventing preterm birth prior to 35 weeks and that overall safety data is adequate and sufficiently reassuring to support marketing approval in women with a history of preterm delivery. The Advisory Committee also recommended the collection of post marketing clinical data. Although Advisory Committee recommendations are not binding, typically FDA final determinations are consistent with their recommendations. Pursuant to Prescription Drug User Fee Act (PDUFA) guidelines, the FDA has a goal to complete its review or otherwise respond to the Gestiva NDA by October 20, 2006.
"We are pleased by the Advisory Committee's support for this important therapeutic for the prevention of preterm birth in women with a history of preterm delivery," said Emory V. Anderson, president and chief executive officer. "With approximately one preterm birth every minute and a $26 billion annual cost to the U.S. health care system, preterm birth is a major public health issue. Treating women with a history of preterm birth with Gestiva could considerably reduce preterm birth and the associated costs for this high risk group."
Gestiva is a long-acting form of a naturally occurring progesterone. 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.
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. In June 2006, Adeza's NDA for Gestiva was granted Priority Review status. 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 National Institutes of Health (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 in 19 clinical trial centers. 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, as reported in the June, 2003 New England Journal of Medicine, 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 serious complications such as necrotizing enterocolitis, intraventricular hemorrhage, use of supplemental oxygen, and mean number of days of respiratory therapy.
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® 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® Test, an infertility-related test to assess receptivity of the uterus to embryo implantation in women with unexplained infertility. In May 2006, Adeza announced the submission of its NDA to the FDA for Gestiva, a long-acting form of a naturally occurring progesterone to prevent preterm birth in women with a history of preterm delivery. Adeza's NDA submission includes data from a clinical study conducted by the National Institutes of Health. 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.
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