Healthcare Industry News: hydroxyprogesterone
News Release - June 5, 2006
FDA Grants Adeza Priority Review for Gestiva to Prevent Preterm BirthsGoal of 6 Months Set by FDA to Review NDA for Gestiva
SUNNYVALE, Calif.--(HSMN NewsFeed)--June 5, 2006--Adeza (NASDAQ:ADZA ) today announced that the U.S. Food and Drug Administration (FDA) has granted the company's New Drug Application (NDA) for Gestiva(TM) 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.
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 an NDA with 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 may be forward-looking statements, including, for example, statements relating to Adeza's product candidate Gestiva, and the timeline for review of regulatory submissions related to Gestiva. 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 and uncertainties relating to the expansion of products, markets and offerings, and additional product indications, risks associated with the regulatory approval process for product candidates, and risks associated with being in both the diagnostic and therapeutic businesses. Further information about these and other risks is included in Adeza's Annual Report on Form 10-K and other periodic and current reports filed by Adeza with the Securities Exchange Commission (SEC), which are available from the SEC's Web site (www.sec.gov), and also available on the Investors 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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