SUNNYVALE, Calif.--(BUSINESS WIRE)--Adeza (NASDAQ:ADZA - News) today announced that the U.S. Food and Drug Administration (FDA) has determined that Gestiva(TM) for the prevention of preterm birth in women with a history of preterm delivery is approvable subject to the completion of an additional animal study and certain other conditions. The approvable letter also outlined post-approval clinical requirements, which are consistent with recommendations made by the FDA advisory committee in August 2006.
"We will request a meeting with the FDA to address comments outlined in the approvable letter as soon as possible," said Emory V. Anderson, president and chief executive officer. "Currently there is no FDA-approved treatment for preterm birth, which represents a major and costly public health issue in the U.S."
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.
A decision by the FDA regarding three-year exclusivity under Hatch-Waxman for Gestiva is expected to be made at the time of any final approval. Discussions with the FDA regarding the company's Orphan Drug application for seven-year exclusivity are ongoing. While Adeza's initial request for Orphan Drug designation was not granted, the company plans to meet with the FDA to provide additional new information for further review by the Agency.
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. 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 and product candidates of third parties addressing similar indications, including costs, timing and outcomes of clinical and preclinical studies. 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.
Adeza Biomedical Corporation
Mark Fischer-Colbrie, Chief Financial Officer
408-745-0975, ext. 520
Lippert/Heilshorn & Associates, Inc.,
Jody Cain / Bruce Voss, 310-691-7100
firstname.lastname@example.org / email@example.com
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