SUNNYVALE, Calif.--(BUSINESS WIRE)--Adeza (NASDAQ:ADZA) today announced that the Office of Orphan Products Development of the U.S. Food and Drug Administration (FDA) has granted Orphan Drug designation covering Gestiva™, the company’s therapeutic candidate for the prevention of preterm birth in women with a history of preterm delivery. If Gestiva is approved, Orphan Drug designation provides the opportunity for seven years of U.S. market exclusivity.
A New Drug Application for Gestiva, a long-acting injectable form of a naturally occurring progesterone, was filed in the second quarter of 2006. In October 2006, Adeza announced receipt of an approvable letter for Gestiva from the FDA, subject to the completion of an additional rodent study and certain other conditions.
“We are pleased to receive Orphan Drug designation from the FDA for Gestiva. This is an important milestone,” said Emory V. Anderson, president and chief executive officer. “Gestiva has the potential to significantly reduce preterm birth, improve neonatal outcomes and reduce associated health care costs in women with a history of preterm delivery.”
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™, 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, market exclusivity 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, as well as competition. 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 disclosures in Adeza’s SEC filings, and Adeza undertakes no obligation to revise or update this news release to reflect events or circumstances after the date hereof.