Adeza Receives Orphan Drug Designation for Gestiva
31 Enero 2007 - 3:00AM
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.� About Adeza 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.
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