Adeza Submits New Drug Application For Gestiva to Prevent Preterm Births; NIH Study Finds 34% Reduction in Preterm Births; Ther
04 Mayo 2006 - 3:03PM
Business Wire
Conference Call to Discuss Gestiva and First Quarter Financial
Results Begins at 4:30 p.m. Eastern Time Today Adeza (NASDAQ:ADZA)
today announced the submission of a New Drug Application (NDA) with
the U.S. Food and Drug Administration (FDA) for Gestiva(TM), the
company's drug candidate to prevent preterm birth in women with a
history of preterm delivery. Adeza has requested Priority Review
for the Gestiva NDA that, if granted, would set a six month goal
for review by the FDA. Adeza has also submitted an application to
the FDA requesting Orphan Drug designation. Gestiva is a
long-acting, naturally occurring form of progesterone. If Gestiva
is approved, Adeza will have the only commercially available,
NIH-studied, ACOG-recommended and FDA-approved therapeutic for the
prevention of recurrent preterm birth. Preterm birth is defined as
delivery before 37 completed weeks of gestation. According to the
New England Journal of Medicine, preterm births have historically
accounted for up to 85% of all pregnancy-related complications and
deaths in the United States. The March of Dimes estimates that more
than $18.1 billion in costs were associated with the care of
preterm or low-birth-weight infants in 2003. Women with a history
of preterm birth represent one of the highest risk groups for a
future preterm delivery. Adeza believes that treating women in this
group with Gestiva has the potential to significantly reduce
preterm birth costs. "Gestiva represents an ideal strategic fit for
Adeza and is consistent with our mission to market and sell a broad
array of high-value innovative products addressing women's
healthcare," said Emory V. Anderson, president and chief executive
officer. "If Gestiva is approved, the Adeza 87-person sales force
will market Gestiva to the same physicians to whom we market
FullTerm(TM), The Fetal Fibronectin Test, thereby leveraging our
direct sales efforts." "OB/GYNs are beginning to use this form of
progesterone in women with a history of prior preterm birth based
on a 2003 American College of Obstetricians and Gynecologists
(ACOG) recommendation that followed an NIH study published in the
June 2003 New England Journal of Medicine. Currently, this form of
progesterone is prepared solely by compounding pharmacies. Subject
to approval, Gestiva will be widely available and manufactured
under strict FDA requirements," said Durlin E. Hickok, MD,
vice-president, medical affairs. "Preterm birth is a major health
problem and Adeza is excited about the opportunity to help infants
and families." Background to Gestiva 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.
Treatment continued until delivery or 37 weeks of gestation,
resulting in a reduction in the preterm birth rate of 34% among
women treated with 17P. 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. Conference
Call Adeza's management will host an investment-community
conference call today beginning at 4:30 p.m. Eastern time (1:30
p.m. Pacific time) to discuss Gestiva and first quarter financial
results. Individuals interested in participating in the conference
call may do so by dialing (888) 463-4383 for domestic callers, or
(706) 634-5615 for international callers. A telephone replay will
be available for 48 hours following the conclusion of the call by
dialing (800) 642-1687 for domestic callers, or (706) 645-9291 for
international callers, and entering reservation code 8492565. The
live call also will be available via the Internet on the Investors
section of the company's Web site at www.adeza.com. A webcast
replay of the call will be available following the conclusion of
the call. 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 TLi(IQ)(R) 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(R) 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 may be forward-looking statements,
including, for example, statements regarding the regulatory path
for Gestiva and marketing plans for 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, statements about its
business and marketing strategy, its business and marketing
execution, risks associated with regulatory review, including the
timing of regulatory approval, and risks associated with being in
both the diagnostic and therapeutic businesses. 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 website (www.sec.gov), and also available on the
Investors section of Adeza's website. 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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