EXHIBIT 99.2
| |
|
|
|
|
COMPANY CONTACT:
|
|
|
|
INVESTOR CONTACTS: |
|
|
|
|
|
Mark Fischer-Colbrie
|
|
|
|
Jody Cain (jcain@lhai.com) |
|
|
|
|
|
Chief Financial Officer
|
|
|
|
Bruce Voss (bvoss@lhai.com) |
|
|
|
|
|
Adeza Biomedical Corporation
Inc.
|
|
|
|
Lippert/Heilshorn & Associates, |
|
|
|
|
|
(408) 745-0975 ext 520
|
|
|
|
(310) 691-7100 |
|
|
|
|
|
ir@adeza.com |
|
|
|
|
For Immediate Release
ADEZA SUBMITS NEW DRUG APPLICATION FOR GESTIVA
TO PREVENT PRETERM BIRTHS
NIH Study Finds 34% Reduction in Preterm Births; Therapy Recommended by ACOG
Conference Call to Discuss Gestiva and First Quarter Financial Results
Begins at 4:30 p.m. Eastern Time Today
SUNNYVALE, Calif. (May 4, 2006) – Adeza (NASDAQ: ADZA) today announced the submission of a New Drug
Application (NDA) with the U.S. Food and Drug Administration (FDA) for Gestiva™, 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™, 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 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 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