Adeza Receives FDA Approvable Letter for Gestiva
23 Octubre 2006 - 3:00AM
Business Wire
Adeza (NASDAQ:ADZA) today announced that the U.S. Food and Drug
Administration (FDA) has determined that Gestiva� 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. 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 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 (NASDAQ:ADZA) 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. 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(TM), The Fetal Fibronectin Test, which utilizes a
single-use, disposable cassette and is analyzed on Adeza's patented
TLiIQ(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 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 (NASDAQ:ADZA)
Gráfica de Acción Histórica
De May 2024 a Jun 2024
Adeza (NASDAQ:ADZA)
Gráfica de Acción Histórica
De Jun 2023 a Jun 2024
Real-Time news about Adeza Biomedical (MM) (NASDAQ): 0 recent articles
Más de Adeza ArtÃculos de Noticias