First At-Home Screening Test for Expectant Mothers
MONTVALE, N.J., Feb. 21 /PRNewswire-FirstCall/ -- Barr Pharmaceuticals,
Inc. (NYSE: BRL) today announced the launch of AmniScreen(TM), the first and
only FDA-approved at-home screening test for amniotic fluid leakage during
pregnancy. AmniScreen is a prescription-only panty liner device that includes
a proprietary polymer-coated polyester strip designed to detect amniotic fluid
leakage, which could indicate a potential problem with a pregnancy. Barr's
proprietary subsidiary, Duramed Pharmaceuticals, Inc., will detail AmniScreen
to physicians and healthcare providers with its Specialty and Institutional
Sales Forces.
"AmniScreen may offer reassurance to women concerned about unexplained
vaginal wetness during pregnancy. The product detects amniotic fluid leakage
that can lead to serious complications, such as infection and preterm
labor,(1)" says Nancy Jasper, MD, Assistant Clinical Professor, Department of
Ob/Gyn, Columbia University, College of Physicians and Surgeons. "It's
important for women to know when wetness may be caused by amniotic fluid
leakage."
In July 2006, Barr announced that it had entered into a development,
manufacturing and supply agreement with Common Sense Ltd. for AmniScreen.
Under the terms of the agreement, the Company agreed to make a one-time
payment to Common Sense following FDA approval.
Common Sense will manufacture and package the product and Duramed will
detail to physicians and healthcare providers. Barr will record net sales of
the product and will pay Common Sense for product delivered.
How AmniScreen Works
AmniScreen works by detecting elevated pH levels, which may indicate
amniotic fluid leakage.(2) Patients are instructed to report or show test
results to their healthcare provider for interpretation and medical care.(3)
The pivotal trial demonstrated that AmniScreen detected amniotic fluid leakage
about 96% of the time.(4) During the trial, patient-read results and
clinician-read results matched more than 97% of the time.(5)
Potential Candidates
Pregnant women who experience unexplained vaginal wetness are potential
candidates for AmniScreen. Additional candidates include high-risk pregnant
women, women who have undergone amniocentesis, have experienced prior amniotic
leakage, and those who are concerned about unexplained wetness.
Safety Information
The AmniScreen Home Detection Liner Kit is intended to detect possible
leakage of amniotic fluid when vaginal wetness is experienced during pregnancy
by indicating pH level. pH levels greater than or equal to 5.2 produce a
blue-green color. Patients are instructed to report or show test results to
their healthcare provider for interpretation and medical care.
AmniScreen should not be used if less than 12 hours have passed since
sexual intercourse or vaginal douching. AmniScreen should not be used if
there is vaginal bleeding or spotting. A healthcare provider should be
consulted if there is unexplained wetness, vaginal bleeding or spotting, or
suspicion of vaginal infection.
Marketing Agreement
Under a marketing agreement, Barr's proprietary subsidiary, Duramed
Pharmaceuticals, Inc., will launch AmniScreen immediately and will detail the
product to physicians and healthcare providers with its Specialty and
Institutional Sales Forces. AmniScreen was developed by the privately-owned
company Common Sense, which was founded in 1999 and is a leading developer and
manufacturer of indicators utilizing common hygienic products such as
panty-liners and diapers as a platform for non-intrusive diagnosis and health
condition monitoring.
About Barr Pharmaceuticals, Inc.
Barr Pharmaceuticals, Inc. is a global specialty pharmaceutical company
that operates in more than 30 countries worldwide and is engaged in the
development, manufacture and marketing of generic and proprietary
pharmaceuticals, biopharmaceuticals and active pharmaceutical ingredients. A
holding company, Barr operates through its principal subsidiaries: Barr
Laboratories, Inc., Duramed Pharmaceuticals, Inc. and PLIVA d.d. and its
subsidiaries. The Barr Group of companies markets more than 120 generic and 26
proprietary products in the U.S. and approximately 1,025 products globally
outside of the U.S. For more information, visit www.barrlabs.com.
Forward-Looking Statements
Except for the historical information contained herein, the statements
made in this press release constitute forward-looking statements within the
meaning of Section 27A of the Securities Act of 1933 and Section 21E of the
Securities Exchange Act of 1934. Forward-looking statements can be identified
by their use of words such as "expects," "plans," "projects," "will," "may,"
"anticipates," "believes," "should," "intends," "estimates" and other words of
similar meaning. Because such statements inherently involve risks and
uncertainties that cannot be predicted or quantified, actual results may
differ materially from those expressed or implied by such forward-looking
statements depending upon a number of factors affecting the Company's
business. These factors include, among others: the difficulty in predicting
the timing and outcome of legal proceedings, including patent-related matters
such as patent challenge settlements and patent infringement cases; the
outcome of litigation arising from challenging the validity or non-
infringement of patents covering our products; the difficulty of predicting
the timing of FDA approvals; court and FDA decisions on exclusivity periods;
the ability of competitors to extend exclusivity periods for their products;
our ability to complete product development activities in the timeframes and
for the costs we expect; market and customer acceptance and demand for our
pharmaceutical products; our dependence on revenues from significant
customers; reimbursement policies of third party payors; our dependence on
revenues from significant products; the use of estimates in the preparation of
our financial statements; the impact of competitive products and pricing on
products, including the launch of authorized generics; the ability to launch
new products in the timeframes we expect; the availability of raw materials;
the availability of any product we purchase and sell as a distributor; the
regulatory environment in the markets where we operate; our exposure to
product liability and other lawsuits and contingencies; the increasing cost of
insurance and the availability of product liability insurance coverage; our
timely and successful completion of strategic initiatives, including
integrating companies (such as PLIVA d.d.) and products we acquire and
implementing our new SAP enterprise resource planning system; fluctuations in
operating results, including the effects on such results from spending for
research and development, sales and marketing activities and patent challenge
activities; the inherent uncertainty associated with financial projections;
our expansion into international markets through our PLIVA acquisition, and
the resulting currency, governmental, regulatory and other risks involved with
international operations; our ability to service our significantly increased
debt obligations as a result of the PLIVA acquisition; changes in generally
accepted accounting principles; and other risks detailed in our SEC filings,
including in our Transition Report on Form 10-K/T for the six months ended
December 31, 2006.
The forward-looking statements contained in this press release speak only
as of the date the statement was made. The Company undertakes no obligation
(nor does it intend) to publicly update or revise any forward-looking
statements, whether as a result of new information, future events or
otherwise, except to the extent required under applicable law.
(1) DeCherney et. al; Current Obstetric & Gynecologic Diagnosis &
Treatment. Chapter 15, Pg. 279
(2) AmniScreen(TM) Prescribing Information
(3) AmniScreen(TM) Prescribing Information
(4) AmniScreen(TM) Prescribing Information
(5) AmniScreen(TM) Prescribing Information
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information are also available on Barr's website (www.barrlabs.com). For
complete indications, warnings and contraindications, contact Barr
Laboratories' Product Information Department at 1-800-Barr Lab. All trademarks
referenced herein are the property of their respective owners.
CONTACT:
Carol A. Cox
Barr Pharmaceuticals, Inc.
+1-201-930-3720
ccox@barrlabs.com
