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 http://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
SOURCE Barr Pharmaceuticals, Inc.
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Related links:
http://www.barrlabs.com
http://www.prnewswire.com/comp/089750.html /
CONTACT:
Carol A. Cox of Barr Pharmaceuticals, Inc.,
+1-201-930-3720, ccox@barrlabs.com
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