AmniScreen(TM) Amniotic Fluid Detection Device is Now Available
MONTVALE, N.J., Feb. 21 /PRNewswire-FirstCall/ — Barr Pharmaceuticals, Inc. 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)
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.
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.
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/.
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
Barr Pharmaceuticals, Inc.
CONTACT: Carol A. Cox of Barr Pharmaceuticals, Inc., +1-201-930-3720,firstname.lastname@example.org
Web site: http://www.barrlabs.com/
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