Duramed to Launch First Lower-Dose, Extended-Cycle Oral Contraceptive
for the Prevention of Pregnancy
MONTVALE, N.J., Oct. 27 /PRNewswire-FirstCall/ -- Barr Pharmaceuticals,
Inc. (NYSE: BRL) today announced that the U.S. Food and Drug Administration
(FDA) has approved its subsidiary Duramed Pharmaceuticals, Inc.'s New Drug
Application (NDA) for LoSEASONIQUE(R) (levonorgestrel/ethinyl estradiol
tablets 0.10 mg/0.02 mg and ethinyl estradiol tablets 0.01 mg)
extended-cycle oral contraceptive. LoSEASONIQUE(R) is the first lower-dose,
extended-cycle oral contraceptive indicated for the prevention of
pregnancy.
Under the LoSEASONIQUE(R) extended-cycle regimen, women take
combination tablets containing 0.10 mg levonorgestrel/0.02 mg of ethinyl
estradiol daily for 84 consecutive days, followed 0.01 mg ethinyl estradiol
tablets for seven days. The regimen is designed to reduce the number of
withdrawal bleeding periods from 13 to four per year. By contrast, the
majority of oral contraceptive products currently available in the United
States are based on a regimen of 21 treatment days, followed by seven days
of placebo.
LoSEASONIQUE(R) will be shipped to trade customers and available by
prescription to women in the first quarter of 2009. Duramed will initiate
promotion to healthcare providers in early 2009 using its sales force and
other marketing initiatives.
"As a leader in women's health, Duramed is committed to continuing to
develop new products that provide women a choice as they discuss birth
control options with their healthcare providers," said Fred Wilkinson,
Duramed's Chief Executive Officer. "We're pleased that the FDA has approved
LoSEASONIQUE(R) as a safe, effective new birth control option for U.S.
women."
About LoSEASONIQUE(R)
LoSEASONIQUE(R) is a lower dose extended cycle oral contraceptive
indicated for the prevention of pregnancy. The clinical data supporting the
LoSEASONIQUE(R) NDA resulted from a 12-month, multi-centered, open label
clinical trial that concluded in June 2007. The clinical trial involved
over 2,100 female subjects between the ages of 18 and 41 at 56 sites
throughout the United States, and subjects completed an equivalent of
nearly 21,000 28-day cycles of exposure.
The most common adverse events in the clinical trial were headache,
irregular and/or heavy uterine bleeding, dysmenorrhea, nausea and/or
vomiting, and back pain.
Important Information About Oral Contraceptives
It is estimated that more than 16 million women currently take oral
contraceptives in the United States. Oral contraceptives are not for every
woman. Serious as well as minor side effects have been reported with the
use of hormonal contraceptives. Serious risks include blood clots, stroke,
and heart attack. Cigarette smoking increases the risk of serious
cardiovascular side effects, especially in women over 35 years. Oral
contraceptives do not protect against HIV infection (AIDS) and other
sexually transmitted diseases.
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 more than 1,200 products globally
outside of the U.S. For more information, visit http://www.barrlabs.com.
Forward-Looking Statements
This communication contains "forward-looking statements" which
represent the current expectations and beliefs of management of Barr
Pharmaceuticals, Inc. (the "Company") concerning the proposed merger of the
Company with Boron Acquisition Corp., a wholly-owned subsidiary of Teva
Pharmaceutical Industries Ltd. (the "merger") and other future events and
their potential effects on the Company. The statements, analyses, and other
information contained herein relating to the proposed merger, as well as
other statements including words such as "anticipate," "believe," "plan,"
"estimate," "expect," "intend," "will," "should," "may," and other similar
expressions, are "forward-looking statements" under the Private Securities
Litigation Reform Act of 1995. These forward-looking statements are not
guarantees of future results and are subject to certain risks and
uncertainties that could cause actual results to differ materially from
those anticipated. Those factors include, without limitation: 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 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; 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;
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; the
reactions of the Company's customers and suppliers to the merger; and
diversion of management time on merger-related issues. These and other
applicable risks, cautionary statements and factors that could cause actual
results to differ from the Company's forward-looking statements are
included in the Company's filings with the U.S. Securities and Exchange
Commission ("SEC"), specifically as described in the Company's annual
report on Form 10-K for the fiscal year ended December 31, 2007. The
Company undertakes no obligation to update or revise any forward-looking
statements to reflect subsequent events or circumstances.
Important Legal Information
In connection with the proposed merger, the Company will prepare a
proxy statement to be filed with the SEC. When completed, a definitive
proxy statement and a form of proxy will be mailed to the stockholders of
the Company. Before making any voting decision, the Company's stockholders
are urged to read the proxy statement regarding the merger carefully and in
its entirety because it will contain important information about the
proposed merger. The Company's stockholders will be able to obtain, without
charge, a copy of the proxy statement (when available) and other relevant
documents filed with the SEC from the SEC's website at http://www.sec.gov.
The Company's stockholders will also be able to obtain, without charge, a
copy of the proxy statement and other relevant documents (when available)
by directing a request by mail or telephone to Barr Pharmaceuticals, Inc.,
225 Summit Avenue, Montvale, NJ, 07645 - Attention: Investor Relations.
The Company and its directors and officers may be deemed to be
participants in the solicitation of proxies from the Company's stockholders
with respect to the proposed merger. Information about the Company's
directors and executive officers and their ownership of the Company's
common stock is set forth in the Company's annual report on Form 10-K for
the fiscal year ended December 31, 2007 and the Company's proxy statement
for the Company's 2008 Annual Meeting of Stockholders. Stockholders may
obtain additional information regarding the interests of the Company and
its directors and executive officers in the merger, which may be different
than those of the Company's stockholders generally, by reading the proxy
statement and other relevant documents regarding the proposed merger, when
filed with the SEC.
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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