FDA Approves Duramed's Synthetic Conjugated Estrogens-A Vaginal Cream
01 Dicembre 2008 - 3:06PM
PR Newswire (US)
- First Local Estrogen Therapy Indicated for the Treatment of Both
Moderate to Severe Vaginal Dryness and Pain With Intercourse -
Symptoms of Vulvar and Vaginal Atrophy Due to Menopause MONTVALE,
N.J., Dec. 1 /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 Synthetic
Conjugated Estrogens-A (SCE-A) 0.625 mg/g Vaginal Cream. SCE-A
Vaginal Cream is a plant-derived local estrogen product indicated
for the treatment of moderate to severe vaginal dryness and pain
with intercourse, both of which are symptoms of vulvar and vaginal
atrophy due to menopause. It is administered intravaginally at a
dose of 1 gram daily for one week, followed by 1 gram
intravaginally twice a week. SCE-A Vaginal Cream 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 the second quarter of 2009 utilizing direct sales
force activities as well as other indirect marketing initiatives.
"SCE-A Vaginal Cream offers an additional treatment option to women
and healthcare professionals," said Fred Wilkinson, Duramed's Chief
Executive Officer. "With its unique indication and dosing regimen,
it is designed to complement our existing line of plant-derived
estrogen therapies for the treatment of post-menopausal symptoms."
According to the North American Menopause Society (NAMS), an
estimated 10 to 40 percent of post-menopausal women suffer from
symptoms related to vaginal atrophy(1). Two of the most common
symptoms of vaginal atrophy are vaginal dryness and pain with
intercourse(2). The symptoms of vaginal atrophy are most commonly
associated with diminished estrogen levels that accompany
menopause(1). If left untreated, vaginal atrophy may result in
years of discomfort.(1) About SCE-A Vaginal Cream SCE-A Vaginal
Cream is indicated for the treatment of moderate to severe vaginal
dryness and pain with intercourse, symptoms of vulvar and vaginal
atrophy associated with menopause. The most common side effects in
the clinical trials (>3%) were vulvovaginal infections, upper
respiratory tract infection, headaches and hot flashes. SCE-A
Vaginal Cream should not be used in individuals with any of the
following conditions: undiagnosed abnormal genital bleeding; known,
suspected, or history of certain cancers; stroke or heart attack in
the past year; currently having or having had blood clots or
thromboembolic disease including stroke or myocardial infarction;
or liver problems; allergy to SCE-A Vaginal Cream or any of its
ingredients; or known or suspected pregnancy. About Menopause
Menopause is the time in a woman's life when the menstrual period
ceases and the ovaries permanently stop releasing eggs. Menopause
is considered complete when a woman has been without her period for
a full year. While some women experience no menopausal symptoms,
others suffer severe symptoms that require treatment. Vasomotor
symptoms (night sweats, hot flashes) and vaginal symptoms (such as
vaginal dryness and pain with intercourse) are common menopausal
symptoms. Although the majority of women experience "natural" or
spontaneous menopause, some women may experience menopause due to a
medical intervention such as surgery, chemotherapy or radiation.
(1) Menopause: The Journal of the North American Menopause Society
Vol. 14, No.3 pp. 357-358 (2) Bachman Ga, Ebert GA, Burd ID.
Vulvovaginal Complaints. In: Lobo RA, ed. Treatment of the
Postmenopausal Woman: Basic and Clinical Aspects. 2nd ed.
Philadelphia, PA: Lippincott Williams & Wilkins; 1999:195-201
Important Information About Estrogens Estrogens Increase the Risk
of Endometrial Cancer Patients should consult their healthcare
providers about whether they need treatment with SCE-A Vaginal
Cream to control their symptoms. If a patient has a uterus, she
should talk to her healthcare provider about whether the addition
of progestin should be considered, as there is an increased risk of
endometrial cancer in a woman with a uterus who uses unopposed
estrogens. Adding a progestin to estrogen therapy has been shown to
reduce the risk of endometrial hyperplasia, which may be a
precursor to endometrial cancer. There is no evidence that the use
of "natural" estrogens results in a different endometrial risk
profile than synthetic estrogens at equivalent estrogen doses.
Cardiovascular Disorders and Probable Dementia Estrogens with or
without progestins should not be used for the prevention of
cardiovascular disease or dementia. The estrogen-alone sub-study of
Women's Health Initiative (WHI) study reported increased risks of
stroke and deep vein thrombosis in postmenopausal women (50 to 79
years of age) during 6.8 years and 7.1 years, respectively, of
treatment with oral conjugated estrogens (CE 0.625 mg) relative to
placebo. The estrogen-plus-progestin sub-study of the WHI reported
increased risks of myocardial infarction, stroke, invasive breast
cancer, pulmonary emboli, and deep vein thrombosis in
postmenopausal women (50 to 79 years of age) during 5.6 years of
treatment with oral CE 0.625 mg combined with medroxyprogesterone
acetate (MPA 2.5 mg) per day, relative to placebo. The Women's
Health Initiative Memory Study (WHIMS), a sub-study of WHI study,
reported increased risk of developing probable dementia in
postmenopausal women 65 years of age or older during 5.2 years of
treatment with CE 0.625 mg alone and during 4 years of treatment
with CE 0.625 mg combined with MPA 2.5 mg, relative to placebo. It
is unknown whether this finding applies to younger postmenopausal
women. In the absence of comparable data, these risks should be
assumed to be similar for other doses of CE and other dosage forms
of estrogens. Because of these risks, estrogens with or without
progestins should be prescribed at the lowest effective doses and
for the shortest duration consistent with treatment goals and risks
for the individual woman. 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. DATASOURCE: Barr Pharmaceuticals,
Inc. CONTACT: Carol A. Cox, Barr Pharmaceuticals, +1-201-930-3720,
Web Site: http://www.barrlabs.com/ Company News On-Call:
http://www.prnewswire.com/comp/089750.html
Copyright
Grafico Azioni Barr (NYSE:BRL)
Storico
Da Giu 2024 a Lug 2024
Grafico Azioni Barr (NYSE:BRL)
Storico
Da Lug 2023 a Lug 2024