Enjuvia 0.9 mg Tablets Strength Approved; New Indication For Vulvar and
Vaginal Atrophy Also Approved
WOODCLIFF LAKE, N.J., April 30 /PRNewswire-FirstCall/ -- Duramed
Pharmaceuticals, Inc., a subsidiary of Barr Pharmaceuticals, Inc. (NYSE:
BRL), today announced that the Company has received two U.S. Food and Drug
Administration (FDA) approvals related to its ENJUVIA(TM) (synthetic
conjugated estrogens, B) product. The FDA has approved the Company's
supplemental New Drug Application (sNDA) for 0.9 mg tablet strength, which
will be added to the Company's existing ENJUVIA product line that includes
the 0.3 mg, 0.45 mg, 0.625 mg, and 1.25 mg tablet dosage strengths.
In addition, ENJUVIA is also the first and only oral estrogen that has
been approved by FDA to treat moderate-to-severe vaginal dryness and pain
with intercourse, symptoms of vulvar and vaginal atrophy, associated with
menopause. When prescribing for the treatment of moderate-to-severe vaginal
dryness and pain with intercourse, topical vaginal products should be
considered. ENJUVIA is already indicated for the treatment of moderate-to-
severe vasomotor symptoms associated with menopause.
"The approval of the 0.9 mg tablet further expands the ENJUVIA line and
will provide healthcare professionals with additional dosing flexibility
for their patients using oral estrogen therapy," said Bruce L. Downey,
Barr's Chairman and Chief Executive Officer. "The approval of the
additional indication for ENJUVIA provides female healthcare providers with
yet another option for addressing symptoms associated with menopause and
may make ENJUVIA an appropriate therapeutic option for a larger group of
menopausal patients. Both approvals expand the value of the ENJUVIA therapy
option for health care providers and patients and our Women's Health Sales
Force will be detailing the additional strength and expanded indication."
The Company plans to launch the ENJUVIA 0.9 mg tablet and the new
indication for the ENJUVIA product line in October 2007 at the North
American Menopausal Society Annual Meeting. Duramed currently promotes
ENJUVIA to healthcare providers using its 250-person Women's Healthcare
Sales Force.
Duramed's ENJUVIA is a plant-derived formulation, ENJUVIA contains a
blend of 10 synthetic estrogenic substances including delta 8,9 -
dehydroesterone sulfate (DHES). ENJUVIA uses a unique delivery system,
consisting of Surelease(R) technology with a cellulose-based polymer tablet
design, to provide slow release of estrogens over several hours.
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, vaginal dryness) are the most 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.
Important Information About Estrogens
Cardiovascular and other Risks
Estrogens with or without progestins should not be used for the
prevention of cardiovascular disease or dementia.
The estrogen alone substudy 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 substudy 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 substudy 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.
Other doses of oral conjugated estrogens with medroxyprogesterone
acetate, and other combinations and dosage forms of estrogens and
progestins were not studied in the WHI clinical trials and, in the absence
of comparable data, these risks should be assumed to be similar. 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 ENJUVIA
ENJUVIA tablets are indicated for: the treatment of moderate-to-severe
vasomotor symptoms associated with menopause; and treatment of moderate to
severe vaginal dryness and pain with intercourse, symptoms of vulvar and
vaginal atrophy, associated with menopause. When prescribing solely for the
treatment of moderate to severe vaginal dryness and pain with intercourse,
topical vaginal products should be considered.
Patients should be started at the lowest approved dose of 0.3 mg
ENJUVIA daily. Subsequent dosage adjustment may be made based upon the
individual patient response. This dose should be periodically reassessed by
the healthcare provider.
The most common side effects in the clinical trials were headache,
pain, nausea, and breast pain.
In clinical trials, adverse events that occurred at a rate greater than
or equal to 5% and greater than placebo, regardless of relationship to
study drug, included: abdominal pain, accidental injury, breast pain,
bronchitis, dizziness, dysmenorrhea, flatulence, flu syndrome, headache,
nausea, pain, paresthesia, rhinitis, sinusitis, and vaginitis.
ENJUVIA tablets should not be used in individuals with any of the
following conditions: undiagnosed abnormal genital bleeding; known,
suspected, or history of cancer of the breast; known or suspected
estrogen-dependent neoplasia; active deep vein thrombosis, pulmonary
embolism or a history of these conditions; active or recent (e.g. within
the past year) arterial thromboembolic disease (e.g. stroke, myocardial
infarction); liver dysfunction or disease; hypersensitivity to its
ingredients; or known or suspected pregnancy. There is no indication for
ENJUVIA in pregnancy. There appears to be little or no increased risk of
birth defects in children born to women who have used estrogens and
progestins from oral contraceptives inadvertently during early pregnancy.
Women and healthcare providers who would like to learn more about
ENJUVIA, including full prescribing information, should visit
http://ENJUVIA.com.
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 245 generic and
25 proprietary products in the U.S. and more than 1,200 products globally
outside of the U.S.
Forward-Looking Statements
Except for the historical information contained herein, the statements
made in this presentation 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 presentation 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.
SOURCE Barr Pharmaceuticals, Inc.
 back to top
Related links:
http://www.barrlabs.com
http://www.prnewswire.com/comp/089750.html
http://www.prnewswire.com/comp/089750.html/
CONTACT:
Carol A. Cox of Barr Pharmaceuticals, Inc.,
+1-201-930-3720, ccox@barrlabs.com
|
