WOODCLIFF LAKE, N.J., May 8 /PRNewswire-FirstCall/ -- Duramed Pharmaceuticals, Inc., a subsidiary of Barr Pharmaceuticals, Inc. , today announced that the Company's ENJUVIA(TM) (synthetic conjugated estrogens, B) tablets are now available in pharmacies nationwide. The Company began shipping ENJUVIA in April and today is initiating its professional communication to physicians at the American College of Obstetricians and Gynecologists (ACOG) Annual Meeting in Washington, DC. The Company plans to immediately initiate physician detailing using its 250-person Duramed Women's Healthcare Sales Force. Additional promotional programs targeting healthcare providers are expected to begin in mid May.
"ENJUVIA is a new option for American women electing, in consultation with their physicians, to use prescription hormone therapy and provides them with a low dose alternative to treat the moderate-to-severe vasomotor symptoms of menopause," said Bruce L. Downey, Barr's Chairman and Chief Executive Officer. "The launch of the ENJUVIA product line not only represents a significant milestone in the Company's on-going commitment to serve the healthcare needs of women, but also provides physicians and patients a new option as they consider hormone therapy choices and make important treatment decisions."
Duramed's ENJUVIA is an U.S. Food & Drug Administration (FDA) approved daily oral estrogen therapy for the treatment of moderate-to-severe vasomotor symptoms associated with menopause. A plant-derived formulation, ENJUVIA contains a blend of 10 synthetic estrogenic substances including delta 8,9 - dehydroesterone sulfate (DHES). ENJUVIA tablets are available in a variety of dosage strengths including 0.3 mg, 0.45 mg, 0.625 mg and 1.25 mg. 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.
"ENJUVIA is an important new treatment option that has been proven to significantly reduce the frequency and severity of vasomotor symptoms (hot flashes and night sweats), which can impact a woman's ability to function," said David Portman, MD, Director and Principal Investigator at the Columbus Center for Women's Health Research in Columbus, Ohio and Clinical Instructor at Ohio State University College of Medicine. "Women suffering with menopausal symptoms should talk to their healthcare professional about finding a low dose hormone therapy that's right for them."
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 and progestins should not be used for the prevention of cardiovascular disease or dementia.
The Women's Health Initiative (WHI) study 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 years of treatment with oral conjugated equine estrogens (CE 0.625 mg) combined with medroxyprogesterone acetate (MPA 2.5 mg) relative to placebo.
The Women's Health Initiative Memory Study (WHIMS), a substudy of WHI, reported increased risk of developing probable dementia in postmenopausal women 65 years of age or older during 4 years of treatment with oral conjugated equine estrogens plus medroxyprogesterone acetate 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 taken orally, once daily, for the treatment of moderate-to-severe vasomotor symptoms associated with menopause. 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 trial were headache, pain, nausea, and breast pain.
In a clinical trial, 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://www.ENJUVIA.com .
About Barr Pharmaceuticals, Inc.
Barr Pharmaceuticals, Inc., a holding company that operates through its principal subsidiaries, Barr Laboratories, Inc. and Duramed Pharmaceuticals, Inc., is engaged in the development, manufacture and marketing of generic and proprietary pharmaceuticals. Duramed currently markets a portfolio of 18 proprietary (branded) products, largely focused in the area of women's health. The Company's Women's Healthcare Sales Force currently markets three products directly to physicians and healthcare providers: ENJUVIA(TM) hormone therapy; SEASONALE(R) extended-cycle oral contraceptive; and Plan B(R) emergency oral contraceptive. Barr is also the leading manufacturer and marketer of oral contraceptives in the United States with a portfolio that includes 22 generic and five proprietary oral contraceptive products.
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; 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 and products we acquire and implementing our new 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; changes in generally accepted accounting principles; and other risks detailed from time-to-time in our filings with the Securities and Exchange Commission, including in our Annual Report on Form 10-K for the fiscal year ended June 30, 2005.
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.
Barr Pharmaceuticals, Inc.CONTACT: Carol A. Cox of Barr Pharmaceuticals, +1-201-930-3720,ccox@barrlabs.com
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