Duramed's Enjuvia (Synthetic Conjugated Estrogens, B) TabletsReceives Two New FDA Approvals
WOODCLIFF LAKE, N.J., April 30, 2007 /PRNewswire-FirstCall/ -- Duramed Pharmaceuticals, Inc., a subsidiary of Barr Pharmaceuticals, Inc. , today announced that the Company has received two U.S. Food and Drug Administration (FDA) approvals related to its Enjuvia (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.
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.
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.
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.
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.
Posted: April 2007