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FDA Approves Duramed Pharmaceuticals, Inc. (BRL)'s Synthetic Conjugated Estrogens-A Vaginal Cream


12/1/2008 7:15:25 AM

MONTVALE, N.J., Dec. 1 /PRNewswire-FirstCall/ -- Barr Pharmaceuticals, Inc. (NYSE: BRL - News) 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 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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