WOODCLIFF LAKE, N.J., April 26 /PRNewswire-FirstCall/ -- Barr Pharmaceuticals, Inc. today announced the U.S. Food and Drug Administration (FDA) has issued a Not Approvable letter for Duramed Pharmaceuticals, Inc.'s New Drug Application (NDA) for Bijuva(TM) (Synthetic Conjugated Estrogens, A) Cream. Duramed is a wholly-owned subsidiary of Barr. The Company is working with FDA to resolve the outstanding issues on the Bijuva application as soon as is practical. Once approved, the Company intends to market Bijuva for the treatment of moderate to severe symptoms of vulvar and vaginal atrophy associated with menopause.
"We have worked closely with the Agency as the review process for our Bijuva vaginal cream product has advanced and, although we are disappointed in the Agency's decision, we are confident that the matters raised in the Agency's Not Approvable letter can be resolved," said Dr. Carole S. Ben- Maimon, President and COO of Duramed Research.
The Company is committed to the estrogen therapy marketplace and currently promotes Cenestin(R) 0.3 mg, 0.45 mg, 0.625 mg, 0.9 mg and 1.25 mg tablets directly to physicians with its Duramed 226-person Women's Healthcare Sales Force. The Company's pipeline of future estrogen therapy products also includes Enjuvia(R), which is expected to launch following the anticipated approval of a 0.9 mg tablet product strength in fiscal 2006. The Company currently has approval for its Enjuvia line 0.3 mg, 0.45 mg, 0.625 mg and 1.25 mg tablet strengths for the treatment of moderate to severe vasomotor symptoms associated with menopause.
Cenestin competes in the Hormone Therapy (HT) market and provides women who choose to take hormone products with a plant-derived option.
Important Information About Estrogens
Estrogen use that is unopposed by progestin is associated with an increased risk of endometrial cancer in postmenopausal women with intact uteri. Estrogens should not be used in women with undiagnosed abnormal genital bleeding, known or suspected breast cancer, estrogen-dependent neoplasia, active deep vein thrombosis, thromboembolic disorders, active or recent arterial thromboembolic disease, or pregnancy. Estrogens should not be used for the prevention of cardiovascular disease. The Women's Health Initiative (WHI) study reported increased risks of myocardial infraction, stroke, invasive breast cancer, pulmonary emboli, and deep vein thrombosis. Due to these risks, estrogen with or without progestins should be prescribed at the lowest effective dose for the shortest duration, consistent with treatment goals and risks for the individual woman; periodic clinical reevaluation of such therapy is also advised.
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.
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, 2004.
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.