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FDA Approves Enjuvia

WOODCLIFF LAKE, N.J., May 11 /PRNewswire-FirstCall/ -- Barr Pharmaceuticals Inc. (NYSE: BRL - News) today announced that it has received U.S. Food and Drug Administration (FDA) approval for its New Drug Application (NDA) for Enjuvia(TM) (synthetic conjugated estrogens, B) 0.625 and 1.25 mg tablets. Enjuvia is the only plant-derived, synthetic conjugated estrogen product that includes the component delta 8,9-dehydroestrone sulfate, an additional active estrogenic component. The patent on Enjuvia expires in 2020.

"The approval of these two strengths of Enjuvia represents the first step in our strategy to broaden our line of hormone therapy products through the launch of a broad Enjuvia product line indicated for the treatment of moderate to severe vasomotor symptoms associated with the menopause. The Company anticipates that its product line will also include Enjuvia 0.3 mg, 0.45 mg and 0.9 mg tablets, and will be promoted by our 250-person Duramed Pharmaceuticals, Inc. Women's Healthcare Sales Force," said Bruce L. Downey, Barr's Chairman and Chief Executive Officer. "We believe that Enjuvia, which is a patented synthetic conjugated estrogens product, will offer a new generation of hormonal products to American women electing to use hormone therapy."

In December 2003, Barr announced that it had signed an asset purchase agreement with Endeavor Pharmaceuticals to acquire the NDA and intellectual property related to Enjuvia synthetic conjugated estrogens product, and two early stage development female healthcare products.

In March 2002, Endeavor filed its application for approval of Enjuvia 0.3 mg, 0.45 mg, 0.625 mg and 1.25 mg tablets for the treatment of moderate to severe vasomotor symptoms associated with the menopause. In April 2003, the FDA issued an approvable letter for the 0.625 mg and the 1.25 mg tablets and a non-approvable letter for the 0.3 mg and the 0.45 mg tablets. Barr's application for Enjuvia 0.3 mg and 0.45 mg tablets is currently pending at the FDA.

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.

Source: Barr Pharmaceuticals, Inc.

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