Berlex Announces FDA Approval of Low Dose CLIMARA for Osteoporosis Indication.

MONTVILLE, N.J.--(BW HealthWire)--March 8, 1999--Berlex Laboratories, Inc. announced today that the Food and Drug Administration (FDA) has approved the new 0.025 mg CLIMARA(R) (estradiol transdermal system) patch for the prevention of osteoporosis. The new 0.025 mg patch provides the lowest effective ERT dosage available in the U.S. for prevention of bone loss. The CLIMARA(R) 0.025 mg patch will be available in June 1999.

In the same FDA approval, Berlex also received the osteoporosis prevention indication for all current dosage strengths: 0.05 mg, 0.075 mg, and 0.1 mg. Approved in 1994 to treat vasomotor symptoms associated with menopause, CLIMARA(R) is now the first and only once-a-week estrogen replacement therapy (ERT) transdermal patch approved for both the prevention of osteoporosis and for treatment of menopause symptoms.

"The new dosage strength and the expanded CLIMARA(R) indication are great news for women who require ERT," said Reinhard Franzen, General Manager - Berlex Female Healthcare. "Through our co-promotion with Forest Laboratories, CLIMARA(R) has been well accepted in the market place and is the No. 1 prescribed transdermal ERT in the U.S. Now women who use CLIMARA(R) for ERT have the added confidence that they are also protected against osteoporosis. The low-dose strength also gives physicians more flexibility in treating patients for osteoporosis prevention. ERT can begin with the lowest effective dose and then be customized to a dosing strength that meets the needs of the individual patient."

Annually osteoporosis, which is a debilitating and sometime life-threatening disease, affects 28 million Americans - 80% of whom are women. A woman's risk of developing a hip fracture is equal to her combined risk of breast, uterine, and ovarian cancer. An average of 24% of hip fracture patients age 50 and over die within the 12 month period following their fracture.

CLIMARA(R) is especially appropriate for women who have had a hysterectomy along with the removal of the ovaries. CLIMARA(R) provides hysterectomized women with several benefits: relief of the menopause symptoms that usually follow surgery, long-term protection against bone loss, flexible dosing strengths, and the convenience of once-a-week patch application without the need for daily pills.

Committed to developing novel therapeutics that address unmet medical needs, Berlex Laboratories, Inc. researches, manufactures and markets ethical pharmaceuticals in three strategic areas: Female Healthcare, Diagnostic Imaging, and Therapeutics for life-threatening and disabling diseases. The company has extensive experience in developing and introducing hormone-related products for Female Healthcare. In addition to CLIMARA(R), Berlex also markets LEVLITE(TM) (levonorgestrel 0.100 mg and ethinyl estradiol 0.020 mg tablets, USP), LEVLEN(R) (levonorgestrel and ethinyl estradiol tablets), and TRI-LEVLEN(R) (levonorgestrel and ethinyl estradiol tablets - triphasic regimen) for contraceptive use. Berlex Laboratories, Inc. has business divisions in Montville and Wayne, New Jersey and in Richmond, California.

Climara is indicated for the treatment of vasomotor menopausal symptoms, vulval and vaginal atrophy, hypoestrogenism, and the prevention of osteoporosis. Estrogens should not be used by patients with known or suspected pregnancy, breast cancer, estrogen-dependent neoplasia, undiagnosed abnormal genital bleeding, active thrombophlebitis, or thromboembolic disorders. Estrogens have been reported to increase the risk of endometrial carcinoma. Please see full prescribing information.