Berlex Announces FDA Approval to Market LEVLITE-tm Low-Dose Oral Contraceptive.

WAYNE, N.J.--(BUSINESS WIRE)--July 14, 1998--Berlex Laboratories, Inc. today announced that the Food and Drug Administration (FDA) has given the company approval to market LEVLITE(tm) (levonorgestrel 0.100 mg and ethinyl estradiol 0.020 mg tablets, USP), a low-dose 20 microgram oral contraceptive (OC).

LEVLITE(tm), which offers patients an effective OC option with the lowest available hormonal dose in a combination OC, will be available to physicians and consumers before the end of the year. In multicenter clinical trials, LEVLITE(tm) was proven to have a safety and efficacy profile like the higher-dose levonorgestrel OCs that have been marketed in the U.S. for more than 20 years. In addition to proven contraceptive efficacy, there is a low potential for hormone-related side effects with this new low-dose product. LEVLITE(tm) will be packaged in a convenient, easy-to-use calendar pack.

With the introduction of LEVLITE(tm), Berlex will enter the rapidly-growing, ultra low-dose segment of the OC market. This is a dynamic and expanding market because women are increasingly looking for safe, effective, and convenient contraceptive options like LEVLITE(tm). The addition of LEVLITE(tm) to its product portfolio is expected to expand Berlex's overall business in Female Healthcare. Women and physicians will be able to confidently choose the type of OC that meets their needs from Berlex's broad-range of proven contraceptive options.

Berlex has extensive experience in the development and introduction of hormone-related products for Female Healthcare. In addition to LEVLITE(tm), the company also markets LEVLEN(R) (levonorgestrel and ethinyl estradiol tablets) and TRI-LEVLEN(R) (levonorgestrel and ethinyl estradiol tablets - triphasic regimen) for contraceptive use. Berlex Laboratories also developed and markets CLIMARA(R) (estradiol transdermal system), a once-a-week transdermal estrogen replacement therapy patch which presents a significant treatment option for women suffering from menopausal symptoms brought on by hysterectomy or natural menopause.

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. Berlex Laboratories, Inc. has business divisions in Montville and Wayne, New Jersey and in Richmond, California.

Serious as well as minor adverse reactions have been reported with the use of all oral contraceptives. Physicians should consult full-prescribing information before prescribing or administering OCs.

Estrogens should not be used by patients with known or suspected pregnancy, breast cancer, estrogen-dependent neoplasia, undiagnosed abnormal genital bleeding, active thrombophlebitis or thrombo-embolic disorders. Estrogens have been reported to increase the risk of endometrial carcinoma.

CONTACT: Berlex Laboratories, Inc.

Wendy Neininger, 973/276-2043

or

DeVries Public Relations

Allison Spiegel, 212/891-0415