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ORTHO LUTREPULSE CLEARS FDA: R.W. JOHNSON GETS THREE LATE 1989 APPROVALS

Executive Summary

Ortho Pharmaceutical is preparing to try to extend its established reputation in contraception and vaginal products into the fertility drug field with the planned 1990 launch of Lutrepulse Pump Kit, an LH-RH delivery system approved by FDA in mid-October. The luteinzing hormone releasing hormone injectable is gonadorelin acetate 0.8 mg/vial and 3.2 mg/vial. It was approved by FDA with a 2C rating -- a new salt with little therapeutic gain over existing treatments. With Lutreplase, Ortho will attempt to break into the fertility niche dominated by Serono Labs. That $100 mil. annual sales firm specializes in the infertility market and has evolved a symposia program for infertile couples. In addition to Lutreplase, Ortho enters 1990 with two other new products to launch: a tampon delivery system for miconazole (Monistat 5) and a new monophasic contractive combo, Ortho Cyclen (norgestimate/ethinyl estradiol). The oral contraceptive was one of FDA's end-of-1989 approvals in the week between Christmas and New Year's Day. The three late-year approvals are an auspicious start for J&J's recently consolidated research effort, the R.W. Johnson Institute. The approvals are bringing three of eight FDA-pending projects from 1989 to the market for J&J.

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