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Executive Summary

ROBERTS PHARMACEUTICAL TO MARKET ORTHO's SUPPRELIN under an exclusive worldwide licensing agreement with the Johnson & Johnson subsidiary, Roberts announced April 13. Designated as an orphan drug, Supprelin (histrelin acetate) was approved by FDA in December for the treatment of central precocious puberty, a disorder that affects an estimated 6,000 children in the U.S., with 2,000 more diagnosed each year ("The Pink Sheet" Jan. 6, p. 12). Roberts Pharmaceutical plans to launch the drug in the U.S. "in the near future." The Eatontown, New Jersey-based company hopes to subsequently market Supprelin in Canada and the United Kingdom, a Roberts Pharmaceutical spokesman said. Approximately 75 Roberts salespeople will market the product; an additional 25 will be added to the staff when Supprelin is marketed abroad. Supprelin is to be administered once daily via subcutaneous injection of 10 mcg/kg of body weight with the injection site varied daily. While Roberts has been developing Somagard (deslorelin) to treat precocious puberty, the company said that the drug will now "be positioned for prostate cancer and endometriosis."

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