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Executive Summary

TAP's LUPRON DEPOT-PED AVAILABLE WEEK OF APRIL 26 following April 16 FDA approval of the gonadotropin-releasing hormone analog for precocious puberty. The new indication is the third for the Takeda-Abbott joint venture's Lupron Depot (leuprolide acetate in a biodegradable copolymer) product since its original approval in 1989. Lupron Depot is also approved for the palliative treatment of advanced prostate cancer and management of endometriosis. Children with central (as opposed to disease-induced) precocious puberty may receive Lupron Depot-PED treatment based on clinical diagnosis of the condition before the ages of eight for girls and nine for boys. The children should also undergo a GnRH stimulus test and their bone age should be at least one year beyond their chronologic age, labeling states. The monthly Lupron Depot-PED therapy should be halted by the age of 11 years for girls and 12 years for boys, labeling recommends. TAP estimates that 5,000 to 6,000 children in the U.S. experience early pubertal changes and there are 2,000 new cases of the condition each year. Precocious puberty, which can begin at any age, results in early menstruation, development of sexual organs and secondary sexual characteristics, and short stature. Clinical trials in almost 400 children showed that monthly injections of Lupron Depot-PED suppress gonadotropin hormone and estrogen-testosterone levels, dropping them to normal childhood levels within three to four weeks. As a result, the children's secondary sexual characteristics stabilize or regress and growth rates normalize. Side effects of Lupron Depot-PED include redness and swelling at the injection site in about 5% of patients. The depot drug also causes an initial exacerbation of the condition, such as light vaginal bleeding in the first months of treatment. Lupron Depot-PED will be marketed in new 11.25 mg and 15 mg monthly injections for use in precocious puberty, although smaller children may begin treatment at a dose as low as 7.5 mg. The starting dose is .3 mg/kg once monthly. TAP charges $361 for the 7.5 mg dose and will charge $541.50 for 11.25 mg and $722 for the 15 mg dose. Lupron Depot-PED will compete with Supprelin (histrelin), launched by Roberts Pharmaceuticals at the end of December ("The Pink Sheet" Jan. 4, T&G-2). Roberts licensed the daily-injection GnRH analog from Ortho in April. The average wholesale price for a 30-day supply of Supprelin ranges from $240 to $540. Syntex' Synarel nasal spray received approval for precocious puberty in February 1992. TAP plans to initiate a patient education program in conjunction with the launch of Lupron Depot-PED. The company is distributing books to pediatrician's offices that explain precocious puberty to children and their parents. A book aimed at younger children is entitled Terry Too-Soon and comes with a "Terry Too-Soon" doll. A book for older children bears the title Why Am I Different? Advertising for the product will target pediatric endocrinologists, but the company also is planning educational seminars for general pediatricians who may administer the drug after the condition has been diagnosed.

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