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TAP TO MARKET LUPRON DEPOT-PED AS TREATMENT FOR PRECOCIOUS PUBERTY

 DEERFIELD, Ill., April 20 /PRNewswire/ -- TAP Pharmaceuticals Inc. announced today that the U.S. Food and Drug Administration (FDA) has cleared its drug, Lupron Depot-PED(TM) (leuprolide acetate for depot suspension) as a treatment for central precocious puberty (premature sexual development). TAP Pharmaceuticals Inc. is a joint venture between Abbott Laboratories and Takeda Chemical Industries of Japan.
 Central precocious puberty is marked by early development of pubertal changes -- before age eight in girls or age nine in boys. In some cases, it can occur in children as young as one year of age. Girls may develop breasts and body hair and begin their menstrual periods. Boys may develop facial hair, deepening of the voice, and enlargement of the penis and testicles. Perhaps most important is that these children will also experience a premature growth spurt. This causes them to be temporarily big for their age but, since their growth will end prematurely, is also results in an adult height much shorter than average.
 "Children trapped in adult bodies are often the target of unrelenting teasing," said Peter A. Lee, M.D., Ph.D., pediatric endocrinologist at the Children's Hospital of Pittsburgh. "Their advanced physical development sets them apart from their peers, resulting in feelings of poor self-esteem and social rejection. Treatment with Lupron Depot-PED will help allow these children to return to being children again."
 Dr. Lee said parents need to recognize the signs of precocious puberty and to consult their family physician should they suspect anything abnormal about their child's growth or development. Precocious puberty affects 5,000 to 6,000 American children, with nearly 2,000 new cases each year.
 Puberty results from a complex interaction among the brain, the pituitary gland, and the sex glands. It begins when the brain starts releasing a substance known as gonadotropin-releasing hormone (GnRH) in periodic, adult-like bursts. GnRH stimulates the pituitary gland to release hormones called gonadotropins, which in turn cause the gonads to produce sex hormones: estrogen in girls and testosterone in boys. These sex hormones, in conjunction with gonadotropins, contribute to the body changes typical of puberty. Researchers are still investigating why adult-pattern release of GnRH begins much earlier than normal in children with precocious puberty.
 Lupron Depot-PED, an analog of naturally occurring GnRH, stimulates the pituitary gland continually rather than in bursts. Although treatment may initially cause the pituitary gland to temporarily increase its gonadotropin output, it soon ceases to respond to this artificial pattern of stimulation. As a result, both gonadtropins and sex hormones drop to normal childhood levels within three to four weeks -- not only halting, but often partially reversing the child's sexual development. Growth rates also return to prepubertal patterns.
 Researchers led by Raymond L. Hintz, M.D., professor of pediatrics at Stanford University Medical Center, studied Lupron Depot-PED's effect on 395 children. "Our results show," Dr. Hintz said, "that with adequate dosing, gonadotropins and sex steroids are suppressed and secondary sex characteristics stabilize or regress. In two clinical trials, Lupron Depot-PED was found to be safe and effective in treating these children."
 Side effects of GnRH analog treatment have included a reaction, such as redness, swelling, or itching, at the site of injection. In addition, some girls may experience light vaginal bleeding or spotting during the first month or two of treatment.
 While children are in treatment, they receive a monthly injection of Lupron Depot-PED and undergo regular blood tests to ensure that puberty is being suppressed. When the child is ready to enter puberty, injections are halted. This allows adolescent sexual development to occur normally.
 Previously available GnRH analogs had required daily injections or use of a nasal spray several times each day.
 "Prior to the use of GnRH analogs, there was really very little we could do for children affected by precocious puberty," Dr. Lee said. "The availability of Lupron Depot-PED is an important step forward in the treatment of this disorder."
 Before GnRH analogs became available, the only treatment alternative for physicians was progesterone, one of the sex hormones secreted by the ovaries. Progesterone, however, could only partially reverse a child's premature sexual development and it did not effect the child's early growth spurt and short adult height. "In addition," Dr. Hintz said, "progesterone has many serious side effects. Because of this, many physicians preferred not to treat the disorder at all."
 Hank Pietraszek, president of TAP Pharmaceuticals Inc., said, "This approval is very important to TAP as a company and to patients we serve. We feel that Lupron Depot-PED will improve the quality of life for many of the children with this disorder."
 Lupron (leuprolide acetate) Injection was cleared by the FDA in 1985 as a palliative treatment for advanced prostate cancer. In 1989, the FDA cleared Lupron Depot (leuprolide acetate for depot suspension) 7.5 mg, a once-a-month formulation of Lupron.
 In 1990, Lupron Depot 3.75 mg was also cleared by the FDA for management of endometriosis, a disease that affects an estimated one in 15 women of reproductive age and is a leading cause of infertility.
 TAP Pharmaceuticals Inc., which was formed in 1977, is headquartered in Deerfield.
 -0- 4/20/93
 /NOTE TO BROADCAST MEDIA: Video news release satellite coordinates:
 Tuesday, April 20, 11:30 a.m. - noon (EDT) Coordinates: C Band: Galaxy 6, Transponder 8 Audio 6.2 & 6.8
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 /CONTACT: Mark Leonard, Leslie Sweeney or Sharon Brown of Edelman


Public Relations, 312-280-7000, for TAP Pharmaceuticals Inc., or Rich Moser of Abbott Laboratories, 708-937-2654/

CO: TAP Pharmaceuticals Inc. ST: Illinois IN: MTC SU:

TS -- NY071 -- 8069 04/20/93 12:28 EDT
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