Press Release

Abbott Park, Illinois (NYSE: ABT) — Abbott today announced that the U.S. Food and Drug Administration (FDA) approved a supplemental New Drug Application (sNDA) for Lupron Depot-PED (leuprolide acetate for depot suspension). The 1-month formulation is the first product in its class to include long-term data in its label for the treatment of central precocious puberty (CPP), a condition which causes children to enter puberty too soon. The prescribing information now contains 18 years of data, including pre-specified outcome results on puberty, height and reproductive function.

"Guiding a child through puberty can be a challenge for any parent, but when things go awry in the body and this process happens too soon, it can be worrisome for everyone," said John Leonard, M.D., senior vice president, Global Pharmaceutical Research and Development, Abbott. "This study provides patients and physicians with important information to better understand Lupron Depot-PED for 1-month administration and its long-term impact, particularly on reproductive function and normalized adult height."

Abbott's submission was supported by an open-label study that enrolled 55 patients (mean age 7 ±2 years) in a treatment phase. Patients were assessed for signs and symptoms of puberty, a particular hormone (called LH), height and reproductive function. During treatment, clinical signs and symptoms of puberty were suppressed and normalized growth rates were achieved in most patients.

Forty children continued in the post-treatment follow-up period. Six months after treatment stopped, puberty resumed and 87.9 percent of patients achieved LH levels in the puberty range. Thirty-three subjects were observed until they achieved final or near final adult height. Results showed that patients experienced an average height gain over predicted adult height before treatment. In a post-treatment survey of 20 females (ages 18-26), 80 percent reported normal menstrual cycles, and seven of these females reported pregnancies.

An increase of CPP signs and symptoms were seen in the first four weeks of treatment in some patients, but resolved over time. The most common side effects reported during treatment in this study were sore throat, headache, flu syndrome and rash, injection site pain, moodiness and hot flushes.

About Central Precocious Puberty

CPP is a condition that causes children to enter puberty too soon, resulting in the development and progression of secondary sex characteristics such as breast development in females and genital development in both males and females and can potentially lead to a diminished adult height. This occurs in one child of every 5,000 to 10,000 children and is more common in girls. By definition, CPP starts in girls under the age of 8 and boys under the age of 9.

During puberty, the brain produces a hormone called gonadotropin-releasing hormone (GnRH). Through a complex process, GnRH causes increases in other hormones like luteinizing hormone (LH) and follicle stimulation hormone (FSH). It is these hormones that cause the ovaries to produce estrogen and the testicles to produce testosterone.

Lupron Depot-PED works by suppressing the level of hormones that cause puberty. This decrease in the production of certain hormones delays premature puberty until a more appropriate time in the child's life.

Use for Lupron Depot-PED® (leuprolide acetate for depot suspension)

Lupron Depot-PED 7.5 mg, 11.25 mg and 15 mg for 1-month administration are prescribed for the treatment of children with central precocious puberty (CPP).

Doctors may diagnose children with CPP when signs of sexual maturity begin to develop in girls under the age of 8 or boys under the age of 9. The doctor should perform tests to rule out possible causes of CPP that would require different treatment (e.g., tumors).

Important Safety Information for Lupron Depot-PED

Children should not receive any formulation of Lupron Depot-PED if they have experienced any type of allergic reaction to Lupron Depot-PED or similar drugs. Females who are or may become pregnant should not receive any formulation of Lupron Depot-PED.

During the first weeks of Lupron Depot-PED treatment, signs of puberty, such as vaginal bleeding, may occur. This is a common initial effect of the drug. The doctor should be notified if signs/symptoms of puberty continue beyond the second month of treatment.

Convulsions have been observed in patients taking leuprolide acetate, including patients who have a history of seizures, epilepsy, or brain disorders (related to blood vessels, nerves, or tumors), and in patients who are taking medications that have been associated with convulsions. Convulsions have also been reported in patients without any of these conditions.

The initial response to Lupron Depot-PED should be monitored, as well as the continued response during treatment, as clinically needed. For children receiving a 1-month injection, response is assessed 1-2 months after the initial injection. Height and bone age should be checked every 6-12 months in children using Lupron Depot-PED.

It is important that children keep their doctor appointments and follow the prescribed injection schedule. Pubertal development could begin again if injections are missed. The most common side effects for any GnRH agonist, including Lupron Depot-PED, are injection site reactions/pain including abscess, general pain, headache, fluctuating emotions, and hot flushes/sweating.

The most frequent adverse reactions in Lupron Depot-PED studies are pain; acne; injection site reactions, including pain, swelling and abscess; rash, including a painful rash with fever, blisters/sores, and facial swelling; vaginitis/vaginal bleeding/vaginal discharge; increased weight; and altered mood.

After the injection, some pain and irritation is expected; however, if more severe symptoms occur or if any new, unusual, or worsened symptoms develop, the child's doctor should be contacted.

Lupron Depot-PED is not for children under 2 years of age. Lupron Depot-PED must be administered under the supervision of a physician.

For more information, talk with a health care provider.

Full prescribing information for Lupron Depot-PED is available at http://www.rxabbott.com/pdf/lupronpediatric.pdf

For additional information on Lupron Depot-PED for the treatment of central precocious puberty, visit www.lupronped.com.

About Abbott

Abbott (NYSE: ABT) is a global, broad-based health care company devoted to the discovery, development, manufacture and marketing of pharmaceuticals and medical products, including nutritionals, devices and diagnostics. The company employs nearly 90,000 people and markets its products in more than 130 countries.

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Media: Elizabeth Hoff	847-935-4236
Financial: Elizabeth Shea	847-935-2211