PHASE III INVESTIGATIONAL MEDICATION, FEBUXOSTAT, BEING STUDIED FOR LOWERING URIC ACID LEVELS IN GOUT PATIENTS

-Data presented at American College of Rheumatology Meeting-

SAN ANTONIO, October 19, 2004 – Phase III clinical data presented today demonstrate the investigational medication febuxostat was more effective at achieving the primary end point compared to treatment with allopurinol among patients with chronic gout. The study’s primary end point was the number of patients in each treatment group whose last three consecutive monthly serum uric acid (sUA) levels were below 6.0 mg/dL. The data were presented at the 68th Annual Scientific Meeting at the American College of Rheumatology.

TAP Pharmaceutical Products Inc. is investigating febuxostat, a novel non-purine, selective inhibitor of xanthine oxidase (NP-SIXO), for lowering levels of serum uric acid in patients with gout. Hyperuricemia, elevated uric acid levels in the body, is associated with gout, a painful type of arthritis.

"More patients taking febuxostat in this trial achieved and maintained serum uric acid levels under 6 mg/dL than patients taking allopurinol," said H. Ralph Schumacher M.D., professor of medicine, University of Pennsylvania School of Medicine. "In addition, the study showed febuxostat to be well-tolerated among patients with gout."

This randomized controlled study involved 760 patients with diagnosed gout and sUA level ≥ 8.0 mg/dL. Patients were randomized to receive either 80 mg or 120 mg febuxostat or 300 mg allopurinol once daily. Allopurinol is the most commonly used treatment in gout. In all treatment groups, subjects who achieved an average sUA level less than 6.0 mg/dL had fewer gout flares requiring treatment and greater reduction in the size of tophi at week 52 compared with those patients who did not achieve an average sUA level lower than 6.0 mg/dL. Experts recognize that the standard goal in the treatment of chronic gout is the reduction and maintenance of serum uric acid levels of less than 6 mg/dL.

Fifty-three percent of the febuxostat 80 mg group (n=255) and 62 percent of the febuxostat 120 mg group (n=250) achieved sUA levels below 6.0 mg/dL at their last three consecutive monthly tests, compared with 21 percent of the allopurinol group (n=251).

Treatment-related adverse events were similar in incidence across groups and included upper respiratory infections, musculoskeletal and connective tissue symptoms, joint-related signs and symptoms, diarrhea, headaches, and increase in liver function test results. Most adverse events observed among trial participants were mild to moderate in severity.

"When sUA levels were measured at their last visit, 81-82 percent of the febuxostat treatment groups had sUA levels lower than 6.0 mg/dL, compared with 39 percent of the allopurinol-treated group after one year of treatment," added Schumacher.

Uric Acid and Gout

Gout is the most common inflammatory arthritis in men older than 40 years. According to the National Health and Nutrition Examination Survey III 1988-1994, an estimated 5.1 million Americans suffer from gout. It is a chronic condition characterized by attacks, or “flares,” marked by intense pain, redness, inflammation, and warmth in the affected joint. These attacks often occur at night, waking the patient from sleep. Typically, symptoms begin in the big toe but may involve other joints. These symptoms are the result of an acute inflammatory response to the presence of crystallized uric acid in the joint(s). As the disease progresses, these attacks may become more frequent and patients may develop large deposits of crystallized uric acid visible under the skin, known as tophi, that can eventually lead to joint deformity.

Uric acid is a by-product created when the body breaks down naturally occurring substances called purines. Hyperuricemia occurs when this process results in elevated uric acid levels, either through overproduction or underexcretion of uric acid or a combination of the two. Hyperuricemia is a precursor to gout; the higher a person’s urate level, the greater the risk for developing gout.

About TAP Pharmaceutical Products Inc.

TAP Pharmaceutical Products Inc., located in Lake Forest, Ill., is a joint venture between Abbott, headquartered in Abbott Park, Ill., and Takeda Pharmaceutical Company Limited, of Osaka, Japan. TAP markets Prevacid® (lansoprazole) and Lupron Depot® (leuprolide acetate for depot suspension). For more information about TAP Pharmaceutical Products Inc., and its products, visit the company's Web site at www.tap.com.