The FDA will review the current new drug application for febuxostat andmake its approval decision. The FDA's decision may or may not follow theCommittee's recommendation.

"Today's vote by the Arthritis Advisory Committee, recommending approval offebuxostat for the treatment of hyperuricemia in patients with gout, is apositive step in bringing this new treatment to market," said NancyJoseph-Ridge, MD, president, Takeda Global Research & Development, Inc.,U.S. "Takeda is committed to developing innovative therapies that fulfillunmet treatment needs, and we believe febuxostat will represent animportant new option for patients who suffer the debilitating effects ofgout. In the coming months, we will work with the FDA to complete theirreview, including the design of post-marketing studies."

Febuxostat is a potent non-purine, selective inhibitor of xanthine oxidase,which was studied for its ability to lower levels of serum uric acid inpatients with hyperuricemia associated with gout. Hyperuricemia, elevateduric acid levels in the body, is associated with gout, a painful type ofarthritis. In clinical trials, febuxostat 40 mg and 80 mg were shown to beeffective treatments for the management of hyperuricemia associated withgout. Both doses were well tolerated and required no dose adjustments inpatients with renal impairment. The most commonly reported adverse eventswere upper respiratory tract infections, musculoskeletal and connectivetissue signs and symptoms, and diarrhea.

About Gout and Uric Acid

Uric acid is an end-product created when the body breaks down naturallyoccurring substances called purines. Hyperuricemia occurs when this processresults in elevated uric acid levels, either through overproduction orunderexcretion of uric acid or a combination of the two. Hyperuricemia is aprecursor to gout; the higher a person's urate level, the greater the riskfor developing gout.

Gout is the most common inflammatory arthritis in men over age 40.According to the National Health and Nutrition Examination Survey III1988-1994, an estimated 5.1 million Americans suffer from gout. It is achronic condition characterized by attacks, or "flares," marked by intensepain, redness, swelling, and heat in the affected joint. These symptoms arethe result of an acute inflammatory response to the presence ofcrystallized uric acid in the joint(s). As the disease progresses, theseattacks may become more frequent and patients may develop large deposits ofcrystallized uric acid visible under the skin, known as tophi, that caneventually lead to complications including pain, soft tissue damage anddeformity, as well as joint destruction and nerve compression syndromessuch as carpal tunnel syndrome.

Takeda Pharmaceutical Company Limited

Takeda, located in Osaka, Japan, is a research-based global company withits main focus on pharmaceuticals. As the largest pharmaceutical company inJapan, and one of the global leaders of the industry, Takeda is committedto striving toward better health for individuals and progress in medicineby developing superior pharmaceutical products. Additional informationabout Takeda is available through its corporate website, www.takeda.com.

Takeda Pharmaceuticals North America, Inc. and Takeda Global Research &Development Center, Inc.

Based in Deerfield, Ill., Takeda Pharmaceuticals North America, Inc. andTakeda Global Research & Development Center, Inc. are subsidiaries ofTakeda Pharmaceutical Company Limited, the largest pharmaceutical companyin Japan. The respective companies currently market oral diabetes, insomniaand gastroenterology treatments and seek to bring innovative products topatients through a pipeline that includes compounds in development fordiabetes, cardiovascular disease, oncology, gastroenterology, neurology,rheumatology and other conditions. Takeda is committed to striving towardbetter health for individuals and progress in medicine by developingsuperior pharmaceutical products. To learn more about these Takedacompanies, visit www.tpna.com.