Wyeth Japan and Takeda Pharmaceutical Company, Limited (Takeda Pharmaceutical) today announced that ENBREL(R)
(etanercept) has been approved by the Japan Ministry of Health, Labour and Welfare (MHLW) for the treatment of rheumatoid
arthritis (RA) in patients who had an inadequate response to existing therapies. As announced earlier, Enbrel in Japan will
be co-promoted by both Wyeth and Takeda Pharmaceutical.
"We are pleased with the approval decision and following pricing approval, we will make the product available to Japanese
patients as soon as possible," says Rune Bremberg, President, Wyeth Japan.
ENBREL is the only fully human, anti-TNF receptor approved to reduce the signs and symptoms of RA in patients who had an
inadequate response to traditional disease-modifying antirheumatic medicines. The biological product can be used alone as a
monotherapy and is administered twice weekly as a subcutaneous injection. Initially the product will be made available to
medical institutions participating in an all-patient surveillance program.
ABOUT RHEUMATOID ARTHRITIS
Rheumatoid arthritis is a chronic and potentially disabling disorder that affects about 700,000 people in Japan. The serious
rheumatic disease causes the body's immune system to attack the lining of the joints, resulting in pain and swelling and may
lead to fatigue, disability, deformity, organ damage, or premature death if not managed effectively. In RA, the immune system
attacks the body's own healthy cells, mistaking them for cells that don't belong. This causes inflammation in the lining and
connective tissues of the joints.
Generally, in Japan the disease affects about four times as many women as men. RA can develop at all ages including
childhood; in most cases it develops between the ages of 25 and 50.
ABOUT ENBREL
Globally physicians have become familiar with the benefits and proven long-term profile of ENBREL. As of today, the product
has been approved in more than 70 countries around the world, and has been used to treat more than 280,000 patients worldwide
across various indications.
ENBREL acts by binding TNF, one of the dominant inflammatory cytokines or regulatory proteins that play an important role in
both normal immune function and the cascade of reactions causing the inflammatory process of rheumatoid arthritis. The
binding of ENBREL to TNF renders the bound TNF biologically inactive, resulting in significant reduction in inflammatory
activity.
Additionally, ENBREL binds to lymphotoxin (LT)-alpha, another cytokine involved in the inflammatory process of RA.
ABOUT WYETH
Wyeth (NYSE: WYE) is one of the world's largest research-driven pharmaceutical and health care products companies. It is a
leader in the discovery, development, manufacturing, and marketing of pharmaceuticals, vaccines, biotechnology products and
nonprescription medicines that improve the quality of life for people worldwide. The Company's major divisions include Wyeth
Pharmaceuticals, Wyeth Consumer Healthcare, and Fort Dodge Animal Health.
The statements in this press release that are not historical facts are forward-looking statements based on current
expectations of future events that involve risks and uncertainties including, without limitation, risks associated with the
inherent uncertainty of the timing and success of pharmaceutical research, product development, manufacturing,
commercialization, economic conditions including interest and currency exchange rate fluctuations, changes in generally
accepted accounting principles, the impact of competitive or generic products, trade buying patterns, wars or terrorist acts,
product liability and other types of lawsuits, the impact of legislation and regulatory compliance and obtaining
reimbursement, favorable drug pricing, access and other approvals, environmental liabilities, and patent, and other risks and
uncertainties, including those detailed from time to time in the Company's periodic reports, including current reports on
Form 8-K, quarterly reports on Form 10-Q and the annual report on Form 10-K, filed with the Securities and Exchange
Commission.
Actual results may vary materially from the forward-looking statements. The Company assumes no obligation to publicly update
any forward-looking statements, whether as a result of new information, future events or otherwise.
wyeth
View drug information on Enbrel.
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