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Title: Rheumatrex (Methotrexate) for Rheumatoid Arthritis Relaunched in US

"Rheumatrex (Methotrexate) for Rheumatoid Arthritis Relaunched in US"

CRANBURY, NJ -- July 9, 2004 -- STADA Pharmaceuticals, Inc., the U.S. subsidiary of STADA Arzneimittel AG (OTC Pink Sheets: STDZF), a German-based, global pharmaceutical company, has relaunched Rheumatrex® (methotrexate sodium tablets), a once-weekly disease-modifying anti-rheumatic drug (DMARD) for moderate and severe rheumatoid arthritis. STADA is offering a comprehensive patient compliance and education program with Rheumatrex brand of methotrexate, the most widely prescribed treatment for this condition. While STADA has focused primarily on generics, Rheumatrex marks the Company's entry into the branded pharmaceuticals marketplace in the U.S. STADA received FDA approval to market Rheumatrex on October 24, 2003, following its acquisition from Wyeth in 2002. "STADA acquired Rheumatrex because it aligns with our strategic plan of launching high-quality branded and specialty pharmaceuticals in the U.S.," said Luis Velez, Executive Vice President, Sales and Marketing. "Rheumatrex has long been considered the gold standard of treatment in moderate and severe rheumatoid arthritis. We intend to expand our product line in arthritis and other rheumatic diseases and become a valuable resource for physicians and patients." Since adherence to the once-weekly treatment regimen is a significant problem with methotrexate, STADA is marketing the drug as Rheumatrex Dose Pack(TM), emphasizing its compliance-friendly, dose-specific blister card packaging, and is offering patients the Rheumatrex COPE (COmpliance and Patient Empowerment) program. The COPE program includes weekly reminders to take the medication (delivered via e-mail or cellular phone text messaging), a telephone hotline, educational literature, and an interactive educational web site, http://www.rheumatrex.info. STADA is focusing on compliance with Rheumatrex since dosing errors with methotrexate can have severe, even fatal, consequences. In a December 2002 safety alert about methotrexate, issued by the Institute for Safe Medication Practices (ISMP), the agency lists among its suggested safeguards the necessity to reduce the risk of dosing error with methotrexate. It strongly recommends to prescribe and "dispense the drug as a dose pack, which helps reinforce the weekly dosing schedule." (e.g., Rheumatrex Dose Pack by STADA Pharmaceuticals). About Rheumatrex® Rheumatrex is a disease-modifying anti-rheumatic drug (DMARD) recommended for moderate and severe active rheumatoid arthritis in adults and active polyarticular juvenile arthritis in children. As a low-dosage oral methotrexate, Rheumatrex is an aggressive treatment for rheumatoid arthritis that decreases symptoms, such as joint swelling and pain, and improves the long-term outcome. According to the American College of Rheumatology Guidelines for the Management of Rheumatoid Arthritis, "Because of its favorable efficacy and toxicity profile, low cost, and established track record in the treatment of RA, methotrexate has become the standard by which new DMARDs are evaluated." Often methotrexate is an initial and maintenance treatment, prescribed alone or in combination with drugs such as nonsteroidal, anti-inflammatory drugs (NSAIDs) or corticosteroids. In low dosage, methotrexate is generally well tolerated, but may cause stomatitis, leukopenia, nausea, abdominal cramps, malaise, undue fatigue, chills and fever, dizziness and decreased resistance to infection. About Rheumatoid Arthritis Rheumatoid arthritis is a chronic and potentially debilitating, systemic, autoimmune disease that affects about 2.1 million Americans, mostly women, with onset usually in middle age and increased risk with age. The disease causes chronic inflammation in the lining of the joints and/or other organs, which causes pain, stiffness, warmth, redness, swelling and difficulty moving. Rheumatoid arthritis occurs when the body's immune system attacks and damages healthy joint tissue, causing inflammation and joint damage. Highly effective treatments are available, such as DMARDS, which often control the condition, and early treatment is critical(1). References: (1) Disease Center, Rheumatoid Arthritis, Arthritis Foundation http://www.arthritis.org/conditions/diseasecenter/ra.asp SOURCE: STADA Pharmaceuticals, Inc.

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