BOSTON, Mass., November 8, 2007 - More than half of patients receiving monthly subcutaneous (SC) injections of golimumab (CNTO 148) 50 mg and 100 mg experienced significant and sustained improvements in the signs and symptoms of active ankylosing spondylitis, according to Phase 3 study results presented at the American College of Rheumatology (ACR) annual meeting. At week 14 of the study, 59 percent of patients receiving golimumab 50 mg and 60 percent of patients receiving golimumab 100 mg achieved at least 20 percent improvement in the Assessment in Ankylosing Spondylitis criteria (ASAS 20) compared with 22 percent of patients receiving placebo (P < 0.001). Investigators also reported that study subjects receiving golimumab 50 mg or golimumab 100 mg showed significant, sustained improvements in physical function through six months as measured by the Bath Ankylosing Spondylitis Functional Index (BASFI).
Golimumab, Centocor Inc. and Schering-Plough Corporation's next-generation human anti-tumor necrosis factor (TNF)-alpha monoclonal antibody, is currently in the most comprehensive Phase 3 development program to date for an anti-TNF-alpha biologic therapy. With ongoing studies for the treatment of rheumatoid arthritis, psoriatic arthritis and ankylosing spondylitis, golimumab is being studied as a monthly SC injection and an every twelve-week intravenous (IV) infusion (approximately 30-minutes) therapy.
"The rapid and significant effects of golimumab as demonstrated by these study findings are encouraging for the rheumatology community and for the patients living with this debilitating disease," said Jurgen Braun, MD, lead physician at the Rheumatological Center in Herne, Germany, professor at the Ruhr-Universitat of Bochum, Germany, and lead study investigator. "Anti-TNF therapies have dramatically advanced our approach to the management of this disease, and these data demonstrate the potential of golimumab as a new efficacious anti-TNF-alpha treatment option."
According to findings from the Golimumab - A Randomized Study in Ankylosing Spondylitis Subjects of a Novel Anti-TNF mAB Injection (SC) Given Every Four Weeks (GO-RAISE) trial, 59 percent of patients receiving golimumab 50 mg and 60 percent of patients receiving golimumab 100 mg achieved the primary endpoint of the study, ASAS 20 at week 14, compared with 22 percent of patients receiving placebo (P < 0.001 for both comparisons). Clinical benefit was demonstrated as early as week four after one dose and was maintained through week 24. At six months, 56 percent of patients receiving golimumab 50 mg and 66 percent of patients receiving golimumab 100 mg achieved ASAS 20 compared with 23 percent of patients receiving placebo (P < 0.001 for both comparisons). Furthermore, at six months, 44 percent of patients receiving golimumab 50 mg and 54 percent of patients receiving golimumab 100 mg achieved ASAS 40, defined as 40 percent improvement in ankylosing spondylitis signs and symptoms, compared with 15 percent of patients receiving placebo (P < 0.001 for both comparisons).
Importantly, at six months, 51 percent of patients receiving golimumab 50 mg and 48 percent of patients receiving golimumab 100 mg achieved a 50 percent reduction in disease activity as measured by the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI 50), a standard measure for assessing ankylosing spondylitis disease activity, compared with 15 percent of patients receiving placebo (P < 0.001). The BASDAI measures important markers of disease activity, including pain, morning stiffness and joint swelling.
"When treating this potentially progressive and debilitating disease, we attempt to reduce pain and other symptoms so that patients can maintain or improve physical function," said Atul Deodhar, MD, associate professor of medicine, Oregon Health and Science University, Portland, Oregon. "These findings show that golimumab improved both the signs and symptoms of ankylosing spondylitis and patients' physical function, which is promising in the treatment of this systemic inflammatory disease."
Findings from the GO-RAISE study showed that golimumab-treated patients experienced significant functional improvements as measured by the BASFI, a 1 to 10 scale (1 representing no impairment and 10 representing severe impairment), which measures physical function and impairment due to the disease and subsequent improvements as a result of treatment. Patients receiving golimumab 50 mg and 100 mg experienced an average decrease of 1.4 and 1.5 units from baseline in BASFI score, respectively, at week 14, compared with an average increase of 0.1 units among patient receiving placebo (P < 0.001 for both comparisons).
"We are encouraged by the findings from this Phase 3 trial evaluating golimumab as a treatment for ankylosing spondylitis," said Jerome A. Boscia, MD, senior vice president, Clinical Research and Development, Centocor, Inc. "These data suggest golimumab may be an effective treatment option for patients with this chronic, progressive spondyloarthropathy."
About the GO-RAISE Trial
The GO-RAISE trial included 356 patients with active ankylosing spondylitis. Subjects were randomized to receive subcutaneous injections of golimumab 50 mg or 100 mg or placebo every four weeks. The primary endpoint was the proportion of patients achieving ASAS 20 at week 14. At week 16, patients in the placebo or 50 mg group demonstrating less than 20 percent improvement from baseline in both total back pain and morning stiffness measures were switched to either golimumab 50 mg (previously receiving placebo) or golimumab 100 mg (previously receiving golimumab 50 mg).
Through week 24, golimumab was generally well tolerated with four percent of patients receiving golimumab 50 mg and six percent of patients receiving golimumab 100 mg experiencing a serious adverse event. Seven percent of patients receiving placebo experienced serious adverse events. Adverse events were reported in 80 percent of patients receiving golimumab and 77 percent of patients receiving placebo, with an increased incidence of infections, primarily upper respiratory infections, in patients treated with golimumab. Antibodies to golimumab were detected in four percent of patients through week 24.
Golimumab, Centocor Inc. and Schering-Plough Corporation's next-generation human anti-tumor necrosis factor (TNF)-alpha monoclonal antibody, is currently in the most comprehensive Phase 3 development program to date for an anti-TNF-alpha biologic therapy. With ongoing studies for the treatment of rheumatoid arthritis, psoriatic arthritis and ankylosing spondylitis, golimumab is being studied as a monthly SC injection and an every twelve-week intravenous (IV) infusion (approximately 30-minutes) therapy. Golimumab targets and neutralizes both the soluble and membrane-bound forms of TNF-alpha.
Centocor discovered golimumab and has exclusive marketing rights to the product in the United States. Schering-Plough has exclusive marketing rights outside the United States except in Japan, Indonesia and Taiwan where golimumab will be co-marketed by Mitsubishi Tanabe Pharma Corporation and Janssen Pharmaceutical Kabushiki Kaisha; Hong Kong, where golimumab will be exclusively marketed by Janssen-Cilag; and China where golimumab will be exclusively marketed by Xian-Janssen.
About Ankylosing Spondylitis
AS is a painful and progressive form of spinal arthritis, and symptoms of inflammatory back pain often first present in people under the age of 35 years. It typically begins in the late teens and early twenties and in severe cases can result in fusing of the spinal vertebrae and cause structural damage to hips and other joints. Often misdiagnosed as "just back pain" or undifferentiated arthritis, AS is a systemic inflammatory disease that, in addition to its effect on the spine, can affect internal organs, peripheral joints and vision. The Spondylitis Association of America estimates that between 350,000 and one million people in the U.S. suffer from AS.
About Centocor, Inc.
Centocor is harnessing the power of world-leading research and biomanufacturing to deliver innovative biomedicines that transform patients' lives. Centocor has already brought innovation to the treatment of Crohn's disease, rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, ulcerative colitis, pediatric Crohn's disease and psoriasis.
The world leader in monoclonal antibody production and technology, Centocor has brought critical biologic therapies to patients suffering from debilitating immune disorders. Centocor, Inc. is a wholly owned subsidiary of Johnson & Johnson.
(This press release contains "forward-looking statements" as defined in the Private Securities Litigation Reform Act of 1995. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or unknown risks or uncertainties materialize, actual results could vary materially from Johnson & Johnson's expectations and projections. Risks and uncertainties include general industry conditions and competition; economic conditions, such as interest rate and currency exchange rate fluctuations; technological advances and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approvals; domestic and foreign health care reforms and governmental laws and regulations; and trends toward health care cost containment. A further list and description of these risks, uncertainties and other factors can be found in Exhibit 99 of Johnson & Johnson's Annual Report on Form 10-K for the fiscal year ended December 31, 2006. Copies of this Form 10-K, as well as subsequent filings, are available online at www.sec.gov, www.jnj.com or on request from Johnson & Johnson. Johnson & Johnson does not undertake to update any forward-looking statements as a result of new information or future events or developments.)
Schering-Plough is a global science-based health care company with leading prescription, consumer and animal health products. Through internal research and collaborations with partners, Schering-Plough discovers, develops, manufactures and markets advanced drug therapies to meet important medical needs. Schering-Plough's vision is to earn the trust of the physicians, patients and customers served by its approximately 33,500 people around the world. The company is based in Kenilworth, N.J., and its Web site is www.schering-plough.com.
SCHERING-PLOUGH DISCLOSURE NOTICE: The information in this press release contains certain "forward-looking" statements within the meaning of the Private Securities Litigation Reform Act of 1995, including statements related to the potential of golimumab. Forward-looking statements relate to expectations or forecasts of future events. Schering-Plough does not assume the obligation to update any forward-looking statement. Many factors could cause actual results to differ materially from Schering-Plough's forward-looking statements, including market forces, economic factors, product availability, patent and other intellectual property protection, current and future branded, generic or over-the-counter competition, the regulatory process, and any developments following regulatory approval, among other uncertainties. For further details and a discussion of risks and uncertainties that may impact forward-looking statements, see Schering-Plough's Securities and Exchange Commission filings, including Part II, Item 1A, "Risk Factors" in Schering-Plough's third quarter 2007 10-Q.