Healthcare Industry News:  infliximab 

Biopharmaceuticals Regulatory

 News Release - March 23, 2006

REMICADE(R) Is Approved in Australia for Treatment of Early Rheumatoid Arthritis and Psoriatic Arthritis

Expanded Indications Offer New Options for Preventing Progression of these Debilitating Diseases

KENILWORTH, N.J., March 23 (HSMN NewsFeed) -- Schering-Plough Corporation (NYSE: SGP ) today announced that the Therapeutic Goods Administration of the Department of Health and Ageing in Australia has revised the indication of REMICADE (infliximab) to include the treatment of early rheumatoid arthritis (RA) and approved a new indication for psoriatic arthritis (PsA). REMICADE, in combination with methotrexate, can now be prescribed as first-line therapy for early rheumatoid arthritis. Previously patients were required to be treated first with methotrexate alone, prior to the addition of REMICADE therapy. Additionally, REMICADE is now indicated for the treatment of signs and symptoms of active PsA in adults where previous response to disease-modifying anti-rheumatic drugs (DMARDs) has been inadequate.

"These approvals represent important developments in the management of early RA and Psoriatic Arthritis in Australia. Patients will now have new treatment options that inhibit the progression of joint structural damage in early RA and in Psoriatic Arthritis a therapy that improves signs and symptoms of joint disease as well as helps clear skin lesions," said Robert Spiegel, MD, chief medical officer and senior vice president, Schering-Plough. "REMICADE continues to expand its proven efficacy and safety profile and demonstrate its clinical value among biological therapies in treating a host of immune-mediated inflammatory disorders."

In Australia, REMICADE, in combination with methotrexate, is currently indicated for the reduction of signs and symptoms and prevention of structural damage (joint erosions and joint space narrowing) in patients with active rheumatoid arthritis despite treatment with methotrexate. REMICADE is also indicated for the reduction of signs and symptoms and improvement in physical function in patients with active Ankylosing Spondylitis.

For patients with Crohn's disease, REMICADE is indicated in the treatment of moderate to severe disease, to reduce the signs and symptoms and to induce and maintain clinical remission in patients who have inadequate response to conventional therapies. REMICADE is also indicated for reducing the number of draining enterocutaneous and rectovaginal fistulas and maintaining fistula closure in patients with Crohn's disease.

REMICADE in Early RA in the EU

REMICADE was approved for early RA in the European Union (EU) in June 2004. That approval was based on data from the ASPIRE (Active Controlled Study of Patients Receiving infliximab for Treatment of Rheumatoid Arthritis of Early Onset) trial, a 54-week, randomized, double blind, active control study involving 1,049 patients with early RA (< 3 years duration) enrolled in 125 centers in North America and Europe. ASPIRE is the first and only trial in early RA to demonstrate the superiority of REMICADE with methotrexate versus methotrexate alone in preventing progression of joint destruction and reducing disability as well as increasing clinical improvement. In these patients, a significant reduction in the rate of the progression of joint damage has been demonstrated.

Patients in the ASPIRE study had an average of only seven months of clinical disease duration yet more than 90 percent already had evidence of erosive joint changes. At week 54, results of the ASPIRE trial met all of the primary endpoints: demonstration of superior efficacy versus methotrexate alone in improvement of signs and symptoms of RA, prevention of progression of structural damage and improvement in physical function. Importantly, in the subgroup of patients who had no joint damage at initiation of the study, 79.7 percent of these patients treated with REMICADE and methotrexate continued to show no joint damage at week 54, versus 63 percent with methotrexate alone.

REMICADE in Psoriatic Arthritis in the EU

Additionally, REMICADE was approved for PsA in the EU in October 2004. The PsA approval was based on data from IMPACT (infliximab Multinational Psoriatic Arthritis Controlled Trial), a randomized, double-blind, placebo- controlled study involving 104 patients with active PsA who had failed at least one DMARD and were enrolled at nine centers in the United States, Canada and Europe. Results demonstrated the safety and efficacy of REMICADE in treating this debilitating disorder.

In IMPACT, patients given REMICADE (5mg/kg) experienced rapid and sustained improvement in their joints, as measured by the ACR 20, 50 and 70 response criteria, measurement tools used to assess disease activity and improvement. Specifically, 34 of the 52 patients (65.4 percent) met the ACR 20 response criteria -- the primary efficacy parameter -- at week 16, compared to five of the 52 patients (9.6 percent) in the placebo group. Responses were sustained through the end of the study (week 50). Results were confirmed in the ACR 50 and ACR 70 scores among those treated with REMICADE: 24 patients (46.2 percent) met the ACR 50 response at week 16 with 26 patients (53.1 percent) meeting it at week 50; 15 patients (28.8 percent) met the ACR 70 response at week 16, with 19 patients (38.8 percent) meeting it at week 50.

Positive results were also seen among patients who qualified for evaluation by the Psoriasis Area and Severity Index (PASI), a scale for assessing skin involvement (psoriasis severity) and treatment effectiveness. Among patients with a PASI score of greater than 2.5, results showed a substantial and significant decrease from baseline in the mean PASI score among patients treated with REMICADE compared to placebo at 16 weeks. In the REMICADE group, 68 percent of patients achieved an improvement of at least 75 percent compared to none of the patients in the placebo group. Among patients treated with REMICADE, sustained improvement in psoriasis manifestations was maintained at week 50.

About Early Rheumatoid Arthritis

RA is a chronic, progressive disease and recent research demonstrates that a critical therapeutic window exists within the first years of disease onset when the progressive joint damage of the disease as measured radiographically can be "reset." Joint damage can occur within two years of disease onset in 50-70 percent of RA patients. The American College of Rheumatology (ACR) suggests control of disease progression should start as early as possible to limit joint damage in RA. RA is associated with substantial disability and economic losses, and one study showed that one-third of patients in the UK who were employed became work-disabled within two years of disease onset.

About Psoriatic Arthritis

The Arthritis Research Campaign estimates 1 in 50 people have psoriasis. Of these, about 1 in 3 will develop PsA. While PsA can develop at any age, onset usually occurs in middle-age, typically in adults between the ages of 30 and 50. Men and women are affected equally. In approximately 75 percent of patients with PsA, the appearance of skin lesions precedes arthritic involvement. Physical symptoms include stiffness, pain, swelling and tenderness of the joints and surrounding soft tissue, reduced range of motion, morning stiffness, and tiredness. Symptoms also could include nail changes, including pitting (small indentations in the nail) or lifting of the nail.

About REMICADE

REMICADE is a monoclonal antibody that specifically targets TNF-alpha, which has been shown to play a role in Crohn's disease (CD), rheumatoid arthritis (RA), ankylosing spondylitis (AS) and psoriatic arthritis (PsA). REMICADE is the global market leader among anti-tumor necrosis factor alpha (TNF-alpha) therapies and the only agent approved for the treatment of both RA and CD in North America, the EU and Japan. The safety and efficacy of REMICADE have been well established in clinical trials over the past 13 years and through commercial experience with over 700,000 patients treated worldwide.

In the U.S., REMICADE, in combination with methotrexate, is indicated for reducing signs and symptoms, inhibiting the progression of structural damage and improving physical function in patients with moderately to severely active RA. REMICADE is the only biologic indicated for the treatment of patients with moderately-to-severely active CD who have had an inadequate response to conventional therapy. REMICADE is also indicated for reducing the number of draining enterocutaneous and rectovaginal fistulas and maintaining fistula closure in patients with fistulizing CD. In December 2004, REMICADE was approved for reducing signs and symptoms in patients with active AS. On May 13, 2005, REMICADE was approved for reducing signs and symptoms of active arthritis in patients with PsA. Additionally, on September 15, 2005, REMICADE was approved for reducing signs and symptoms, achieving clinical remission and mucosal healing, and eliminating corticosteroid use in patients with moderately to severely active UC who have had an inadequate response to conventional therapy. This approval makes REMICADE the first and only biologic approved for the treatment of moderate to severe UC.

In the EU, REMICADE is indicated for the treatment of severe, active CD in patients who have not responded despite a full and adequate course of therapy with a corticosteroid and an immunosuppressant; or who are intolerant to or have medical contraindications for such therapies. REMICADE also is indicated for the treatment of fistulizing, active CD in patients who have not responded despite a full and adequate course of therapy with conventional treatment (including antibiotics, drainage and immunosuppressive therapy).

For RA patients in the EU, REMICADE, in combination with methotrexate, is indicated for the reduction of signs and symptoms as well as the improvement in physical function in patients with active disease when the response to disease-modifying drugs, including methotrexate, has been inadequate, and in patients with severe, active and progressive disease not previously treated with methotrexate or other DMARDs. In these patient populations, a reduction in the rate of the progression of joint damage, as measured by X-ray, has been demonstrated.

In the EU, REMICADE is also indicated for the treatment of AS in patients who have severe axial symptoms, elevated serological markers of inflammatory activity and who have responded inadequately to conventional therapy. REMICADE, in combination with methotrexate, is also approved for the treatment of active and progressive PsA in patients who have responded inadequately to disease modifying anti-rheumatic drugs. Additionally, in September 2005, REMICADE was approved in the EU for the treatment of moderate to severe plaque psoriasis in adults who failed to respond to, or have a contraindication to, or are intolerant of other systemic therapy including cyclosporine, methotrexate or psoralen plus ultraviolet A light (PUVA). In February 2006, REMICADE was approved in the EU for the treatment of moderately to severely active ulcerative colitis (UC) in patients who have had an inadequate response to conventional therapy, including corticosteroids and 6-MP or AZA, or who are intolerant to or have medical contraindications for such therapies.

REMICADE is unique among available anti-TNF biologic therapies. Unlike self-administered therapies that require patients to inject themselves frequently, REMICADE is the only anti-TNF biologic administered directly by caregivers in the clinic or office setting. In RA (3 mg/kg), CD (5 mg/kg), PsA (5 mg/kg), and UC (5 mg/kg), REMICADE is a two-hour infusion administered every 8 weeks, following a standard induction regimen that requires treatment at weeks 0, 2 and 6. As a result, REMICADE patients may require as few as six treatments each year. In AS (5 mg/kg), REMICADE is a two-hour infusion administered every 6 to 8 weeks, following a standard induction regimen that requires treatment at weeks 0, 2 and 6.

Centocor discovered REMICADE and has exclusive marketing rights to the product in the United States. Schering-Plough markets REMICADE in all countries outside of the United States, except in Japan and parts of the Far East where Tanabe Seiyaku, Ltd. markets the product and in China where Xian- Janssen markets REMICADE.

Important Safety Information

Many people with heart failure should not take REMICADE; so prior to treatment you should discuss any heart condition with your doctor. Tell your doctor right away if you develop new or worsening symptoms of heart failure (such as shortness of breath or swelling of your ankles or feet).

There are reports of serious infections, including tuberculosis (TB), sepsis and pneumonia. Some of these infections have been fatal. Tell your doctor if you have had recent or past exposure to people with TB. Your doctor will evaluate you for TB and perform a skin test. If you have latent (inactive) TB, your doctor should begin TB treatment before you start REMICADE. REMICADE can lower your ability to fight infections, so if you are prone to or have a history of infections, or develop any signs of an infection such as fever, fatigue, cough, or the flu while taking REMICADE, tell your doctor right away. Also tell your doctor if you have lived in a region where histoplasmosis or coccidioidomycosis is common.

There have been rare cases of serious liver injury in people taking REMICADE, some fatal. Contact your doctor immediately if you develop symptoms such as jaundice (yellow skin and eyes), dark brown urine, right-sided abdominal pain, fever, or severe fatigue.

Blood disorders have been reported, some fatal. Tell your doctor if you develop possible signs of blood disorders such as persistent fever, bruising, bleeding, or paleness while taking REMICADE. Nervous system disorders have also been reported. Tell your doctor if you have or have had a disease that affects the nervous system, or if you experience any numbness, weakness, tingling, or visual disturbances while taking REMICADE.

Reports of a type of blood cancer called lymphoma in patients on REMICADE or other TNF blockers are rare but occur more often than expected for people in general. People who have been treated for rheumatoid arthritis, Crohn's disease, ankylosing spondylitis, or psoriatic arthritis for a long time, particularly those with highly active disease may be more prone to develop lymphoma. Cancers, other than lymphoma, have also been reported. If you take REMICADE or other TNF blockers, your risk for developing lymphoma or other cancers may increase. You should also tell your doctor if you have had or develop lymphoma or other cancers while you are taking REMICADE.

Serious infusion reactions have been reported with REMICADE, including hives, difficulty breathing, and low blood pressure. Reactions have occurred during or after infusions. In clinical studies, some people experienced the following common side effects: respiratory infections (that may include sinus infections and sore throat), coughing, and stomach pain or mild reactions to infusion such as rash or itchy skin.

Please read important information about REMICADE, including full US prescribing information, at www.remicade.com. For complete EU prescribing information, please visit http://www.emea.eu.int.

About Schering-Plough

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 more than 32,000 people around the world. The company is based in Kenilworth, N.J., and its Web site is http://www.schering-plough.com.

SCHERING-PLOUGH DISCLOSURE NOTICE: The information in this press release includes certain "forward-looking statements" within the meaning of the Securities Litigation Reform Act of 1995, including statements relating to REMICADE and the potential market for REMICADE. 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 about these and other factors that may impact the forward-looking statements, see Schering-Plough's Securities and Exchange Commission filings, including Item 1A. Risk Factors in the Company's 2005 10-K.


Source: Schering-Plough

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