Healthcare Industry News: Methotrexate
News Release - November 6, 2007
REMICADE(R) Becomes First Anti-TNF Biologic Therapy to Treat One Million Patients WorldwideHORSHAM, Pa. and KENILWORTH, N.J., Nov. 6 (HSMN NewsFeed) -- Centocor, Inc., Schering-Plough Corporation, and Mitsubishi Tanabe Pharma Corporation announced today that an estimated one million patients have now been treated with REMICADE® (infliximab), the leading anti-tumor necrosis factor (TNF)-alpha therapy worldwide. In fact, REMICADE has been used to treat more patients worldwide than all other anti-TNF-alpha agents combined. REMICADE was the first anti-TNF-alpha treatment approved by the U.S. Food and Drug Administration (FDA), when it was indicated for the treatment of acute moderate to severe Crohn's disease in 1998. The indication for Crohn's disease was quickly followed by additional indications, such as rheumatoid arthritis.
"Rheumatoid arthritis derailed my life," said Ellen Shmueli, RA patient. "Simple tasks like lifting my child or holding a pen were nearly impossible. It's hard to put into words what REMICADE has meant to me."
Through a long line of firsts in the biotechnology industry, the history of REMICADE includes 15 FDA indications spanning across inflammatory diseases that include Crohn's disease (adult and pediatric), ulcerative colitis, rheumatoid arthritis (RA), ankylosing spondylitis, psoriatic arthritis and psoriasis.
"This significant milestone was achieved as a result of nearly three decades of expanding and improving access for people living with life-altering inflammatory diseases," said Neal Fowler, President, Centocor, Inc. "In partnership with Centocor R&D, we will continue our pledge of bringing the promise of biomedicine to physicians and patients through continued research and development, REMICADE and our promising pipeline portfolio."
REMICADE has been studied in more than 37 clinical trials, evaluating its use in a wide variety of diseases of the immune system and is approved for use in 88 countries.
"Having been a part of its initial approval in 1998, I have personally witnessed how REMICADE has satisfied unmet therapeutic needs and resulted in significant life-changing improvements in patients," said Thomas F. Schaible, PhD, Vice President, Medical Affairs, Centocor, Inc. "Almost a decade later, REMICADE continues to positively affect patients' lives and Centocor continues its commitment to developing novel and important therapies for diseases of the immune system."
"Around the world, the treatment of patients with inflammatory diseases, such as rheumatoid arthritis, ankylosing spondylitis, ulcerative colitis and Crohn's disease, has been transformed by the availability of REMICADE," said Robert J. Spiegel, M.D., chief medical officer and senior vice president, Schering-Plough Research Institute. "Schering-Plough is committed to bringing the benefits of REMICADE, with its proven efficacy and rapid onset of action, to relieve the suffering of patients with these chronic inflammatory conditions."
Important firsts for REMICADE include:
-- In August 1998, REMICADE was approved on an accelerated basis for the acute treatment of moderate-to-severe Crohn's disease in patients who have had an inadequate response to conventional therapy and fistulizing disease. This approval made REMICADE the first TNF-alpha inhibitor available in the U.S.
-- In August 1999, REMICADE became the first TNF-alpha inhibitor approved in the European Union (EU) for the short-term treatment of severe, active Crohn's disease and fistulizing, active Crohn's disease in patients who have not responded to conventional therapy.
-- In December 2001, REMICADE became the first TNF-alpha inhibitor approved in Japan for the treatment of moderate-to-severe Crohn's disease.
-- In February 2002, REMICADE became the first TNF-alpha inhibitor indicated in the U.S. to improve physical function in patients with moderate to severe RA who have had an inadequate response to Methotrexate.
-- In June 2002, REMICADE became the first TNF-alpha inhibitor approved by the FDA for maintenance therapy in patients with moderate to severe Crohn's disease. And in April 2003, it became the first TNF-alpha inhibitor approved for maintenance therapy of fistulising Crohn's disease.
-- In May 2003, REMICADE became the first TNF-alpha inhibitor approved in the EU for the treatment of ankylosing spondylitis in patients who have severe axial symptoms, elevated serological markers of inflammatory activity and who have responded inadequately to conventional therapy.
-- In October 2004, REMICADE became the first TNF-alpha inhibitor approved for the treatment of active and progressive psoriatic arthritis in patients who have responded inadequately to disease modifying anti-rheumatic drug therapy.
-- In September 2005, the FDA approved REMICADE as the first and only biologic for reducing signs and symptoms, achieving clinical remission and mucosal healing and eliminating corticosteroid use in adults with moderately to severely active UC who have had an inadequate response to conventional therapy. The FDA extended the indication to include maintenance therapy for UC in October 2006.
-- In March 2006, REMICADE became the first biologic therapy approved to treat moderately to severely active UC in the European Union (EU), in patients with an inadequate response to conventional therapy, including corticosteroids and 6-MP or AZA, or those intolerant to or contraindicated for such therapies.
-- In May 2006, REMICADE became the first and only biologic indicated to reduce signs and symptoms and induce and maintain clinical remission in pediatric patients with moderately to severely active Crohn's disease who have had an inadequate response to conventional therapy.
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) psoriatic arthritis (PsA), ulcerative colitis (UC), pediatric Crohn's disease (PCD) and psoriasis (PsO). REMICADE is the global market leader among anti-tumor necrosis factor alpha (TNF-alpha) therapies and the only agent approved globally in the 3 regions of North America, the EU and Japan for the treatment of both RA and CD. Additionally, REMICADE is the only anti-TNF approved in three different therapeutic areas: gastroenterology, rheumatology and dermatology. The safety and efficacy of REMICADE have been well established in clinical trials over the past 15 years and through commercial experience with more than one million 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 reducing signs and symptoms and inducing and maintaining clinical remission in adult and pediatric 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. In May 2005, REMICADE was approved for reducing signs and symptoms of active arthritis in patients with PsA. Additionally, in September 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 May 2006, REMICADE was approved for reducing signs and symptoms and inducing and maintaining clinical remission in pediatric patients with moderately to severely active Crohn's disease who have had an inadequate response to conventional therapy. This approval establishes REMICADE as the first and only biologic therapy approved for the treatment of PCD. In August 2006, REMICADE was approved for inhibiting progression of structural damage and improving physical function in patients with psoriatic arthritis. In September 2006, REMICADE was approved for the treatment of adults with chronic, severe (i.e., extensive and/or disabling) plaque psoriasis who are candidates for systemic therapy and when other systemic therapies are medically less appropriate. In October 2006, REMICADE was approved for maintaining clinical remission and mucosal healing in patients with moderately to severely active UC, who have had an inadequate response to conventional therapy.
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/or 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 carefully selected patients with RA who have tolerated three initial two-hour infusions of REMICADE, consideration may be given to administering subsequent infusions over a period of not less than one hour.
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 is also approved for the treatment of active and progressive PsA in adults when the response to previous disease modifying anti-rheumatic drug therapy has been inadequate. REMICADE should be administered in combination with Methotrexate or alone in patients who show intolerance to Methotrexate or for whom Methotrexate is contraindicated. REMICADE is also 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 PUVA (psoralen plus ultraviolet A light).
In February 2006, REMICADE was approved in the EU for the treatment of moderately to severely active UC in patients who have had an inadequate response to conventional therapy, including corticosteroids and 6-MP or azathioprine, or who are intolerant to or have medical contraindications for such therapies. This approval made REMICADE the first and only biologic therapy approved to treat moderate to severe UC in the EU. In May 2007, REMICADE was indicated for the treatment of severe, active Crohn's disease, in pediatric patients aged 6 to 17 years, who have not responded to conventional therapy including a corticosteroid, an immunomodulator and primary nutrition therapy; or who are intolerant to or have contraindications for such therapies. REMICADE has been studied only in combination with conventional immunosuppressive therapy
REMICADE is available in an IV form. REMICADE is actually a powder to be reconstituted as a solution for IV infusion. 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), UC (5 mg/kg), PCD (5 mg/kg), and PsO (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 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, China and parts of the Far East. In China, Xian-Janssen markets REMICADE. In Japan and other parts of the Far East, Mitsubishi Tanabe Pharma Corporation markets the product.
Important Safety Information
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 TB 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, flu or warm, red or painful skin while taking REMICADE, tell your doctor right away. Also, tell your doctor if you are scheduled to receive a vaccine or if you have lived in a region where histoplasmosis or coccidioidomycosis is common.
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. Rarely, children and young adults who have been treated for Crohn's disease with REMICADE in combination with azathioprine or 6-mercaptopurine have developed a rare type of lymphoma, hepatosplenic T cell lymphoma (HSTL), that often results in death. 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 or if you have a lung disease called chronic obstructive pulmonary disease (COPD).
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, swelling of your ankles or feet, or sudden weight gain).
Reactivation of hepatitis B virus has been reported in patients who are carriers of this virus and are taking TNF blockers, such as REMICADE. Some of these cases have been fatal. Tell your doctor if you know or think you may be a carrier of hepatitis B virus or if you experience signs of hepatitis B infection, such as feeling unwell, poor appetite, tiredness, fever, skin rash and/or joint pain.
There have been rare cases of serious liver injury in people taking REMICADE, some fatal. Tell your doctor if you have liver problems and 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, visual disturbances or seizures while taking REMICADE.
Allergic reactions, some severe have been reported during or after infusions with REMICADE. Signs of an allergic reaction include hives, difficulty breathing, chest pain, high or low blood pressure, swelling of face and hands, and fever or chills. Tell your doctor if you have experienced a severe allergic reaction. The most common side effects of REMICADE are: respiratory infections, such as sinus infections and sore throat, headache, rash, coughing, and stomach pain.
Please read important information about REMICADE, including full U.S. prescribing information and Medication Guide, at www.REMICADE.com. For complete EU prescribing information, please visit www.emea.eu.int.
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 DISCLOSURE NOTICE: 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 the Centocor 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. Centocor 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 healthcare 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 international market potential 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 Part II, Item 1A, "Risk Factors" in Schering-Plough's third quarter 2007 10-Q.
About Mitsubishi Tanabe Pharma Corporation
Mitsubishi Tanabe Pharma Corporation, one of the leading Japanese pharmaceutical companies, specializes in developing and marketing globally competitive pharmaceutical products in the fields of cardiovascular and metabolic diseases, brain and nerve diseases, and renal and urinary system diseases. The company, established through the merger of Tanabe Seiyaku Co., Ltd. and Mitsubishi Pharma Corporation in October 2007, drives for the expansion of its operations and the reinforcement of its future growth with the aim of becoming a global research-driven pharmaceutical company and taking on challenge of new business opportunities. Mitstubishi Tanabe Pharma Corporation is committed to protect the health of people around the world and contribute to comfortable lifestyles through creating pharmaceuticals. For more information, please visit the web site at www.mt-pharma.co.jp.
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