Janssen Submits Applications Requesting Approval Of SIMPONI® In U.S. And Europe For Treatment Of Moderately To Severely Active Ulcerative Colitis

HORSHAM, Pa. and LEIDEN, Netherlands, July 16, 2012 /PRNewswire/ -- Janssen Biotech, Inc. and Janssen Biologics B.V. announced today the submission of a supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration (FDA) and a Type II Variation to the European Medicines Agency (EMA) requesting approval of SIMPONI® (golimumab) for the treatment of adult patients with moderately to severely active ulcerative colitis (UC) who have had an inadequate response to conventional therapy.  Approximately 700,000 people in the United States[1] and 1.1 million people in the European Union (EU)[2] are affected by UC, a chronic inflammatory bowel disease marked by inflammation and ulceration of the colonic mucosa, or innermost lining, which may lead to bloody stools, severe diarrhea and frequent abdominal pain.

"We are pleased to bring forward submissions for SIMPONI as a potential therapeutic option for patients who fail to respond to conventional treatments and who face the continued debilitating effects of living with ulcerative colitis, and in some circumstances, a decision of surgery," said Jerome A. Boscia, M.D., Vice President, Head of Immunology Development, Janssen Research & Development, LLC.  "We look forward to collaborating with the health authorities on these submissions seeking approval of SIMPONI as a subcutaneously administered anti-tumor necrosis factor-alpha treatment for moderately to severely active ulcerative colitis."

SIMPONI became the first subcutaneous anti-tumor necrosis factor (TNF)-alpha therapy to receive approvals in the U.S., Canada and the EU in 2009 for three rheumatic indications simultaneously.  In May 2012, findings from a Phase 3 investigational study reported the efficacy and safety of SIMPONI subcutaneous induction therapy in the treatment of moderately to severely active UC among patients who failed or were intolerant to conventional treatments.  Data from the SIMPONI Phase 3 UC maintenance study will be submitted for presentation in the future.

Both the U.S. and EU applications are supported by efficacy and safety findings from the Program of Ulcerative Colitis Research Studies Utilizing an Investigational Treatment (PURSUIT), which included Phase 3 multicenter, randomized, double-blind, placebo-controlled studies designed to evaluate the safety and efficacy of subcutaneous induction and every-four-week maintenance regimens of SIMPONI in adults with moderately to severely active UC.  All trial patients had failed to respond to or tolerate treatment with 6-mercaptopurine (6-MP), azathioprine (AZA), corticosteroids and/or 5-aminosalicylate (5-ASA), or were corticosteroid dependent.  Study participants were naive to treatment with TNF inhibitors and had a baseline Mayo score between 6 and 12 and endoscopic subscore of 2 or more. 

The induction trial (PURSUIT-SC) had an adaptive design with a Phase 2 dose-finding portion followed by a Phase 3 dose-confirming component.  The primary endpoint was clinical response at week 6.  Secondary endpoints at week 6 included clinical remission, mucosal healing and a change from baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) scores.  Overall, 1,065 patients were treated in the study; 774 of these patients were randomized into the Phase 3 component of the study.  Patients responding to induction treatment with SIMPONI were eligible to continue in the Phase 3 PURSUIT-Maintenance study. 

About Ulcerative Colitis

Ulcerative colitis (UC), a chronic inflammatory bowel disease (IBD) affecting 2.5 million individuals worldwide,[3] is marked by the inflammation and ulceration of the colonic mucosa, or innermost lining, which may lead to bloody stools, severe diarrhea and frequent abdominal pain.  Tiny open sores, or ulcers, form on the surface of the lining, where they bleed and produce pus and mucus.  Symptoms of the disease may lead to loss of appetite, subsequent weight loss and fatigue.  On average, people are diagnosed with UC in their mid-30s, but the disease can occur at any age.[1]  Between 25 and 40 percent of people living with UC will require surgery at some point in their life.[2]  UC is a chronic disease, and there is no cure.  Although progress has been made in IBD research, researchers do not know what causes this disease.[1] 

About SIMPONI® (golimumab)

SIMPONI is a human monoclonal antibody that targets and neutralizes excess TNF-alpha, a protein that when overproduced in the body due to chronic inflammatory diseases can cause inflammation and damage to bones, cartilage and tissue.  SIMPONI is approved in 52 countries for rheumatologic indications, including the United States, where SIMPONI received FDA approval in April 2009 for the treatment of moderately to severely active rheumatoid arthritis (RA) with the medicine methotrexate, active psoriatic arthritis alone or with the medicine methotrexate and active ankylosing spondylitis, and in the European Union (EU), where SIMPONI received European Commission approval in October 2009 for the treatment of moderate-to-severe, active RA in combination with methotrexate, for the treatment of active and progressive psoriatic arthritis alone or in combination with methotrexate and for the treatment of severe, active ankylosing spondylitis.  SIMPONI is available either through the SmartJect® autoinjector/prefilled pen or a prefilled syringe as a subcutaneously administered injection.  For more information about SIMPONI in the United States, visit www.SIMPONI.com.  

SIMPONI is currently being investigated in Phase 3 studies as a subcutaneously administered treatment for active polyarticular juvenile idiopathic arthritis (JIA) and as an intravenous (I.V.) formulation for the treatment of moderately to severely active RA. 

Janssen Biotech, Inc. discovered and developed SIMPONI and markets the product in the United States.  Janssen pharmaceutical companies market SIMPONI in Canada, Central and South America, the Middle East, Africa and Asia Pacific. 

In Europe, Russia and Turkey, Janssen Biotech, Inc. licenses distribution rights to SIMPONI to Schering-Plough (Ireland) Company, a subsidiary of Merck & Co., Inc. 

In Japan, Indonesia and Taiwan, Janssen Biotech, Inc. licenses distribution rights to SIMPONI to Mitsubishi Tanabe Pharma Corporation and has retained co-marketing rights in those countries. 

For further information about SIMPONI outside of the United States, please consult the relevant official product information applicable to that country location.

Important Safety Information (U.S.) 

SIMPONI® (golimumab) is a prescription medicine. SIMPONI® can lower your ability to fight infections. There are reports of serious infections caused by bacteria, fungi, or viruses that have spread throughout the body, including tuberculosis (TB) and histoplasmosis. Some of these infections have been fatal. Your doctor will test you for TB before starting SIMPONI® and will monitor you for signs of TB during treatment. Tell your doctor if you have been in close contact with people with TB. Tell your doctor if you have been in a region (such as the Ohio and Mississippi River Valleys and the Southwest) where certain fungal infections like histoplasmosis or coccidioidomycosis are common. 

You should not start SIMPONI® if you have any kind of infection. Tell your doctor if you are prone to or have a history of infections or have diabetes, HIV or a weak immune system. You should also tell your doctor if you are currently being treated for an infection or if you have or develop any signs of an infection such as:

• fever, sweat, or chills
• muscle aches
• cough
• shortness of breath
• blood in phlegm
• weight loss
• warm, red, or painful skin or sores on your body
• diarrhea or stomach pain
• burning when you urinate or urinate more than normal
• feel very tired

Unusual cancers have been reported in children and teenage patients taking TNF-blocker medicines. For children and adults taking TNF blockers, including SIMPONI®, the chances for getting lymphoma or other cancers may increase. You should tell your doctor if you have had or develop lymphoma or other cancers.

Tell your doctor about all the medications you take including ORENCIA (abatacept), KINERET (anakinra), ACTEMRA (tocilizumab), RITUXAN (rituximab), or another TNF blocker, or if you are scheduled to or recently received a vaccine. People taking SIMPONI® should not receive live vaccines.

Reactivation of hepatitis B virus has been reported in patients who are carriers of this virus and are taking TNF-blocker medicines, such as SIMPONI®. Some of these cases have been fatal. Your doctor should do blood tests before and after you start treatment with SIMPONI®. 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:

• feel very tired
• dark urine
• skin or eyes look yellow
• little or no appetite
• vomiting
• muscle aches
• clay-colored bowel movements
• fevers
• chills
• stomach discomfort
• skin rash

Heart failure can occur or get worse in people who use TNF blockers, including SIMPONI®. Your doctor will closely monitor you if you have heart failure. Tell your doctor right away if you get new or worsening symptoms of heart failure like shortness of breath or swelling of your lower legs or feet. 

Rarely, people using TNF blockers, including SIMPONI®, can have nervous system problems such as multiple sclerosis or Guillain-Barre syndrome. Tell your doctor right away if you have symptoms like vision changes, weakness in your arms or legs, or numbness or tingling in any part of your body.  

Serious liver problems can happen in people using TNF blockers, including SIMPONI®. Contact your doctor immediately if you develop symptoms such as feeling very tired, skin or eyes look yellow, poor appetite or vomiting, or pain on the right side of your stomach.

Low blood counts have been seen with people using TNF blockers, including SIMPONI®. If this occurs, your body may not make enough blood cells to help fight infections or help stop bleeding. Your doctor will check your blood counts before and during treatment. Tell your doctor if you have signs such as fever, bruising, bleeding easily, or paleness.

Rarely, people using TNF blockers have developed lupus-like symptoms. Tell your doctor if you have any symptoms such as a rash on your cheeks or other parts of the body, sensitivity to the sun, new joint or muscle pain, becoming very tired, chest pain or shortness of breath, swelling of the feet, ankles, and/or legs.

New or worse psoriasis symptoms may occur. Tell your doctor if you develop red scaly patches or raised bumps that are filled with pus.  

Tell your doctor if you are pregnant, planning to become pregnant or are breastfeeding or have a baby and were using SIMPONI® during pregnancy. Tell your baby's doctor before your baby receives any vaccine because of an increased risk of infection for up to 6 months after birth.

Tell your doctor if you are allergic to rubber or latex. The needle cover contains dry natural rubber.

Tell your doctor if you have any symptoms of an allergic reaction while taking SIMPONI® such as hives, swollen face, breathing trouble, chest pain. Some reactions can be serious and life-threatening.

Common side effects of SIMPONI® include: upper respiratory tract infection, reaction at site of injection, and viral infections. 

Please read the Medication Guide for SIMPONI® and discuss any questions you have with your doctor.

The U.S. full prescribing information for SIMPONI® can be accessed at the following link:  http://www.simponi.com/sites/default/files/pdf/prescribing-information.pdf.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.

Important Safety Information (EU) 

In the European Union, SIMPONI is contraindicated in patients with active tuberculosis, severe infections such as sepsis, opportunistic infections, in patients with moderate or severe heart failure (NYHA Class III/IV), as well as in patients who are hypersensitive to SIMPONI or any of its excipients.  Serious infections, including sepsis, pneumonia, tuberculosis, invasive fungal and opportunistic infections, have been observed with the use of TNF antagonists including SIMPONI.  Some of these infections have been fatal.  SIMPONI should not be given to patients with a clinically important, active infection.  Caution should be exercised when considering the use of SIMPONI in patients with a chronic infection or a history of recurrent infection.  Patients should be monitored for signs and symptoms of infection before, during and for several months after treatment with SIMPONI.  If a patient develops a new serious infection or sepsis, SIMPONI therapy should be discontinued and appropriate antimicrobial or antifungal therapy should be initiated until the infection is controlled.  Patients should be advised of and avoid exposure to potential risk factors for infection as appropriate.  For patients who have resided in or traveled to regions where invasive fungal infections such as histoplasmosis, coccidioidomycosis, or blastomycosis are endemic, the benefits and risks of SIMPONI treatment should be carefully considered before initiation of SIMPONI therapy.  Patients must be evaluated for the risk of tuberculosis (TB), including latent TB, prior to initiation of SIMPONI.  If active TB is diagnosed, SIMPONI must not be initiated.  If latent TB is suspected or diagnosed then the benefit/risk balance of SIMPONI therapy should be carefully considered.  Treatment of latent tuberculosis infection should be initiated prior to therapy with SIMPONI.  Anti-TB therapy prior to initiating SIMPONI should also be considered in patients who have several or significant risk factors for tuberculosis infection and have a negative test for latent tuberculosis.  Patients receiving SIMPONI should be monitored closely for signs and symptoms of active TB during and after treatment, including patients who tested negative for latent TB infections.  Use of anti-TB therapy should also be considered before the initiation of SIMPONI in patients with a past history of latent or active tuberculosis in whom an adequate course of treatment cannot be confirmed.

The use of TNF blocking agents including SIMPONI has been associated with reactivation of hepatitis B virus (HBV) in patients who are chronic carriers of the virus.  Some of these cases have been fatal.  Carriers of hepatitis B should be appropriately evaluated and monitored prior to the initiation of, during treatment with, and for several months following discontinuation of SIMPONI.  In patients who develop HBV reactivation, SIMPONI should be discontinued.

The potential role of TNF-blocking therapy in the development of malignancies is not known.  Based on the current knowledge, a possible risk for the development of lymphomas, leukaemia or other malignancies in patients treated with a TNF-antagonist cannot be excluded.  Caution should be exercised when considering TNF-blocking therapy for patients with a history of malignancy or when considering continuing treatment in patients who develop malignancy.  Lymphomas have been observed in patients treated with TNF blocking agents, including SIMPONI.  In controlled clinical studies, the incidence of lymphoma was higher than in control patients while the incidence of non-lymphoma malignancies was similar to controls.  In an exploratory clinical trial evaluating the use of SIMPONI in patients with severe persistent asthma, more malignancies were reported in patients treated with SIMPONI compared with control patients.  The significance of this finding is unknown.  Based on an exploratory clinical trial with another TNF blocking agent in patients with chronic obstructive pulmonary disease (COPD), caution should be exercised when using any TNF-blocking therapy in patients with COPD, as well as in patients with an increased risk for malignancy due to heavy smoking. 

Worsening and new onset congestive heart failure (CHF) have been reported with TNF blockers, including SIMPONI.  Worsening of CHF and increased mortality due to CHF have been reported with another TNF blocker.  SIMPONI has not been studied in patients with CHF.  SIMPONI should be used with caution in patients with mild heart failure (NYHA class I/II) and must be discontinued if new or worsening symptoms of heart failure appear. 

TNF-blocking agents, including SIMPONI, have been associated with cases of new onset or exacerbation of demyelinating disorders, including multiple sclerosis and peripheral demyelinating disorders.  The benefits and risks of anti-TNF treatment should be carefully considered before initiation of SIMPONI therapy in patients with pre-existing or recent onset of demyelinating disorders. 

There is limited safety experience of SIMPONI treatment in patients who have undergone surgical procedures, including arthroplasty.  A patient who requires surgery while on SIMPONI should be closely monitored for infections, and appropriate actions should be taken. 

The possibility exists for TNF-blocking agents, including SIMPONI, to affect host defenses against infections and malignancies.  Treatment with SIMPONI may result in the formation of auto-antibodies and, rarely, in the development of a lupus-like syndrome. 

There have been post-marketing reports of pancytopenia, leukopenia, neutropenia, aplastic anemia, and thrombocytopenia in patients receiving TNF blockers.  Cytopenias including pancytopenia, have been infrequently reported with SIMPONI in clinical trials.  Discontinuation of SIMPONI should be considered in patients with confirmed significant hematologic abnormalities. 

The concurrent administration of TNF-antagonists with anakinra or abatacept is not recommended.  Concurrent administration has been associated with increased infections, including serious infections without increased clinical benefit.

Patients treated with SIMPONI may receive concurrent vaccinations, except for live vaccines. 

In controlled Phase 3 clinical trials 5.8 percent of SIMPONI-treated patients had injection site reactions compared to 2.2 percent in control patients. The majority of the injection site reactions were mild and moderate and the most frequent manifestation was injection site erythema.  In post-marketing experience, serious systemic hypersensitivity reactions (including anaphylactic reaction) have been reported following SIMPONI administration.  Allergic reactions may occur after first or subsequent administration of SIMPONI.  If an anaphylactic reaction or other serious allergic reactions occurs, administration of SIMPONI should be discontinued immediately and appropriate therapy initiated. 

The needle cover on the syringe in the pre-filled pen is manufactured from dry natural rubber containing latex, and may cause allergic reactions in individuals sensitive to latex.  SIMPONI contains sorbitol; patients with rare hereditary problems of fructose intolerance should not take SIMPONI. 

Patients should be given detailed instructions on how to administer SIMPONI.  After proper training, patients may self inject if their physician determines that this is appropriate. The full amount of SIMPONI should be administered at all times.

Women of childbearing potential must use adequate contraception to prevent pregnancy and continue its use for at least 6 months after the last SIMPONI treatment.  Women must not breast feed during and for at least 6 months after SIMPONI treatment.

SIMPONI may have a minor influence on the ability to drive and use machines.  Dizziness may occur following administration of SIMPONI.

The most common adverse drug reaction (ADR) reported from controlled Phase 3 clinical trials through week 16 was upper respiratory tract infection (7.2 percent of SIMPONI-treated patients compared with 5.8 percent in control-treated patients).  The most serious ADRs that have been reported for SIMPONI include serious infections (including sepsis, pneumonia, TB, invasive fungal and opportunistic infections), demyelinating disorders, lymphoma, HBV reactivation, CHF, autoimmune processes (lupus-like syndrome) and haematologic reactions.  Common (greater than or equal to 1/100 to less than 1/10) ADRs include: bacterial infections, viral infections, bronchitis, sinusitis, superficial fungal infections, anaemia, allergic reactions, autoantibody positive, depression, insomnia, dizziness, paraesthesia, headache, hypertension, constipation, dyspepsia, gastrointestinal and abdominal pain, nausea, alanine aminotransferase increased, aspartate aminotransferase increased, alopecia, dermatitis, pruritus, rash, pyrexia, asthenia, injection site reaction, impaired healing and chest discomfort.  

The SIMPONI Patient Alert Card provides safety information to the patient.  It should be given and explained to all patients before treatment.  Patients must show the Patient Alert Card to any doctor involved in his/her treatment, during and up to 6 months after SIMPONI treatment.

For complete EU prescribing information, please visit www.ema.europa.eu. 

About Janssen Biotech, Inc.

Janssen Biotech, Inc. redefines the standard of care in immunology, oncology, urology and nephrology. Built upon a rich legacyofinnovative firsts, Janssen Biotech has delivered on the promise of new treatments and ways to improve the health of individuals with serious disease. Beyond its innovative medicines, Janssen Biotech is at the forefront of developing education and public policy initiatives to ensure patients and their families, caregivers, advocates and health care professionals have access to the latest treatment information, support services and quality care. For more information on Janssen Biotech, Inc. or its products, visit www.janssenbiotech.com.

Janssen Biotech is one of the Janssen Pharmaceutical Companies of Johnson & Johnson which are dedicated to addressing and solving some of the most important unmet medical needs in oncology, immunology, neuroscience, infectious diseases and vaccines, and cardiovascular and metabolic diseases. Driven by our commitment to patients, we work together to bring innovative ideas, products, services and solutions to people throughout the world.  Follow us on Twitter at www.twitter.com/JanssenUS.

About Janssen Biologics B.V.

Janssen Biologics B.V., based in Leiden, The Netherlands, maintains a leading position in the biotechnology industry developing and producing medicines through biopharmaceutical processes.  As one of the Janssen Pharmaceutical Companies of Johnson & Johnson, we remain committed to delivering important biological medicines in the fight against heart, vascular and infectious diseases, and immunological diseases such as rheumatoid arthritis, Crohn's disease, ulcerative colitis and psoriasis.  For more information on Janssen Biologics, visit http://www.janssen-emea.com/news/centocor-now-janssen-biologics.

About Janssen Research & Development, LLC

At Janssen Research & Development, LLC, we are united and energized by one mission—to discover and develop innovative medicines that ease patients' suffering, and solve the most important unmet medical needs of our time.  As one of the Janssen Pharmaceutical Companies of Johnson & Johnson, our strategy is to identify the biggest unmet medical needs and match them with the best science, internal or external, to find solutions for patients worldwide. We leverage our world-class discovery and development expertise, and operational excellence, to bring innovative, effective treatments in oncology, immunology, neuroscience, infectious diseases and vaccines, and cardiovascular and metabolic diseases.  For more information on Janssen R&D, visit http://www.janssenrnd.com/.

(This press release contains "forward-looking statements" as defined in the Private Securities Litigation Reform Act of 1995. The reader is cautioned not to rely on these forward-looking statements. 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 expectations and projections of Janssen Biotech, Inc., Janssen Biologics B.V., Janssen Research & Development, LLC and/or Johnson & Johnson. Risks and uncertainties include, but are not limited to, general industry conditions and competition; economic factors, such as interest rate and currency exchange rate fluctuations; technological advances, new products and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approvals; challenges to patents; product efficacy or safety concerns resulting in product recalls or regulatory action; changes in behavior and spending patterns or financial distress of purchasers of health care products and services; changes to governmental laws and regulations and domestic and foreign health care reforms; trends toward health care cost containment; and increased scrutiny of the health care industry by government agencies. 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 January 1, 2012. 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. Janssen Biotech, Inc., Janssen Biologics B.V., Janssen Research & Development, LLC and Johnson & Johnson do not undertake to update any forward-looking statements as a result of new information or future events or developments.)

References:

1. Crohn's & Colitis Foundation of America. What is Ulcerative Colitis? http://www.ccfa.org/info/about/ucp. Accessed July 11, 2012. 
2. European Federation of Crohn's and Ulcerative Colitis Associations. What is IBD? http://www.efcca.org/index.php/about-efcca/what-are-ibd. Accessed July 11, 2012.
3. World IBD Day. About Us. http://ibdday.bvsalud.org/. Accessed July 11, 2012.

SOURCE Janssen Research & Development, LLC

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