Approval follows positive opinion by the CHMP and analyses of the PURSUIT-Maintenance study
LEIDEN, The Netherlands, July 9, 2018 ― The Janssen Pharmaceutical Companies of Johnson & Johnson announced today that the European Commission (EC) has approved SIMPONI® (golimumab) for early dose optimization for patients living with moderate to severe ulcerative colitis (UC) with a body weight of less than 80 kg who have not responded adequately to induction therapy (the first two doses of SIMPONI). Based on data from post-hoc analyses of the pivotal Phase 3 PURSUIT-Maintenance study evaluating SIMPONI in adult patients with moderate to severe UC, the EC approval indicates that patients weighing less than 80 kg who do not demonstrate an adequate response at week 6 to SIMPONI following the initial 200 mg subcutaneous injection and second 100 mg dose at week 2 may benefit from continuing with 100 mg every four weeks. Patients with a body weight of less than 80 kg who do achieve an adequate response to SIMPONI at week 6 should receive 50 mg at week 6 and every four weeks thereafter. For patients with a body weight greater than or equal to 80 kg, SIMPONI should be administered as an initial dose of 200 mg, followed by 100 mg at week 2, then 100 mg every four weeks, thereafter. The EC approval follows a positive opinion issued by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) in May 2018.
“The European Commission approval of early dose optimization represents an important clinical need for both gastroenterologists and for those living with ulcerative colitis who have been unable to achieve an optimal response with SIMPONI,” said Newman Yeilding, M.D., Interim Global Therapeutic Area Head, Immunology, Janssen Research & Development, LLC. “We commend both the European Commission and the Committee for Medicinal Products for Human Use for their concerted effort to make optimized dosing of SIMPONI available in Europe.”
At week 6, data from the PURSUIT-Maintenance study show that UC patients who experienced an inadequate response to SIMPONI had lower trough levels compared with patients who achieved an adequate response. Findings suggest that SIMPONI is cleared by the body at a higher rate in patients who do not respond to treatment compared with patients who respond to treatment. Data from subgroups examined based on body weight suggested that early non-responders with a body weight less than 80 kg may require the 100 mg SIMPONI dose at week 6 and every four weeks thereafter to achieve drug trough levels similar to those observed in responder patients who either weigh less than 80 kg receiving 50 mg or patients with a body weight greater than or equal to 80 kg receiving 100 mg during maintenance.
About the PURSUIT-Maintenance Study
In the PURSUIT-Maintenance study, patients with moderate to severe ulcerative colitis who did not respond to SIMPONI induction treatment at week 6 were given SIMPONI 100 mg every four weeks from week 6 through week 54. It was previously shown that 28 percent of patients who did not respond at week 6, after two post-induction doses of SIMPONI 100 mg, became responders at week 14. Serum SIMPONI levels were used to assess the exposure-response relationship in patients who either demonstrated a response or did not demonstrate a response to SIMPONI induction treatment at week 6.
SIMPONI levels were measured (as μg/ml) in week 6 responders and week 6 non-responders. In this post-hoc analyses, median trough levels were examined at week 6, week 10, and week 14 (when steady-state levels are achieved on maintenance treatment). Also, subgroups based on body weight (less than 80 kg and greater than or equal to 80 kg) were examined; the 80 kg cut-point was selected based on the maintenance doses currently approved in the EU: either 50 mg for patients with a body weight of less than 80 kg or 100 mg for patients with a body weight of greater than or equal to 80 kg.
About Ulcerative Colitis
Ulcerative colitis (UC), a chronic inflammatory bowel disease (IBD) affecting 1.5 million individuals in Europe1 and 2.5 million worldwide,2 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.3 Tiny open sores, or ulcers, form on the surface of the lining, where they bleed and produce pus and mucus.3 Symptoms of the disease may lead to loss of appetite, subsequent weight loss and fatigue.3 On average, people are diagnosed with UC in their mid-30s, but the disease can occur at any age.3 As many as 30 percent of people living with UC will require surgery at some point in their life.4 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.3
About SIMPONI® (golimumab)
SIMPONI is a human monoclonal antibody that targets and neutralizes excess tumor necrosis factor (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 more than 100 countries for indications including rheumatoid arthritis (RA), ankylosing spondylitis, psoriatic arthritis, non-radiographic axial spondyloarthritis, ulcerative colitis (UC) and polyarticular juvenile idiopathic arthritis. In the European Union (EU), SIMPONI received European Commission (EC) 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. In September 2013, SIMPONI received EC approval for the treatment of moderately to severely active UC in adults. In June 2015, SIMPONI received EC approval for the treatment of adults with severe, active non-radiographic axial spondyloarthritis with objective signs of inflammation. In June 2016, SIMPONI received EC approval for polyarticular juvenile idiopathic arthritis. SIMPONI is available either through the SmartJect® autoinjector/prefilled pen or a prefilled syringe as a subcutaneously administered injection.
Janssen Biotech, Inc., part of the Janssen Pharmaceutical Companies of Johnson & Johnson, discovered and developed SIMPONI and markets the product in the United States. Janssen markets 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.
Selected Safety Information About SIMPONI® (golimumab)
- Hypersensitivity to the active substance or to any of the excipients.
- Active tuberculosis (TB) or other severe infections such as sepsis, and opportunistic infections.
- Moderate or severe heart failure (NYHA class III/IV).
Special warnings and precautions for use
Patients must be monitored closely for infections including tuberculosis before, during and after treatment with SIMPONI. Because the elimination of golimumab may take up to 5 months, monitoring should be continued throughout this period. Further treatment with SIMPONI must not be given if a patient develops a serious infection or sepsis.
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 advised of, and avoid exposure to, potential risk factors for infection as appropriate.
Patients taking TNF-blockers are more susceptible to serious infections. Bacterial (including sepsis and pneumonia), mycobacterial (including TB), invasive fungal and opportunistic infections, including fatalities, have been reported in patients receiving SIMPONI. Some of these serious infections have occurred in patients on concomitant immunosuppressive therapy that, in addition to their underlying disease, could predispose them to infections. Patients who develop a new infection while undergoing treatment with SIMPONI should be monitored closely and undergo a complete diagnostic evaluation. Administration of SIMPONI should be discontinued if a patient develops a new serious infection or sepsis, and appropriate antimicrobial or antifungal therapy should be initiated until the infection is controlled.
For patients who have resided in or travelled 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. In at-risk patients treated with SIMPONI, an invasive fungal infection should be suspected if they develop a serious systemic illness. Diagnosis and administration of empiric antifungal therapy in these patients should be made in consultation with a physician with expertise in the care of patients with invasive fungal infections, if feasible.
There have been reports of tuberculosis in patients receiving SIMPONI. It should be noted that in the majority of these reports, tuberculosis was extrapulmonary presenting as either local or disseminated disease.
Before starting treatment with SIMPONI, all patients must be evaluated for both active and inactive (‘latent’) tuberculosis. This evaluation should include a detailed medical history with personal history of tuberculosis or possible previous contact with tuberculosis and previous and/or current immunosuppressive therapy. Appropriate screening tests, i.e. tuberculin skin or blood test and chest X-ray, should be performed in all patients (local recommendations may apply). It is recommended that the conduct of these tests should be recorded in the patient’s alert card. Prescribers are reminded of the risk of false negative tuberculin skin test results, especially in patients who are severely ill or immunocompromised.
If active tuberculosis is diagnosed, SIMPONI therapy must not be initiated.
If latent tuberculosis is suspected, a physician with expertise in the treatment of tuberculosis should be consulted. In all situations described below, the benefit/risk balance of SIMPONI therapy should be very carefully considered.
If inactive (‘latent’) tuberculosis is diagnosed, treatment for latent tuberculosis must be started with anti-tuberculosis therapy before the initiation of SIMPONI, and in accordance with local recommendations.
In patients who have several or significant risk factors for tuberculosis and have a negative test for latent tuberculosis, anti-tuberculosis therapy should be considered before the initiation of SIMPONI. Use of anti-tuberculosis 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.
Cases of active tuberculosis have occurred in patients treated with SIMPONI during and after treatment for latent tuberculosis. Patients receiving SIMPONI should be monitored closely for signs and symptoms of active tuberculosis, including patients who tested negative for latent tuberculosis, patients who are on treatment for latent tuberculosis, or patients who were previously treated for tuberculosis infection.
All patients should be informed to seek medical advice if signs/symptoms suggestive of tuberculosis (e.g. persistent cough, wasting/weight loss, low-grade fever) appear during or after SIMPONI treatment.
Hepatitis B virus reactivation
Reactivation of hepatitis B has occurred in patients receiving a TNF-antagonist including SIMPONI, who are chronic carriers of this virus (i.e. surface antigen positive). Some cases have had fatal outcome.
Patients should be tested for HBV infection before initiating treatment with SIMPONI. For patients who test positive for HBV infection, consultation with a physician with expertise in the treatment of hepatitis B is recommended.
Carriers of HBV who require treatment with SIMPONI should be closely monitored for signs and symptoms of active HBV infection throughout therapy and for several months following termination of therapy. Adequate data of treating patients who are carriers of HBV with anti-viral therapy in conjunction with TNF-antagonist therapy to prevent HBV reactivation are not available. In patients who develop HBV reactivation, SIMPONI should be stopped and effective anti-viral therapy with appropriate supportive treatment should be initiated.
Malignancies and lymphoproliferative disorders
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.
Malignancies, some fatal, have been reported among children, adolescents and young adults (up to 22 years of age) treated with TNF-blocking agents (initiation of therapy ≤ 18 years of age) in the post marketing setting. Approximately half the cases were lymphomas. The other cases represented a variety of different malignancies and included rare malignancies usually associated with immunosuppression. A risk for the development of malignancies in children and adolescents treated with TNF-blockers cannot be excluded.
Lymphoma and leukaemia
In the controlled portions of clinical trials of all the TNF-blocking agents including SIMPONI, more cases of lymphoma have been observed among patients receiving anti-TNF treatment compared with control patients. During the SIMPONI Phase IIb and Phase III clinical trials in RA, PsA and AS, the incidence of lymphoma in SIMPONI-treated patients was higher than expected in the general population. Cases of leukaemia have been reported in patients treated with SIMPONI. There is an increased background risk for lymphoma and leukaemia in rheumatoid arthritis patients with long-standing, highly active, inflammatory disease, which complicates risk estimation.
Rare post-marketing cases of hepatosplenic T-cell lymphoma (HSTCL) have been reported in patients treated with other TNF-blocking agents (see section 4.8). This rare type of T-cell lymphoma has a very aggressive disease course and is usually fatal. The majority of cases have occurred in adolescent and young adult males with nearly all on concomitant treatment with azathioprine (AZA) or 6-mercaptopurine (6–MP) for inflammatory bowel disease. The potential risk with the combination of AZA or 6-MP and SIMPONI should be carefully considered. A risk for the development for hepatosplenic T-cell lymphoma in patients treated with TNF-blockers cannot be excluded.
Malignancies other than lymphoma
In the controlled portions of the SIMPONI Phase IIb and Phase III clinical trials in RA, PsA, AS, and UC, the incidence of non-lymphoma malignancies (excluding non-melanoma skin cancer) was similar between the SIMPONI and the control groups.
It is not known if golimumab treatment influences the risk for developing dysplasia or colon cancer. All patients with ulcerative colitis who are at increased risk for dysplasia or colon carcinoma (for example, patients with long-standing ulcerative colitis or primary sclerosing cholangitis), or who had a prior history of dysplasia or colon carcinoma should be screened for dysplasia at regular intervals before therapy and throughout their disease course. This evaluation should include colonoscopy and biopsies per local recommendations. In patients with newly diagnosed dysplasia treated with SIMPONI, the risks and benefits to the individual patient must be carefully reviewed and consideration should be given to whether therapy should be continued.
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.
In an exploratory clinical trial evaluating the use of another anti-TNF agent, infliximab, in patients with moderate to severe chronic obstructive pulmonary disease (COPD), more malignancies, mostly in the lung or head and neck, were reported in infliximab-treated patients compared with control patients. All patients had a history of heavy smoking. Therefore, caution should be exercised when using any TNF-antagonist in COPD patients, as well as in patients with an increased risk of malignancy due to heavy smoking.
Melanoma and Merkel cell carcinoma have been reported in patients treated with TNF-blocking agents, including SIMPONI. Periodic skin examination is recommended, particularly for patients with risk factors for skin cancer.
Congestive heart failure (CHF)
Cases of worsening congestive heart failure (CHF) and new onset CHF have been reported with TNF blockers, including SIMPONI. Some cases had a fatal outcome. In a clinical trial with another TNF-antagonist worsening congestive heart failure and increased mortality due to CHF have been observed. 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). Patients should be closely monitored and SIMPONI must be discontinued in patients who develop new or worsening symptoms of heart failure.
Use of TNF-blocking agents, including SIMPONI, has been associated with cases of new onset or exacerbation of clinical symptoms and/or radiographic evidence of central nervous system demyelinating disorders, including multiple sclerosis and peripheral demyelinating disorders. In patients with pre-existing or recent onset of demyelinating disorders, the benefits and risks of anti-TNF treatment should be carefully considered before initiation of SIMPONI therapy. Discontinuation of SIMPONI should be considered if these disorders develop.
There is limited safety experience of SIMPONI treatment in patients who have undergone surgical procedures, including arthroplasty. The long half-life should be taken into consideration if a surgical procedure is planned. 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 defences against infections and malignancies since TNF mediates inflammation and modulates cellular immune responses.
The relative deficiency of TNFα caused by anti-TNF therapy may result in the initiation of an autoimmune process. If a patient develops symptoms suggestive of a lupus-like syndrome following treatment with SIMPONI and is positive for antibodies against double-stranded DNA, treatment with SIMPONI should be discontinued.
There have been reports of pancytopenia, leucopenia, neutropenia, agranulocytosis, aplastic anemia, and thrombocytopenia in patients receiving TNF-blockers, including Simponi. All patients should be advised to seek immediate medical attention if they develop signs and symptoms suggestive of blood dyscrasias (e.g. persistent fever, bruising, bleeding, pallor). Discontinuation of SIMPONI therapy should be considered in patients with confirmed significant haematologic abnormalities.
Concurrent administration of TNF-antagonists and anakinra
Serious infections and neutropenia were seen in clinical studies with concurrent use of anakinra and another TNF-blocking agent, etanercept, with no added clinical benefit. Because of the nature of the adverse events seen with this combination therapy, similar toxicities may also result from the combination of anakinra and other TNF-blocking agents. The combination of SIMPONI and anakinra is not recommended.
Concurrent administration of TNF-antagonists and abatacept
In clinical studies concurrent administration of TNF-antagonists and abatacept has been associated with an increased risk of infections including serious infections compared to TNF-antagonists alone, without increased clinical benefit. The combination of SIMPONI and abatacept is not recommended.
Concurrent administration with other biological therapeutics
There is insufficient information regarding the concomitant use of SIMPONI with other biological therapeutics used to treat the same conditions as SIMPONI. The concomitant use of SIMPONI with these biologics is not recommended because of the possibility of an increased risk of infection, and other potential pharmacological interactions.
Switching between biological DMARDs
Care should be taken and patients should continue to be monitored when switching from one biologic to another, since overlapping biological activity may further increase the risk for adverse events, including infection.
Vaccinations/therapeutic infectious agents
Patients treated with SIMPONI may receive concurrent vaccinations, except for live vaccines. In patients receiving anti-TNF therapy, limited data are available on the response to vaccination with live vaccines or on the secondary transmission of infection by live vaccines. Use of live vaccines could result in clinical infections, including disseminated infections.
Other uses of therapeutic infectious agents such as live attenuated bacteria (e.g. BCG bladder instillation for the treatment of cancer) could result in clinical infections, including disseminated infections. It is recommended that therapeutic infectious agents not be given concurrently with SIMPONI.
In post-marketing experience, serious systemic hypersensitivity reactions (including anaphylactic reaction) have been reported following SIMPONI administration. Some of these reactions occurred after the first administration of SIMPONI. If an anaphylactic reaction or other serious allergic reactions occur, administration of SIMPONI should be discontinued immediately and appropriate therapy initiated.
The needle cover on the pre-filled pen or the pre-filled syringe is manufactured from dry natural rubber containing latex, and may cause allergic reactions in individuals sensitive to latex.
Elderly (≥ 65 years)
In the Phase III studies in RA, PsA, AS, and UC, no overall differences in adverse events (AEs), serious adverse events (SAEs), and serious infections in patients age 65 or older who received SIMPONI were observed compared with younger patients. However, caution should be exercised when treating the elderly and particular attention paid with respect to occurrence of infections. There were no patients age 45 and over in the nr-Axial SpA study.
Renal and hepatic impairment
Specific studies of SIMPONI have not been conducted in patients with renal or hepatic impairment. SIMPONI should be used with caution in subjects with impaired hepatic function.
If possible, it is recommended that prior to initiating SIMPONI therapy, paediatric patients be brought up to date with all immunisations in agreement with current immunisation guidelines.
SIMPONI contains sorbitol (E420). Patients with rare hereditary problems of fructose intolerance should not take SIMPONI.
Potential for medication errors
SIMPONI is registered in 50 mg and 100 mg strengths for subcutaneous administration. It is important that the right strength is used to administer the correct dose as indicated in the posology. Care should be taken to provide the right strength to ensure that patients are not underdosed or overdosed.
Fertility, pregnancy and lactation
Women of childbearing potential
Women of childbearing potential must use adequate contraception to prevent pregnancy and continue its use for at least 6 months after the last golimumab treatment.
There are no adequate data on the use of golimumab in pregnant women. Due to its inhibition of TNF, golimumab administered during pregnancy could affect normal immune responses in the newborn. Studies in animals do not indicate direct or indirect harmful effects with respect to pregnancy, embryonal/foetal development, parturition or postnatal development. The use of golimumab in pregnant women is not recommended; golimumab should be given to a pregnant woman only if clearly needed.
Golimumab crosses the placenta. Following treatment with a TNF-blocking monoclonal antibody during pregnancy, the antibody has been detected for up to 6 months in the serum of the infant born by the treated woman. Consequently, these infants may be at increased risk of infection. Administration of live vaccines to infants exposed to golimumab in utero is not recommended for 6 months following the mother’s last golimumab injection during pregnancy.
It is not known whether golimumab is excreted in human milk or absorbed systemically after ingestion. Golimumab was shown to pass over to breast milk in monkeys, and because human immunoglobulins are excreted in milk, women must not breast feed during and for at least 6 months after golimumab treatment.
No animal fertility studies have been conducted with golimumab. A fertility study in mice, using an analogous antibody that selectively inhibits the functional activity of mouse TNFα, showed no relevant effects on fertility
Summary of the safety profile
In the controlled period of the pivotal trials in RA, PsA, AS, nr-Axial SpA, and UC, upper respiratory tract infection was the most common adverse drug reaction (ADR) reported in 12.6% of golimumab-treated patients compared with 11.0% of control patients. The most serious ADRs that have been reported for golimumab include serious infections (including sepsis, pneumonia, TB, invasive fungal and opportunistic infections), demyelinating disorders, HBV reactivation, CHF, autoimmune processes (lupus-like syndrome), haematologic reactions, serious systemic hypersensitivity (including anaphylactic reaction), vasculitis, lymphoma and leukaemia.
Very common (≥1/10) and common (≥1/100, <1/10) ADRs reported in clinical trials and post-marketing experience with SIMPONI include: upper respiratory tract infections (nasopharyngitis, pharyngitis, laryngitis, and rhinitis), bacterial infections (such as cellulitis), lower respiratory tract infections (such as pneumonia), viral infections (such as influenza and herpes), bronchitis, sinusitis, superficial fungal infections, abscess, anaemia, allergic reactions (bronchospasm, hypersensitivity, urticaria), autoantibody positive, depression, insomnia, dizziness, headache, paraesthesia, hypertension, asthma and related symptoms (such as wheezing and bronchial hyperactivity), dyspepsia, gastrointestinal and abdominal pain, nausea, gastrointestinal inflammatory disorders (such as gastritis and colitis), stomatitis, increased alanine aminotransferase and aspartate aminotransferase, pruritus, rash, alopecia, dermatitis, pyrexia, asthenia, injection-site reaction (such as injection-site erythema, urticaria, induration, pain, bruising, pruritus, irritation and paraesthesia), chest discomfort and bone fractures.
For additional safety information, please consult the Summary of Product Characteristics.
About the Janssen Pharmaceutical Companies of Johnson & Johnson
At the Janssen Pharmaceutical Companies of Johnson & Johnson, we are working to create a world without disease. Transforming lives by finding new and better ways to prevent, intercept, treat and cure disease inspires us. We bring together the best minds and pursue the most promising science.
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Cautions Concerning Forward-Looking Statements
This press release contains "forward-looking statements" as defined in the Private Securities Litigation Reform Act of 1995 regarding product development of SIMPONI® (golimumab). 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 known or unknown risks or uncertainties materialize, actual results could vary materially from the expectations and projections of Janssen Research & Development, Janssen Biotech, Inc., Janssen Biologics B.V., any of the other Janssen Pharmaceutical Companies and/or Johnson & Johnson. Risks and uncertainties include, but are not limited to: challenges and uncertainties inherent in product research and development, including the uncertainty of clinical success and of obtaining regulatory approvals; uncertainty of commercial success; manufacturing difficulties and delays; competition, including technological advances, new products and patents attained by competitors; 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 applicable laws and regulations, including global health care reforms; and trends toward health care cost containment. A further list and descriptions of these risks, uncertainties and other factors can be found in Johnson & Johnson's Annual Report on Form 10-K for the fiscal year ended December 31, 2017, including in the sections captioned “Cautionary Note Regarding Forward-Looking Statements” and “Item 1A. Risk Factors,” and in the company's subsequent Quarterly Reports on Form 10-Q and other filings with the Securities and Exchange Commission. Copies of these filings are available online at www.sec.gov, www.jnj.com or on request from Johnson & Johnson. None of the Janssen Pharmaceutical Companies or Johnson & Johnson undertakes to update any forward-looking statement as a result of new information or future events or developments.
Joseph J. Wolk
Johnson & Johnson
Office: +1 732-524-1142
Johnson & Johnson
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