THOUSAND OAKS, Calif., Nov. 4, 2015 /PRNewswire/ -- Amgen (NASDAQ:AMGN) today announced that it will present key results from several studies related to Enbrel® (etanercept) and ABP 501, an adalimumab biosimilar candidate, at the American College of Rheumatology (ACR) and Association of Rheumatology Health Professionals (ARHP) Annual Meeting in San Francisco, Nov. 7-11, 2015. These data reinforce Amgen's continued commitment to delivering high-quality medicines that may help to improve the lives of people with serious rheumatologic diseases.
"Amgen is a pioneer in rheumatology research and development, and we are pleased to share scientific insights from our growing portfolio in this space," said Sean E. Harper, M.D., executive vice president of Research and Development at Amgen. "These insights have the potential to help improve care for the millions of people worldwide affected by rheumatologic diseases."
SELECTED ABSTRACTS OF INTEREST
Abstracts are available on the ACR/ARHP Annual Meeting website at http://acrabstracts.org/meetings/2015-acrarhp-annual-meeting.
- Randomized, Double-blind, Phase 3 Study of Efficacy and Safety of ABP 501 Compared With Adalimumab in Subjects With Moderate to Severe Rheumatoid Arthritis
Abstract #2054, Monday, Nov. 9, at 2:30 p.m. PT
- Higher Persistence and Adherence with Combination Therapy With Tumor Necrosis Factor Inhibitor+Methotrexate Combination Versus Triple Therapy in U.S. Veterans With Rheumatoid Arthritis
Abstract #2102, Monday, Nov. 9, at 4:30 p.m. PT
- Clinical Practice Experience in Rheumatoid Arthritis Patients Treated With Triple Therapy and Methotrexate - Tumor Necrosis Factor Inhibition Differs From That of Randomized Controlled Trials
Abstract #3197, Tuesday, Nov. 10, at 4:30 p.m. PT
- Comparison of Dose Escalation and Co-therapy Intensification Between Patients With Rheumatoid Arthritis Initiating Biologic Treatment With Etanercept, Adalimumab and Infliximab
Abstract #548, Sunday, Nov. 8, from 8:30 a.m. – 4 p.m. PT
- One-year Cost of Etanercept, Adalimumab, and Infliximab per Treated Patient With Chronic Inflammatory Arthritides in U.S. Veterans
Abstract #139, Sunday, Nov. 8, from 8:30 a.m. – 4 p.m. PT
- Prevalence of Joint Symptoms and Frequency of Joint Exams for Patients With Plaque Psoriasis Without Confirmed Psoriatic Arthritis: A U.S. Analysis
Abstract #1716, Monday, Nov. 9, from 8:30 a.m. – 4 p.m. PT
- Secondary Efficacy Endpoints: Results From a Phase 3 Study Comparing ABP 501 with Adalimumab in Subjects With Moderate to Severe Rheumatoid Arthritis
Abstract #2757, Tuesday, Nov. 10, from 8:30 a.m. – 4 p.m. PT
About Rheumatoid Arthritis
Rheumatoid arthritis (RA) is a chronic inflammatory disease of unknown etiology that affects approximately one percent of the adult population worldwide. RA can cause pain, stiffness, swelling and limitations in the motion and function of multiple joints.1 In RA, joint damage can significantly worsen over time, especially if left untreated and may impair function.2
About Psoriatic Arthritis
Psoriatic arthritis is an auto-immune disease that causes pain, stiffness and swelling in and around the joints.1 In addition, psoriatic arthritis patients may experience skin lesions similar to those seen in plaque psoriasis. Approximately 600,000 Americans have psoriatic arthritis.2 In fact, up to 30 percent of people diagnosed with plaque psoriasis may actually have psoriatic arthritis.2
About ABP 501
ABP 501 is being developed as a biosimilar candidate for adalimumab, an anti-TNF-α monoclonal antibody, which is approved in many regions for the treatment of several inflammatory diseases. The active ingredient of ABP 501 is an anti-TNF-α monoclonal antibody that has the same amino acid sequence as adalimumab. ABP 501 has the same pharmaceutical dosage form and strength as adalimumab (U.S.) and adalimumab (EU).
About Enbrel® (etanercept)
ENBREL is a soluble form of a fully human tumor necrosis factor (TNF) receptor with a clinical efficacy and safety profile established over 15 years of collective clinical experience. ENBREL was first approved in 1998 for moderate-to-severe rheumatoid arthritis. ENBREL was approved in 1999 to treat moderate-to-severe polyarticular juvenile idiopathic arthritis, in 2002 to treat psoriatic arthritis, for the treatment of patients with ankylosing spondylitis in 2003, and in 2004 to treat moderate-to-severe plaque psoriasis in adults. Prescription ENBREL is given by injection.
ENBREL indications in the U.S.:
- ENBREL is indicated for reducing signs and symptoms, inducing major clinical response, inhibiting the progression of structural damage, and improving physical function in patients with moderately-to-severely active rheumatoid arthritis (RA). ENBREL can be initiated in combination with methotrexate (MTX) or used alone.
- ENBREL is indicated for reducing signs and symptoms of moderately-to-severely active polyarticular juvenile idiopathic arthritis in patients ages two and older.
- ENBREL is indicated for reducing signs and symptoms, inhibiting the progression of structural damage of active arthritis, and improving physical function in patients with psoriatic arthritis. ENBREL can be used with or without methotrexate.
- ENBREL is indicated for reducing signs and symptoms in patients with active ankylosing spondylitis.
- ENBREL is indicated for the treatment of adult patients (18 years or older) with chronic moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy.
Important Safety Information
Patients treated with ENBREL are at increased risk for developing serious infections that may lead to hospitalization or death. Most patients who developed these infections were taking concomitant immunosuppressants such as methotrexate or corticosteroids or were predisposed to infection because of their underlying disease. ENBREL should not be initiated in the presence of sepsis, active infections, or allergy to ENBREL or its components. ENBREL should be discontinued if a patient develops a serious infection or sepsis. Reported infections include: 1) Active tuberculosis (TB), including reactivation of latent TB. Patients with TB have frequently presented with disseminated or extrapulmonary disease. Patients should be tested for latent TB before ENBREL use and periodically during therapy. Treatment for latent infection should be initiated prior to ENBREL use, 2) Invasive fungal infections, including histoplasmosis, coccidioidomycosis, candidiasis, aspergillosis, blastomycosis, and pneumocystosis. Patients with histoplasmosis or other invasive fungal infections may present with disseminated, rather than localized, disease. Antigen and antibody testing for histoplasmosis may be negative in some patients with active infection. Empiric antifungal therapy should be considered in patients at risk for invasive fungal infections who develop severe systemic illness, and 3) Bacterial, viral, and other infections due to opportunistic pathogens, including Legionella and Listeria.
The risks and benefits of treatment with ENBREL should be carefully considered prior to initiating therapy in patients 1) with chronic or recurrent infection, 2) who have been exposed to TB, 3) who have resided or traveled in areas of endemic TB or endemic mycoses, or 4) with underlying conditions that may predispose them to infections such as advanced or poorly controlled diabetes. Patients should be closely monitored for the development of signs and symptoms of infection during and after treatment with ENBREL, including the possible development of TB in patients who tested negative for latent TB prior to initiating therapy.
Lymphoma and other malignancies, some fatal, have been reported in children and adolescent patients treated with tumor necrosis factor (TNF) blockers, including ENBREL.
In adult clinical trials of all TNF blockers, more cases of lymphoma were seen compared to control patients. The risk of lymphoma may be up to several-fold higher in RA and psoriasis patients. The role of TNF blocker therapy in the development of malignancies is unknown. Cases of acute and chronic leukemia have been reported in association with postmarketing TNF blocker use in RA and other indications. The risk of leukemia may be higher in patients with RA (approximately 2-fold) than the general population. Melanoma and non-melanoma skin cancer (NMSC) have been reported in patients treated with TNF blockers, including ENBREL. Periodic skin examinations should be considered for all patients at increased risk for skin cancer. In patients who initiated therapy at ≤ 18 years of age, approximately half of the reported malignancies were lymphomas (Hodgkin's and non-Hodgkin's lymphoma). Other cases included rare malignancies usually associated with immunosuppression and malignancies that are not usually observed in children and adolescents. Most of the patients were receiving concomitant immunosuppressants.
Treatment with TNF-blocking agents, including ENBREL, has been associated with rare (< 0.1%) cases of new onset or exacerbation of central nervous system demyelinating disorders, some presenting with mental status changes and some associated with permanent disability, and with peripheral nervous system demyelinating disorders. Cases of transverse myelitis, optic neuritis, multiple sclerosis, Guillain-Barré syndromes, other peripheral demyelinating neuropathies, and new onset or exacerbation of seizure disorders have been reported in postmarketing experience with ENBREL therapy. Prescribers should exercise caution in considering the use of ENBREL in patients with preexisting or recent-onset central or peripheral nervous system demyelinating disorders.
Cases of worsening congestive heart failure (CHF) and, rarely, new-onset cases have been reported in patients taking ENBREL. Caution should be used when using ENBREL in patients with CHF. These patients should be carefully monitored. Rare cases of pancytopenia, including aplastic anemia, some fatal, have been reported. The causal relationship to ENBREL therapy remains unclear. Exercise caution when considering ENBREL in patients who have a previous history of significant hematologic abnormalities. Advise patients to seek immediate medical attention if they develop signs or symptoms of blood dyscrasias or infection. Consider discontinuing ENBREL if significant hematologic abnormalities are confirmed. Reactivation of hepatitis B has been reported in patients who were previously infected with hepatitis B virus (HBV) and received concomitant TNF-blocking agents, including ENBREL. Most reports occurred in patients also taking immunosuppressive agents, which may contribute to hepatitis B reactivation. Exercise caution when considering ENBREL in these patients.
Allergic reactions associated with administration of ENBREL during clinical trials have been reported in < 2% of patients. If an anaphylactic reaction or other serious allergic reaction occurs, administration of ENBREL should be discontinued immediately and appropriate therapy initiated. Live vaccines should not be administered to patients on ENBREL. JIA patients, if possible, should be brought up to date with all immunizations prior to initiating ENBREL. In patients with exposure to varicella virus, consider temporary discontinuation of ENBREL and prophylactic treatment with Varicella Zoster Immune Globulin. Autoantibodies may develop with ENBREL, and rarely lupus-like syndrome or autoimmune hepatitis may occur. These may resolve upon withdrawal of ENBREL. Stop ENBREL if lupus-like syndrome or autoimmune hepatitis develops. The use of ENBREL in patients with Wegener's granulomatosis receiving immunosuppressive agents (e.g., cyclophosphamide) is not recommended. Based on a study of patients treated for alcoholic hepatitis, exercise caution when using ENBREL in patients with moderate-to-severe alcoholic hepatitis.
The most commonly reported adverse events in RA clinical trials were injection site reaction, infection, and headache. In clinical trials of all other adult indications, adverse events were similar to those reported in RA clinical trials. In a JIA study, adverse reactions in pediatric patients were generally similar in frequency and type as those seen in adult patients. The types of infections reported in pediatric patients were generally mild and consistent with those commonly seen in the general pediatric population.
Please see Prescribing Information and Medication Guide at www.ENBREL.com
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Forward Looking Statements
This news release contains forward-looking statements that are based on the current expectations and beliefs of Amgen Inc. and its subsidiaries (Amgen or us) and are subject to a number of risks, uncertainties and assumptions that could cause actual results to differ materially from those described. All statements, other than statements of historical fact, are statements that could be deemed forward-looking statements, including estimates of revenues, operating margins, capital expenditures, cash, other financial metrics, expected legal, arbitration, political, regulatory or clinical results or practices, customer and prescriber patterns or practices, reimbursement activities and outcomes and other such estimates and results. Forward-looking statements involve significant risks and uncertainties, including those discussed below and more fully described in the Securities and Exchange Commission (SEC) reports filed by Amgen Inc., including Amgen Inc.'s most recent annual report on Form 10-K and any subsequent periodic reports on Form 10-Q and Form 8-K. Please refer to Amgen Inc.'s most recent Forms 10-K, 10-Q and 8-K for additional information on the uncertainties and risk factors related to our business. Unless otherwise noted, Amgen is providing this information as of Nov. 4, 2015, and expressly disclaims any duty to update information contained in this news release.
No forward-looking statement can be guaranteed and actual results may differ materially from those we project. Discovery or identification of new product candidates or development of new indications for existing products cannot be guaranteed and movement from concept to product is uncertain; consequently, there can be no guarantee that any particular product candidate or development of a new indication for an existing product will be successful and become a commercial product. Further, preclinical results do not guarantee safe and effective performance of product candidates in humans. The complexity of the human body cannot be perfectly, or sometimes, even adequately modeled by computer or cell culture systems or animal models. The length of time that it takes for us and our partners to complete clinical trials and obtain regulatory approval for product marketing has in the past varied and we expect similar variability in the future. We develop product candidates internally and through licensing collaborations, partnerships and joint ventures. Product candidates that are derived from relationships may be subject to disputes between the parties or may prove to be not as effective or as safe as we may have believed at the time of entering into such relationship. Also, we or others could identify safety, side effects or manufacturing problems with our products after they are on the market. Our business may be impacted by government investigations, litigation and product liability claims. If we fail to meet the compliance obligations in the corporate integrity agreement between us and the U.S. government, we could become subject to significant sanctions. We depend on third parties for a significant portion of our manufacturing capacity for the supply of certain of our current and future products and limits on supply may constrain sales of certain of our current products and product candidate development.
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The scientific information discussed in this news release related to our product candidates is preliminary and investigative. Such product candidates are not approved by the U.S. Food and Drug Administration, and no conclusions can or should be drawn regarding the safety or effectiveness of the product candidates.
CONTACT: Amgen, Thousand Oaks
Kristen Davis, 805-447-3008 (media)
Kristen Neese, 805-313-8267 (media)
Arvind Sood, 805-447-1060 (investors)
1 Arthritis Foundation. About Rheumatoid Arthritis. http://www.arthritis.org/about-arthritis/types/rheumatoid-arthritis/symptoms.php
2 Arthritis Foundation. About Psoriatic Arthritis. http://www.arthritis.org/about-arthritis/types/psoriatic-arthritis/what-is-psoriatic-arthritis.php
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