Pivotal Results Comparing Brodalumab With Stelara® (Ustekinumab) and Placebo to be Presented in Late-Breaking SessionPresentations Include Detailed Results From Across the Phase 3 AMAGINE Program Evaluating Brodalumab in More Than 4,200 Patients With Moderate-to-Severe Plaque Psoriasis
THOUSAND OAKS, Calif., March 17, 2015 /PRNewswire/ -- Amgen (NASDAQ:AMGN) today announced that it will present data from multiple brodalumab and Enbrel® (etanercept) studies at the 73rd Annual Meeting of the American Academy of Dermatology (AAD) in San Francisco, March 20-24, 2015. The breadth of data to be presented highlights Amgen's long-term commitment to advancing innovative treatment options for patients with serious, chronic dermatologic diseases.
"Patients with psoriasis struggle on a daily basis with the serious symptoms of the disease, and we are excited to share research findings at this year's AAD meeting that highlight our continued commitment to advancing science to help these patients," said Sean E. Harper, M.D., executive vice president of Research and Development at Amgen. "Results from our Phase 3 brodalumab clinical trial program draw on research from more than 4,200 patients and provide important insights on safety and efficacy of this IL-17 receptor inhibitor in moderate-to-severe plaque psoriasis, while new ENBREL data offer perspectives on use and adherence in a real-world setting."
Data to be presented include results from all three of the brodalumab Phase 3 AMAGINE pivotal trials, evaluating the efficacy and safety of the IL-17 receptor inhibitor in patients with moderate-to-severe plaque psoriasis from the induction through the maintenance phase through week 52. Additional brodalumab long-term data from the Phase 2 open-label extension study provide further insights on the maintenance of clinical response with long-term brodalumab therapy in patients with moderate-to-severe psoriasis. Brodalumab is being co-developed by Amgen and AstraZeneca.
Kyowa Hakko Kirin, which has an exclusive license to develop and commercialize brodalumab in Japan, China and certain other Asian countries, will present additional, long-term Phase 3 brodalumab efficacy and safety data from its open-label extension study in Japanese patients with moderate-to-severe plaque psoriasis.
ENBREL data provide insights from OBSERVE-5, an observational registry designed to examine the use of ENBREL in a real-world setting over five years, as well as on treatment patterns with ENBREL compared with other agents in U.S. veterans with moderate-to-severe plaque psoriasis and psoriatic arthritis.
Additional data to be presented will look at patient-reported psoriasis symptom severity using the Psoriasis Symptom Inventory (PSI) scale compared to Physician Global Assessment results.
SELECTED ABSTRACTS OF INTEREST
Late-Breaking Abstracts of Interest
AMAGINE-2: A Randomized, Double-blind, Phase 3 Efficacy and Safety Study of Brodalumab Compared With Placebo and Ustekinumab in Moderate-to-Severe Plaque Psoriasis Patients, Abstract 2574, Late-Breaking Research, Friday, March 20, 10 – 10:12 a.m. PT (Room 2022)
Brodalumab Abstracts of Interest
Efficacy and Safety of Brodalumab in Patients With Moderate-To-Severe Plaque Psoriasis: Results of AMAGINE-1, a Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Through Week 12, Poster 275, available to view beginning Friday, March 20, 7 a.m. PT; poster presentation Sunday, March 22, 10:20 a.m. PT (West Building, Level 2)
AMAGINE-3: A Phase 3 Study of Efficacy and Safety of Brodalumab Compared With Placebo and Ustekinumab in Moderate-to-Severe Plaque Psoriasis Patients, Poster 1146, available to view beginning Friday, March 20, 7 a.m. PT; poster presentation Sunday, March 22, 7:55 a.m. PT (West Building, Level 2)
Improvement of Psoriasis in Patients With and Without Prior Biologic Experience: Subanalysis of a Brodalumab (AMG 827) Phase 2 Study for Moderate-to-Severe Plaque Psoriasis, Poster 955, available to view beginning Friday, March 20, 7 a.m. PT; poster presentation Sunday, March 22, 11:45 a.m. PT (West Building, Level 2)
Maintenance of Clinical Response With Long-Term Brodalumab (AMG 827) Therapy for Psoriasis: Week 144 Results from an Open-Label Extension Study, Poster 956, available to view beginning Friday, March 20, 7 a.m. PT; poster presentation Sunday, March 22, 12:15 p.m. PT (West Building, Level 2)
Clinical Efficacy and Safety of Brodalumab (KHK4827), Anti-Interleukin-17-Receptor A Fully Human Monoclonal Antibody, in Japanese Patients with Moderate-to-Severe Plaque Psoriasis: An Open-Label Extension (OLE) Study, (KHK4827-003 Study), Poster 909, available to view beginning Friday, March 20, 7 a.m. PT; poster presentation Sunday, March 22, 8:45 a.m. PT (West Building, Level 2)
Clinical Efficacy and Safety of Brodalumab (KHK4827), A Fully Human Anti-Interleukin-17-Receptor A Monoclonal Antibody, in Japanese Patients With Generalized Pustular Psoriasis and Psoriatic Erythroderma: A Phase 3, Open-Label, Long-Term Study (4827-004 Study), Poster 365, available to view beginning Friday, March 20, 7 a.m. PT; poster presentation Sunday, March 22, 8:50 a.m. PT (West Building, Level 2)
ENBREL (Amgen-sponsored) Abstracts of Interest
Discontinuation from Etanercept in OBSERVE-5, a 5-year Surveillance Registry of Patients With Moderate-to-Severe Plaque Psoriasis, Poster 1074, available to view beginning Friday, March 20, 7 a.m. PT; poster presentation Sunday, March 22, 9:40 a.m. PT (West Building, Level 2)
Predictors of Topical Use in Psoriasis Patients in the REFINE Study, Poster 1289, available to view beginning Friday, March 20, 7 a.m. PT; poster presentation Sunday, March 22, 1:25 p.m. PT (West Building, Level 2)
Additional Abstracts of Interest
Biologic Use and Associated Factors in a Nationally Representative Sample of Medicare Patients With Psoriasis, Poster 432, available to view beginning Friday, March 20, at 7 a.m. PT; poster presentation Saturday, March 21, 2:35 p.m. PT (West Building, Level 2)
Differences in Patient Reported Psoriasis Symptom Severity between Patients Rated as 'Clear' Versus 'Almost Clear' based on Physician Global Assessment, Poster 1224, available to view beginning Friday, March 20, at 7 a.m. PT; poster presentation Sunday, March 22, 9:30 a.m. PT (West Building, Level 2)
Persistence of Biologics Used in Plaque Psoriasis and Psoriatic Arthritis in US Veterans, Poster 1193, available to view beginning Friday, March 20, at 7 a.m. PT; poster presentation Sunday, March 22, 1:05 p.m. PT (West Building, Level 2)
Amgen Webcast Investor Call
Amgen will host a webcast investor call on Monday, March 23, at noon PT. Elliott M. Levy, M.D., senior vice president of Global Development at Amgen, along with members of Amgen's clinical development team and clinical investigators, will participate in the call to discuss brodalumab clinical data presented at AAD.
Live audio of the investor meeting will be simultaneously broadcast over the Internet and will be available to members of the news media, investors and the general public.
The webcast, as with other selected presentations regarding developments in Amgen's business given by management at certain investor and medical conferences, can be found on Amgen's website, www.amgen.com, under Investors. Information regarding presentation times, webcast availability and webcast links are noted on Amgen's Investor Relations Events Calendar. The webcast will be archived and available for replay for at least 90 days after the event.
Psoriasis is a serious, chronic inflammatory disease that causes raised, red, scaly patches to appear on the skin, typically affecting the outside of the elbows, knees or scalp, though it can appear on any location.1,2 The patches may join together and cover large parts of a patient's body. Psoriasis can be mild, moderate or severe; patients with more than 10 percent of their body affected are considered to have severe psoriasis.3 Approximately 125 million people worldwide have psoriasis and 80 percent of those patients have plaque psoriasis.4,5
Amgen's Commitment to Dermatology
Amgen has been dedicated to advancing treatment options for patients with serious dermatologic diseases for nearly 15 years. Since the introduction of ENBREL, one of the first TNF inhibitors, Amgen has continued to be at the forefront of innovative research and development in the field of dermatology. Building upon the company's expertise in the science of using living cells to make biologic and biosimilar medicines, Amgen continues to expand its dermatology product portfolio, which includes the development of brodalumab, currently in Phase 3 development for patients with moderate-to-severe plaque psoriasis, as well as two biosimilar anti-TNF treatments.
About Brodalumab (AMG 827)
Brodalumab is a novel human monoclonal antibody that binds to the interleukin-17 (IL-17) receptor, thereby blocking the binding of multiple IL-17 cytokines (A, F and A/F) that are key drivers of the pro-inflammatory IL-17 pathway. The IL-17 pathway plays a central role in inducing and promoting inflammatory disease processes.6 The robust Phase 3 clinical development program evaluating brodalumab in patients with moderate-to-severe plaque psoriasis, known as the AMAGINE program, is comprised of three pivotal studies that include more than 4,200 patients. AMAGINE-1 is evaluating brodalumab compared with placebo, while AMAGINE-2 and AMAGINE-3 are evaluating brodalumab compared with both Stelara (ustekinumab) and placebo. Brodalumab is also being evaluated as a potential treatment for psoriatic arthritis (Phase 3) and asthma (Phase 2).
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 2002 to treat psoriatic arthritis, and later approved 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 in combination with methotrexate in patients who do not respond adequately to methotrexate alone.
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.
ENBREL indications in the EU:
ENBREL is an anti-inflammatory medicine. It is used for the treatment of the following diseases:
moderate to severe rheumatoid arthritis (an immune system disease causing inflammation of the joints) in adults (aged 18 years or over). ENBREL is used with methotrexate (a medicine that acts on the immune system) in adults with moderate or severe disease who have not responded adequately to other treatments, or on its own if methotrexate is not suitable for the patient. ENBREL can also be used in patients with severe rheumatoid arthritis who have not taken methotrexate before;
certain forms of juvenile idiopathic arthritis (a rare childhood disease causing inflammation of many joints) in the following groups:
patients aged two to 17 years who have polyarthritis (rheumatoid factor positive or negative) and extended oligoarthritis and have not responded adequately to or cannot take methotrexate;
adolescents aged 12 to 17 years who have psoriatic arthritis (a disease causing red, scaly patches on the skin and inflammation of the joints) and have not responded adequately to or cannot take methotrexate;
adolescents aged 12 to 17 years who have enthesitis-related arthritis and have not responded adequately to or cannot take standard treatment.
psoriatic arthritis in adults who have not responded adequately to other treatments;
severe ankylosing spondylitis (a disease causing inflammation of the joints of the spine) in adults who have not responded adequately to other treatments;
plaque psoriasis (a disease causing red, scaly patches on the skin) in adults with moderate to severe disease and in patients from the age of six years with long-term severe disease. ENBREL is used in patients who have not responded to or cannot receive other treatments for this disease.
severe non-radiographic axial spondyloarthritis (a chronic inflammatory disease of the spine) when there are objective signs of inflammation but no abnormalities seen on x-ray.
For more information, see the summary of product characteristics (also part of the EPAR).
Pfizer retains full marketing rights for ENBREL outside North America.
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.
Please see Prescribing Information and Medication Guide at www.ENBREL.com
Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology.
Amgen focuses on areas of high unmet medical need and leverages its biologics manufacturing expertise to strive for solutions that improve health outcomes and dramatically improve people's lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world's leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential.
For more information, visit www.amgen.com and follow us on www.twitter.com/amgen.
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, we 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 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, we are providing this information as of March 17, 2015, and expressly disclaim 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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CONTACT: Amgen, Thousand Oaks
Kristen Davis, 805-447-3008 (media)
Cuyler Mayer, 805-447-6332 (media)
Arvind Sood, 805-447-1060 (investors)
1 National Psoriasis Foundation. Symptoms and diagnosis. http://www.psoriasis.org/about-psoriasis/symptoms-and-diagnosis. Accessed on September 10, 2014.
2 National Psoriasis Foundation. Frequently Asked Questions. http://www.psoriasis.org/about-psoriasis/faqs. Last updated 2014. Accessed on September 10, 2014.
3 National Psoriasis Foundation. Psoriasis Severity. http://www.psoriasis.org/about-psoriasis/treatments/severity. Accessed on January 30, 2015.
4 International Federation of Psoriasis Associations. Psoriasis is a Serious Disease Deserving Global Attention: A report by the International Federation of Psoriasis Associations. www.ifpa-pso.org/getfile.ashx?cid=279366&cc=3&refid=18. Accessed on September 10, 2014.
5 American Academy of Dermatology. Psoriasis. http://www.aad.org/media-resources/stats-and-facts/conditions/psoriasis. Last updated 2014. Accessed on September 10, 2014.
6 Miossec P, Korn T, Kuchroo VK. Interleukin-17 and Type 17 Helper T Cells. The New England Journal of Medicine. 2009; 361: 888-98.
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