THOUSAND OAKS, Calif. and LONDON, Dec. 11, 2014 /PRNewswire/ -- Amgen (NASDAQ: AMGN) and AstraZeneca (NYSE: AZN) today announced that additional results from AMAGINE-1TM, a pivotal, multi-arm Phase 3 trial evaluating two doses of brodalumab in patients with moderate-to-severe plaque psoriasis will be presented at the Psoriasis: From Gene to Clinic International Congress in London on Saturday, Dec. 13, 2014, at 11:20 a.m. GMT (Abstract FC30). Brodalumab is the only investigational treatment in development that binds to the interleukin-17 (IL-17) receptor and inhibits inflammatory signaling by blocking the binding of several IL-17 cytokines (A, F and A/F) to the receptor. The IL-17 receptor and cytokine family play a central role in the development and clinical manifestations of plaque psoriasis.
"We are excited to present additional data from AMAGINE-1, which provide further insight into brodalumab's potential role in addressing the unmet needs of patients living with psoriasis," said Sean E. Harper, M.D., executive vice president of Research and Development at Amgen. "We continue to be encouraged by the emerging data from this program and look forward to initiating global regulatory filings in 2015."
The AMAGINE-1 trial assessed the safety and efficacy of brodalumab given every two weeks via subcutaneous injection at two doses (140 mg or 210 mg) compared with placebo after 12 weeks of treatment in patients with moderate-to-severe plaque psoriasis. Another purpose of the study was to assess safety and efficacy when patients treated with brodalumab, who responded to treatment, continued receiving brodalumab compared to patients who had treatment withdrawn and began receiving placebo. Data being presented include results through week 52.
The AMAGINE program comprises three pivotal Phase 3 studies designed to assess the efficacy and safety of brodalumab in more than 4,200 patients with moderate-to-severe plaque psoriasis. Positive top-line results from AMAGINE-1 were released in May 2014. Positive top-line results from AMAGINE-2TM and AMAGINE-3TM, comparing brodalumab with Stelara® (ustekinumab) and placebo, were announced in November 2014. AMAGINE-2 and AMAGINE-3 are identical in design.
About Brodalumab (AMG 827) Brodalumab is a novel human monoclonal antibody that binds to the interleukin-17 (IL-17) receptor and inhibits inflammatory signaling by blocking the binding of several IL-17 ligands to the receptor. By stopping IL-17 ligands from activating the receptor, brodalumab prevents the body from receiving signals that may lead to inflammation. The IL-17 pathway plays a central role in inducing and promoting inflammatory disease processes.1 In addition to moderate-to-severe plaque psoriasis (Phase 3), brodalumab is currently being investigated for the treatment of psoriatic arthritis (Phase 3) and asthma (Phase 2).
About the Amgen and AstraZeneca Collaboration In April 2012, Amgen and AstraZeneca formed a collaboration to jointly develop and commercialize five monoclonal antibodies from Amgen's clinical inflammation portfolio. With oversight from joint governing bodies, Amgen leads clinical development and commercialization for brodalumab (Phase 3 for moderate-to-severe plaque psoriasis and psoriatic arthritis, Phase 2 for asthma) and AMG 557/MEDI5872 (Phase 1b for autoimmune diseases, such as systemic lupus erythematosus). AstraZeneca, through its biologics arm MedImmune, leads clinical development and commercialization for MEDI7183/AMG 181 (Phase 2 for ulcerative colitis and Crohn's disease), MEDI2070/AMG 139 (Phase 2 for Crohn's disease) and MEDI9929/AMG 157 (Phase 2 for asthma).
About Amgen 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.
About AstraZeneca AstraZeneca is a global, innovation-driven biopharmaceutical business that focuses on the discovery, development and commercialisation of prescription medicines, primarily for the treatment of cardiovascular, metabolic, respiratory, inflammation, autoimmune, oncology, infection and neuroscience diseases. AstraZeneca operates in over 100 countries and its innovative medicines are used by millions of patients worldwide. For more information please visit: www.astrazeneca.com.
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 Dec. 11, 2014, and expressly disclaim any duty to update information contained in this news release.
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Stelara® is a registered trademark of Janssen Biotech, Inc.
CONTACT: Amgen, Thousand Oaks Eva Groves, 805-447-2739 (media) Kristen Davis, 805-447-3008 (media) Arvind Sood, 805-447-1060 (investors)
CONTACT: AstraZeneca Media: Esra Erkal-Paler, +44 20 7604 8030 (UK/Global) Michele Meixell, +1 302 885 2677 (US)
Investors: Thomas Kudsk Larsen, +44 20 7604 8199, mob: +44 7818 524185 Karl Hård, +44 20 7604 8123, mob: +44 7789 654364
- Miossec P, Korn T, Kuchroo VK. Interleukin-17 and Type 17 Helper T Cells. The New England Journal of Medicine. 2009; 361: 888-98.