Amgen Presents Detailed Results From Phase 3 Study Demonstrating Clinical Equivalence Of Biosimilar Candidate ABP 501 With Adalimumab

First Completed Phase 3 Study of Adalimumab Biosimilar in the Treatment of Patients With Moderate-to-Severe Rheumatoid Arthritis

THOUSAND OAKS, CA, USA I November 9, 2015 I Amgen (NASDAQ:AMGN) today presented detailed findings from a head-to-head Phase 3 study comparing the safety, efficacy and immunogenicity of biosimilar candidate ABP 501 with adalimumab in patients with moderate-to-severe rheumatoid arthritis. The results were presented today in an oral presentation at the 2015 American College of Rheumatology (ACR)/Association of Rheumatology Health Professionals (ARHP) Annual Meeting in San Francisco.

The study met the primary endpoint, which was achievement of ACR20 (20 percent or greater improvement in ACR assessment) at week 24.  At week 24, 74.6 percent of patients in the ABP 501 group and 72.4 percent in the adalimumab group met the ACR20 response criteria. The risk ratio of ACR20 was 1.039 with the two-sided 90 percent CI of 0.954–1.133, which fell within the predefined equivalence margin.

"Demonstrating biosimilarity is scientifically complex, but Amgen's 35 years of proven biologic R&D experience is facilitating the advancement of exciting programs like ABP 501," said Sean E. Harper, M.D., executive vice president of Research and Development at Amgen. "Our long-term commitment to advancing care in inflammation is as strong as ever, with a portfolio of novel and biosimilar compounds that have the potential to benefit patients worldwide."

ABP 501 is being developed as a biosimilar candidate to adalimumab, an anti-TNF-α monoclonal antibody, which is approved in many countries for the treatment of inflammatory diseases, including moderate-to-severe rheumatoid arthritis, moderate-to-severe plaque psoriasis, moderate-to-severe polyarticular juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, moderate-to-severe Crohn's disease and moderate-to-severe ulcerative colitis.

Secondary endpoints included the achievement of ACR50 and ACR70 (a 50 or 70 percent improvement in ACR assessment) within the predefined equivalence margin. At week 24, patients treated with ABP 501 compared with those treated with adalimumab achieved ACR50 (49.2 percent vs. 52.0 percent) and ACR70 (26.0 percent vs. 22.9 percent), respectively. Additionally, the secondary endpoint of a difference in change from baseline of DAS28-CRP (Disease Activity Score examines 28 joints in the body as measured by C reactive protein in the blood) over the entire study was also achieved. The difference in mean change from baseline in DAS28-CRP between ABP 501 and adalimumab was –0.01 (90 percent CI, –0.18 to 0.17) at week 24.

The incidence of treatment-emergent adverse events (TEAEs) was 50 percent for ABP 501 and 55 percent for adalimumab. The most frequently reported TEAEs (for ABP 501 and adalimumab, respectively) were nasopharyngitis (6.4 percent vs. 7.3 percent), headache (4.5 percent vs. 4.2 percent), arthralgia (3.0 percent vs. 3.4 percent), cough (2.7 percent vs. 3.1 percent) and upper respiratory tract infection (1.5 percent vs. 3.8 percent). Serious adverse events (3.8 percent vs. 5.0 percent) and serious infections (0.8 percent vs. 1.1 percent) were reported in patients treated with ABP 501 and adalimumab, respectively. By the end of week 24, binding antibodies (38.3 percent vs. 38.2 percent) and neutralizing antibodies were identified (9.1 percent vs. 11.1 percent) in patients treated with ABP 501 and adalimumab, respectively.

Study Design
This randomized, double-blind, active-controlled study (study number 20120262) evaluated safety, efficacy and immunogenicity of ABP 501 compared to adalimumab in adult patients with moderate-to-severe rheumatoid arthritis who had an inadequate response to methotrexate. The study consisted of a screening period of four weeks and a treatment period of 22 weeks. Patients were randomized to receive either 40 mg ABP 501 subcutaneous injection (SC) every two weeks (n=264) or 40 mg SC adalimumab every two weeks (n=262) until week 22. The study completed at week 24, followed by a safety follow-up period through to week 26.

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 joints1. In RA, joint damage can significantly worsen over time, especially if left untreated2 and may impair function.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.

About Amgen Biosimilars
Amgen Biosimilars is committed to building upon Amgen's experience in the development and manufacturing of innovative human therapeutics to expand Amgen's reach to patients suffering from serious illnesses. Biosimilars offer the potential to increase patient access to vital medicines, and Amgen is well positioned to leverage its 35 years of experience in biotechnology to create high-quality biosimilars and reliably supply them to patients worldwide.

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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.


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