Press Release Details

Study Evaluated the Efficacy, Safety and Immunogenicity of ABP 959 Compared to Eculizumab in Patients With Paroxysmal Nocturnal Hemoglobinuria

THOUSAND OAKS, Calif., Aug. 23, 2022 /PRNewswire/ -- Amgen (NASDAQ: AMGN) today announced positive top-line results from the DAHLIA study, a randomized, double-blind, active-controlled, two-period crossover Phase 3 study evaluating the efficacy and safety of ABP 959, a biosimilar candidate to SOLIRIS^® (eculizumab), compared with SOLIRIS in adult patients with paroxysmal nocturnal hemoglobinuria (PNH).

The study met its primary endpoints, demonstrating no clinically meaningful differences between ABP 959 and SOLIRIS based on the control of intravascular hemolysis as measured by lactate dehydrogenase (LDH) at week 27 for the parallel comparison, and the time-adjusted area under the effect curve (AUEC) of LDH from week 13 to week 27, from week 39 to week 53, and from week 65 to week 79 for the crossover comparison. The safety and immunogenicity profile of ABP 959 was comparable to SOLIRIS.

"Today's positive results with ABP 959 demonstrate similar efficacy, safety and immunogenicity as the reference product, further highlighting Amgen's commitment to providing patients with access to high-quality, biologic therapies," said David M. Reese, M.D., executive vice president of Research and Development at Amgen. "We look forward to working with regulators to make this potential biosimilar option available to patients."

Detailed results of this study will be presented at a future medical congress and submitted for publication.

ABP 959 is being developed as a biosimilar candidate to SOLIRIS, for the treatment of PNH and other indications. ABP 959 has the same pharmaceutical form, dosage strength, route of administration and dosing regimen as licensed eculizumab in the United States (U.S.) and European Union (EU).

This is not an offer for sale. ABP 959 is currently not available commercially.

Amgen has a total of 11 biosimilars in its portfolio, including five that have been approved in the U.S., three that are approved in the EU, and three in Phase 3 development.

This Phase 3 study is a randomized, double-blind, active-controlled, two-period crossover study in adult patients with paroxysmal nocturnal hemoglobinuria (PNH), who have been previously treated with eculizumab for at least six months. Subjects were randomized (1:1) to receive each investigational product (IP) in 1 of 2 sequences, either treatment T followed by treatment R (TR) or treatment R followed by treatment T (RT). Treatment was administered over 2 periods: Period 1 was 52 weeks in duration; Period 2 started at week 53 with a crossover in treatment and was 26 weeks in duration.

Period 1 (week 1 to week 53):   
Treatment T: ABP 959 at a dose of 900 mg intravenously (IV) every 14 ± 2 days for 52 weeks 
Treatment R: eculizumab at a dose of 900 mg IV every 14 ± 2 days for 52 weeks

Period 2 (week 53 to week 79)   
Treatment T: ABP 959 at a dose of 900 mg IV every 14 ± 2 days for 26 weeks  
Treatment R: eculizumab at a dose of 900 mg IV every 14 ± 2 days for 26 weeks

Paroxysmal nocturnal hemoglobinuria (PNH) is a rare, life-threatening, bone marrow disorder characterized by intravascular hemolytic anemia, bone marrow failure, and thrombo-embolic episodes, and is associated with a significant increase in mortality, development of arterial and venous thrombo-embolic episodes, visceral organ damage, and rapid deterioration in quality of life.^1,2,3,4 The disease is caused by the expansion of a clone of hematopoietic cells lacking glycosylphosphatidylinositol-anchored membrane proteins, which leads to chronic, complement-mediated intravascular hemolysis.²

ABP 959 is an investigational biosimilar candidate to SOLIRIS^® (eculizumab) for the treatment of paroxysmal nocturnal hemoglobinuria (PNH) and other indications. It is a monoclonal antibody that specifically binds to the complement protein C5 and inhibits the progression of both the classical and alternative complement cascades. ABP 959 has the same amino acid sequence as eculizumab and equivalent non-clinical pharmacologic function, based on comprehensive bioanalytical assays.

Amgen is committed to building upon Amgen's experience in the development and manufacturing of innovative human therapeutics to expand Amgen's reach to patients with serious illnesses. Biosimilars help to maintain Amgen's commitment to connect patients with vital medicines, and Amgen is well positioned to leverage its nearly four decades of experience in biotechnology to create high-quality biosimilars and reliably supply them to patients worldwide.

For more information, visit www.amgenbiosimilars.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 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.  

Amgen is one of the 30 companies that comprise the Dow Jones Industrial Average and is also part of the Nasdaq-100 index.  In 2021, Amgen was named one of the 25 World's Best Workplaces™ by Fortune and Great Place to Work™ and one of the 100 most sustainable companies in the world by Barron's.

For more information, visit www.amgen.com and follow us on www.twitter.com/amgen.  

This news release contains forward-looking statements that are based on the current expectations and beliefs of Amgen. All statements, other than statements of historical fact, are statements that could be deemed forward-looking statements, including any statements on the outcome, benefits and synergies of collaborations, or potential collaborations, with any other company (including BeiGene, Ltd., Kyowa-Kirin Co., Ltd., or any collaboration to manufacture therapeutic antibodies against COVID-19), the performance of Otezla^® (apremilast) (including anticipated Otezla sales growth and the timing of non-GAAP EPS accretion), the Five Prime Therapeutics, Inc. acquisition, or the Teneobio, Inc. acquisition or the recently announced proposed acquisition of ChemoCentryx, Inc., as well as 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, effects of pandemics or other widespread health problems such as the ongoing COVID-19 pandemic on our business, 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, including our most recent annual report on Form 10-K and any subsequent periodic reports on Form 10-Q and current reports on Form 8-K. Unless otherwise noted, Amgen is providing this information as of the date of this news release and does not undertake any obligation to update any forward-looking statements contained in this document as a result of new information, future events or otherwise.

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CONTACT: Amgen, Thousand Oaks   
Kelley Davenport, 202-585-9637 (media)  
Megan Fox, 805-447-1423 (media)  
Arvind Sood, 805-447-1060 (investors) 

¹ Kelly R, Richards S, Hillmen P, Hill A. The pathophysiology of paroxysmal nocturnal hemoglobinuria and treatment with eculizumab. Ther Clin Risk Manag. 2009;5:911-921.  
² Hill A, Richards SJ, Hillmen P. Recent developments in the understanding and management of paroxysmal nocturnal haemoglobinuria. Br J Haematol. 2007;137:181-192.  
³ Hillmen P, Young NS, Schubert J, et al. The complement inhibitor eculizumab in paroxysmal nocturnal hemoglobinuria. N Engl J Med. 2006;355:1233-1243.  
⁴ Rother RP, Bell L, Hillmen P, et al. The clinical sequelae of intravascular hemolysis and extracellular plasma hemoglobin: a novel mechanism of human disease. JAMA. 2005;293:1653-1662.

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SOURCE Amgen