Amgen (NASDAQ:AMGN) and Allergan plc. (NYSE:AGN) today announced positive top-line results from a Phase 1/ Phase 3 study evaluating the pharmacokinetics, efficacy and safety of biosimilar candidate ABP 798, a biosimilar candidate to RITUXAN® (rituximab), compared to rituximab in patients with moderate-to-severe rheumatoid arthritis.
| THOUSAND OAKS, Calif. /PRNewswire/ --Amgen (NASDAQ:AMGN) and Allergan plc. (NYSE:AGN) today announced positive top-line results from a Phase 1/ Phase 3 study evaluating the pharmacokinetics, efficacy and safety of biosimilar candidate ABP 798, a biosimilar candidate to RITUXAN® (rituximab), compared to rituximab in patients with moderate-to-severe rheumatoid arthritis. The results demonstrate that the study met its primary endpoint of pharmacokinetic (PK) similarity. Additionally, equivalent efficacy was established and a similar safety profile was demonstrated. The primary objective of the study was PK similarity comparing ABP 798 to rituximab. The PK endpoints of the study were area under the serum concentration–time curve (AUC) and maximum serum concentration (Cmax), both of which were within the pre-specified equivalence margin. The pre-specified equivalence in efficacy endpoint was measured by Disease Activity Score 28-joint count C reactive protein (DAS28-CRP) change from baseline at week 24. Overall, safety and immunogenicity of ABP 798 were comparable to rituximab. This is the first of two studies intended to form the basis for global regulatory submissions for ABP 798. The second study is being conducted in patients with non-Hodgkin’s lymphoma. “Results from this study show pharmacokinetic and clinical equivalence between ABP 798 and rituximab, further demonstrating Amgen’s commitment to providing patients with access to high-quality, biological therapies,” said David M. Reese, M.D., executive vice president of Research and Development at Amgen. “We look forward to continuing to leverage our experience and expertise in biotechnology to bring more biosimilars to patients.” ABP 798 is being developed as a biosimilar candidate to rituximab, a CD20-directed cytolytic antibody that is approved in many regions for the treatment of adult patients with moderate-to-severe rheumatoid arthritis, non-Hodgkin’s lymphoma, chronic lymphocytic leukemia, pemphigus vulgaris, granulomatosis with polyangiitis and microscopic polyangiitis. Amgen has a total of 10 biosimilars in its portfolio, including two that are approved in the United States (U.S.) and three that are approved in the European Union (EU). About the Study Design About Rheumatoid Arthritis
About ABP 798 About the Amgen and Allergan Collaboration About Amgen Biosimilars For more information, visit www.amgenbiosimilars.com and follow us on www.twitter.com/amgenbiosim.
About Amgen 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 the world’s largest independent biotechnology company, 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. About Allergan plc. Allergan markets a portfolio of leading brands and best-in-class products for the central nervous system, eye care, medical aesthetics and dermatology, gastroenterology, women’s health, urology and anti-infective therapeutic categories. Allergan is an industry leader in Open Science, the Company’s R&D model, which defines our approach to identifying and developing game-changing ideas and innovation for better patient care. This approach has led to Allergan building one of the broadest development pipelines in the pharmaceutical industry with 70+ mid-to-late stage pipeline programs in development. Our Company’s success is powered by our more than 16,000 global colleagues’ commitment to being Bold for Life. Together, we build bridges, power ideas, act fast and drive results for our customers and patients around the world by always doing what is right. With commercial operations in approximately 100 countries, Allergan is committed to working with physicians, healthcare providers and patients to deliver innovative and meaningful treatments that help people around the world live longer, healthier lives every day. For more information, visit Allergan’s website at www.Allergan.com. Forward Looking Statements 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 to complete clinical trials and obtain regulatory approval for product marketing has in the past varied and we expect similar variability in the future. Even when clinical trials are successful, regulatory authorities may question the sufficiency for approval of the trial endpoints we have selected. 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The discovery of significant problems with a product similar to one of our products that implicate an entire class of products could have a material adverse effect on sales of the affected products and on our business and results of operations. Our efforts to acquire other companies or products and to integrate the operations of companies we have acquired may not be successful. A breakdown, cyberattack or information security breach could compromise the confidentiality, integrity and availability of our systems and our data. Our stock price is volatile and may be affected by a number of events. Our business performance could affect or limit the ability of our Board of Directors to declare a dividend or our ability to pay a dividend or repurchase our common stock. We may not be able to access the capital and credit markets on terms that are favorable to us, or at all. CONTACT: Amgen, Thousand Oaks References:
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Company Codes: NASDAQ-NMS:AMGN, NYSE:AGN |
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