THOUSAND OAKS, Calif. and DUBLIN, July 21, 2016 /PRNewswire/ -- Amgen (NASDAQ:AMGN) and Allergan plc (NYSE:AGN) today announced results from a Phase 3 study evaluating efficacy and safety of ABP 980 compared with trastuzumab in patients with human epidermal growth factor receptor 2-positive (HER2-positive) early breast cancer. The results ruled out inferiority compared to trastuzumab but could not rule out superiority based on its primary efficacy endpoint of the difference of the percentage of patients with a pathologic complete response (pCR). The primary endpoint had a prespecified equivalence margin of +/- 13 percent and the observed upper end of the confidence interval was 13.4 percent.
Overall, adverse events were comparable between ABP 980 and trastuzumab. In the neoadjuvant phase of the study, which included chemotherapy, there were more serious adverse events reported in the ABP 980 group, the majority of which were reported by the investigators as unlikely related to investigational product. In the adjuvant phase of the study, which did not include chemotherapy, serious adverse events were comparable between treatment groups. The overall results also showed comparable immunogenicity.
"We believe this study confirms no clinically meaningful differences between ABP 980 and trastuzumab, and we look forward to continued discussions with regulatory authorities," said Sean E. Harper, M.D., executive vice president of Research and Development at Amgen. "Biosimilars are approved based on the analytical, nonclinical and clinical data, and we believe that the totality of the evidence we've generated supports ABP 980 as highly similar to the reference product."
"These results provide significant clinical evidence that ABP 980 could be an important biosimilar treatment option for patients with HER2-positive early breast cancer," said David Nicholson, chief research and development officer, Allergan. "Allergan is committed to the continued development of ABP 980 and other biosimilars that provide safe, high-quality and effective therapies in key disease areas."
ABP 980 is being developed as a biosimilar to trastuzumab, a recombinant DNA-derived humanized monoclonal immunoglobulin G1 kappa antibody which targets HER2. Trastuzumab is approved in many regions for the treatment of HER2-positive early breast cancer, metastatic breast cancer and metastatic gastric cancer.
Amgen and Allergan are collaborating on the development and commercialization of four oncology biosimilars. Amgen has a total of nine biosimilars in development. Allergan is also independently developing biosimilars.
This above referenced Phase 3 study was a randomized, multicenter, double-blinded, active-controlled study (study number 20120283) that evaluated safety and efficacy of ABP 980 compared to trastuzumab in adult female patients with HER2-positive early breast cancer. There were 725 patients randomized, with 364 patients in the ABP 980 group and 361 patients in the trastuzumab group.
In the neoadjuvant phase, enrolled patients received run-in chemotherapy consisting of epirubicin and cyclophosphamide (EC) every three weeks (Q3W) for four cycles. Once run-in chemotherapy was completed, patients with adequate cardiac function were randomized 1:1 to receive investigational product (ABP 980 or trastuzumab), plus paclitaxel, Q3W for four cycles. Surgery (breast and sentinel node or axillary lymph node resection) was complete three to seven weeks after the last dose of investigational product in the neoadjuvant phase, and pCR was analyzed.
In the adjuvant phase, following surgery, patients received investigational product (ABP 980 or trastuzumab) Q3W for up to one year from the first day of investigational product administered in the neoadjuvant phase. Patients who received ABP 980 during the neoadjuvant phase continued to receive ABP 980 Q3W for the adjuvant phase. Patients who received trastuzumab during the neoadjuvant phase received either ABP 980 or trastuzumab Q3W for the adjuvant phase. The allocation to a treatment group during the neoadjuvant or adjuvant phase occurred at randomization.
The primary analysis was conducted when the last patient completed the surgery following the neoadjuvant therapy. Clinical equivalence was assessed by comparing the confidence interval of the risk difference and risk ratio of the pCR in breast tissue and axillary lymph nodes with the prespecified equivalence margins. The final analysis of safety will be conducted when the last patient has completed their last study assessment in the adjuvant phase.
About HER2-Positive Early Breast Cancer
HER2-positive early breast cancer is a breast cancer that tests positive for a protein called human epidermal growth factor receptor 2 (HER2), which promotes the growth of cancer cells.1 Approximately 20 percent of all breast cancers are HER2-positive.2 Breast cancer is the second leading cause of cancer death among women and each year it is estimated that over 230,000 women in the United States will be diagnosed.3 HER2-positive breast cancers tend to grow and spread more aggressively than HER2-negative breast cancers.1
About ABP 980
ABP 980 is being developed as a biosimilar to trastuzumab, a recombinant DNA-derived humanized monoclonal immunoglobulin G1 kappa antibody approved in many regions for the treatment of HER2-overexpressing early breast cancer, metastatic breast cancer and metastatic gastric cancer. The active ingredient of ABP 980 is a humanized monoclonal antibody which has the same amino acid sequence as trastuzumab. ABP 980 has the same pharmaceutical dosage form and strength as trastuzumab (US) and trastuzumab (EU).
About the Amgen and Allergan Collaboration
In December 2011, Amgen and Allergan plc. (then Watson Pharmaceuticals, Inc.) formed a collaboration to develop and commercialize, on a worldwide basis, four oncology antibody biosimilar medicines. This collaboration reflects the shared belief that the development and commercialization of biosimilar products will not follow a pure brand or generic model, and will require significant expertise, infrastructure, and investment to ensure safe, reliably supplied therapies for patients. Under the terms of the agreement, Amgen will assume primary responsibility for developing, manufacturing and initially commercializing the oncology antibody products.
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 more than 35 years of experience in biotechnology to create high-quality biosimilars and reliably supply them to patients worldwide.
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.
Allergan plc (NYSE: AGN), headquartered in Dublin, Ireland, is a unique, global pharmaceutical company and a leader in a new industry model – Growth Pharma. Allergan is focused on developing, manufacturing and commercializing innovative branded pharmaceuticals, high-quality generic and over-the-counter medicines and biologic products for patients around the world.
Allergan markets a portfolio of best-in-class products that provide valuable treatments for the central nervous system, eye care, medical aesthetics, gastroenterology, women's health, urology, cardiovascular and anti-infective therapeutic categories, and operates the world's third-largest global generics business, providing patients around the globe with increased access to affordable, high-quality medicines. Allergan is an industry leader in research and development, with one of the broadest development pipelines in the pharmaceutical industry and a leading position in the submission of generic product applications globally.
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.
Amgen Forward-Looking Statements
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 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, including our most recent annual report on Form 10-K and any subsequent periodic reports on Form 10-Q and 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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Allergan plc Forward-Looking Statements
Statements contained in this press release that refer to future events or other non-historical facts are forward-looking statements that reflect Allergan's current perspective of existing trends and information as of the date of this release. Except as expressly required by law, Allergan disclaims any intent or obligation to update these forward-looking statements. Actual results may differ materially from Allergan's current expectations depending upon a number of factors affecting Allergan's business. These factors include, among others, the difficulty of predicting the timing or outcome of FDA approvals or actions, if any; the impact of competitive products and pricing; market acceptance of and continued demand for Allergan's products; difficulties or delays in manufacturing; and other risks and uncertainties detailed in Allergan's periodic public filings with the Securities and Exchange Commission, including but not limited to Allergan's Annual Report on Form 10-K for the year ended December 31, 2015 and Quarterly Report on Form 10-Q for the quarter ended March 31, 2016 (certain of such periodic public filings having been filed under the "Actavis plc" name). Except as expressly required by law, Allergan disclaims any intent or obligation to update these forward-looking statements.
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CONTACT: Amgen, Thousand Oaks
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1. Mayo Clinic. HER2-Positive Breast Cancer: What is it? http://www.mayoclinic.org/breast-cancer/expert-answers/faq-20058066. Last updated 2015. Accessed on July 1, 2016.
2. American Cancer Society. Targeted therapy for breast cancer. http://www.cancer.org/cancer/breastcancer/detailedguide/breast-cancer-treating-targeted-therapy. Last updated 2016. Accessed on July 2, 16.
3. National Breast Cancer Foundation, Inc. Breast Cancer Facts. http://www.nationalbreastcancer.org/breast-cancer-facts. Last updated 2015. Accessed on July 2, 2016.