January - March 2011
March 30, 2011
Takeda Pharmaceutical Company Limited
THOUSAND OAKS, Calif., CAMBRIDGE, Mass., OSAKA, Japan, (March 30, 2011) – Amgen (NASDAQ: AMGN), Millennium: The Takeda Oncology Company, and Takeda Pharmaceutical Company Limited (TSE:4502) today announced top-line results from the MONET1 pivotal Phase 3 trial evaluating motesanib administered in combination with paclitaxel and carboplatin in 1,090 patients with advanced non-squamous non-small cell lung cancer (NSCLC). The trial did not meet its primary objective of demonstrating an improvement in overall survival (OS) (hazard ratio 0.90, 95 percent CI 0.78 – 1.04, p=0.14).
"We are disappointed with the results from this trial, but look forward to further analysis of the data which may ultimately help inform future research in this area," said Roger M. Perlmutter, M.D., Ph.D., executive vice president of Research and Development at Amgen.
“We thank the patients, caregivers, and investigators for their participation and engagement in the clinical evaluation of motesanib worldwide,” said Nancy Simonian, M.D., chief medical officer, Millennium. “These disappointing results support the need for new treatments to address the unmet need in advanced non-squamous NSCLC.”
Overall, the adverse event profile for motesanib was consistent with that seen in previous motesanib studies in NSCLC. Notable adverse events reported included hypertension, GI events (abdominal pain, diarrhea, nausea, and vomiting), gallbladder events (cholecystitis, gallbladder enlargement), fatigue, and hematological events (neutropenia, thrombocytopenia). Serious adverse events were more frequently reported in the motesanib arm.
Detailed results will be submitted for presentation at an upcoming medical congress.
MONET1 (MOtesanib NSCLC Efficacy and Tolerability Study) is a Phase 3, multicenter, randomized, placebo-controlled, double-blind trial that enrolled more than 1,000 men and women with NSCLC. Patients were randomized to receive either paclitaxel (200 mg/m2 IV Q3W), carboplatin (target AUC of 6 mg/mL x min IV Q3W), and motesanib (125 mg PO QD) or paclitaxel, carboplatin, and placebo. The primary endpoint of the study was OS, and secondary endpoints included progression-free survival (PFS), objective response rate (ORR), association of placental growth factor with OS, duration of response, and safety and tolerability.
Motesanib is an investigational, orally-administered small molecule antagonist of vascular endothelial growth factor receptors 1, 2, and 3, platelet-derived growth factor receptors, and stem cell factor receptor.
Amgen discovers, develops, manufactures, and delivers innovative human therapeutics. A biotechnology pioneer since 1980, Amgen was one of the first companies to realize the new science's promise by bringing safe, effective medicines from lab to manufacturing plant to patient. Amgen therapeutics have changed the practice of medicine, helping millions of people around the world in the fight against cancer, kidney disease, rheumatoid arthritis, bone disease, and other serious illnesses. With a deep and broad pipeline of potential new medicines, Amgen remains committed to advancing science to dramatically improve people's lives. To learn more about our pioneering science and vital medicines, visit www.amgen.com.
Located in Osaka, Japan, Takeda is a research-based global company with its main focus on pharmaceuticals. As the largest pharmaceutical company in Japan and one of the global leaders of the industry, Takeda is committed to strive towards better health for patients worldwide through leading innovation in medicine. Additional information about Takeda is available through its corporate website, www.takeda.com.
Millennium: The Takeda Oncology Company, a leading biopharmaceutical company based in Cambridge, Mass., markets a first-in-class proteasome inhibitor, and has a robust clinical development pipeline of product candidates. Millennium Pharmaceuticals, Inc. was acquired by Takeda Pharmaceutical Company Ltd. ("Takeda", TSE: 4502) in May, 2008. The Company's research, development and commercialization activities are focused in oncology. Additional information about Millennium is available through its website, www.millennium.com.
This news release contains forward-looking statements that are based on Amgen’s current expectations and beliefs 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 (SEC) reports filed by Amgen, including Amgen’s most recent annual report on Form 10-K and most recent periodic reports on Form 10-Q and Form 8-K. Please refer to Amgen’s most recent Forms 10-K, 10-Q and 8-K for additional information on the uncertainties and risk factors related to Amgen’s business. Unless otherwise noted, Amgen is providing this information as of March 30, 2011 and expressly disclaims any duty to update information contained in this news release.
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This press release contains forward-looking statements regarding Takeda / Millennium’s current plans, outlook, strategies, and results for the future. All forward-looking statements are based on judgments derived from the anticipated information available to Takeda / Millennium at this time. Forward looking statements can sometimes be identified by the use of forward-looking words such as "may," "believe," "will," "expect," "project," "estimate," "should," "anticipate," "plan," "continue," "seek," "pro forma," "potential," "target, " "forecast," or "intend" or other similar words or expressions of the negative thereof. Certain risks and uncertainties could cause Takeda / Millennium’s actual results to differ materially from any forward looking statements contained in this press release. These risks and uncertainties include, but are not limited to, (1) the economic circumstances surrounding Takeda / Millennium’s business, including general economic conditions in the US and worldwide; (2) competitive pressures; (3) applicable laws and regulations; (4) the success or failure of product development programs; (5) decisions of regulatory authorities and the timing thereof; (6) changes in exchange rates; (7) claims or concerns regarding the safety or efficacy of marketed products or product candidates; and (8) integration activities with acquired companies.
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Leanne Madison: 1 (805) 447- 1201, lmadisonamgen.com (Media)
Arvind Sood: 1 (805) 447- 1060, arvindsamgen.com (Investors)
Millennium: The Takeda Oncology Company
Manisha Pai: 1 (617) 551- 7877, manisha.paimpi.com (Media)
Takeda Pharmaceutical Company Limited
Seizo Masuda: 81- 3- 3278- 2037, masuda_seizotakeda.co.jp (Media and Investors)