amgen inc (AMGN) Key Developments
Amgen to Present Data from Multiple Brodalumab and Enbrel (etanercept) Studies at the 73rd Annual Meeting of the American Academy of Dermatology in San Francisco
Mar 17 15
Amgen announced that it will present data from multiple brodalumab and Enbrel (etanercept) studies at the 73rd Annual Meeting of the American Academy of Dermatology (AAD) in San Francisco, March 20-24, 2015. The breadth of data to be presented highlights Amgen's long-term commitment to advancing innovative treatment options for patients with serious, chronic dermatologic diseases. Data to be presented include results from all three of the brodalumab Phase 3 AMAGINE pivotal trials, evaluating the efficacy and safety of the IL-17 receptor inhibitor in patients with moderate-to-severe plaque psoriasis from the induction through the maintenance phase through week 52. Additional brodalumab long-term data from the Phase 2 open-label extension study provide further insights on the maintenance of clinical response with long-term brodalumab therapy in patients with moderate-to-severe psoriasis. Brodalumab is being co-developed by Amgen and AstraZeneca. Kyowa Hakko Kirin, which has an exclusive license to develop and commercialize brodalumab in Japan, China and certain other Asian countries, will present additional, long-term Phase 3 brodalumab efficacy and safety data from its open-label extension study in Japanese patients with moderate-to-severe plaque psoriasis. ENBREL data provide insights from OBSERVE-5, an observational registry designed to examine the use of ENBREL in a real-world setting over five years, as well as on treatment patterns with ENBREL compared with other agents in U.S. veterans with moderate-to-severe plaque psoriasis and psoriatic arthritis. Additional data to be presented will look at patient-reported psoriasis symptom severity using the Psoriasis Symptom Inventory (PSI) scale compared to Physician Global Assessment results.
Amgen Reports Positive One-Year Data from Phase II (Osler-1) and Phase III (Osler-2) Trials of Repatha
Mar 17 15
Amgen has reported positive one-year data from pre-specified exploratory endpoints of adjudicated cardiovascular events in the Phase II (OSLER-1) and Phase III (OSLER-2) open-label extension trials of Repatha (evolocumab). The product is a new investigational, low-density lipoprotein cholesterol decreasing medication. The company enrolled a total of 4,465 patients in the trial who had completed one of 12 Phase II and III Repatha trials, 2,976 of whom were randomised to subcutaneous Repatha 140mg every two weeks or 420mg monthly plus standard of care therapy and 1,489 were randomised to SOC alone over one year. One-year data from these ongoing trials showed that Repatha plus SOC treatment reduced adjudicated cardiovascular events.
Amgen Announces New Detailed Data from the Phase 3 YUKAWA-2 Study Evaluating Repatha™ (Evolocumab)
Mar 14 15
Amgen announced new detailed data from the Phase 3 YUKAWA-2 study evaluating Repatha™ (evolocumab), a novel investigational cholesterol-lowering medication, in Japanese patients with high cardiovascular risk and high cholesterol. Data from the study showed subcutaneous Repatha 140 mg every two weeks or 420 mg monthly, compared to placebo, in combination with different daily doses of atorvastatin, reduced low-density lipoprotein cholesterol (LDL-C) by 67% to 76% from baseline at week 12 and at the mean of weeks 10 and 12. The data were presented at the American College of Cardiology's 64th Annual Scientific Session (ACC.15). In the YUKAWA-2 study, the most common adverse events that occurred in greater than 2% of the Repatha group were nasopharyngitis (16.8% Repatha; 17.8% placebo), gastroenteritis (3.0% Repatha; 1.0% placebo) and pharyngitis (2.5% Repatha; 2.5% placebo). Repatha is an investigational fully human monoclonal antibody that inhibits proprotein convertase subtilisin/kexin type 9 (PCSK9), a protein that reduces the liver's ability to remove LDL-C, or "bad" cholesterol, from the blood.1 In Japan, LDL-C levels are not adequately controlled for many high-risk patients taking statins, nearly half of whom have not reached their LDL-C goal. High cholesterol is the most common form of dyslipidemia, which is an abnormality of cholesterol and/or fats in the blood.4,5 There are approximately 300 million cases of dyslipidemia in the U.S., Japan and Western Europe. YUKAWA-2 Study Design: YUKAWA-2 (StudY of LDL-Cholesterol Reduction Using a Monoclonal PCSK9 Antibody in Japanese Patients With Advanced Cardiovascular Risk) is a Phase 3, multicenter, double-blind, randomized, placebo-controlled trial designed to evaluate the safety, tolerability and efficacy of Repatha™ (evolocumab) in 404 Japanese patients with high cardiovascular risk based on the Japan Atherosclerosis Society guidelines2 and with hyperlipidemia or mixed dyslipidemia (LDL-C >100 mg/dL). Patients were randomized to one of eight treatment groups in a two-step randomization. Eligible patients were initially randomized to one of the following background therapies: atorvastatin 5 mg daily or atorvastatin 20 mg daily and entered a four-week lipid stabilization period. At completion of lipid stabilization, patients were then randomized to one of four treatment arms: Repatha 140 mg every two weeks, Repatha 420 mg monthly, subcutaneous placebo every two weeks or subcutaneous placebo monthly. The co-primary endpoints were the percent reduction from baseline in LDL-C at week 12 and the mean percent reduction from baseline in LDL-C at weeks 10 and 12. Co-secondary efficacy endpoints included means at weeks 10 and 12 and at week 12 for the following: LDL-C <70 mg/dL; absolute change from baseline in LDL-C; and the percentage change from baseline in non-high-density lipoprotein cholesterol (non-HDL-C), apolipoprotein B (ApoB), total cholesterol (TC), TC/HDL-C ratio, ApoB/apolipoprotein A1 (ApoA1) ratio, lipoprotein(a), triglycerides, HDL-C and very low-density lipoprotein cholesterol (VLDL-C).
Amgen Inc. Announces Availability of Neulasta Delivery Kit in US
Mar 11 15
Amgen Inc. announced the availability of Neulasta delivery kit in the US. The Neulasta Delivery Kit includes a specially designed single-use prefilled syringe co-packaged with the new On-body Injector for Neulasta. The Neulasta Delivery Kit will enable the healthcare provider (HCP) to initiate administration of Neulasta on the same day as cytotoxic chemotherapy - with delivery of the patient's full dose of Neulasta the day following chemotherapy administration, consistent with the Neulasta prescribing information (PI). Although Neulasta has been available for 12 years, some patients still do not receive their Neulasta at least 24 hours after cytotoxic chemotherapy as specified in the Neulasta PI. Among appropriate patients receiving myelosuppressive chemotherapy, many return to their HCP one day after chemotherapy treatment for the sole purpose of receiving a Neulasta injection; however, a portion of patients requiring Neulasta may not be able to return to their HCP, which means they may not be in accordance with PI recommended dosing. With the Neulasta Delivery Kit, HCPs now have an administration option for patients who would not need to return to the clinic or hospital the day after chemotherapy for anything other than their Neulasta injection. Results from a Phase I pharmacokinetic study demonstrated that the On-body Injector for Neulasta offers comparable pharmacokinetics to Neulasta delivered via the prefilled syringe for manual use. In addition to the On-body Injector, the Neulasta Delivery Kit includes a specifically designed Neulasta prefilled syringe along with HCP and Patient Instructions for Use and a Quick Reference Guide. On the same day as a chemotherapy session, the HCP initiates Neulasta administration by using the co-packaged syringe to fill the injector and activate it. The On-body Injector is then applied to the patient, to deliver Neulasta approximately 27 hours after the administration of cytotoxic chemotherapy. Activation of the injector leads to the subsequent insertion of the subcutaneous cannula while under HCP supervision.
Amgen to Cut About 300 Jobs, Close Onyx San Francisco Facility
Mar 11 15
Amgen Inc. will cut about 300 jobs and close a facility of its Onyx subsidiary in South San Francisco amid a restructuring of the biotechnology company's cancer business. About 250 field staff will be retained. In the restructuring, Amgen plans to combine its cancer business with the one it acquired by buying Onyx Pharmaceuticals for $10.4 billion in 2013.