February 07, 2017: Amgen announced that the U.S. Food and Drug Administration (FDA) has approved Parsabiv™ (etelcalcetide) for the treatment of secondary hyperparathyroidism (HPT) in adult patients with chronic kidney disease (CKD) on hemodialysis. Parsabiv is the first therapy approved for this condition in 12 years and the only calcimimetic that can be administered intravenously by the dialysis health care team three times a week at the end of the hemodialysis session.
Often occurring in patients in Stage 5 of CKD,1,2 secondary HPT refers to the excessive secretion of parathyroid hormone (PTH) by the parathyroid glands in response to decreased renal function and impaired mineral metabolism.1,3 Parsabiv binds to and activates the calcium-sensing receptor on the parathyroid gland, thereby causing decreases in PTH.
Secondary HPT is a serious condition and the proportion of patients unable to reach recommended secondary HPT lab targets has more than doubled in the last five years.4 Sensipar® (cinacalcet), the first FDA-approved calcimimetic, became an important treatment for patients with secondary HPT on dialysis based on its ability to reduce three important biochemical abnormalities (PTH, calcium, phosphorus). Parsabiv is a novel calcimimetic that can be delivered intravenously at the end the hemodialysis session and has been demonstrated to effectively reduce levels of PTH, corrected calcium and phosphate. These reductions were maintained for up to 78 weeks.
February 3, 2017: Amgen Inc reports Q4 EPS of $2.89 versus the $2.77 estimate. Revenue also beat coming in at $5.97 billion versus the $5.74 billion estimate.
– Aranesp sales $526M, +5%
– Epogen sales $316M, -8%
– Neulasta sales $1.12B, -3%
– Enbrel sales $1.64B, +14%
– Sensipar/Mimpara sales $411M, +7%
The CEO said, “We finished the year with strong operating performance… We anticipate several new product development opportunities and launches in 2017, and are excited about the Repatha cardiovascular outcomes data we released today [February 2 see below]. We have established a firm foundation for longer-term growth.”
February 2, 2017: Amgen Inc announced that the FOURIER trial evaluating whether Repatha® (evolocumab) reduces the risk of cardiovascular events in patients with clinically evident atherosclerotic cardiovascular disease (ASCVD) met its primary composite endpoint (cardiovascular death, non-fatal myocardial infarction (MI), non-fatal stroke, hospitalization for unstable angina or coronary revascularization) and the key secondary composite endpoint (cardiovascular death, non-fatal MI or non-fatal stroke). No new safety issues were observed.
The EBBINGHAUS cognitive function trial conducted in FOURIER patients also achieved its primary endpoint, demonstrating that Repatha was non-inferior to placebo for the effect on cognitive function.
Detailed results from the Repatha FOURIER outcomes trial will be presented at the American College of Cardiology (ACC) 66th Annual Scientific Session Late-Breaking Clinical Trials session in Washington, D.C. on Friday, March 17 at 8 a.m. ET. Detailed results from the Repatha EBBINGHAUS cognitive function trial will be presented at the Late-Breaking Clinical Trials session on Saturday, March 18 at 8 a.m. ET.
FOURIER (Further Cardiovascular OUtcomes Research with PCSK9 Inhibition in Subjects with Elevated Risk) is a multinational Phase3 double-blind, randomized, placebo-controlled trial in approximately 27,500 patients who had either an MI, an ischemic stroke or symptomatic peripheral artery disease and an LDL =70 mg/dL or a non-HDL-C =100 mg/dL on optimized statin therapy. Optimized statin therapy was defined as at least atorvastatin 20 mg or equivalent daily with a recommendation for at least atorvastatin 40 mg or equivalent daily where approved. Patients were randomized to receive Repatha subcutaneous 140 mg every two weeks or 420 mg monthly or placebo subcutaneous every two weeks or monthly. The study continued until at least 1,630 patients experienced a key secondary MACE (major adverse cardiac event) endpoint of cardiovascular death, MI or stroke, whichever occured first.
EBBINGHAUS (Evaluating PCSK9 Binding antiBody Influence oN coGnitive HeAlth in high cardiovascUlar risk Subjects) is a double-blind, placebo-controlled randomized non-inferiority trial involving approximately 1,900 patients enrolled in the FOURIER outcomes study. Executive function (Spatial Working Memory strategy index – primary endpoint) and secondary endpoints of working memory, memory function, and psychomotor speed were assessed using a tablet-based tool (CANTAB) at baseline and select time points.
February 1, 2017: BofA/Merrill raised Amgen to a Buy rating, from Neutral, and set a price target of $192. BofA/Merrill upgraded Amgen because they think there will be a positive outcome for the highly anticipated Repatha’s cardiovascular outcome trial, and because of new product launches in 2017. BofA/Merrill also said there could be potential benefits from cash repatriation.
January 27, 2017: Amgen Inc announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion for the Marketing Authorization of ABP 501 (biosimilar adalimumab), recommending approval for all available indications. ABP 501 has been recommended for approval for the treatment of certain inflammatory diseases in adults, including moderate-to-severe rheumatoid arthritis, psoriatic arthritis, severe ankylosing spondylitis (AS), severe axial spondyloarthritis without radiographic evidence of AS, moderate-to-severe chronic plaque psoriasis, moderate-to-severe hidradenitis suppurative, non-infectious intermediate, posterior and panuveitis, moderate-to-severe Crohn’s disease and moderate-to-severe ulcerative colitis. The CHMP opinion also recommends approval for the treatment of certain pediatric inflammatory diseases, including moderate-to-severe Crohn’s disease (ages six and older), severe chronic plaque psoriasis (ages four and older), enthesitis-related arthritis (ages six and older) and polyarticular juvenile idiopathic arthritis (ages two and older).
The Marketing Authorization Application (MAA) submission for ABP 501 was based on a comprehensive data package supporting biosimilarity to adalimumab based on analytical, pharmacokinetic and clinical data, including results from two Phase 3 studies conducted in moderate-to-severe plaque psoriasis and moderate-to-severe rheumatoid arthritis patients. The Phase 3 studies each met their primary endpoint showing no clinically meaningful differences to adalimumab. Safety and immunogenicity of ABP 501 were also comparable to adalimumab. Data to support the transition of adalimumab patients to ABP 501 were also included in the submission.
The CHMP positive opinion will now be reviewed by the European Commission (EC), which has the authority to approve medicines for the European Union (EU). If approved, a centralized marketing authorization will be granted that will be valid in the 28 countries that are members of the EU. Norway, Iceland and Liechtenstein, as members of the European Economic Area (EEA), will take corresponding decisions on the basis of the decision of the EC.
ABP 501 was approved in the United States (U.S.) by the U.S. Food and Drug Administration (FDA) on Sept. 23, 2016, where it goes by the brand name AMJEVITA™ (adalimumab-atto).
January 11, 2017: Amgen announced the Journal of the American Medical Association (JAMA) publication of findings from three Phase 3 studies of Parsabiv (etelcalcetide), an investigational intravenous calcimimetic agent in the U.S. The studies evaluated Parsabiv in more than 1,700 adults with secondary hyperparathyroidism (sHPT) on hemodialysis and showed that the drug produced statistically significant and clinically meaningful reductions in serum parathyroid hormone (PTH) levels, a key marker of sHPT. sHPT is a chronic and serious condition that is often progressive among patients with chronic kidney disease (CKD) and is associated with significant clinical consequences.
In two parallel Phase 3 randomized placebo-controlled studies in CKD patients with sHPT on hemodialysis, Parsabiv met the primary endpoint and significantly reduced serum PTH by more than 30 percent in 74.7 percent of patients compared to 8.9 percent given placebo. In addition, a head-to-head study comparing Parsabiv to oral Sensipar(cinacalcet) also met its primary endpoint. This head-to-head study showed Parsabiv was non-inferior to oral Sensipar in the proportion of patients achieving 30 percent or greater serum PTH reduction. Further, Parsabiv was superior to Sensipar for the secondary endpoints of proportion of patients achieving greater than 30 percent and greater than 50 percent reduction in mean PTH during the Efficacy Assessment Phase (EAP) compared with baseline.
A total of 1,706 patients were enrolled across the three trials to evaluate the safety and efficacy of Parsabiv in the treatment of adult sHPT patients on hemodialysis.
The two placebo-controlled trials were double-blind studies in a total of 1,023 adult patients with sHPT on hemodialysis. The patients were randomized to receive intravenous Parsabiv or placebo three times a week at the end of their dialysis sessions, and both arms also received standard of care as prescribed by the treating physician. Both of the trials showed that, by weeks 20-27, significantly more Parsabiv patients compared to placebo patients achieved:
— Greater than a 30 percent reduction from baseline in mean serum PTH during weeks 20-27: 74.0 percent versus 8.3 percent (p<0.001) and 75.3 percent versus 9.6 percent (p<0.001)
— Serum PTH levels of 300 pg/mL or less: 49.6 percent versus 5.1 percent (p<0.001) and 53.3 percent versus 4.6 percent (p<0.001)
The most common treatment-emergent adverse events (TEAEs) in the placebo-controlled studies that occurred at a rate greater than 10 percent in the Parsabiv group, and more frequently than in the placebo group in either of the studies, were blood calcium decreases (asymptomatic reductions in serum calcium), muscle spasms, diarrhea, nausea and vomiting. The overall rates of fatal adverse events, serious adverse events and adverse events leading to discontinuation of investigational product were similar in the Parsabiv and placebo groups.
January 3, 2017: Judge finds Amgen PCSK9 patent case verdict win against Sanofi will stand. Today’s ruling is on defendants’ motions for a new trial and judgment as a matter of law on written description and enablement and plaintiffs’ motion to strike the opening brief in support of defendants’ motion for judgment as a matter of law.
In today’s decision, the court denies defendants’ motions for a new trial and judgment as a matter of law on written description and enablement, and denies as moot plaintiffs’ motion to strike the opening brief in support of defendants’ motion for judgment as a matter of law Case is Amgen Inc. et al v. Sanofi et al, #1:14-cv-01317 in Delaware District Court
December 12, 2016: The US Supreme Court rejects Apotex claim over Neulasta; won’t overturn the ruling that requires an 180-day wait to market Neulasta biosimilar according to the mainstream media. Back on September 6, 2016, Amgen lost ruling in Neulasta patent case; judge says Apotex’s biosimilar does not infringe Amgen patent on the chemotherapy drug.
December 2, 2016: Amgen and Allergan announced the submission of a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for ABP 215, a biosimilar candidate to Avastin (bevacizumab). The companies believe this submission is the first bevacizumab biosimilar application submitted to the EMA.
ABP 215 is a biosimilar candidate to bevacizumab, a recombinant immunoglobulin G1 (IgG1) monoclonal antibody (mAb) that binds to vascular endothelial growth factor (VEGF) and inhibits the interaction of VEGF with its receptors, VEGF receptor-1 and VEGF receptor-2, thus inhibiting establishment of new blood vessels necessary for the maintenance and growth of solid tumors.
The MAA submission includes analytical, pharmacokinetic and clinical data, as well as pharmacology and toxicology data. The Phase 3 comparative efficacy, safety and immunogenicity study was conducted in adult patients with non-squamous non-small cell lung cancer (NSCLC). The Phase 3 study confirmed no clinically meaningful difference to bevacizumab regarding efficacy, safety, and immunogenicity.
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Amgen is one of the world’s leading biotechnology companies. Amgen is a values-based company, deeply rooted in science and innovation to transform new ideas and discoveries into medicines for patients with serious illnesses. Founded in 1980, Amgen has grown to be one of the world’s leading independent biotechnology companies.