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.