Amgen Value Stock - Dividend - Research Selection
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Description of the company
Amgen Inc. (including its subsidiaries, referred to as “Amgen,” “the Company,” “we,” “our” or “us”) 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, 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.
Our strategy is to develop innovative medicines in six focused therapeutic areas that meet important unmet medical needs in addressing serious illness. We have a presence in approximately 100 countries worldwide focusing on: oncology/hematology, cardiovascular disease, inflammation, bone health, nephrology and neuroscience.
Amgen was incorporated in California in 1980 and became a Delaware corporation in 1987. Amgen operates in one business segment: human therapeutics.
Following is a summary of significant developments affecting our business that have occurred and that we have reported since the filing of our Annual Report on Form 10-K for the year ended December 31, 2015, and in early 2017.
• In February 2016, we and UCB, our global collaboration partner in the development of EVENITY™, announced that the phase 3 FRAME (FRActure study in postmenopausal woMen with ostEoporosis) study met its co-primary endpoints.
• In March 2016, we and UCB announced that the phase 3 BRIDGE (placeBo-contRolled study evaluatIng the efficacy anD safety of EVENITY™ in treatinG mEn with osteoporosis) study met its primary endpoint.
• In September 2016, we and UCB announced that the U.S. Food and Drug Administration (FDA) accepted for review the Biologics License Application (BLA) for EVENITY™ for the treatment of osteoporosis in postmenopausal women at increased risk for fracture. The FDA has set a Prescription Drug User Fee Act (PDUFA) target action date of July 19, 2017.
• In December 2016, we and UCB announced that we submitted an application to the Pharmaceuticals and Medical Devices Agency in Japan, together with our joint venture partner Astellas Pharma, Inc., seeking marketing approval for EVENITY™ for the treatment of osteoporosis for those at high risk of fracture.
• In August 2016, we announced that the phase 3 randomized, double-blind, double-dummy, active-controlled study evaluating the safety and efficacy of Prolia® compared with risedronate in patients receiving glucocorticoid treatment met all primary and secondary endpoints at 12 months.
• In October 2016, we announced that the phase 3 study evaluating XGEVA® versus Zometa® (zoledronic acid) in the prevention of skeletal-related events (SREs) in patients with multiple myeloma met its primary endpoint of non-inferiority in delaying the time to first on-study SRE. The secondary endpoints of superiority in delaying time to first SRE and delaying time to first-and-subsequent SREs were not met.
• In July 2016, we announced that the FDA approved the Repatha® Pushtronex™ system (on-body infusor with prefilled cartridge), a new, monthly single-dose administration option. The Pushtronex™ system is a hands-free device designed to provide 420 mg of Repatha® in a single dose.
• In September 2016, we announced that the phase 3 GLAGOV (GLobal Assessment of Plaque ReGression with a PCSK9 AntibOdy as Measured by IntraVascular Ultrasound) study evaluating the effect of Repatha® on coronary artery disease met its primary and secondary endpoints.
• In December 2016, we announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion for an extension to the marketing authorization of a new 420 mg single-dose delivery option for Repatha®.
• In January 2017, the United States District Court in Delaware granted Amgen’s request for a permanent injunction prohibiting Sanofi, Sanofi-Aventis U.S. LLC, Aventisub LLC, formerly doing business as Aventis Pharmaceuticals Inc. (collectively, Sanofi) and Regeneron Pharmaceuticals, Inc. (Regeneron) from infringing two patents that Amgen holds for Repatha® by manufacturing, using, selling or offering alirocumab for sale in the United States. Sanofi and Regeneron subsequently appealed the case to the U.S. Court of Appeals for the Federal Circuit (the Federal Circuit Court), and following a motion by Sanofi and Regeneron, in February 2017 the Federal Circuit Court entered a stay of the permanent injunction during the pendency of the appeal. See Part IV—Note 18, Contingencies and commitments, to the Consolidated Financial Statements.
• In February 2017, we announced that the phase 3 FOURIER (Further Cardiovascular OUtcomes Research with PCSK9 Inhibition in Subjects with Elevated Risk) study evaluating the effects of Repatha® on cardiovascular outcomes met its primary composite endpoint (cardiovascular death, non-fatal myocardial infarction (MI), non-fatal stroke, hospitalization for unstable angina or coronary revascularization) and key secondary composite endpoint (cardiovascular death, non-fatal MI or non-fatal stroke). No new safety issues were observed.
• In February 2017, we announced that the phase 3 EBBINGHAUS (Evaluating PCSK9 Binding antiBody Influence oN coGnitive HeAlth in high cardiovascUlar risk Subjects) cognitive function study achieved its primary endpoint.
• In November 2016, we announced that the FDA approved the supplemental Biologics License Application (sBLA) for the expanded use of ENBREL, making it the first and only systemic therapy to treat pediatric patients (ages 4-17) with chronic moderate-to-severe plaque psoriasis.
• In November 2016, we announced that the European Commission (EC) granted marketing authorization for Parsabiv™ for the treatment of secondary hyperparathyroidism (sHPT) in adult patients with chronic kidney disease (CKD) who are on hemodialysis.
• In February 2017, we announced that the FDA approved Parsabiv™ for the treatment of sHPT in adult patients with CKD who are on hemodialysis.
Erenumab (formerly AMG 334)
• In June 2016, we announced that the global phase 2 study evaluating the efficacy and safety of erenumab in chronic migraine prevention met its primary endpoint. Erenumab is being developed jointly with Novartis AG (Novartis).
• In September 2016, we announced that the phase 3 ARISE (A phase 3, RandomIzed, double-blind, placebo-controlled Study to Evaluate the efficacy and safety of erenumab in migraine prevention) study evaluating the efficacy of erenumab in episodic migraine prevention met its primary endpoint.
• In November 2016, we announced the positive top-line results of the global phase 3, randomized, double-blind, placebo-controlled STRIVE (STudy to evaluate the efficacy and safety of erenumab in migRaIne preVEntion) study. The study met its primary endpoint.
• In September 2016, we announced that the FDA approved the sBLA for BLINCYTO® to include new data supporting the treatment of pediatric patients with Philadelphia chromosome-negative (Ph-) relapsed or refractory (R/R) B-cell precursor acute lymphoblastic leukemia (ALL).
• In February 2017, we announced the submission of a sBLA to the FDA to include overall survival data from the Phase 3 TOWER study, supporting the conversion of BLINCYTO®’s accelerated approval to full approval. The sBLA also includes new data supporting the treatment of patients with Philadelphia chromosome-positive (Ph+) R/R B-cell precursor ALL.
• In June 2016, the EC approved a variation to the marketing authorization for KYPROLIS® to include use in combination with dexamethasone alone for adult patients with multiple myeloma who have received at least one prior therapy. The EC approved the extended indication for KYPROLIS® based on data from the phase 3 head-to-head ENDEAVOR (RandomizEd, OpeN Label, Phase 3 Study of Carfilzomib Plus DExamethAsone Vs Bortezomib Plus DexamethasOne in Patients With Relapsed Multiple Myeloma) study.
• In September 2016, we announced the top-line results of the phase 3 CLARION (Carfilzomib, Melphalan, Prednisone vs Bortezomib, Melphalan, Prednisone in Newly Diagnosed Multiple Myeloma) study, which evaluated an investigational regimen of KYPROLIS®, melphalan and prednisone versus VELCADE® (bortezomib), melphalan and prednisone for 54 weeks in patients with newly diagnosed multiple myeloma who were ineligible for hematopoietic stem-cell transplant. The study did not meet the primary endpoint of superiority in progression-free survival (PFS).
• In April 2016, we announced that the phase 3 study of Nplate® in children with symptomatic immune thromobocytopenia met its primary endpoint.
AMJEVITA™ (adalimumab-atto) /ABP 501
• In September 2016, we announced that the FDA approved AMJEVITA™ across all eligible indications of the reference product, HUMIRA® (adalimumab), including treatment of psoriatic arthritis, ankylosing spondylitis and moderate-to-severe rheumatoid arthritis, polyarticular juvenile idiopathic arthritis in patients four years of age or older, chronic plaque psoriasis, adult Crohn’s disease and ulcerative colitis. For discussion of ongoing, related litigation, see Part IV—Note 18, Contingencies and commitments, to the Consolidated Financial Statements.
• In January 2017, we announced that the CHMP of the EMA adopted a positive opinion for the marketing authorization of ABP 501, recommending approval for all available indications.
• In November 2016, we and Allergan plc (Allergan), our collaboration partner in the development and commercialization of certain biosimilar candidates, announced the submission of a BLA to the FDA for ABP 215, a biosimilar candidate to Avastin® (bevacizumab). The FDA has accepted the BLA and set the Biosimilar User Fee Act target action date of September 14, 2017.
• In December 2016, we and Allergan announced the submission of a Marketing Authorization Application (MAA) to the EMA for ABP 215.
• In July 2016, we and Allergan announced the results from a phase 3 study evaluating the efficacy and safety of ABP 980 compared with trastuzumab (Herceptin®) in patients with human epidermal growth factor receptor 2-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.