Amgen
Amgen Inc. (formerly Applied Molecular Genetics Inc.) is an American multinational biopharmaceutical company headquartered in Thousand Oaks, California.[3][4] One of the world's largest independent biotechnology companies, Amgen's Thousand Oaks staff in 2022 numbered approximately 5,000[5] (8.5% of total city employment)[6] and included hundreds of scientists, making Amgen the largest employer in Ventura County.[7][8] As of 2022, Amgen has approximately 24,000 staff in total.[9]
Formerly
Applied Molecular Genetics (1980–1983)
April 8, 1980
US$7.897 billion (2023)
US$6.717 billion (2023)
US$97.15 billion (2023)
US$6.232 billion (2023)
c. 26,700 (2023)
In 2019, the company's largest selling products were Enbrel (etanercept),[10] a tumor necrosis factor blocker used in the treatment of rheumatoid arthritis and other autoimmune diseases, and Neulasta (pegfilgrastim), an immunostimulator used to prevent infections in patients undergoing cancer chemotherapy.[11] Other marketed products include Evenity (romosozumab-aqqg), Otezla (apremilast), Prolia (denosumab), Repatha (evolocumab), and Lumakras (sotorasib).
Pipeline and clinical trials[edit]
As of August 2022, Amgen had 17 clinical programs underway in Phase III, eight in Phase II, and 19 in Phase I.[146]
In September 2019, FDA granted fast track designation to sotorasib for the treatment of metastatic non-small-cell lung carcinoma (NSCLC) with the KRAS G12C mutation.[147]
In August 2020, Amgen, Takeda, and AbbVie, as part of a COVID-19 research and development (R&D) alliance, announced the first patients enrolled in the I-SPY COVID clinical trial. The trial evaluated the efficacy of Otezla and two other medicines in severely ill, hospitalized COVID-19 patients who required high-flow oxygen.[148]
In October 2020, Amgen announced positive topline Phase 2 results from the CodeBreaK 100 clinical study, evaluating sotorasib in 126 patients with KRAS G12C-mutant advanced NSCLC who had failed three or fewer prior lines of anti-cancer therapies (including immunotherapy and/or chemotherapy).[149] Amgen, the Global Coalition for Adaptive Research, and Eisai Co., Ltd. also announced enrollment of the first patient in a study testing multiple interventions for the treatment of patients hospitalized with COVID-19.[150][151]
In November 2020, Amgen, Takeda, and UCB, as part of the COVID R&D alliance, announced the first patient enrolled in another trial evaluating Otezla and two other drugs as treatments for COVID-19.[152] Amgen also announced that it would terminate its collaboration with Cytokinetics and transition the development and commercialization rights for omecamtiv mecarbil and AMG 594.[153] Amgen and AstraZeneca announced positive topline results from a Phase 3 trial in which the investigational medicine tezepelumab demonstrated a statistically significant reduction in exacerbations in patients with severe asthma.[154]
In December 2020, the FDA granted breakthrough therapy designation to sotorasib for advanced or metastatic non-small cell lung cancer patients with KRAS G12C mutation.[155]
In May 2021, sotorasib received accelerated approval from FDA for treatment of adult patients with NSCLC whose tumors have a KRAS G12C mutation and who have received at least one prior systemic therapy; this was the first approved targeted therapy for tumors with any KRAS mutation.[156] Similar approvals for sotorasib in NSCLC followed in January 2022 in Europe[157] and Japan.[158]
In September 2022, data from a late-stage study showed the company's cancer pill Lumakras beating out chemotherapy. This was the first approved drug in the set of treatments that target KRAS, among the most common generic mutations found in cancers but one where researchers have struggled for years to design drugs to treat. The drug was approved in 2021 with a list price of $17,900 per month.[159]