Amgen

Amgen Inc. (formerly Applied Molecular Genetics Inc.) is an American multinational biopharmaceutical company headquartered in Thousand Oaks, California. One of the world's largest independent biotechnology companies, As of 2022, Amgen has approximately 24,000 staff in total.

The name "AMGen" is a portmanteau of the company's original name, Applied Molecular Genetics, which became the official name of the company in 1983 (three years after incorporation and coincident with its initial public offering).

History
Amgen was established in Thousand Oaks in 1980, as Applied Molecular Genetics. Amgen was backed by a small group of venture capitalists, and its early focus was on recombinant DNA technology and recombinant human insulin.

Its initial scientific advisory board consisted of Norman Davidson, Leroy Hood, Arnold Berk, John Carbon, Robert Schimke, Arno Motulsky, Marvin H. Caruthers, and Dave Gibson. In October 1980, Amgen named George Rathmann its first president and chief executive officer.

On June 17, 1983, Amgen went public, selling two million common shares and raising nearly $40 million. That same year, after more than two years of work, an Amgen research team led by Fu-Kuen Lin had a breakthrough in finding and cloning the erythropoietin gene, a protein created in the kidney that stimulates red blood cell production. Lin's team created what would become Epogen (epoetin alfa).

In 1985, Amgen researcher Larry Souza and his team cloned granulocyte colony-stimulating factor (G-CSF), leading to the development of Neupogen (filgrastim).

In October 1988, Gordon Binder was named CEO, succeeding George Rathmann. The following year, in 1989, Amgen received approval for the first recombinant human erythropoetin product, Epogen (epoetin alfa).

In February 1991, Amgen received FDA approval for Neupogen for the prevention of infections in patients whose immune systems are suppressed due to cancer chemotherapy.

Amgen opened a new manufacturing facility in Puerto Rico, in March 1993, which later became the company's flagship manufacturing site.

In 1994, Amgen became the fifth company to receive the U.S. Department of Commerce's National Medal of Technology and Innovation, in recognition of its work developing medicines to improve quality of life for kidney and cancer patients. Also around this time, Amgen researcher Steve Elliott and his team added more sugar molecules to erythropoietin, causing it to remain in the body longer. This led to the development of Aranesp (darbepoetin alfa).

In November 1998, Immunex, a future acquisition of Amgen, received approval for Enbrel (etanercept), the first rheumatoid arthritis drug targeting tumor necrosis factor alpha (TNF-alpha).

2000-2014
Binder was succeeded as CEO by Kevin W. Sharer in 2000. Robert A. Bradway became Amgen's president and chief executive officer in May 2012, following Sharer's retirement.

In March 2011, Amgen acquired a manufacturing facility near Dublin, Ireland, in March.

Amgen also opened an affiliate in China in 2013.

In November 2014 the company announced it was halting all trials of rilotumumab in advanced gastric cancer patients after one of the trials found more deaths in those who took the compound with chemotherapy, than those without. Later in the same week, the company in conjunction with AstraZeneca reported positive results for brodalumab in a Phase III trial comparing the compound with ustekinumab and a placebo in treating psoriasis. In the same month, construction was completed on Amgen's next-generation biomanufacturing facility in Singapore. Blincyto (blinatumomab) was approved by the FDA in December of that year.

Amgen sponsored the Tour of California from 2011 to 2017.

Amgen's Thousand Oaks staff in 2022 numbered approximately 5,000 (8.5% of total city employment) and included hundreds of scientists, making Amgen the largest employer in Ventura County.

Timeline

 * 1984: In June, Amgen and Kirin formed a joint venture giving Kirin the rights to Epogen in Japan.
 * 2002: In July, Amgen acquired Immunex, the developer of Enbrel (etanercept).
 * 2004: Also, Amgen acquired Tularik, another biotechnology company, expanding the company's research and development pipeline.
 * 2006: In April, Amgen acquired Abgenix, the developer of Vectibix (panitumumab), a treatment developed for certain patients with metastatic colorectal cancer.
 * 2010: On June 6, 2010, Amgen received FDA approval for Prolia, a protein drug for the treatment of post-menopausal osteoporosis. In clinical trials, Prolia reduced the rate of vertebral fractures by 61% and the risk of hip fractures by 40%. In November 2010 the FDA approved Xgeva for the prevention of complications of bone metastases in patients with solid tumors. The clinical trials primarily enrolled patients with breast or prostate cancer.
 * 2011: In May, Amgen acquired BioVex, developer of Imlygic (talimogene laherparepvec). In December, Amgen and Watson Pharmaceuticals announced a collaboration to develop and commercialize several biosimilar medicines worldwide.
 * 2013: Lawmakers inserted text into the fiscal cliff bill that will allow the drugmaker to sell a class of drugs that includes Sensipar without government controls for an additional two years. The New York Times estimated that the paragraph in the fiscal cliff bill will cost taxpayers an estimated $500 million but other assessments concluded that the change would protect seniors in rural areas and reduce overall Medicare spending. Amgen acquired Micromet, a company focused on BiTE technology, in March. In May, Kevin Sharer retired, and Robert Bradway, formerly Amgen's president and chief operating officer, became CEO. In June, Amgen acquired Turkish company Mustafa Nevzat Pharmaceuticals, expanding Amgen's presence in Turkey and nearby areas. In July, Amgen acquired KAI Pharmaceuticals, developer of Parsabiv (etelcalcetide).  Amgen acquired Iceland-based deCODE Genetics in December.
 * 2013: In October, Amgen acquired Onyx Pharmaceuticals, developer of Kyprolis (carfilzomib).
 * 2015: In March, the company announced it would license its Phase II candidate drug AMG 714 to developer Celimmune who plan to develop the anti-IL-15 monoclonal antibody for treatment against diet nonresponsive celiac disease and refractory celiac disease.
 * 2015: Repatha (evolocumab) was approved by the FDA in August. In September the company announced it would acquire Dezima Pharma for more than $1.55 billion. The same day the company announced a collaboration with Xencor on 6 early stage immuno-oncology and inflammation programmes. As part of the deal Amgen will pay $45 million upfront, with the deal being worth up to another $1.7 billion. In October, the FDA approved Imlygic.
 * 2016: In September, the company announced it would purchase the rights to Boehringer Ingelheims Phase I bispecific T-cell engager compound (BI 836909, now AMG 420) for use in the treatment of multiple myeloma. Also in September, the FDA approved Amjevita (adalimumab-atto).
 * 2017: Cash returned to shareholders totalled a record $6.5 billion through dividends and share repurchases. The FDA approved Parsabiv in February and Mvasi (bevacizumab-awwb) in September.
 * 2018:Amgen began constructing a next-generation biomanufacturing plant at its West Greenwich, Rhode Island, campus in July.
 * 2019: In January, Evenity (romosozumab) received approval in Japan, followed by FDA approval in April. In June, Kanjinti (trastuzumab-anns) was approved by the FDA. Amgen announced it would acquire Nuevolution AB for 1.61 billion Swedish crowns ($166.8 million) to enhance its drug discovery capabilities. In August the company announced it would acquire the Otezla drug programme from Celgene for $13.4 billion, as part of Celgene and Bristol-Myers Squibbs merger deal.  In October, Amgen announced it would be acquiring a 20.5% stake in the Beijing-based BeiGene for $2.7 billion. In November, Amgen awarded a $2 million grant to the CDC Foundation to launch the latter's EmPOWERED Health Program, promoting patient engagement in decision making for their cancer treatment. In December, the FDA approved Avsola (infliximab-axxq).
 * 2020: In April, Amgen established Amgen K.K. as the company's wholly-owned affiliate in Japan. Amgen announced in July that the United States Court of Appeals for the Federal Circuit had upheld the validity of two Amgen patents that described and claimed Enbrel and methods for making it. The appellate court affirmed an August 2019 decision by the United States District Court for the District of New Jersey and rejected Sandoz's attempt to invalidate the patents on Enbrel. Amgen joined the Dow Jones Industrial Average on August 24, 2020. In September, Amgen and Eli Lilly and Company announced a global manufacturing collaboration for COVID-19 antibody therapies. On December 10, Amgen announced that it joined OneTen, a coalition of large employers that aims to hire and advance one million black Americans over the next ten years. Later that month, the FDA approved Riabni (rituximab-arrx), a biosimilar to Rituxan.
 * 2021: In March, the company announced it would acquire Five Prime Therapeutics and its lead candidate, bemarituzumab, for $1.9 billion and Rodeo Therapeutics for up to $720 million. The FDA approved Amgen's Lumakras in May for treatment of patients with KRAS-G12C-mutated non-small cell lung cancer. In June, Amgen and Kyowa Kirin announced joint plans to develop and commercialize a treatment for atopic dermatitis. In July, Amgen acquired Teneobio for $900 million. In October, Amgen and Neumora Therapeutics announced a research and development collaboration focused on novel precision therapies for certain brain diseases.  Amgen began construction on a new biomanufacturing plant in New Albany, Ohio, in November. In December, the FDA approved Amgen and AstraZeneca's Tezspire (tezepelumab) for severe asthma. The FDA also approved Amgen's Otezla for adults with plaque psoriasis of any severity level.
 * 2022: In January, Amgen announced a research collaboration with Generate Biomedicines across multiple modalities and several therapeutic areas for up to $1.9 billion. The company also launched a multi-target collaboration with Arrakis Therapeutics to identify novel targeted RNA degrader therapeutics.  The next month, Amgen entered a multi-year collaboration with Plexium to discover novel targeted protein degradation therapies.  Also in February, Amgen issued its first green bond to fund various environmentally friendly initiatives across the company.  The company broke ground on a new manufacturing facility in Holly Springs, North Carolina, in March.  In August, the company agreed to acquire ChemoCentryx for $3.7 billion in an all-cash deal. ChemoCentryx is the maker of Tavneos—a drug treatment for rare diseases called anti-neutrophil cytoplasmic autoantibody-associated vasculitis—which was approved last year. In December, the company announced it would acquire Horizon Therapeutics for $27.8 billion ($116.50 in cash for each Horizon share, a 20% premium) expanding its rare disease treatments.
 * 2023: Amgen completed the acquisition of Horizon Therapeutics in October 2023. In December, announced plans to use artificial intelligence in partnership with Amazon Web Services to help discover and create medicines. Amgen will use Amazon's SageMaker machine learning service to help with the manufacturing process.

Amgen Foundation
In October 2017, the Amgen Foundation pledged $3 million to Khan Academy to support the development of free online biology lessons. In July 2020, Amgen granted an additional $3 million Khan Academy to support educational equity and science learning.

In January 2020, the Amgen Foundation and Harvard University debuted LabXchange, a free online science education platform. Amgen and the Amgen Foundation announced a commitment of up to $12.5 million to support COVID-19 relief efforts in March.

Acquisition history

 * Amgen (Founded 1983 as Applied Molecular Genetics)
 * Synergen Inc (Acq 1994)
 * Kinetix Pharmaceuticals Inc (Acq 2000)
 * Immunex Corporation (Acq 2002)
 * Tularik Inc (Acq 2004)
 * Abgenix Inc (Acq 2006)
 * Avidia Inc (Acq 2006)
 * Alantos Pharmaceuticals (Acq 2007)
 * Ilypsa Inc (Acq 2007)
 * BioVex Group Inc (Acq 2011)
 * Micromet Inc (Acq 2012)
 * Mustafa Nevzat İlaç (Acq 2012)
 * KAI Pharmaceuticals (Acq 2012)
 * deCODE genetics (Acq 2012)
 * Onyx Pharmaceuticals (Acq 2013)
 * NextCODE genetics (Spun off 2013)
 * Dezima Pharma (Acq 2015)
 * Catherex (Acq 2015)
 * Nuevolution AB (Acq 2019)
 * Otezla (apremilast) (Acq 2019)
 * Five Prime Therapeutics (Acq 2021)
 * Rodeo Therapeutics Corporation (Acq 2021)
 * Teneobio (Acq 2021)
 * ChemoCentryx (Acq 2022)
 * Horizon Therapeutics (Acq 2023)
 * Vidara Therapeutics International (Acq 2014)
 * Hyperion Therapeutics (Acq 2015)
 * Crealta Holdings (Acq 2015)
 * Raptor Pharmaceutical (Acq 2016)
 * River Vision Development Corp. (Acq 2017)
 * Viela Bio Inc (Acq 2021)

Products
Amgen's approved drugs or therapeutic biologicals include:


 * Aimovig (erenumab-aooe) for migraine headaches (FDA approved May 2018)
 * Amjevita (adalimumab)
 * Aranesp (darbepoetin alfa) for anemia (FDA approval in September 2001)
 * Blincyto (blinatumomab for the treatment of acute lymphoblastic leukemia)
 * Corlanor (ivabradine)
 * Enbrel (etanercept) for various forms of arthritis
 * Epogen (erythropoietin) for anemia
 * Evenity (romosozumab-aqqg) for osteoporosis
 * Imlygic (talimogene laherparepvec) for local treatment of unresectable cutaneous, subcutaneous, and nodal lesions in melanoma recurrent after initial surgery
 * Kanjinti (trastuzumab-anns)
 * Kyprolis (carfilzomib)
 * Lumakras (sotorasib)
 * Mvasi (bevacizumab-awwb)
 * Neulasta (pegfilgrastim) for neutropenia (FDA approved 2002)
 * Neupogen (granulocyte colony-stimulating factor) for neutropenia
 * Nplate (romiplostim) for chronic immune thrombocytopenic purpura (FDA approved 2008)
 * Otezla (apremilast)
 * Parsabiv (etelcalcetide)
 * Prolia (denosumab) for postmenopausal osteoporosis
 * Repatha (evolocumab)
 * Riabni (rituximab-arrx)
 * Sensipar/Mimpara (cinacalcet for primary and secondary hyperparathyroidism, a mineral metabolism complication common in patients with kidney failure) (FDA approved 2004)
 * Tezspire (tezepelumab-ekko)
 * Vectibix (panitumumab for colon cancer) (FDA approved 2006)
 * Xgeva (denosumab) for the prevention of skeletal-related events (pathological fracture, radiation to bone, spinal cord compression or surgery to bone in adults with bone metastases from solid tumors)

Products developed and then sold off
In 2019, the company's largest selling products were Enbrel (etanercept), 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.
 * Kepivance (palifermin for oral mucositis, sold to Biovitrium, now Swedish Orphan Biovitrum, in December 2008
 * StemGen (ancestim) for use in combination with filgrastim for mobilizing peripheral hematopoietic stem cells ) (sold to Biovitrium, now Swedish Orphan Biovitrum, in December 2008)
 * Kineret (anakinra) for rheumatoid arthritis, exclusively licensed to Biovitrium, now Swedish Orphan Biovitrum, in December 2008

Pipeline and clinical trials
As of August 2022, Amgen had 17 clinical programs underway in Phase III, eight in Phase II, and 19 in Phase I.

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.

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.

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). 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.

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. Amgen also announced that it would terminate its collaboration with Cytokinetics and transition the development and commercialization rights for omecamtiv mecarbil and AMG 594. 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.

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.

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. Similar approvals for sotorasib in NSCLC followed in January 2022 in Europe and Japan.

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.

Carbon footprint
Amgen reported Total CO2e emissions (Direct + Indirect) for the twelve months ending 31 December 2020 at 243 Kt (-6 /-2.4% y-o-y) and aims to reach net zero emissions by 2027.

Controversies
The Los Angeles Times reported on December 18, 2012, that Amgen pleaded guilty and agreed to pay $150 million in criminal penalty and $612 million to resolve 11 related whistleblower complaints. Federal prosecutors accused the company of pursuing profits while putting patients at risk. Larry Husten, a contributor at Forbes.com elaborates on AMGEN's illegal marketing practices in this case, namely that the "government accused Amgen of marketing Aranesp for indications not approved by the FDA and other illegal marketing practices".

Public-private engagement
Amgen engages with the public and private sectors in a variety of settings including to promote research and development, academic funding, event sponsorship, philanthropy, and political lobbying.

Academia

 * Institute for Advanced Study - Donor to various IAS campaigns, including the IAS/Park City Mathematics Institute (PCMI), the Regional Initiative in Science and Education (RISE), and the Opportunity Equation (OE).
 * LA Promise Fund - Sponsor of the Amgen Biotech Experience Los Angeles (ABE-LA).
 * University of Toronto - Donor to U of T's Boundless campaign.
 * University of Washington - Donor.

Events and conferences

 * Alberta Kidney Days - Virtual series sponsor.
 * BC Kidney Days - Sponsor.
 * Mentoring in IBD - Sponsor.
 * Princess Margaret Cancer Centre (PMCC) Conference - Sponsor.

Health care

 * Kingston General Hospital - Donor.
 * Princess Margaret Cancer Centre - Donor to the Princess Margaret Cancer Foundation.
 * Providence Health Care - Donor.
 * Scarborough Health Network - Donor to the SHN Foundation.
 * SickKids - Donor to the SickKids Foundation.
 * Sinai Health System - Donor to the Sinai Health Foundation.
 * St. Michael's Hospital - Donor.
 * Sunnybrook Health Sciences Centre - Donor to the Sunnybrook Foundation.
 * Unity Health Toronto - Donor.
 * University Health Network - Donor to the UHN Foundation.
 * Women's College Hospital - Donor.

Media

 * National Geographic Society - Donor.

Medical societies

 * American Society of Hematology - Corporate funder.
 * Arthritis Society (Canada) - Partner.
 * Canadian Society of Hospital Pharmacists - Donor to the CSHP Foundation.
 * Canadian Society of Nephrology - Corporate partner.
 * Endocrine Society - Corporate liaison board member.
 * European Society of Cardiology - Sponsor for the EORP registry programme.
 * Federation of Medical Women in Canada - Sponsor.

Political lobbying

 * Alliance for a Stronger FDA - Member.
 * Alliance for Aging Research - Donor.
 * BIOTECanada - Member.
 * Bipartisan Policy Center - Donor.
 * The Business Council - Member, represented by Amgen chairman and CEO Robert A. Bradway.
 * CDC Foundation - Funding partner.
 * Centre for Commercialization of Regenerative Medicine (CCRM) - Industry partner.
 * Council on Foreign Relations - Affiliate.
 * European Federation of Pharmaceutical Industries and Associations (EFPIA) - Member.
 * Foundation for the National Institutes of Health (FNIH) - Donor.
 * Global Health Progress - Partner. GHP is a multinational resource hub hosted by the International Federation of Pharmaceutical Manufacturers & Associations (IFPMA).
 * Health Products Stewardship Association - Member.
 * Innovative Medicines Canada - Member company.
 * International Federation of Pharmaceutical Manufacturers & Associations (IFPMA) - Member.
 * Life Sciences British Columbia - Sponsor.
 * Mayor's Fund for Los Angeles - Disaster relief grant provider.
 * National Health Council - Member.
 * Personalized Medicine Coalition - Member.
 * Pharmaceutical Advertising Advisory Board (PAAB) - Client. PAAB "maintains a collaborative relationship” with Health Canada.
 * Pharmaceutical Research and Manufacturers of America (PhRMA) - Member.
 * Reagan-Udall Foundation for the Food and Drug Administration - Donor.
 * Research!America - Member.

Professional associations

 * British Columbia Pharmacy Association - Sponsor.
 * Canadian Association of Gastroenterology - Corporate sponsor.
 * Canadian Association of Radiologists - Corporate partner.
 * Canadian Rheumatology Association - Corporate sponsor.
 * Canadian Urological Association - Corporate sponsor.
 * Colorectal Cancer Canada - Sponsor.
 * Ontario Medical Association - Donor.

Research and development

 * Alberta Kidney Disease Network - Grant provider.
 * Can-SOLVE CKD Network - Funding partner.
 * Urban Institute - Donor.

Awards and recognition
Amgen was ranked 123 on the Fortune 500 list of the largest United States corporations by revenue in 2018.