Wikipedia

User:JZindler/sandbox-Amgen-updates

< User:JZindler

Hi there! I have a COI: Amgen is a client of my employer, Porter Novelli. Requesting some edits to this article to provide a more complete reflection of the company's history as depicted in independent, reliable sources over the years.

Lead

edit
  • Update the second mention of "Thousand Oaks, California" to just "Thousand Oaks" – not necessary to repeat the state two sentences in a row.
  • Update
Amgen's Thousand Oaks staff in 2017 numbered 5,125 (7.5% of total city employment) and included hundreds of scientists, making Amgen the largest employer in Ventura County.[1][2][3]
to
Amgen's Thousand Oaks staff in 2022 numbered approximately 5,000[4] (8.5% of total city employment)[5] and included hundreds of scientists, making Amgen the largest employer in Ventura County.[2][6] As of 2022, Amgen has approximately 24,000 staff[7] and, as of 2016, has a presence in approximately 100 countries. The company develops products in six therapeutic areas: cardiovascular disease, oncology, bone health, neuroscience, nephrology and inflammation.[8]
  • Delete
Focused on molecular biology and biochemistry, its goal is to provide a healthcare business based on recombinant DNA technology.[9]
Given that the source is more than 20 years old, I think it's fair to say this isn't the best representation of the organization's current goals.
  • Update
In 2018, the company's largest selling product lines were Neulasta, an immunostimulator used to prevent infections in patients undergoing cancer chemotherapy and Enbrel, a tumor necrosis factor blocker used in the treatment of rheumatoid arthritis and other autoimmune diseases.
to
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]
  • Update
Other products include Epogen, Aranesp, Sensipar/Mimpara, Nplate, Vectibix, Prolia and XGEVA.
to include recent products, as follows:
Other marketed products include Evenity (romosozumab-aqqg), Otezla (apremilast), Prolia (denosumab), Repatha (evolocumab), and Lumakras (sotorasib).
  • Move
Amgen sponsored the Tour of California from 2011 to 2017.[12]
from the lead into the History section.

History

edit
  • Move the following sentence from the intro into the history section as the first sentence:
Amgen was established in Thousand Oaks, California, in 1980.

Timeline

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  • Add to beginning of "1980" bullet:
Founded in Thousand Oaks, California, as Applied Molecular Genetics, Amgen was backed by a small group of venture capitalists. Its focus in early days was on recombinant DNA technology and recombinant human insulin.[13]
  • Add to end of "1980" bullet:
In October, Amgen named George Rathmann its first president and chief executive officer.[13]
  • Add:
  • 1983. On June 17, Amgen went public, selling two million common shares and raising nearly $40 million.[14][15][16] 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).[17][18]
  • 1984. In June, Amgen and Kirin formed a joint venture giving Kirin the rights to Epogen in Japan.[19]
  • 1985. Amgen researcher Larry Souza and his team cloned granulocyte colony-stimulating factor (G-CSF), leading to the development of Neupogen (filgrastim).[18][20][21]
  • 1988. In October, Gordon Binder was named CEO, succeeding George Rathmann.[22]
  • Update
  • 1989. Amgen received approval for the first recombinant human erythropoetin product, Epogen, for the treatment of anemia associated with chronic kidney failure. Epogen (also marketed by Johnson and Johnson under the tradename Procrit) would later be approved for anemia due to cancer chemotherapy, anemia due to treatment with certain HIV drugs, and for the reduction of the need for transfusions associated with surgery.[23]
to
  • 1989. Amgen received approval for the first recombinant human erythropoetin product, Epogen (epoetin alfa).[23][24]
The synopsis currently in the article doesn't reflect the product label.
  • Add:
  • 1993. In March, Amgen opened a new manufacturing facility in Puerto Rico, which later became the company's flagship manufacturing site.[25]
  • 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.[26] 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).[27]
  • Add:
  • 2000. In May, Kevin Sharer became Amgen's third CEO, following Gordon Binder's retirement.[28]
  • 2001. Aranesp received FDA approval in September.[29]
  • 2002. At the beginning of the year, the FDA approved Neulasta.[30] In July, Amgen acquired Immunex, the developer of Enbrel (etanercept).[31]
  • 2004. Sensipar (cinacalcet) was approved by the FDA.[32][33] Also, Amgen acquired Tularik, another biotechnology company, expanding the company's research and development pipeline.[34][35]
  • 2006. In April, Amgen acquired Abgenix, the developer of Vectibix (panitumumab), a treatment developed for certain patients with metastatic colorectal cancer.[36] Vectibix was approved by the FDA in September 2006.[37]
  • 2008. In August, Nplate (romiplostim) was approved by the FDA.[38][39]
  • Add:
  • Add:
  • 2012. Amgen acquired Micromet, a company focused on BiTE technology, in March.[44] In May, Kevin Sharer retired, and Robert Bradway, formerly Amgen's president and chief operating officer, became CEO.[45] In June, Amgen acquired Turkish company Mustafa Nevzat Pharmaceuticals, expanding Amgen's presence in Turkey and nearby areas.[46] In July, Amgen acquired KAI Pharmaceuticals, developer of Parsabiv (etelcalcetide).[47][48] Amgen acquired Iceland-based deCODE Genetics in December.[49] Amgen also opened an affiliate in China.[50][51]
  • 2013. In October, Amgen acquired Onyx Pharmaceuticals, developer of Kyprolis (carfilzomib).[52]
  • Add:
  • 2014. In November, construction was completed on Amgen's next-generation biomanufacturing facility in Singapore.[53] Blincyto (blinatumomab) was approved by the FDA in December.[54][55]
  • Add to beginning of "2015" bullet:
Repatha (evolocumab) was approved by the FDA in August.[56]
  • Add to end of "2015" bullet:
In October, the FDA approved Imlygic.[57]
  • Add to end of "2016" bullet:
Also in September, the FDA approved Amjevita (adalimumab-atto).[58]
  • Add to end of "2017" bullet:
The FDA approved Parsabiv in February[59] and Mvasi (bevacizumab-awwb) in September.[60] In October, the Amgen Foundation pledged $3 million to Khan Academy to support the development of free online biology lessons.[61][62]
  • Add to end of "2018" bullet:
In May, Aimovig (erenumab-aooe) was approved by the FDA.[63] Amgen began constructing a next-generation biomanufacturing plant at its West Greenwich, Rhode Island, campus in July.[64]
  • Add to beginning of "2019" bullet:
In January, Evenity (romosozumab) received approval in Japan,[65][66] followed by FDA approval in April.[67] In June, Kanjinti (trastuzumab-anns) was approved by the FDA.[68]
  • Add to end of "2019" bullet:
In December, the FDA approved Avsola (infliximab-axxq).[69]
  • Add:
  • 2020. In January, the Amgen Foundation and Harvard University debuted LabXchange, a free online science education platform.[70][71] Amgen and the Amgen Foundation announced a commitment of up to $12.5 million to support COVID-19 relief efforts in March.[72] In April, Amgen established Amgen K.K. as the company’s wholly-owned affiliate in Japan.[73][74] 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.[75] Also in July, Amgen granted an additional $3 million Khan Academy to support educational equity and science learning.[76][77] Amgen joined the Dow Jones Industrial Average on August 24, 2020.[78] In September, Amgen and Eli Lilly and Company announced a global manufacturing collaboration for COVID-19 antibody therapies.[79] 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.[80] Later that month, the FDA approved Riabni (rituximab-arrx), a biosimilar to Rituxan.[81]
  • Add to "2021" bullet, before "In July,":
The FDA approved Amgen's Lumakras in May for treatment of patients with KRAS-G12C-mutated non-small cell lung cancer.[82] In June, Amgen and Kyowa Kirin announced joint plans to develop and commercialize a treatment for atopic dermatitis.[83]
  • Add to end of "2021" bullet:
In October, Amgen and Neumora Therapeutics announced a research and development collaboration focused on novel precision therapies for certain brain diseases.[84][85] Amgen began construction on a new biomanufacturing plant in New Albany, Ohio, in November.[86] In December, the FDA approved Amgen and AstraZeneca's Tezspire (tezepelumab) for severe asthma.[87] The FDA also approved Amgen's Otezla for adults with plaque psoriasis of any severity level.[88]
  • Add to beginning of "2022" bullet:
In January, Amgen announced a research collaboration with Generate Biomedicines across multiple modalities and several therapeutic areas for up to $1.9 billion.[89][90] The company also launched a multi-target collaboration with Arrakis Therapeutics to identify novel targeted RNA degrader therapeutics.[91][92] The next month, Amgen entered a multi-year collaboration with Plexium to discover novel targeted protein degradation therapies.[93][94] Also in February, Amgen issued its first green bond to fund various environmentally friendly initiatives across the company.[95][96] The company broke ground on a new manufacturing facility in Holly Springs, North Carolina, in March.[7][97]

Acquisition history

edit

Add:

    • Otezla (apremilast) (Acq 2019)[98]
    • Rodeo Therapeutics Corporation (Acq 2021)[99]
    • Five Prime Therapeutics (Acq 2021)[100]
    • ChemoCentryx (Acq 2021)[101]

Products

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  • Add where alphabetically appropriate:

Pipeline and clinical trials

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  • Update
In December 2013, Amgen had 11 drugs in Phase III clinical trials.[103]
to
As of August 2022, Amgen had 17 clinical programs underway in Phase III, eight in Phase II, and 19 in Phase I.[104]
  • I think it makes sense to move all the info from November 2014 and March 2015 to the Timeline section, since those candidates are no longer in the pipeline. Since Aimovig's approval is mentioned earlier in the article, it might make sense to just delete it from here as well.
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.[105]
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).[106] 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.[107][108]
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.[109] Amgen also announced that it would terminate its collaboration with Cytokinetics and transition the development and commercialization rights for omecamtiv mecarbil and AMG 594.[110] 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.[111]
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.[112]

References

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  2. ^ a b Cite error: The named reference Baker, Pam 2002 Page 37 was invoked but never defined (see the help page).
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