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Amgen

Amgen

Amgen Inc. (formerly Applied Molecular Genetics Inc.) is an American multinational biopharmaceutical company founded in 1980 with headquarters in Thousand Oaks, California.

Amgen works in discovery, development and manufacturing of human therapeutics for treatment of illnesses in the areas of oncology, hematology, cardiovascular disease, inflammation, bone health, nephrology and neuroscience.

Products

Amgen’s products include the following: Neulasta (pegfilgrastim); erythropoiesis-stimulating agents (ESAs), such as Aranesp (darbepoetin alfa) and EPOGEN (epoetin alfa); Sensipar/Mimpara (cinacalcet); XGEVA (denosumab); Prolia (denosumab); NEUPOGEN (filgrastim), and other marketed products, such as KYPROLIS (carfilzomib), Vectibix (panitumumab), Nplate (romiplostim), Repatha (evolocumab), BLINCYTO (blinatumomab), IMLYGIC (talimogene laherparepvec) and Corlanor (ivabradine)and Aimovig.

The top protein-based therapeutics include Neulasta, Neupogen, Aranesp, Epogen and Enbrel. ENBREL is on the market in the United States to treat rheumatoid arthritis, plaque psoriasis and psoriatic arthritis. Neulasta treats people receiving chemotherapy to reduce infection. Aranesp and EPOGEN are used to treat anemia in different circumstances including chronic kidney disease. Cinacalcet (Sensipar in US and Mimpara in Europe) is used for secondary hyperparathyroidism with chronic kidney disease. XGEVA is for prevention of skeletal related events in patients with bone metastases from solid tumors. Prolia is used to treat postmenopausal women with osteoporosis at risk of fracture . NEUPOGEN is a recombinant-methionyl human granulocyte colony-stimulating factor (G-CSF) to reduce chance of infection due to low white blood cell count for cancer patients receiving chemotherapy . Aimovig was FDA approved in 2018 and will be marketed in partnership with Novartis as a drug to prevent migraines .

Clinical Trials

The following Amgen therapeutics are candidates in Phase III clinical trials: Erenumab for episodic migraine; Aranesp for myelodysplastic syndromes; BLINCYTO for acute lymphoblastic leukemia (ALL); ENBREL for psoriatic arthritis and rheumatoid arthritis remission; IMLYGIC for metastatic melanoma; Kyprolis for multiple myeloma; Prolia for glucocorticoid-induced osteoporosis; Repatha for hyperlipidemia; XGEVA for delay or prevention of bone metastases in breast cancer and also for the treatment of cancer-related bone damage in patients with multiple myeloma; Vectibix for metastatic colorectal cancer (mCRC); Omecamtiv mecarbil for chronic heart failure, and EVENITY for postmenopausal osteoporosis and male osteoporosis.

The following Amgen therapeutics are candidates in Phase II clinical trials: BLINCYTO for diffuse Large B-Cell Lymphoma (DLBCL) and relapsed/refractory Philadelphia positive (R/R Ph+) and minimal residual disease of ALL; Erenumab for Chronic migraine; AMG 157 for asthma and atopic dermatitis; AMG 520 for Alzheimer's disease, and AMG 899 for dyslipidemia.

The following Amgen therapeutics are candidates in Phase I clinical trials: IMLYGIC for various cancer types; KYPROLIS for small-cell lung cancer; Oprozomib for multiple myeloma; AMG 176 for various cancer types; AMG 211 for various cancer types; AMG 224 for multiple myeloma, and AMG 301 for migraine. The Company's product candidates in Phase I also include AMG 330 for acute myeloid leukemia; AMG 420 for multiple myeloma; AMG 557 for systemic lupus erythematosus; AMG 570 for systemic lupus erythematosus; AMG 592 for inflammatory diseases; AMG 820 for various cancer types, and AMG 986 for heart failure.

Autoimmune disease

The approved drug Otezla (apremilast), acquired from Celgene in 2019, is a notable therapeutic in Amgen’s autoimmune portfolio. Otezla is for treatment of moderate-to-severe plaque psoriasis and psoriatic arthritis.

Amgen is partnered with EVOQ Therapeutics for license and collaboration to discover and develop drugs for autoimmune disorders.

Timeline

December 22, 2020
Amgen and Medicines Development for Global Health (MDGH) announces that the companies have entered into a license agreement for AMG 634, a phosphodiesterase type 4 (PDE4) inhibitor being investigated for the treatment of tuberculosis (TB) and erythema nodosum leprosum (ENL), an inflammatory cutaneous and systemic complication of leprosy.
November 23, 2020
Amgen announces it has provided notice to Cytokinetics of termination of its collaboration and its intention to transition the development and commercialization rights for omecamtiv mecarbil and AMG 594.

November 9, 2020
Amgen and AstraZeneca announce positive topline results from the Phase 3 NAVIGATOR trial in which the investigational medicine tezepelumab demonstrated a statistically significant reduction in exacerbations compared to placebo in patients with severe asthma.

2019
Amgen acquires AMG 634 (formerly CC-11050) as part of its acquisition of Otezla® (apremilast) from Celgene.

Acquisitions

People

Name
Role
LinkedIn

Abid AZAM

Employee

Adam Hardin

Employee

Aditya Nag

Employee

aditya narula

Employee

Ahilaa Kamuthurai

Employee

AKASH ARYA

Employee

Alan Jamijian

Employee

Albert Hidayat

Employee

Alberto Chan

Employee

Alejandro Diaz

Employee

Alekhya Narni

Employee

Aleksander Malinowski

Employee

Alessandro Seveso

Employee

Alex Marzo

Employee

Alex Roman

Employee

Alex Shoshitaishvili

Employee

Alexander Julian Veach

Employee

Alfonso Kondo

Employee

Alfredo Zambonini

Employee

Alice Augustine

Employee

Alina Karimova

Employee

Alix Taffle

Employee

Allen Walker

Employee

Allison S

Employee

Alok Gandhi

Employee

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Further reading

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Documentaries, videos and podcasts

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Companies

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News

Title
Author
Date
Publisher
Description
Kyle LaHucik
September 24, 2021
FierceBiotech
After about a year at Roivant Sciences, Roger Sidhu, M.D., is headed for the exit to take up the chief medical officer post at a smaller biotech, Brooklyn ImmunoTherapeutics.
Nick Paul
September 17, 2021
FierceBiotech
Mirati Therapeutics has spent 2021 watching Amgen blast past it to win the race to bring a KRAS drug to market in lung cancer. Yet, with Amgen's Lumakras underwhelming in colorectal cancer, Mirati still has a shot at carving out a niche. The small biotech rocked up to this year's European Society of Medical Oncology congress with data to make its case.
Annalee Armstrong
September 9, 2021
FierceBiotech
Amgen has already won the KRAS race by getting Lumakras across the finish line, but Cardiff Oncology has just rolled out some early data for a follow-on candidate showing partial responses and extended survival without disease progression compared to standard of care.
Nick Paul
September 7, 2021
FierceBiotech
Piece by piece, Amgen and AstraZeneca are building the case for their potential asthma blockbuster. The latest brick to fall into place comes from a new slice of phase 3 data, which suggests tezepelumab may be particularly effective in a subgroup of severe asthma patients.
Kyle LaHucik
August 26, 2021
FierceBiotech
DiCE Molecules raised $60 million in a series C extension on Tuesday. The next day, the eight-year-old preclinical biotech filed for an initial public offering to take its oral small-molecule therapeutics into the clinic.
Nick Paul
August 4, 2021
FierceBiotech
Amgen has stopped enrolling acute myeloid leukemia patients in a phase 1 clinical trial of its FLT3 bispecific T-cell engager (BiTE). News of the stoppage comes months after Amgen hit pause on a clutch of other BiTE clinical trials.
Ben Adams
July 28, 2021
FierceBiotech
Just two months after getting a swift approval for its closely watched KRAS lung cancer drug Lumakras, Amgen is not resting on its laurels and has penned a major new buyout deal to further boost its oncology pipeline.
Ben Adams
July 19, 2021
FierceBiotech
Topline midstage data out of Cytokinetics, under pressure to perform after losing a Big Pharma partner and after recent setbacks, is good enough for the biotech to kickstart a phase 3 later this year.
Mark Terry
July 9, 2021
BioSpace
BioSpace's Pharm Country Hotbed ranges from Connecticut, New York, New Jersey, Pennsylvania and Rhode Island.
July 8, 2021
WebWire
AstraZeneca's Biologics License Application (BLA) for tezepelumab has been accepted and granted Priority Review for the treatment of asthma from the US Food and Drug Administration (FDA). Tezepelumab is being developed by AstraZeneca in collaboration with Amgen. The FDA grants Priority Review to applications for medicines that offer significant advantages over available options by demonstrating safety or efficacy improvements, preventing serious conditions, or enhancing patient compliance...
Nick Paul
July 8, 2021
FierceBiotech
The FDA has granted a priority review to asthma drug candidate tezepelumab, teeing Amgen and AstraZeneca up to win approval for the thymic stromal lymphopoietin inhibitor in the first quarter.
Kyle LaHucik
July 6, 2021
FierceBiotech
Amgen has hired Jean-Charles Soria, M.D., Ph.D., to lead its oncology therapeutic area as a senior vice president after he served in a similar role at AstraZeneca from 2017 to 2020.
Brandon May
June 29, 2021
BioSpace
Major players in the biotech industry are targeting Ohio for their new facilities, including Amgen, which recently dropped $365 million on a "digitally advanced" smart facility just 15 miles outside the state's capital.
Annalee Armstrong
June 28, 2021
FierceBiotech
The FDA is launching Project Optimus from the FDA's Oncology Center of Excellence, which will develop guidelines for cancer drug makers to test a wider range of doses early in development. At least two companies--Amgen and Kura Therapeutics--have already experienced the new program firsthand. Both say they were ready. Investors, on the other hand, were not.
Kyle LaHucik
June 25, 2021
FierceBiotech
Mirati Therapeutics might've missed out on KRAS gold to Amgen, but the biotech is gaining ground with a breakthrough therapy designation for adagrasib in non-small cell lung cancer.
BioSpace
June 23, 2021
BioSpace
Immusoft, a cell therapy company dedicated to improving the lives of patients with rare diseases, announced today the formation of its Scientific Advisory Board (SAB) composed of world-renowned experts to provide external scientific review and high-level counsel on the Company's research and development programs.
Amgen
June 23, 2021
www.prnewswire.com:443
/PRNewswire/ -- Amgen (NASDAQ:AMGN) today announced that the Japanese Ministry of Health, Labour and Welfare has granted marketing approval for Aimovig®...
Research and Markets
June 18, 2021
www.prnewswire.com:443
/PRNewswire/ -- The "Regenerative Medicine Market - Global Outlook and Forecast 2021-2026" report has been added to ResearchAndMarkets.com's offering. The...
June 8, 2021
BioSpace
Karyopharm Announces Key Changes to Its Commercial Leadership Team - read this article along with other careers information, tips and advice on BioSpace
Karyopharm Therapeutics Inc.
June 8, 2021
www.prnewswire.com:443
/PRNewswire/ -- Karyopharm Therapeutics Inc. (Nasdaq:KPTI), a commercial-stage pharmaceutical company pioneering novel cancer therapies, today announced key...
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References

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