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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.
April 8, 1980
Amgen was founded by George Rathmann.

Products

Acquisitions

Invested in

Patents

Funding Rounds Participated In

Further Resources

Title
Author
Link
Type
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Amgen featured in Nasdaq's 2021 Innovation Realized Series

Web

November 3, 2021

Fast Facts About the Regulatory Approval Pathway for Biosimilars - Amgen Science

Web

January 4, 2022

News

Title
Author
Date
Publisher
Description
Nick Paul
October 4, 2021
FierceBiotech
When Amgen splashed $400 million upfront on Kyowa Kirin's anti-OX40 antibody, the world was yet to see midphase data on the prospect. Amgen and Kyowa lifted the lid on the data over the weekend in a presentation of phase 2 results in eczema patients.
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.
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References

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