07.16.21
Headquarters: Thousand Oaks, CA
twitter.com/Amgen
www.amgen.com
Headcount: 24,000
Year Established: 1886
Pharma Revenues: $25,424 (+9%)
Net Income: $7,264 (-7%)
R&D: $4,085 (+7%)
TOP SELLING DRUGS
2020 was a successful year for Amgen, with growth for many newer medicines, including cholesterol treatment Repatha (+34%), migraine therapy Aimovig (+24%), and osteoporosis drug EVENITY (+85%). Product sales increased 9% for the year driven by 15% volume growth. Sales in the U.S. grew 9%, sales outside the U.S. grew 10%, and revenues in the Asia-Pacific region exceeded $1 billion for the first time.
Also adding significant revenue, Amgen integrated Otezla, which was acquired from Celgene in November 2019, strengthening its leadership position in inflammation. Otezla generated sales of $2.2 billion in 2020 and it’s expected to be strong growth driver for several years to come.
With four Amgen biosimilars now available, biosimilars sales grew to $1.7 billion. The most recent addition RIABNI, was approved in the U.S. in December 2020 as a biosimilar to Roche’s cancer drug Rituxan. Three additional biosimilars are in Phase 3 development.
Amgen has high hopes for two products in particular, sotorasib for non-small cell lung cancer and tezepelumab for severe asthma. Sotorasib holds a great deal of promise in treating non-small cell lung cancer and other solid tumors harboring the KRASG12C mutation. Until now, KRASG12C protein was long considered an “undruggable” target. Additionally, tezepelumab is a potential first-in-class human monoclonal antibody that targets a protein associated with multiple inflammatory cascades critical in the initiation and persistence of airway inflammation associated with severe asthma. Unlike existing treatments, tezepelumab is the first biologic shown to consistently and significantly reduce exacerbations in a broad population of severe asthma patients.
In 2020, Amgen and AstraZeneca updated their 2012 collaboration agreement for tezepelumab and will continue to share costs and profits equally after AstraZeneca pays an inventor royalty to Amgen.
In a big win for Amgen, last July, the U.S. Court of Appeals for the Federal Circuit held in Amgen's favor on the validity of two Enbrel patents and methods for making it.
Investment endeavors
This past March, Amgen entered an agreement to acquire Five Prime Therapeutics for approximately $1.9 billion, expanding its oncology portfolio with Five Prime's lead asset, bemarituzumab, a first-in-class, Phase 3 ready anti-FGFR2b antibody with positive Phase 2 results in advanced gastric cancer. Bemarituzumab targets FGFR2b, which has been found to be overexpressed in approximately 30% of patients with non-HER2 positive gastric cancer, as well as other solid tumors. This correlation suggests that FGFR2b could play a role in other epithelial cancers, including lung, breast, ovarian and other cancers.
The acquisition also supports Amgen's international expansion strategy. Gastric cancer is one of the world's most common forms of cancer and is particularly prevalent in the Asia-Pacific region, where Amgen plans to leverage its presence in Japan and other Asia-Pacific markets to maximize bemarituzumab's potential.
Amgen previously had purchased from Astellas 49% of shares of Amgen Astellas BioPharma K.K. (AABP), a joint venture between the companies dating back to 2013. AABP is now a wholly-owned Amgen affiliate in Japan renamed Amgen K.K. and established Amgen’s presence in the country.
Also this past March, for a $55 million upfront and future milestones potentially worth an additional $666 million, Amgen acquired Rodeo Therapeutics, a biopharmaceutical company based in Seattle that develops small-molecule therapies designed to promote regeneration and repair of multiple tissues. Rodeo's 15-PGDH program expands Amgen's inflammation portfolio and efforts to develop first-in-class therapeutics. Rodeo's lead 15-prostaglandin dehydrogenase (15-PGDH) modulators have generated compelling data in preclinical studies and have clinical potential in multiple indications.
Back in July, Amgen made an additional investment of approximately $421 million in BeiGene, which maintains Amgen's current ownership of BeiGene of approximately 20%. This additional investment reflects Amgen's confidence in the progress the companies are making in their ongoing oncology collaboration in China.
R&D
Several assets advanced this past year with a key approval for Lumakras, in addition to late-stage pipeline assets that include several potential new medicines in Phase 2 development for the treatment of atherosclerosis, systemic lupus erythematosus, and celiac disease.
The FDA recently approved Amgen's KRAS-blocking drug Lumakras (sotorasib) for patients with advanced lung cancer. The drug is the first medicine approved to target the KRAS gene, which is frequently mutated in lung, colon and pancreatic cancers. Decades of research went into developing treatments that block the mutated gene's effects, and now those efforts have proved successful.
Amgen and partner AstraZeneca recently submitted a Biologics License Application to the FDA for tezepelumab in severe asthma. The submission is supported by positive clinical trial results which demonstrated a statistically significant and clinically meaningful reduction in the annualized asthma exacerbation rate in patients with severe, uncontrolled asthma compared to placebo.
Meanwhile, Amgen's investigational targeted treatment Bemarituzumab was granted breakthrough therapy designation as first-line targeted therapy for tumors that overexpress FGFR2b in gastric and gastroesophageal junction cancers, in combination with modified FOLFOX6, based on an FDA-approved companion diagnostic. Following sotorasib, bemarituzumab was the second Amgen oncology asset to receive the designation in the past six months.
Amgen and Kyowa Kirin Co. partnered to develop and commercialize KHK4083, Kyowa Kirin's potential first-in-class, Phase 3-ready anti-OX40 fully human monoclonal antibody in development for the treatment of atopic dermatitis, with potential in other autoimmune diseases. KHK4083 has been shown to selectively deplete activated T cells that are critical in the development of atopic dermatitis. Amgen will lead the development, manufacturing, and commercialization for KHK4083 for all markets globally, except Japan. Amgen paid $400 million upfront and will pay up to an additional $850 million in potential milestones. Amgen will leverage unique data from its deCODE Genetics subsidiary for the potential use of KHK4083 in other indications.
In other asset news, Amgen and Medicines Development for Global Health (MDGH), entered a license agreement for AMG 634, a phosphodiesterase type 4 (PDE4) inhibitor being investigated in Phase 2 trials for the treatment of tuberculosis (TB) and erythema nodosum leprosum, an inflammatory skin and systemic complication of leprosy. Amgen had acquired AMG 634 as part of its acquisition of Otezla from Celgene in 2019. MDGH will assume full responsibility for the further development and commercialization of AMG 634.
Lastly, Amgen terminated its collaboration with Cytokinetics and transitioned the development and commercialization rights for omecamtiv mecarbil and AMG 594 to Cytokinetics. Omecamtiv mecarbil, an investigational selective cardiac myosin activator, is being studied chronic heart failure, and AMG 594, a novel mechanism selective cardiac troponin activator, is in Phase 1 development other types of heart failure.
COVID efforts
An alliance with the Global Coalition for Adaptive Research (GCAR) and Lilly aims to support global COVID efforts. The collaboration with GCAR and Eisai Co., Ltd. is studying the immune modulation in COVID, testing multiple interventions for the treatment of patients hospitalized with COVID-19. Amgen's apremilast and Eisai's investigational eritoran are being evaluated as potential therapeutic agents.
Amgen’s apremilast is an oral drug which inhibits the activity of PDE4 (Phosphodiesterase 4), an enzyme found in inflammatory cells. By inhibiting PDE4, apremilast is thought to modulate the production of inflammatory cytokines and other mediators, which may prove helpful in inhibiting the inflammatory response associated with the signs, symptoms and pulmonary involvements observed in some COVID-19 patients. Apremilast is currently approved for use in more than 45 countries as an oral treatment for inflammatory diseases including moderate to severe plaque psoriasis, psoriatic arthritis and oral ulcers associated with Behcet’s disease.
Finally, a global antibody manufacturing collaboration with Eli Lilly and Co. aims to significantly increase the supply capacity available for Lilly's COVID-19 therapies Bamlanivimab and Etesevimab, which were recently authorized by the FDA under an Emergency Use Authorization. Through this collaboration, the two companies will have the ability to quickly scale up production and serve more patients globally.
twitter.com/Amgen
www.amgen.com
Headcount: 24,000
Year Established: 1886
Pharma Revenues: $25,424 (+9%)
Net Income: $7,264 (-7%)
R&D: $4,085 (+7%)
TOP SELLING DRUGS
Drug | Indication | 2020 Sales | (+/-%) |
Enbrel | rheumatoid arthritis | $4,996 | -4% |
Prolia | bone cancer | $2,763 | 3% |
Neulasta | chemotherapy induced neutropenia | $2,293 | -29% |
Otezla | psoriasis | $2,195 | n/a |
Xgeva | bone cancer | $1,899 | -2% |
Aranesp | chemotherapy induced anemia | $1,568 | -9% |
Kyprolis | multiple myeloma | $1,065 | 2% |
Repatha | hypercholesterolaemia, hyperlipidaemia, myocardial infarction, stroke prophylaxis | $887 | 34% |
Nplate | immune thromboytopenia | $850 | 7% |
Vectibix | colorectal cancer | $811 | 9% |
2020 was a successful year for Amgen, with growth for many newer medicines, including cholesterol treatment Repatha (+34%), migraine therapy Aimovig (+24%), and osteoporosis drug EVENITY (+85%). Product sales increased 9% for the year driven by 15% volume growth. Sales in the U.S. grew 9%, sales outside the U.S. grew 10%, and revenues in the Asia-Pacific region exceeded $1 billion for the first time.
Also adding significant revenue, Amgen integrated Otezla, which was acquired from Celgene in November 2019, strengthening its leadership position in inflammation. Otezla generated sales of $2.2 billion in 2020 and it’s expected to be strong growth driver for several years to come.
With four Amgen biosimilars now available, biosimilars sales grew to $1.7 billion. The most recent addition RIABNI, was approved in the U.S. in December 2020 as a biosimilar to Roche’s cancer drug Rituxan. Three additional biosimilars are in Phase 3 development.
Amgen has high hopes for two products in particular, sotorasib for non-small cell lung cancer and tezepelumab for severe asthma. Sotorasib holds a great deal of promise in treating non-small cell lung cancer and other solid tumors harboring the KRASG12C mutation. Until now, KRASG12C protein was long considered an “undruggable” target. Additionally, tezepelumab is a potential first-in-class human monoclonal antibody that targets a protein associated with multiple inflammatory cascades critical in the initiation and persistence of airway inflammation associated with severe asthma. Unlike existing treatments, tezepelumab is the first biologic shown to consistently and significantly reduce exacerbations in a broad population of severe asthma patients.
In 2020, Amgen and AstraZeneca updated their 2012 collaboration agreement for tezepelumab and will continue to share costs and profits equally after AstraZeneca pays an inventor royalty to Amgen.
In a big win for Amgen, last July, the U.S. Court of Appeals for the Federal Circuit held in Amgen's favor on the validity of two Enbrel patents and methods for making it.
Investment endeavors
This past March, Amgen entered an agreement to acquire Five Prime Therapeutics for approximately $1.9 billion, expanding its oncology portfolio with Five Prime's lead asset, bemarituzumab, a first-in-class, Phase 3 ready anti-FGFR2b antibody with positive Phase 2 results in advanced gastric cancer. Bemarituzumab targets FGFR2b, which has been found to be overexpressed in approximately 30% of patients with non-HER2 positive gastric cancer, as well as other solid tumors. This correlation suggests that FGFR2b could play a role in other epithelial cancers, including lung, breast, ovarian and other cancers.
The acquisition also supports Amgen's international expansion strategy. Gastric cancer is one of the world's most common forms of cancer and is particularly prevalent in the Asia-Pacific region, where Amgen plans to leverage its presence in Japan and other Asia-Pacific markets to maximize bemarituzumab's potential.
Amgen previously had purchased from Astellas 49% of shares of Amgen Astellas BioPharma K.K. (AABP), a joint venture between the companies dating back to 2013. AABP is now a wholly-owned Amgen affiliate in Japan renamed Amgen K.K. and established Amgen’s presence in the country.
Also this past March, for a $55 million upfront and future milestones potentially worth an additional $666 million, Amgen acquired Rodeo Therapeutics, a biopharmaceutical company based in Seattle that develops small-molecule therapies designed to promote regeneration and repair of multiple tissues. Rodeo's 15-PGDH program expands Amgen's inflammation portfolio and efforts to develop first-in-class therapeutics. Rodeo's lead 15-prostaglandin dehydrogenase (15-PGDH) modulators have generated compelling data in preclinical studies and have clinical potential in multiple indications.
Back in July, Amgen made an additional investment of approximately $421 million in BeiGene, which maintains Amgen's current ownership of BeiGene of approximately 20%. This additional investment reflects Amgen's confidence in the progress the companies are making in their ongoing oncology collaboration in China.
R&D
Several assets advanced this past year with a key approval for Lumakras, in addition to late-stage pipeline assets that include several potential new medicines in Phase 2 development for the treatment of atherosclerosis, systemic lupus erythematosus, and celiac disease.
The FDA recently approved Amgen's KRAS-blocking drug Lumakras (sotorasib) for patients with advanced lung cancer. The drug is the first medicine approved to target the KRAS gene, which is frequently mutated in lung, colon and pancreatic cancers. Decades of research went into developing treatments that block the mutated gene's effects, and now those efforts have proved successful.
Amgen and partner AstraZeneca recently submitted a Biologics License Application to the FDA for tezepelumab in severe asthma. The submission is supported by positive clinical trial results which demonstrated a statistically significant and clinically meaningful reduction in the annualized asthma exacerbation rate in patients with severe, uncontrolled asthma compared to placebo.
Meanwhile, Amgen's investigational targeted treatment Bemarituzumab was granted breakthrough therapy designation as first-line targeted therapy for tumors that overexpress FGFR2b in gastric and gastroesophageal junction cancers, in combination with modified FOLFOX6, based on an FDA-approved companion diagnostic. Following sotorasib, bemarituzumab was the second Amgen oncology asset to receive the designation in the past six months.
Amgen and Kyowa Kirin Co. partnered to develop and commercialize KHK4083, Kyowa Kirin's potential first-in-class, Phase 3-ready anti-OX40 fully human monoclonal antibody in development for the treatment of atopic dermatitis, with potential in other autoimmune diseases. KHK4083 has been shown to selectively deplete activated T cells that are critical in the development of atopic dermatitis. Amgen will lead the development, manufacturing, and commercialization for KHK4083 for all markets globally, except Japan. Amgen paid $400 million upfront and will pay up to an additional $850 million in potential milestones. Amgen will leverage unique data from its deCODE Genetics subsidiary for the potential use of KHK4083 in other indications.
In other asset news, Amgen and Medicines Development for Global Health (MDGH), entered a license agreement for AMG 634, a phosphodiesterase type 4 (PDE4) inhibitor being investigated in Phase 2 trials for the treatment of tuberculosis (TB) and erythema nodosum leprosum, an inflammatory skin and systemic complication of leprosy. Amgen had acquired AMG 634 as part of its acquisition of Otezla from Celgene in 2019. MDGH will assume full responsibility for the further development and commercialization of AMG 634.
Lastly, Amgen terminated its collaboration with Cytokinetics and transitioned the development and commercialization rights for omecamtiv mecarbil and AMG 594 to Cytokinetics. Omecamtiv mecarbil, an investigational selective cardiac myosin activator, is being studied chronic heart failure, and AMG 594, a novel mechanism selective cardiac troponin activator, is in Phase 1 development other types of heart failure.
COVID efforts
An alliance with the Global Coalition for Adaptive Research (GCAR) and Lilly aims to support global COVID efforts. The collaboration with GCAR and Eisai Co., Ltd. is studying the immune modulation in COVID, testing multiple interventions for the treatment of patients hospitalized with COVID-19. Amgen's apremilast and Eisai's investigational eritoran are being evaluated as potential therapeutic agents.
Amgen’s apremilast is an oral drug which inhibits the activity of PDE4 (Phosphodiesterase 4), an enzyme found in inflammatory cells. By inhibiting PDE4, apremilast is thought to modulate the production of inflammatory cytokines and other mediators, which may prove helpful in inhibiting the inflammatory response associated with the signs, symptoms and pulmonary involvements observed in some COVID-19 patients. Apremilast is currently approved for use in more than 45 countries as an oral treatment for inflammatory diseases including moderate to severe plaque psoriasis, psoriatic arthritis and oral ulcers associated with Behcet’s disease.
Finally, a global antibody manufacturing collaboration with Eli Lilly and Co. aims to significantly increase the supply capacity available for Lilly's COVID-19 therapies Bamlanivimab and Etesevimab, which were recently authorized by the FDA under an Emergency Use Authorization. Through this collaboration, the two companies will have the ability to quickly scale up production and serve more patients globally.