Tim Wright, Editor, Contract Pharma07.20.20
Headquarters: Thousand Oaks, CA
twitter.com/Amgen
www.amgen.com
Headcount: 22,000
Year Established: 1980
Revenues: $23,362 (-2%)
Net Income: $7,842 (-7%)
R&D: $4,116 (+10%)
TOP SELLING DRUGS
In 2019, Amgen’s newer drugs continued to drive growth, though not enough to offset revenues falling 2% to $23.4 billion. To bolster its portfolio, Amgen executed a major deal during the year to expand its inflammation franchise when it agreed to pay $13.4 billion for Celgene’s Otezla (apremilast), the only oral, non-biologic treatment for psoriasis and psoriatic arthritis. Amgen said that the acquisition is a strong strategic fit with its inflammation franchise offering a differentiated, oral therapy, along with Otezla’s sales growth potential over the next five years. Sales of Otezla in 2018 were $1.6 billion.
Otezla is currently approved for three indications in the U.S., including patients with moderate-to-severe plaque psoriasis who are candidates for phototherapy or systemic therapy; adult patients with active psoriatic arthritis; and adult patients with oral ulcers associated with Behçet's Disease. Otezla is approved in more than 50 markets outside the U.S., including the EU and Japan, and has patent exclusivity through at least 2028 in the U.S.
More positive news was reported in 2019 when Amgen launched Evenity, the first and only osteoporosis treatment that both increases bone formation and reduces bone loss, thereby rapidly reducing the risk of fracture.
China expansion plans unfold
Amgen made its intentions clear to expand in China when it entered into a strategic collaboration with BeiGene that will significantly accelerate its expansion plans in the country. BeiGene is a research-based, oncology-focused biotechnology company with an established and experienced team in China, including a 700-person commercial organization and a 600-person clinical development organization. As part of the collaboration Amgen paid $2.7 billion for a 20.5% stake in BeiGene.
Under the agreement, BeiGene will commercialize Xgeva, Kyprolis and Blincyto in China during which time the parties will equally share profits and losses. Two of these products will revert to Amgen, one after five years and one after seven years. Following the commercialization period, BeiGene will have the right to retain one product and will be entitled to receive royalties on sales in China for an additional five years on the products not retained. Xgeva was launched in China in September of 2019; Kyprolis and Blincyto are both in Phase 3 trials in China.
The two companies will collaborate to advance 20 medicines from Amgen's innovative oncology pipeline in China and globally. BeiGene will share global research and development costs and contribute up to $1.25 billion to advance these medicines. Amgen will pay royalties to BeiGene on sales of these products outside of China, with the exception of AMG 510, Amgen's first-in-class KRASG12C inhibitor that is being studied as a potential treatment for solid tumors.
Of the 20 oncology medicines, BeiGene will assume commercial rights in China for seven years after launch for those that receive approval in China, including AMG 510. After this time, BeiGene will retain rights to up to six of these products in China, excluding AMG 510, while rights on remaining products revert to Amgen.
Amgen will continue to commercialize its non-oncology product portfolio in China. Earlier this year, Amgen launched its first-ever product in China, Repatha, an LDL cholesterol-lowering treatment proven to reduce the risk of heart attacks and stroke. Amgen expects to launch a number of other non-oncology medicines in China over the next several years, including Prolia, which reduces the risk of fracture in postmenopausal women with osteoporosis.
Xgeva, Kyprolis and Blincyto, as well as the medicines in Amgen's oncology pipeline, will be manufactured at Amgen's existing facilities.
Drug discovery and research
To boost its drug discovery platform, in 2019 Amgen acquired Copenhagen, Denmark-based Nuevolution, for $167 million. Now called Amgen Research Copenhagen, the company has developed Chemetics, a pioneering technology in the emerging field of DNA-encoded libraries. In a DNA-encoded library, each compound is tagged with a unique sequence of DNA that functions like a barcode, and mixtures containing billions of unique DNA-tagged compounds can be screened in a single small test tube, according to the company.
In a research collaboration, Amgen and Syapse, a precision medicine insight company, entered a partnership to develop observational research analytics to assess treatment outcomes for areas of unmet need in oncology.
This effort aims to identify existing patients within the Syapse Learning Health Network that could be eligible for Amgen-sponsored clinical trials and to bring these trials to community health system sites. The companies will create opportunities for physicians and researchers within the Syapse Network to gain access to analytics, real-world evidence-based insights, and collaborative research opportunities.
Amgen will have access to real-world evidence for potential use in regulatory filings in support of certain agreed upon development candidates in oncology. Amgen will also work with Syapse to develop real-world evidence standards to support the acceleration of therapies to market.
In another research tie-up, Amgen and the University of Washington's Institute for Protein Design (IPD) entered a broad collaboration that will cover multiple projects with a goal of testing new technologies and creating protein-building approaches that can be broadly applied to drug research.
This will include optimizing Amgen's repertoire of BiTE (bispecific T cell engager) antibodies, with the goal of expanding the types of tumors that can be targeted with these molecules. IPD's expertise could also help Amgen to generate antibodies against very challenging drug targets and to devise new ways to modulate the activity of the immune system. In the longer-term, the broad-based collaboration could help shape the discovery and development of protein-based therapies.
To further enhance its R&D capabilities, at the end of the year, Amgen signed a lease with BioMed Realty for a new 240,000-square-foot Leadership in Energy and Environmental Design (LEED) candidate facility in the Gateway of Pacific campus development in South San Francisco. The new location, currently under construction at Oyster Point, will house Amgen's Bay Area employees focused on cardiometabolic, inflammation and oncology, research. The new site will include modular green wet labs and green molecular lab design and is scheduled to open in early 2022.
twitter.com/Amgen
www.amgen.com
Headcount: 22,000
Year Established: 1980
Revenues: $23,362 (-2%)
Net Income: $7,842 (-7%)
R&D: $4,116 (+10%)
TOP SELLING DRUGS
| Drug | Indication | 2019 Sales | (+/-%) |
| Enbrel | rheumatoid arthritis | $5,226 | 4% |
| Neulasta | chemotherapy induced neutropenia | $3,221 | -28% |
| Prolia | bone cancer | $2,672 | 17% |
| Xgeva | bone cancer | $1,935 | 8% |
| Aranesp | chemotherapy induced anemia | $1,729 | -8% |
| Kyprolis | multiple myeloma | $1,044 | % |
| Epogen | anemia | $867 | -14% |
| Nplate | immune thromboytopenia | $795 | 11% |
| Vectibix | colorectal cancer | $744 | 8% |
| Repatha | hypercholesterolaemia | $661 |
20% |
In 2019, Amgen’s newer drugs continued to drive growth, though not enough to offset revenues falling 2% to $23.4 billion. To bolster its portfolio, Amgen executed a major deal during the year to expand its inflammation franchise when it agreed to pay $13.4 billion for Celgene’s Otezla (apremilast), the only oral, non-biologic treatment for psoriasis and psoriatic arthritis. Amgen said that the acquisition is a strong strategic fit with its inflammation franchise offering a differentiated, oral therapy, along with Otezla’s sales growth potential over the next five years. Sales of Otezla in 2018 were $1.6 billion.
Otezla is currently approved for three indications in the U.S., including patients with moderate-to-severe plaque psoriasis who are candidates for phototherapy or systemic therapy; adult patients with active psoriatic arthritis; and adult patients with oral ulcers associated with Behçet's Disease. Otezla is approved in more than 50 markets outside the U.S., including the EU and Japan, and has patent exclusivity through at least 2028 in the U.S.
More positive news was reported in 2019 when Amgen launched Evenity, the first and only osteoporosis treatment that both increases bone formation and reduces bone loss, thereby rapidly reducing the risk of fracture.
China expansion plans unfold
Amgen made its intentions clear to expand in China when it entered into a strategic collaboration with BeiGene that will significantly accelerate its expansion plans in the country. BeiGene is a research-based, oncology-focused biotechnology company with an established and experienced team in China, including a 700-person commercial organization and a 600-person clinical development organization. As part of the collaboration Amgen paid $2.7 billion for a 20.5% stake in BeiGene.
Under the agreement, BeiGene will commercialize Xgeva, Kyprolis and Blincyto in China during which time the parties will equally share profits and losses. Two of these products will revert to Amgen, one after five years and one after seven years. Following the commercialization period, BeiGene will have the right to retain one product and will be entitled to receive royalties on sales in China for an additional five years on the products not retained. Xgeva was launched in China in September of 2019; Kyprolis and Blincyto are both in Phase 3 trials in China.
The two companies will collaborate to advance 20 medicines from Amgen's innovative oncology pipeline in China and globally. BeiGene will share global research and development costs and contribute up to $1.25 billion to advance these medicines. Amgen will pay royalties to BeiGene on sales of these products outside of China, with the exception of AMG 510, Amgen's first-in-class KRASG12C inhibitor that is being studied as a potential treatment for solid tumors.
Of the 20 oncology medicines, BeiGene will assume commercial rights in China for seven years after launch for those that receive approval in China, including AMG 510. After this time, BeiGene will retain rights to up to six of these products in China, excluding AMG 510, while rights on remaining products revert to Amgen.
Amgen will continue to commercialize its non-oncology product portfolio in China. Earlier this year, Amgen launched its first-ever product in China, Repatha, an LDL cholesterol-lowering treatment proven to reduce the risk of heart attacks and stroke. Amgen expects to launch a number of other non-oncology medicines in China over the next several years, including Prolia, which reduces the risk of fracture in postmenopausal women with osteoporosis.
Xgeva, Kyprolis and Blincyto, as well as the medicines in Amgen's oncology pipeline, will be manufactured at Amgen's existing facilities.
Drug discovery and research
To boost its drug discovery platform, in 2019 Amgen acquired Copenhagen, Denmark-based Nuevolution, for $167 million. Now called Amgen Research Copenhagen, the company has developed Chemetics, a pioneering technology in the emerging field of DNA-encoded libraries. In a DNA-encoded library, each compound is tagged with a unique sequence of DNA that functions like a barcode, and mixtures containing billions of unique DNA-tagged compounds can be screened in a single small test tube, according to the company.
In a research collaboration, Amgen and Syapse, a precision medicine insight company, entered a partnership to develop observational research analytics to assess treatment outcomes for areas of unmet need in oncology.
This effort aims to identify existing patients within the Syapse Learning Health Network that could be eligible for Amgen-sponsored clinical trials and to bring these trials to community health system sites. The companies will create opportunities for physicians and researchers within the Syapse Network to gain access to analytics, real-world evidence-based insights, and collaborative research opportunities.
Amgen will have access to real-world evidence for potential use in regulatory filings in support of certain agreed upon development candidates in oncology. Amgen will also work with Syapse to develop real-world evidence standards to support the acceleration of therapies to market.
In another research tie-up, Amgen and the University of Washington's Institute for Protein Design (IPD) entered a broad collaboration that will cover multiple projects with a goal of testing new technologies and creating protein-building approaches that can be broadly applied to drug research.
This will include optimizing Amgen's repertoire of BiTE (bispecific T cell engager) antibodies, with the goal of expanding the types of tumors that can be targeted with these molecules. IPD's expertise could also help Amgen to generate antibodies against very challenging drug targets and to devise new ways to modulate the activity of the immune system. In the longer-term, the broad-based collaboration could help shape the discovery and development of protein-based therapies.
To further enhance its R&D capabilities, at the end of the year, Amgen signed a lease with BioMed Realty for a new 240,000-square-foot Leadership in Energy and Environmental Design (LEED) candidate facility in the Gateway of Pacific campus development in South San Francisco. The new location, currently under construction at Oyster Point, will house Amgen's Bay Area employees focused on cardiometabolic, inflammation and oncology, research. The new site will include modular green wet labs and green molecular lab design and is scheduled to open in early 2022.
