07.15.19
Headquarters: Tokyo, Japan
twitter.com/DaiichiSankyoJP
www.daiichisankyo.com
Headcount: 14,887
Year Established: 2005
Revenues: $8,659 (flat)
Net Income: $688 (-14%)
R&D: $2,129 (+10%)
Top Selling Drugs
It was busy and transformative year for Daiichi-Sankyo, as it returns to the top 25, and 2019 is shaping up to be another year of change for the company. Daiichi recently made organizational changes to oversee strategic priorities that aim to deliver seven new molecular entities in oncology by 2025. Sunao Manabe took the helm as CEO on June 17th succeeding George Nakayama, who will continue to serve as chairman.
As part of its efforts to establish a more efficient production system and become a global pharma innovator with a competitive advantage in oncology, Daiichi transferred and sold domestic manufacturing and assets for 41 long-listed products, from antacids to antibiotics, to Alfresa Pharma Corp. for $78 million. Daiichi has been focusing on oncology, targeting 500 billion yen ($4.5 billion) in annual sales from the business in fiscal 2025 from 20 billion yen in 2017.
In June, Ministry of Health, Labor and Welfare (MHLW) of Japan approved VANFLYTA (quizartinib) for the treatment of relapsed/refractory FLT3-ITD acute myeloid leukemia (AML), as detected by an MHLW-approved test. Quizartinib is aimed at treating AML patients with a specific genetic mutation called FLT3.
However, in May, independent experts on an advisory panel to the U.S. FDA voted 8-3 against the treatment after assessing data presented by the company. The FDA is not bound by these recommendations and the NDA for quizartinib is currently under FDA Priority Review. A decision is expected by August 25, 2019. On June 24, Daiichi received a Complete Response Letter from the FDA and will determine the next steps in the U.S.
Separately, an advisory committee voted 12-3 in favor of the approval of pexidartinib, another treatment from Daiichi, that aims to treat a type of rare, non-cancerous tumor usually affecting joints and limbs. If approved by the FDA, pexidartinib would be the first and only therapy for tenosynovial giant cell tumor, which is associated with severe morbidity or functional limitations, and not amenable to improvement with surgery. Pexidartinib is among the seven new molecular entities that Daiichi is committed to delivering from its oncology pipeline by 2025.
A clinical trial collaboration with Merck KGaA and Pfizer is evaluating the combination of trastuzumab deruxtecan (DS-8201), an HER2 targeting antibody drug conjugate (ADC), in combination with the checkpoint inhibitor avelumab and/or an investigational Merck KGaA, DNA damage response (DDR) inhibitor, in patients with HER2 expressing or mutated solid tumors. A separate research collaboration is evaluating trastuzumab deruxtecan in combination with avelumab, the DDR inhibitor and other investigational compounds in Merck KGaA’s and Pfizer’s pipelines.
Additionally, a global development and commercialization agreement with AstraZeneca is exploring trastuzumab deruxtecan for multiple HER2 expressing cancers including breast and gastric cancer, as well as non-small cell lung and colorectal cancer. The companies will jointly develop and commercialize trastuzumab deruxtecan as a monotherapy or a combination therapy. Daiichi Sankyo will be responsible for manufacturing and the supply of trastuzumab deruxtecan.
twitter.com/DaiichiSankyoJP
www.daiichisankyo.com
Headcount: 14,887
Year Established: 2005
Revenues: $8,659 (flat)
Net Income: $688 (-14%)
R&D: $2,129 (+10%)
Top Selling Drugs
Drug | Indication | 2018 Sales | (+/-%) |
Lixiana | deep vein thrombosis | $1,061 | 53% |
Nexium | GERD | $706 | -10% |
Benicar | Hypertension | $486 | -45% |
Namenda | Alzheimer’s disease | $453 | 3% |
Injectafer | Anaemia, iron-deficiency | $399 | 29% |
Loxonin | Musculoskeletal inflammation | $275 | -16% |
Venofer | Anaemia in chronic kidney disease | $261 | -7% |
Prolia | Osteoporosis | $247 | 18% |
Inavir | Influenza | $164 | -28% |
It was busy and transformative year for Daiichi-Sankyo, as it returns to the top 25, and 2019 is shaping up to be another year of change for the company. Daiichi recently made organizational changes to oversee strategic priorities that aim to deliver seven new molecular entities in oncology by 2025. Sunao Manabe took the helm as CEO on June 17th succeeding George Nakayama, who will continue to serve as chairman.
As part of its efforts to establish a more efficient production system and become a global pharma innovator with a competitive advantage in oncology, Daiichi transferred and sold domestic manufacturing and assets for 41 long-listed products, from antacids to antibiotics, to Alfresa Pharma Corp. for $78 million. Daiichi has been focusing on oncology, targeting 500 billion yen ($4.5 billion) in annual sales from the business in fiscal 2025 from 20 billion yen in 2017.
In June, Ministry of Health, Labor and Welfare (MHLW) of Japan approved VANFLYTA (quizartinib) for the treatment of relapsed/refractory FLT3-ITD acute myeloid leukemia (AML), as detected by an MHLW-approved test. Quizartinib is aimed at treating AML patients with a specific genetic mutation called FLT3.
However, in May, independent experts on an advisory panel to the U.S. FDA voted 8-3 against the treatment after assessing data presented by the company. The FDA is not bound by these recommendations and the NDA for quizartinib is currently under FDA Priority Review. A decision is expected by August 25, 2019. On June 24, Daiichi received a Complete Response Letter from the FDA and will determine the next steps in the U.S.
Separately, an advisory committee voted 12-3 in favor of the approval of pexidartinib, another treatment from Daiichi, that aims to treat a type of rare, non-cancerous tumor usually affecting joints and limbs. If approved by the FDA, pexidartinib would be the first and only therapy for tenosynovial giant cell tumor, which is associated with severe morbidity or functional limitations, and not amenable to improvement with surgery. Pexidartinib is among the seven new molecular entities that Daiichi is committed to delivering from its oncology pipeline by 2025.
A clinical trial collaboration with Merck KGaA and Pfizer is evaluating the combination of trastuzumab deruxtecan (DS-8201), an HER2 targeting antibody drug conjugate (ADC), in combination with the checkpoint inhibitor avelumab and/or an investigational Merck KGaA, DNA damage response (DDR) inhibitor, in patients with HER2 expressing or mutated solid tumors. A separate research collaboration is evaluating trastuzumab deruxtecan in combination with avelumab, the DDR inhibitor and other investigational compounds in Merck KGaA’s and Pfizer’s pipelines.
Additionally, a global development and commercialization agreement with AstraZeneca is exploring trastuzumab deruxtecan for multiple HER2 expressing cancers including breast and gastric cancer, as well as non-small cell lung and colorectal cancer. The companies will jointly develop and commercialize trastuzumab deruxtecan as a monotherapy or a combination therapy. Daiichi Sankyo will be responsible for manufacturing and the supply of trastuzumab deruxtecan.