We deliver innovative products that enhance the lives of millions of people around the world.
Daiichi Sankyo discovered prasugrel, an oral antiplatelet agent that prevents blood clots, with our Japanese research partner, Ube Industries, and developed it globally in collaboration with Eli Lilly and Company. In 2009, we launched it as Effient® in the United States and as Efient® in Europe to prevent atherothrombotic events in patients with acute coronary syndrome undergoing percutaneous coronary intervention (PCI). To date, prasugrel has been approved in more than 70 countries around the world.
In Japan, prasugrel was developed in collaboration with Ube Industries. We launched Efient® for the treatment of patients with ischemic heart disease undergoing PCI in May 2014, and are currently conducting phase 3 studies on patients with ischemic cerebrovascular disease.
Developed solely by Daiichi Sankyo, edoxaban is an once-daily, oral anticoagulant that specifically, reversibly and directly inhibits factor Xa, which is an important factor in the coagulation system that leads to blood clotting. In 2011, we launched edoxaban as Lixiana® in Japan for the prevention of venous thromboembolism (VTE) in patients undergoing total knee replacement surgery, total hip replacement surgery, and hip fracture surgery.
Two global phase 3 studies, ENGAGE AF-TIMI 48 for the prevention of stroke or systematic embolic events in patients with atrial fibrillation (irregular heart rate) and Hokusai-VTE for the treatment and prevention of recurrences of VTE in patients with an acute symptomatic deep vein thrombosis (DVT) and/or pulmonary embolism (PE), were completed and, based on the results of the two studies, the first approval of edoxaban for those indications was received in Japan in 2014, followed by the United States and the EU in 2015.
In addition to Japan, the United States and the EU, edoxaban was launched in South Korea in 2016. In other countries, regulatory review is ongoing.
Denosumab is the world’s first fully human monoclonal antibody that specifically targets human RANK ligand, a protein that plays a key role in bone breakdown. Daiichi Sankyo has been working on denosumab since 2007, when we received the rights from Amgen Inc. to manufacture the antibody in Japan. In April 2012, Denosumab went on sale in Japan as RANMARK® for the treatment of bone complications stemming from multiple myeloma and bone metastases from solid tumors, and in May 2014 for the treatment of giant cell tumor of bone.
Additionally, denosumab received approval in Japan for the treatment of osteoporosis in March 2013 and went on sale in June 2013 as PRALIA®. Daiichi Sankyo also completed a phase 3 study on Japanese patients with rheumatoid arthritis and currently is preparing an application for manufacturing and marketing approval for that indication. In addition, Daiichi Sankyo is currently participating in a global phase 3 study of adjuvant treatment for women with early-stage breast cancer.
Mirogabalin, originally developed by Daiichi Sankyo, is preferentially selective in regard to how it binds to α2δ-1 subunit, a protein that may help to regulate how the brain processes pain signals. It has a unique binding profile and long duration of action, and is currently being studied for the treatment of pain associated with fibromyalgia and peripheral neuropathic pain (diabetic peripheral neuropathic pain and postherpetic neuralgia). A global phase 3 clinical trial for pain associated with fibromyalgia is ongoing mainly in the US and Europe, while a phase 3 clinical trial for peripheral neuropathic pain (diabetic peripheral neuropathic pain and postherpetic neuralgia) is currently underway in Japan and other Asian countries.
CL-108 is a fixed-dose, immediate-release bi-layered tablet with a rapid release layer containing 12.5 mg of promethazine and a second layer containing 7.5 mg of hydrocodone and 325 mg of acetaminophen. If approved, CL-108 would represent the first opioid-containing formulation indicated to relieve moderate to severe pain while preventing or reducing the associated opioid-induced nausea and vomiting (OINV). Opioid-related adverse events, such as nausea and vomiting, may significantly compromise the management of pain. Reports in the literature suggest approximately 40 percent of patients experience OINV The incidence may be higher in clinical practice. In August 2014, Charleston Laboratories Inc. and Daiichi Sankyo signed an exclusive U.S. license agreement to co-develop and co-commercialize CL-108.
Quizartinib is an FLT3 inhibitor currently in development by Ambit Biosciences for the treatment of recurrent or refractory Acute Myeloid Leukemia (AML). It potently and selectively inhibits FLT3, which is an effective target of AML. Currently, phase 3 clinical trials for this drug are being conducted. Since there has been no approved treatment for this disorder in 30 years, the US FDA is fast-tracking the process. Quizartinib has been granted Orphan Drug Designation by the US Food and Drug Administration (FDA) and the European Commission for the treatment of acute myeloid leukemia (AML).
Pexidartinib is a kinase inhibitor being jointly developed by Daiichi Sankyo and Plexxikon, a member of the Daiichi Sankyo Group, which selectively inhibits the receptors tyrosine kinase of Fms/Kit/Flt3-ITD. It is currently in Phase 3 development for tenosynovial giant cell tumor (TGCT), a rare and usually non-metastatic tumor affecting the synovium-lined joints, bursae and tendon sheaths. TGCT is a group of neoplasms including pigmented villonodular synovitis (PVNS) and giant cell tumors of the tendon sheath (GCT-TS).
PLX3397 has been granted Orphan Drug Designation by the US Food and Drug Administration (FDA) for the treatment of PVNS/GCT-TS and has received Orphan Designation from the European Commission for the treatment of TGCT.
Tivantinib is an investigational oral MET inhibitor currently in Phase 3 development for the second-line treatment of hepatocellular carcinoma (HCC), the most common type of liver cancer. Tivantinib is being developed in partnership with ArQule Inc. in the US and Europe, South American and rest of the world, excluding Japan, China (including Hong Kong), South Korea and Taiwan.
Tivantinib for HCC has been granted Orphan Drug Designation by the US Food and Drug Administration (FDA) and the European Commission.