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. It was the first factor Xa inhibitor available in that country.
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, approval of edoxaban for those indications was received in Japan in September 2014 and in the United States in January 2015. Moreover, Daiichi Sankyo is aiming for AF and VTE approval in Europe within 2015.
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 for the treatment of osteoporosis in March 2013 and went on sale in June 2013 as PRALIA®. Daiichi Sankyo is currently participating in a global phase 3 study of adjuvant treatment for women with early-stage breast cancer, and is also conducting a phase 3 study on Japanese patients with rheumatoid arthritis.
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 novel hydrocodone combination product containing hydrocodone, acetaminophen and promethazine which is being developed by LOCL Pharma Inc., a subsidiary of Charleston Laboratories Inc., to treat acute pain as well as reduce Opioid-Induced Nausea and Vomiting (OINV). Opioid-induced nausea affects up to 30 percent of patients treated with hydrocodone, with approximately 15 percent of all patients experiencing vomiting. CL-108 has the potential to greatly reduce those undesired side effects. In August 2014, Charleston Laboratories Inc. and Daiichi Sankyo signed a development and marketing agreement, and the drug is currently at the phase 3 clinical trial stage.
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.
PLX3397 is a kinase inhibitor developed by Plexxikon Inc. which selectively inhibits the receptors tyrosine kinase of Fms/Kit/Flt3-ITD. It is currently under development as a treatment for Pigmented Villonodular Synovitis (PVNS). Encouraging results were obtained in a phase 1 clinical trial and an orphan drug application was approved by the US FDA. A phase 3 trial is currently planned to aim for first-in-class approval in the market. There is currently no effective systemic therapy for PVNS apart from surgical removal of tumors, so there is a great expectation that this drug can meet a significant unmet medical need. It is also hoped to be an effective treatment for other cancers like acute myelogenous leukemia and metastatic breast cancer.