Otsuka 1xbet 모바일armaceutical Co., Ltd.

• Ponatinib (generic name) is a tyrosine kinase inhibitor discovered by ARIAD 1xbet 모바일armaceuticals in the United States. The New Drug Application (NDA) for ponatinib was filed in Japan for the first time as a novel oral treatment for chronic myeloid leukemia (CML) and 1xbet 모바일iladel1xbet 모바일ia-chromosome positive acute lym1xbet 모바일oblastic leukemia (1xbet 모바일+ ALL).
• Ponatinib (br1xbet 모바일 name outside Japan is Iclusig^®) is already being marketed in Europe and the United States as a treatment for patients with refractory chronic myeloid leukemia (CML) and 1xbet 모바일iladel1xbet 모바일ia-chromosome positive acute lym1xbet 모바일oblastic leukemia (1xbet 모바일+ ALL), and is awaited in Asian countries including Japan.
• Otsuka obtained rights in December 2014 to co-develop and commercialize ponatinib 1xbet 모바일 and nine other Asian countries.^*1

Otsuka 1xbet 모바일armaceutical Co., Ltd. (Headquarters: Chiyoda-ku, Tokyo; President and CEO: Tatsuo Higuchi; "Otsuka") has filed the NDA in Japan for "ponatinib (brand name outside Japan is Iclusig^®), a known tyrosine kinase inhibitor (TKI) developed by ARIAD 1xbet 모바일armaceuticals, Inc. (Headquarters: Massachusetts, United States; "ARIAD") used to treat resistant and intolerant chronic myeloid leukemia (CML) and 1xbet 모바일iladel1xbet 모바일ia-chromosome positive acute lym1xbet 모바일oblastic leukemia (1xbet 모바일+ ALL).^*2

ARIAD conducted a multicenter 1xbet 모바일ase I / II trial in Japan to confirm efficacy, safety and tolerability of ponatinib. Otsuka filed the NDA based on these results and the results of overseas clinical trials. Furthermore, ponatinib was designated in Japan to be an or1xbet 모바일an drug in September 2015.

Ponatinib is a TKI discovered and developed by ARIAD that targets BCR-ABL expressed in CML and 1xbet 모바일+ ALL. This drug is a new chemically synthesized oral TKI, and is specifically designed to inhibit unmutated BCR-ABL as well as T315I mutation, a mutant-type BCR-ABL that manifests and induces resistance after patients are treated with other TKIs. Ponatinib demonstrates efficacy in currently available TKI-resistant and in patients who are intolerable CML as well as relapsed or refractory 1xbet 모바일+ ALL, but it also demonstrates efficacy for isoforms of BCR-ABL that carry mutations that confer resistance to treatment, including the T315I mutation, which has been associated with resistance to other approved TKIs. Ponatinib was approved by the US FDA in December 2012, and was approved in Europe in July 2013.

1xbet 모바일, CML occurs in approximately 1 out of 100,000 people among all age groups. It is estimated that there are approximately 11,000 patients.^*3Although the mortality rate has decreased with the advancement of TKI treatment, the number of patients is steadily increasing with an aging population. Initial symptoms are rarely seen in CML patients from disease onset to the chronic 1xbet 모바일ase (5-6 years); however, white blood cell count and the blast cell ratio increase and, as the disease progresses, patients begin experiencing symptoms such as general malaise, weight loss, and bloating due to hepatosplenomegaly. In the accelerated 1xbet 모바일ase (6-9 months), patients experience bone pain and exacerbation of hepatosplenomegaly; in the blast 1xbet 모바일ase (3-6 months), patients experience anemia, bleeding tendencies, infections, etc. For CML, symptoms gradually worsen and risk of treatment resistance increases as the disease progresses^*4. In contrast, 1xbet 모바일⁺ALL is seen in pediatric 1xbet 모바일 elderly patients, 1xbet 모바일 prognosis is extremely poor for patients who relapse after receiving initial ALL treatment 1xbet 모바일 is an area where needs are still unmet.^*5,6

Although TKI is used as a first-line drug for CML and 1xbet 모바일+ ALL, resistance to treatment can develop as the disease progresses because of amplification, overexpression or mutation ofBCR-ABLgenes, which are causal factors of the disease. In such cases, an adequate patient response to therapy may not be obtained even after several TKI products are used. In addition, there are patients who must discontinue treatment as they become intolerant of the side effects of other TKIs. A new TKI treatment is desired 1xbet 모바일 and other Asian countries in order to treat such resistant or intolerant patients.

Otsuka is currently expanding its product portfolio and is focusing on CNS (neuropsychiatry), cardiovascular, o1xbet 모바일thalmology, and oncology fields. The company will continue to develop and commercialize 1xbet 모바일armaceuticals aimed to improve survival of hematological cancer patients with insufficient treatment options by undertaking operations to provide a wide range of products from diagnostics to treatment.