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• Ponatinib (generic name) is a tyrosine kinase inhibitor discovered by ARIAD Pharmaceuticals 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) 1xbet 모바일 Philadelphia-chromosome positive acute lymphoblastic leukemia (Ph+ ALL).
• Ponatinib (br1xbet 모바일 name outside Japan is Iclusig^®) is already being marketed in Europe 1xbet 모바일 the United States as a treatment for patients with refractory chronic myeloid leukemia (CML) 1xbet 모바일 Philadelphia-chromosome positive acute lymphoblastic leukemia (Ph+ ALL), 1xbet 모바일 is awaited in Asian countries including Japan.
• Otsuka obtained rights in December 2014 to co-develop 1xbet 모바일 commercialize ponatinib in Japan 1xbet 모바일 nine other Asian countries.^*1

Otsuka Pharmaceutical Co., Ltd. (Headquarters: Chiyoda-ku, Tokyo; President 1xbet 모바일 CEO: Tatsuo Higuchi; "Otsuka") has filed the NDA in Japan for "ponatinib (br1xbet 모바일 name outside Japan is Iclusig^®), a known tyrosine kinase inhibitor (TKI) developed by ARIAD Pharmaceuticals, Inc. (Headquarters: Massachusetts, United States; "ARIAD") used to treat resistant 1xbet 모바일 intolerant chronic myeloid leukemia (CML) 1xbet 모바일 Philadelphia-chromosome positive acute lymphoblastic leukemia (Ph+ ALL).^*2

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

Ponatinib is a TKI discovered 1xbet 모바일 developed by ARIAD that targets BCR-ABL expressed in CML 1xbet 모바일 Ph+ ALL. This drug is a new chemically synthesized oral TKI, 1xbet 모바일 is specifically designed to inhibit unmutated BCR-ABL as well as T315I mutation, a mutant-type BCR-ABL that manifests 1xbet 모바일 induces resistance after patients are treated with other TKIs. Ponatinib demonstrates efficacy in currently available TKI-resistant 1xbet 모바일 in patients who are intolerable CML as well as relapsed or refractory Ph+ 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, 1xbet 모바일 was approved in Europe in July 2013.

1xbet 모바일 Japan, CML occurs 1xbet 모바일 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 phase (5-6 years); however, white blood cell count 1xbet 모바일 the blast cell ratio increase 1xbet 모바일, as the disease progresses, patients begin experiencing symptoms such as general malaise, weight loss, 1xbet 모바일 bloating due to hepatosplenomegaly. In the accelerated phase (6-9 months), patients experience bone pain 1xbet 모바일 exacerbation of hepatosplenomegaly; in the blast phase (3-6 months), patients experience anemia, bleeding tendencies, infections, etc. For CML, symptoms gradually worsen 1xbet 모바일 risk of treatment resistance increases as the disease progresses^*4. 1xbet 모바일 contrast, Ph⁺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 1xbet 모바일 Ph+ 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 in Japan 1xbet 모바일 other Asian countries in order to treat such resistant or intolerant patients.

Otsuka is currently exp1xbet 모바일ing its product portfolio 1xbet 모바일 is focusing on CNS (neuropsychiatry), cardiovascular, ophthalmology, 1xbet 모바일 oncology fields. The company will continue to develop 1xbet 모바일 commercialize pharmaceuticals 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.