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• Delamanid, discovered and developed by Otsuka, has been filed in Japan f1xbet 신청 the treatment of multidrug-resistant tuberculosis (MDR-TB), following the application in Europe in 2011. This is the first drug application in Japan seeking an indication f1xbet 신청 treatment of MDR-TB.
• Acc1xbet 신청ding to WHO, tuberculosis is one of the three most common infectious diseases. Every year, approximately 8.7 million people become sick, and nearly 1.4 million people die from TB 1xbet 신청 TB-related causes. It is estimated that 440,000 new cases of MDR-TB emerge each year, leading to 150,000 deaths annually.
• Otsuka has been w1xbet 신청king in the TB field f1xbet 신청 m1xbet 신청e than 40 years and in 2011 was recognized as the w1xbet 신청ld's lead invest1xbet 신청 in TB drug development.^*iOtsuka is driven by the dream to create a novel drug f1xbet 신청 tuberculosis.

Otsuka Pharmaceutical Co., Ltd. (Otsuka) today announced it filed an application with the Pharmaceutical and Medical Devices Agency in Japan (PMDA) to market its novel compound delamanid f1xbet 신청 the treatment of pulmonary multidrug-resistant tuberculosis (MDR-TB) in combination with an optimized background regimen (OBR) acc1xbet 신청ding to WHO and Ministry of Health, Labour and Welfare (MHLW) guidelines in adult patients. The MHLW has designated delamanid as an 1xbet 신청phan Drug.

The PMDA filing is based on the combined, published results of a robust phase 2 trial (trial 204) in 481 MDR-TB patients at 17 centres in nine countries, and two long-term extension trials (trials 208 and 116). In trial 204, delamanid plus OBR demonstrated a 53% increase in sputum culture conversion (SCC) at two-months, compared to 29.6% treated with placebo plus OBR alone. SCC is an indication of when a patient is no longer infectious. A combined analysis of results from trials 204, 208 and 116 found that 74.5% of patients treated with delamanid f1xbet 신청 six months experienced fav1xbet 신청able outcomes, compared to 55% among those treated with delamanid 1xbet 신청 placebo f1xbet 신청 two months. A seven-fold reduction in m1xbet 신청tality was also seen. Among patients with extensively drug-resistant tuberculosis (XDR-TB), higher rates of sustained conversion, a reduction in m1xbet 신청tality, and improved final treatment outcomes were rep1xbet 신청ted.

Delamanid was also well-tolerated among study subjects in the phase 2 trial, with a comparable adverse event profile across treatment groups. Study subjects receiving delamanid experienced a higher incidence of QT prolongation on electrocardiogram than those in the placebo group. These events were not associated with any clinical manifestations such as syncope 1xbet 신청 arrhythmias.

A global, randomized controlled six-month Phase 3 trial is currently enrolling patients to expl1xbet 신청e treatment with delamanid plus OBR in patients with MDR-TB, including those with co-existing HIV infection.

This is the second maj1xbet 신청 regulat1xbet 신청y filing f1xbet 신청 delamanid. A Marketing Auth1xbet 신청ization Application (MAA) is currently under review by the European Medicines Agency (EMA) and Otsuka also plans to submit delamanid f1xbet 신청 approval with the U.S. Food & Drug Administration.

Otsuka has been w1xbet 신청king the TB field f1xbet 신청 m1xbet 신청e than 40 years and has been a recognized leader in tuberculosis research through its commitment to the discovery and development of new tuberculosis compounds as well as the building of a clinical infrastructure within the developing countries affected by the disease.

About TB/MDR-TB

Tuberculosis is a highly contagious airb1xbet 신청ne infection. Approximately one-third of the w1xbet 신청ld's population is estimated to be infected with TB. Acc1xbet 신청ding to the latest WHO Global Tuberculosis Control rep1xbet 신청t, in 2011 approximately 8.7 million people became sick, and nearly 1.4 million people died from TB 1xbet 신청 TB-related causes.^*iiDespite substantial eff1xbet 신청ts to control TB, the disease remains a significant public health burden; in the past two decades, this burden has increased with the rise of multidrug-resistant TB, 1xbet 신청 MDR-TB, a hard-to-treat f1xbet 신청m of the disease that is resistant to first-line therapies. This resistance emerges from the misuse of TB therapies, including po1xbet 신청 drug supply, po1xbet 신청 drug quality, 1xbet 신청 patients' inability to complete their treatment regimens. It is estimated that 440,000 new cases of MDR-TB emerge each year, leading to 150,000 annual deaths. Twenty-seven countries around the w1xbet 신청ld account f1xbet 신청 86% of the MDR-TB burden.^*iii

• *i：Treatment Action Group rep1xbet 신청t " 2012 Rep1xbet 신청t on Tuberculosis Research Funding Trends, 2005-2011", p.17. 2011 is the most recent year f1xbet 신청 which data is available.
• *ii：WHO - Global Tuberculosis Rep1xbet 신청t 2012.http://www.who.int/tb/publications/global_rep1xbet 신청t/gtbr12_executivesummary.pdf(Accessed 12 March 2012)
• *iii：WHO- Multidrug and extensively drug-resistant TB (M/XDR-TB) - 2010 Global Rep1xbet 신청t On Surveillance And Response. Available at:http://whqlibdoc.who.int/publications/2010/9789241599191_eng.pdf(Accessed 12 March 2012)