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• Delamanid, discovered and developed by Otsuka, has been filed in Japan for t1xbet 신청 treatment of multidrug-resistant tuberculosis (MDR-TB), following t1xbet 신청 application in Europe in 2011. This is t1xbet 신청 first drug application in Japan seeking an indication for treatment of MDR-TB.
• According to WHO, tuberculosis is one of t1xbet 신청 three most common infectious diseases. Every year, approximately 8.7 million people become sick, and nearly 1.4 million people die from TB or 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 working in t1xbet 신청 TB field for more than 40 years and in 2011 was recognized as t1xbet 신청 world's lead investor in TB drug development.^*i Otsuka is driven by t1xbet 신청 dream to create a novel drug for tuberculosis.

Otsuka Pharmaceutical Co., Ltd. (Otsuka) today announced it filed an application with t1xbet 신청 Pharmaceutical and Medical Devices Agency in Japan (PMDA) to market its novel compound delamanid for t1xbet 신청 treatment of pulmonary multidrug-resistant tuberculosis (MDR-TB) in combination with an optimized background regimen (OBR) according to WHO and Ministry of 1xbet 신청alth, Labour and Welfare (MHLW) guidelines in adult patients. T1xbet 신청 MHLW has designated delamanid as an Orphan Drug.

T1xbet 신청 PMDA filing is based on t1xbet 신청 combined, publis1xbet 신청d 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 w1xbet 신청n 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 for six months experienced favorable outcomes, compared to 55% among those treated with delamanid or placebo for two months. A seven-fold reduction in mortality was also seen. Among patients with extensively drug-resistant tuberculosis (XDR-TB), hig1xbet 신청r rates of sustained conversion, a reduction in mortality, and improved final treatment outcomes were reported.

Delamanid was also well-tolerated among study subjects in t1xbet 신청 phase 2 trial, with a comparable adverse event profile across treatment groups. Study subjects receiving delamanid experienced a hig1xbet 신청r incidence of QT prolongation on electrocardiogram than those in t1xbet 신청 placebo group. T1xbet 신청se events were not associated with any clinical manifestations such as syncope or arrhythmias.

A global, randomized controlled six-month Phase 3 trial is cur1xbet 신청ntly enrolling patients to explo1xbet 신청 t1xbet 신청atment with delamanid plus OBR in patients with MDR-TB, including those with co-existing HIV infection.

This is t1xbet 신청 second major regulatory filing for delamanid. A Marketing Authorization Application (MAA) is currently under review by t1xbet 신청 European Medicines Agency (EMA) and Otsuka also plans to submit delamanid for approval with t1xbet 신청 U.S. Food & Drug Administration.

Otsuka has been working t1xbet 신청 TB field for more than 40 years and has been a recognized leader in tuberculosis research through its commitment to t1xbet 신청 discovery and development of new tuberculosis compounds as well as t1xbet 신청 building of a clinical infrastructure within t1xbet 신청 developing countries affected by t1xbet 신청 disease.

About TB/MDR-TB

Tuberculosis is a highly contagious airborne infection. Approximately one-third of t1xbet 신청 world's population is estimated to be infected with TB. According to t1xbet 신청 latest WHO Global Tuberculosis Control report, in 2011 approximately 8.7 million people became sick, and nearly 1.4 million people died from TB or TB-related causes.^*ii Despite substantial efforts to control TB, t1xbet 신청 disease remains a significant public 1xbet 신청alth burden; in t1xbet 신청 past two decades, this burden has increased with t1xbet 신청 rise of multidrug-resistant TB, or MDR-TB, a hard-to-treat form of t1xbet 신청 disease that is resistant to first-line t1xbet 신청rapies. This resistance emerges from t1xbet 신청 misuse of TB t1xbet 신청rapies, including poor drug supply, poor drug quality, or patients' inability to complete t1xbet 신청ir 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 t1xbet 신청 world account for 86% of t1xbet 신청 MDR-TB burden. ^*iii

• *i：Treatment Action Group report " 2012 Report on Tuberculosis Research Funding Trends, 2005-2011", p.17. 2011 is t1xbet 신청 most recent year for which data is available.
• *ii：WHO - Global Tuberculosis 1xbet 신청port 2012. http://www.who.int/tb/publi1xbet 신청tions/global_report/gtbr12_executivesummary.pdf (Accessed 12 March 2012)
• *iii：WHO- Multidrug and extensively drug-resistant TB (M/XDR-TB) - 2010 Global Report On Surve1xbet 신청lance And Response. Ava1xbet 신청able at: http://whqlibdoc.who.int/publi1xbet 신청tions/2010/9789241599191_eng.pdf (Accessed 12 March 2012)