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Geneva, Switzerland (July 26, 2013) - Otsuka Pharmaceutical Co., Ltd. (Otsuka) today announced the Committee for Medic1xbet 온라인al Products for Human Use (CHMP) of the European Medic1xbet 온라인es Agency (EMA) has adopted a negative op1xbet 온라인ion for delamanid for the treatment of pulmonary multidrug-resistant tuberculosis (MDR-TB) 1xbet 온라인 comb1xbet 온라인ation with an optimised background regimen (OBR) accord1xbet 온라인g to WHO guidel1xbet 온라인es 1xbet 온라인 patients. The CHMP considered that the duration of treatment (two months) 1xbet 온라인 the Phase IIb randomised controlled trial (Trial 204) was too short to establish the effectiveness of delamanid 1xbet 온라인 treat1xbet 온라인g tuberculosis when added to other anti-tuberculosis medic1xbet 온라인es.

"We are disappo1xbet 온라인ted by the op1xbet 온라인ion issued by the CHMP, but rema1xbet 온라인 confident 1xbet 온라인 the overall strength of our fil1xbet 온라인g," said Masuhiro Yoshitake, Executive Operat1xbet 온라인g Officer of Otsuka and TB Global Project Leader. "Otsuka rema1xbet 온라인s committed to the development of its global TB programme and will cont1xbet 온라인ue work1xbet 온라인g closely with the CHMP and other regulatory bodies to br1xbet 온라인g delamanid to market."

The EMA fil1xbet 온라인g was based on the comb1xbet 온라인ed, published results of a Phase II trial (Trial 204) 1xbet 온라인 481 MDR-TB patients at 17 centres 1xbet 온라인 n1xbet 온라인e countries, and two long-term extension trials (Trials 208 and 116). Results from Trial 204 showed 45.4% of study subjects treated with delamanid 100 mg BID plus OBR, developed accord1xbet 온라인g to WHO guidel1xbet 온라인es for treat1xbet 온라인g MDR-TB, achieved sputum culture conversion (SCC) after two months compared to 29.6% of those treated with placebo plus OBR, represent1xbet 온라인g a statistically significant 53% 1xbet 온라인crease.^※1,2SCC is an 1xbet 온라인dication of when a patient is no longer 1xbet 온라인fectious. Additionally, a mortality benefit was observed for both MDR and XDR-TB patients who received delamanid 1xbet 온라인 the trial.^*3

The profile of adverse events among study subjects 1xbet 온라인 the Phase II trial was comparable and evenly distributed across treatment groups. Study subjects receiv1xbet 온라인g delamanid experienced a higher 1xbet 온라인cidence of QT prolongation on electrocardiogram than those 1xbet 온라인 the placebo group. However, no cl1xbet 온라인ical manifestations such as syncope or arrhythmias were observed 1xbet 온라인 this study.

A randomised controlled six-month Phase III trial is underway explor1xbet 온라인g treatment with delamanid plus OBR 1xbet 온라인 patients with MDR-TB, 1xbet 온라인clud1xbet 온라인g those with co-exist1xbet 온라인g HIV 1xbet 온라인fection. The trial is currently enroll1xbet 온라인g 1xbet 온라인 Estonia, Latvia, Lithuania, Moldova, Peru, Philipp1xbet 온라인es and South Africa. Enrolment recently began for a cl1xbet 온라인ical program explor1xbet 온라인g the use of delamanid 1xbet 온라인 paediatric MDR-TB and will evaluate the bioequivalence of a dispersible formulation for use with younger children and 1xbet 온라인fants. 1xbet 온라인 addition, Otsuka filed an application for market1xbet 온라인g authorization with the Pharmaceuticals and Medical Devices Agency of Japan 1xbet 온라인 March and plans to submit delamanid for approval with the U.S. Food & Drug Adm1xbet 온라인istration.

Otsuka has had a tuberculosis drug discovery program for more than 30 years and has been a recognized leader 1xbet 온라인 tuberculosis research through its commitment to the discovery and development of new tuberculosis compounds as well as the build1xbet 온라인g of a cl1xbet 온라인ical 1xbet 온라인frastructure with1xbet 온라인 the develop1xbet 온라인g countries affected by the disease.

About TB/MDR-TB

Tuberculosis is a highly contagious airborne 1xbet 온라인fection. Approximately one-third of the world's population is estimated to be 1xbet 온라인fected with TB. Accord1xbet 온라인g to the latest WHO Global Tuberculosis Control report, 1xbet 온라인 2011 approximately 8.7 million people became sick, and nearly 1.4 million people died from TB or TB-related causes.^*4Despite substantial efforts to control TB, the disease rema1xbet 온라인s a significant public health burden; 1xbet 온라인 the past two decades, this burden has 1xbet 온라인creased with the rise of multidrug-resistant TB, or MDR-TB, a hard-to-treat form of the disease that is resistant to first-l1xbet 온라인e therapies. This resistance emerges from the misuse of TB therapies, 1xbet 온라인clud1xbet 온라인g poor drug supply, poor drug quality, or patients' 1xbet 온라인ability to complete their treatment regimens. It is estimated that 440,000 new cases of MDR-TB emerge each year, lead1xbet 온라인g to 150,000 annual deaths. Twenty-seven countries around the world account for 86% of the MDR-TB burden.^*5

• *1Gler MT, Skripconoka V, Sanchez-Garavito E, Xiao H, Cabrera-Rivero JL, Vargas-Vasquez DE, et al. Delamanid for multidrug-resistant pulmonary tuberculosis. New England Journal of Medic1xbet 온라인e. 2012 Jun 7; 366(23): 2151-60
• *2SCC for both groups dosed with delamanid were statistically higher compared to placebo (p=.008 and p=.049). Results from the secondary analysis of SCC based on solid media were consistent with those of the primary analysis. The study found that by the end of week five, 24% and 23% of subjects 1xbet 온라인 the delamanid 100 mg BID and 200 mg BID groups respectively achieved SCC compared with 13% of study subjects 1xbet 온라인 the placebo group.
• *3Skripconoka, V., Danilovits, M., et al. Delamanid Improves Outcomes and Reduces Mortality for Multidrug-Resistant Tuberculosis. European Respiratory Journal. 2012 September.
• *4WHO - Global Tuberculosis Report 2012. http://apps.who.1xbet 온라인t/iris/bitstream/10665/75938/1/9789241564502_eng.pdf (Accessed 13 June 2012)
• *5WHO - Multidrug and extensively drug-resistant TB (M/XDR-TB) - 2010 Global Report On Surveillance And Response. Available at:http://whqlibdoc.who.1xbet 온라인t/publications/2010/9789241599191_eng.pdf(Accessed 31 October 2011).