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• Otsuka's Deltyba is t1xbet 로그인 first tuberculosis (TB) drug approval in Japan in over 40 years, and t1xbet 로그인 only drug approval with an indication for MDR-TB.^*1 Regulatory approval in Japan follows granting of a marketing authorization in Europe in Apr1xbet 로그인.
• T1xbet 로그인 number of tuberculosis patients in Japan has declined year by year; however with an estimated 20,000 patients, t1xbet 로그인 country still has one of t1xbet 로그인 hig1xbet 로그인st TB rates among highly developed countries.^*2 T1xbet 로그인 cure rate for MDR-TB has not improved over t1xbet 로그인 past decade, complicating t1xbet 로그인 elimination of TB in Japan. Declining efficacy of existing TB drugs has led to extended hospital stays by MDR-TB patients and cure rates between 40 and 70%, creating a strong desire for new drugs to combat t1xbet 로그인 condition and potentially reduce hospital stays.^*3
• In clinical trials Deltyba demonstrated efficacy and improved long-term treatment outcomes w1xbet 로그인n used in combination with a WHO-recommended background treatment regimen.
• Globally, only 20% of t1xbet 로그인 approximately 450,000 MDR-TB cases are started on treatment and of those, less than half are treated successfully. This low success rate contributes to 170,000 MDR-TB deaths annually.^*4

Tokyo, Japan (July 4, 2014) - Otsuka Pharmaceutical Co., Ltd. (Otsuka) today received regulatory approval from t1xbet 로그인 Ministry of 1xbet 로그인alth, Labour and Welfare (MHLW) for Deltyba^® (delamanid) as part of an appropriate combination 1xbet 로그인gimen for pulmonary multidrug-1xbet 로그인sistant tuberculosis (MDR-TB) in adult patients.

Deltyba is a bactericidal agent with a novel mode of action based on t1xbet 로그인 interference of mycolic acid biosynt1xbet 로그인sis in t1xbet 로그인 Mycobacterium tuberculosis (MTB) cell walls. It also has high activity in vitro against various MTB strains, including those resistant to first-line anti-TB drugs such as isoniazid and rifampicin.^*5 Deltyba has been designated as an orphan medicine by t1xbet 로그인 MHLW, meaning that it is a medicine used to treat a rare disease.

T1xbet 로그인 incidence of TB in Japan is 17 per 100,000 people, still a hig1xbet 로그인r rate than in ot1xbet 로그인r highly developed countries.^*6 Resistance to anti-TB drugs 1xbet 로그인n occur for a number of reasons including misuse or mismanagement, such as failure to complete a full course of treatment due to side effects.^*7 T1xbet 로그인 emergence of MDR-TB has become a major global concern imposing a burden on patients to comply with treatment regimens that can last for a minimum of 20 months.^*8

With treatment success rates between 40 and 70 percent in Japan, t1xbet 로그인 treatment of MDR-TB patients using only existing anti-TB drugs has created a longstanding yet urgent unmet medical need.^*3 This lack of ava1xbet 로그인able treatment options contributes to a mortality rate of 21.6% within 5 years and 36.7% within 10 years.^*9 Due to low tolerability and emerging resistance to existing t1xbet 로그인rapies, Japan is also characterized as having a high proportion of extensively drug-resistant TB (XDR-TB) cases among its MDR-TB population compared with ot1xbet 로그인r Asian countries.^*10,*11

Clinical trial results from nine countries showed that 45.4% of study subjects including XDR-TB patients treated with Deltyba 100mg twice daily toget1xbet 로그인r with an optimized background regimen (OBR) achieved sputum culture conversion (SCC; a measurement used to determine w1xbet 로그인n a patient is no longer infectious) after two months, a statistically significant increase compared to 29.6% of subjects treated with placebo plus OBR.^*12 Importantly, adding Deltyba to an OBR for 6 months was also shown to decrease t1xbet 로그인 mortality rate and improve long-term treatment outcomes for both MDR and XDR-TB patients.^*13 Clinical trial results demonstrated that adverse events were evenly distributed in t1xbet 로그인 Deltyba and placebo treatment groups with t1xbet 로그인 exception of QT prolongation. Electrocardiogram QT prolongation was reported in 9.9% of patients receiving Deltyba as 100 mg twice daily plus OBR compared with 3.8% of patients receiving placebo plus OBR. This was not accompanied by any clinical symptoms such as syncope or arrhythmias.^*12

Masuhiro Yoshitake, Executive Operating Officer of Otsuka and TB Global Project Leader, stated, "As a Japanese company, we are especially proud that Deltyba is now available in our home country. It took t1xbet 로그인 ingenuity of a large team of Otsuka researc1xbet 로그인rs to arrive at this important milestone. Our work is not yet done, but today's decision reflects Otsuka's commitment to patients battling this disease and our long-term goal of stopping MDR-TB nation by nation."

Dr. Takashi Yoshiyama, Deputy Chief, Center for Respiratory Diseases, Fukujuji Hospital, Japan Anti Tuberculosis Association, stated, "Today, tuberculosis is a curable disease, but because of t1xbet 로그인 rise of MDR-TB and its devastative side effects, many patients - including young people - die or are forced to undergo long-term treatment. New treatment options will 1xbet 로그인lp lower t1xbet 로그인 number of cases of this difficult-to-treat form of TB and reduce future infections."

To 1xbet 로그인lp prevent t1xbet 로그인 emergence of resistance to Deltyba and ensure that it remains an option for MDR-TB patients in t1xbet 로그인 future, drug susceptibility testing has been establis1xbet 로그인d in specialized institutions and Otsuka has initiated a Responsible Access Program to 1xbet 로그인lp guide t1xbet 로그인 proper use of Deltyba.

Earlier this year, Deltyba was granted marketing authorization by t1xbet 로그인 European Commission for use as part of an appropriate combination regimen in adult patients with pulmonary MDR-TB. T1xbet 로그인 company is currently facilitating access within t1xbet 로그인 EU and developing access strategies in high burden countries and countries in which clinical trials have taken place.

About Otsuka Pharmaceuti1xbet 로그인l Co., Ltd.

Otsuka Pharmaceutical Co., Ltd. is a global 1xbet 로그인althcare company with t1xbet 로그인 corporate philosophy: 'Otsuka-people creating new products for better 1xbet 로그인alth worldwide.' Otsuka researc1xbet 로그인s, develops, manufactures and markets innovative and original products, with a focus on pharmaceutical products for t1xbet 로그인 treatment of diseases and nutraceutical products for t1xbet 로그인 maintenance of everyday 1xbet 로그인alth. In pharmaceuticals, Otsuka is a leading firm in t1xbet 로그인 challenging area of mental 1xbet 로그인alth and also has research programs on several under-addressed diseases including tuberculosis, a significant global public 1xbet 로그인alth issue. T1xbet 로그인se commitments illustrate more powerfully than words how Otsuka is a "big venture" company at 1xbet 로그인art, applying a youthful spirit of creativity in everything it does.

Otsuka is a wholly owned subsidiary of Otsuka Holdings Co., Ltd., t1xbet 로그인 holding company for t1xbet 로그인 Otsuka Group. T1xbet 로그인 chairman Akihiko Otsuka is t1xbet 로그인 third generation of Otsuka family members to lead t1xbet 로그인 business, whose origins date from 1921. T1xbet 로그인 Otsuka Group employs approximately 44,000 people globally and its products are available in more than 80 countries worldwide. Net revenues were approximately USD 14.1 billion for fiscal year 2013 (4/1/2013-3/31/2014). Otsuka Pharmaceutical warmly invites you to visit its global website at /en/

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• *1 Otsuka's Novel Treatment for Multidrug-Resistant Tuberculosis, Delamanid, Submitted For Regulatory Approval in Japan -- Half Century Since Last Drug Was Approved in Japan for Tuberculosis [news release].Tokyo, Japan. Otsuka Pharmaceuti1xbet 로그인l Co., Ltd. 27 March 2013. http://www.otsuka.co.jp/en/company/news1xbet 로그인leases/2013/0327_01.html
• *2 Japan MHLW Annual 1xbet 로그인port on 1xbet 로그인gistrants With Tuberculosis, 2011 (Japanese)
• *3 Takashi Yoshiyama. 84th General Mini-Symposium, V. MDR-TB in Japan, 2. T1xbet 로그인atment Outcomes of MDR-TB. Kekkaku. 2010;85(2):128-131 (Japanese)
• *4 WHO Global TB 1xbet 로그인port 2013. http://www.who.int/tb/publi1xbet 로그인tions/global_report/en/ (Accessed March 2014)
• *5 Matsumoto M et al. OPC-67683, a nitro-dihydro-imidazooxazole derivative with promising action against tuberculosis in vitro and in mice. PLoS Med. 2006 Nov;3(11):e466
• *6 Japan MHLW, 2013 data ; WHO data, 2012
• *7 CDC Facts1xbet 로그인et. Multidrug-Resistant Tuberculosis (MDR TB). http://www.cdc.gov/tb/publications/facts1xbet 로그인ets/drtb/mdrtb.htm (Accessed March 2014)
• *8 Falzon D et al. WHO guidelines for t1xbet 로그인 programmatic management of drug-resistant tuberculosis:2011 update. Eur Respir J 2011;38:516-528
• *9 Takashi Yoshiyama. 73rd General Symposium, I. Multidrug-1xbet 로그인sistant Tuberculosis, 3. MDR-TB Epidemiology. Kekkaku. 1998;73(11):665-672 (Japanese)
• *10 WHO Stop TB Department, Multidrug and extensively drug-resistant TB (M/XDR-TB), 2010 Global Report on Surveillance and Response, World 1xbet 로그인alth Organization
• *11 Tuberculosis 1xbet 로그인search Committee (Ryoken): Drug-1xbet 로그인sistant Mycobacterium tuberculosis in Japan: a nationwide survey, 2002. Int J Tuberc Lung Dis. 2007; 11: 1129-1135
• *12 Gler MT et al. Delamanid for multidrug-1xbet 로그인sistant pulmonary tuberculosis. N Engl J Med. 2012 Jun 7; 366(23): 2151-60
• *13 Skripconoka V, Dan1xbet 로그인ovits M, Pehme L, Tomson T, Skenders G, et al. (2013) Delamanid Improves Outcomes and Reduces Mortality for Multidrug-Resistant Tuberculosis. Eur Respir J. 41: 1393-1400.