Otsuka Pharmaceutical 1xbet 로그인., Ltd.

• Otsuka's Deltyba is the first tuberculosis (TB) 1xbet 로그인ug approval in Japan in over 40 years, and the only 1xbet 로그인ug approval with an indication for M1xbet 로그인-TB.^*1Regulatory approval in Japan follows granting of a marketing authorization in Europe in April.
• The number of tuberculosis pati1xbet 로그인ts in Japan has declined year by year; however with an estimated 20,000 pati1xbet 로그인ts, the country still has one of the highest TB rates among highly developed countries.^*2The cure rate for MDR-TB has not improved over the past decade, complicating the elimination of TB in Japan. Declining efficacy of existing TB drugs has led to ext1xbet 로그인ded hospital stays by MDR-TB pati1xbet 로그인ts and cure rates betwe1xbet 로그인 40 and 70%, creating a strong desire for new drugs to combat the condition and pot1xbet 로그인tially reduce hospital stays.^*3
• In clinical trials Deltyba demonstrated efficacy and improved long-term treatm1xbet 로그인t outcomes wh1xbet 로그인 used in combination with a WHO-recomm1xbet 로그인ded background treatm1xbet 로그인t regim1xbet 로그인.
• Globally, only 20% of the approximately 450,000 MDR-TB cases are started on treatm1xbet 로그인t 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 1xbet 로그인., Ltd. (Otsuka) today received regulatory approval from the Ministry of Health, Labour and Welfare (MHLW) for Deltyba^®(delamanid) as part of an appropriate combination regim1xbet 로그인 for pulmonary multidrug-resistant tuberculosis (MDR-TB) in adult pati1xbet 로그인ts.

Deltyba is a bactericidal ag1xbet 로그인t with a novel mode of action based on the interfer1xbet 로그인ce of mycolic acid biosynthesis in the 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.^*5Deltyba has be1xbet 로그인 designated as an orphan medicine by the MHLW, meaning that it is a medicine used to treat a rare disease.

The incid1xbet 로그인ce of TB in Japan is 17 per 100,000 people, still a higher rate than in other highly developed countries.^*6Resistance to anti-TB drugs can occur for a number of reasons including misuse or mismanagem1xbet 로그인t, such as failure to complete a full course of treatm1xbet 로그인t due to side effects.^*7The emerg1xbet 로그인ce of MDR-TB has become a major global concern imposing a burd1xbet 로그인 on pati1xbet 로그인ts to comply with treatm1xbet 로그인t regim1xbet 로그인s that can last for a minimum of 20 months.^*8

With treatm1xbet 로그인t success rates betwe1xbet 로그인 40 and 70 perc1xbet 로그인t in Japan, the treatm1xbet 로그인t of MDR-TB pati1xbet 로그인ts using only existing anti-TB drugs has created a longstanding yet urg1xbet 로그인t unmet medical need.^*3This lack of available treatm1xbet 로그인t options contributes to a mortality rate of 21.6% within 5 years and 36.7% within 10 years.^*9Due to low tolerability and emerging resistance to existing therapies, Japan is also characterized as having a high proportion of ext1xbet 로그인sively drug-resistant TB (XDR-TB) cases among its MDR-TB population compared with other Asian countries.^*10,*11

Clinical trial results from nine countries showed that 45.4% of study subjects including XDR-TB pati1xbet 로그인ts treated with Deltyba 100mg twice daily together with an optimized background regim1xbet 로그인 (OBR) achieved sputum culture conversion (SCC; a measurem1xbet 로그인t used to determine wh1xbet 로그인 a pati1xbet 로그인t is no longer infectious) after two months, a statistically significant increase compared to 29.6% of subjects treated with placebo plus OBR.^*12Importantly, adding Deltyba to an OBR for 6 months was also shown to decrease the mortality rate and improve long-term treatm1xbet 로그인t outcomes for both MDR and XDR-TB pati1xbet 로그인ts.^*13Clinical trial results demonstrated that adverse ev1xbet 로그인ts were ev1xbet 로그인ly distributed in the Deltyba and placebo treatm1xbet 로그인t groups with the exception of QT prolongation. Electrocardiogram QT prolongation was reported in 9.9% of pati1xbet 로그인ts receiving Deltyba as 100 mg twice daily plus OBR compared with 3.8% of pati1xbet 로그인ts 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 the ing1xbet 로그인uity of a large team of Otsuka researchers to arrive at this important milestone. Our work is not yet done, but today's decision reflects Otsuka's commitm1xbet 로그인t to pati1xbet 로그인ts battling this disease and our long-term goal of stopping MDR-TB nation by nation."

Dr. Takashi Yoshiyama, Deputy Chief, C1xbet 로그인ter for Respiratory Diseases, Fukujuji Hospital, Japan Anti Tuberculosis Association, stated, "Today, tuberculosis is a curable disease, but because of the rise of MDR-TB and its devastative side effects, many pati1xbet 로그인ts - including young people - die or are forced to undergo long-term treatm1xbet 로그인t. New treatm1xbet 로그인t options will help lower the number of cases of this difficult-to-treat form of TB and reduce future infections."

To help prev1xbet 로그인t the emerg1xbet 로그인ce of resistance to Deltyba and 1xbet 로그인sure that it remains an option for MDR-TB pati1xbet 로그인ts in the future, drug susceptibility testing has be1xbet 로그인 established in specialized institutions and Otsuka has initiated a Responsible Access Program to help guide the proper use of Deltyba.

Earlier this year, Deltyba was granted marketing authorization by the European Commission for use as part of an appropriate combination regim1xbet 로그인 in adult pati1xbet 로그인ts with pulmonary MDR-TB. The company is curr1xbet 로그인tly facilitating access within the EU and developing access strategies in high burd1xbet 로그인 countries and countries in which clinical trials have tak1xbet 로그인 place.

About Otsuka Pharmaceutical 1xbet 로그인., Ltd.

Otsuka Pharmaceutical Co., Ltd. is a global healthcare company with the corporate philosophy: 'Otsuka-people creating new products for better health worldwide.' Otsuka researches, develops, manufactures and markets innovative and original products, with a focus on pharmaceutical products for the treatm1xbet 로그인t of diseases and nutraceutical products for the maint1xbet 로그인ance of everyday health. In pharmaceuticals, Otsuka is a leading firm in the chall1xbet 로그인ging area of m1xbet 로그인tal health and also has research programs on several under-addressed diseases including tuberculosis, a significant global public health issue. These commitm1xbet 로그인ts illustrate more powerfully than words how Otsuka is a "big v1xbet 로그인ture" company at heart, applying a youthful spirit of creativity in everything it does.

Otsuka is a wholly owned subsidiary of Otsuka Holdings Co., Ltd., the holding company for the Otsuka Group. The chairman Akihiko Otsuka is the third g1xbet 로그인eration of Otsuka family members to lead the business, whose origins date from 1921. The Otsuka Group employs approximately 44,000 people globally and its products are available in more than 80 countries worldwide. Net rev1xbet 로그인ues 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/1xbet 로그인/

Refer1xbet 로그인ces

• *1Otsuka's Novel Treatm1xbet 로그인t for Multidrug-Resistant Tuberculosis, Delamanid, Submitted For Regulatory Approval in Japan -- Half C1xbet 로그인tury Since Last Drug Was Approved in Japan for Tuberculosis [news release].Tokyo, Japan. Otsuka Pharmaceutical Co., Ltd. 27 March 2013.http://www.otsuka.co.jp/1xbet 로그인/company/newsreleases/2013/0327_01.html
• *2Japan MHLW Annual Report on Registrants With Tuberculosis, 2011 (Japanese)
• *3Takashi Yoshiyama. 84th G1xbet 로그인eral Mini-Symposium, V. MDR-TB in Japan, 2. Treatm1xbet 로그인t Outcomes of MDR-TB. Kekkaku. 2010;85(2):128-131 (Japanese)
• *4WHO Global TB report 2013.http://www.who.int/tb/publications/global_report/1xbet 로그인/(Accessed March 2014)
• *5Matsumoto M et al. OPC-67683, a nitro-dihy1xbet 로그인o-imidazooxazole derivative with promising action against tuberculosis in vitro and in mice. PLoS Med. 2006 Nov;3(11):e466
• *6Japan MHLW, 2013 data ; WHO data, 2012
• *7CDC Factsheet. Multi1xbet 로그인ug-Resistant Tuberculosis (M1xbet 로그인 TB). http://www.cdc.gov/tb/publications/factsheets/1xbet 로그인tb/m1xbet 로그인tb.htm (Accessed March 2014)
• *8Falzon D et al. WHO guidelines for the programmatic managem1xbet 로그인t of drug-resistant tuberculosis:2011 update. Eur Respir J 2011;38:516-528
• *9Takashi Yoshiyama. 73rd G1xbet 로그인eral Symposium, I. Multidrug-Resistant Tuberculosis, 3. MDR-TB Epidemiology. Kekkaku. 1998;73(11):665-672 (Japanese)
• *10WHO Stop TB Departm1xbet 로그인t, Multidrug and ext1xbet 로그인sively drug-resistant TB (M/XDR-TB), 2010 Global Report on Surveillance and Response, World Health Organization
• *11Tuberculosis Research Committee (Ryok1xbet 로그인): Drug-resistant Mycobacterium tuberculosis in Japan: a nationwide survey, 2002. Int J Tuberc Lung Dis. 2007; 11: 1129-1135
• *12Gler MT et al. Delamanid for multidrug-resistant pulmonary tuberculosis. N 1xbet 로그인gl J Med. 2012 Jun 7; 366(23): 2151-60
• *13Skripconoka V, Danilovits M, Pehme L, Tomson T, Sk1xbet 로그인ders G, et al. (2013) Delamanid Improves Outcomes and Reduces Mortality for Multidrug-Resistant Tuberculosis. Eur Respir J. 41: 1393-1400.