1xbet 로그인 Pharmaceutical Co., Ltd.

• Otsuka's Deltyba is 1xbet 로그인 first tuberculosis (TB) drug approval in Japan in over 40 years, and 1xbet 로그인 only drug approval with an indication for MDR-TB.^*1Regulatory approval in Japan follows granting 1xbet 로그인 a marketing authorization in Europe in April.
• The number 1xbet 로그인 tuberculosis patients in Japan has declined year by year; however with an estimated 20,000 patients, the country still has one 1xbet 로그인 the highest TB rates among highly developed countries.^*2The cure rate for MDR-TB has not improved over the past decade, complicating the elimination 1xbet 로그인 TB in Japan. Declining efficacy 1xbet 로그인 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 the condition and potentially reduce hospital stays.^*3
• 1xbet 로그인 cl1xbet 로그인ical trials Deltyba demonstrated efficacy and improved long-term treatment outcomes when used 1xbet 로그인 comb1xbet 로그인ation with a WHO-recommended background treatment regimen.
• Globally, only 20% 1xbet 로그인 the approximately 450,000 MDR-TB cases are started on treatment and 1xbet 로그인 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 the Ministry 1xbet 로그인 Health, Labour and Welfare (MHLW) for Deltyba^®(delamanid) as part 1xbet 로그인 an appropriate combination regimen for pulmonary multidrug-resistant tuberculosis (MDR-TB) in adult patients.

Deltyba is a bactericidal agent with a novel mode 1xbet 로그인 action based on the interference 1xbet 로그인 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 been designated as an orphan medicine by 1xbet 로그인 MHLW, meaning that it is a medicine used to treat a rare disease.

The incidence 1xbet 로그인 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 1xbet 로그인 reasons including misuse or mismanagement, such as failure to complete a full course 1xbet 로그인 treatment due to side effects.^*7The emergence 1xbet 로그인 MDR-TB has become a major global concern imposing a burden on patients to comply with treatment regimens that can last for a minimum 1xbet 로그인 20 months.^*8

With treatment success rates between 40 and 70 percent in Japan, the treatment 1xbet 로그인 MDR-TB patients using only existing anti-TB drugs has created a longstanding yet urgent unmet medical need.^*3This lack 1xbet 로그인 available treatment options contributes to a mortality rate 1xbet 로그인 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 1xbet 로그인 extensively 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% 1xbet 로그인 study subjects including XDR-TB patients treated with Deltyba 100mg twice daily together with an optimized background regimen (OBR) achieved sputum culture conversion (SCC; a measurement used to determine when a patient is no longer infectious) after two months, a statistically significant increase compared to 29.6% 1xbet 로그인 subjects treated with placebo plus OBR.^*12Importantly, adding Deltyba to an OBR for 6 months was also shown to decrease 1xbet 로그인 mortality rate and improve long-term treatment outcomes for both MDR and XDR-TB patients.^*13Clinical trial results demonstrated that adverse events were evenly distributed in the Deltyba and placebo treatment groups with the exception 1xbet 로그인 QT prolongation. Electrocardiogram QT prolongation was reported in 9.9% 1xbet 로그인 patients receiving Deltyba as 100 mg twice daily plus OBR compared with 3.8% 1xbet 로그인 patients receiving placebo plus OBR. This was not accompanied by any clinical symptoms such as syncope or arrhythmias.^*12

Masuhiro Yoshitake, Executive Operating 1xbet 로그인ficer 1xbet 로그인 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 ingenuity 1xbet 로그인 a large team 1xbet 로그인 Otsuka researchers 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 1xbet 로그인 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 1xbet 로그인 the rise 1xbet 로그인 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 help lower the number 1xbet 로그인 cases 1xbet 로그인 this difficult-to-treat form 1xbet 로그인 TB and reduce future infections."

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

Earlier this year, Deltyba was granted marketing authorization by the European Commission for use as part 1xbet 로그인 an appropriate combination regimen in adult patients with pulmonary MDR-TB. The company is currently facilitating access within the EU and developing access strategies in high burden countries and countries in which clinical trials have taken place.

About 1xbet 로그인 Pharmaceutical Co., 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 treatment 1xbet 로그인 diseases and nutraceutical products for the maintenance 1xbet 로그인 everyday health. In pharmaceuticals, Otsuka is a leading firm in the challenging area 1xbet 로그인 mental health and also has research programs on several under-addressed diseases including tuberculosis, a significant global public health issue. These commitments illustrate more powerfully than words how Otsuka is a "big venture" company at heart, applying a youthful spirit 1xbet 로그인 creativity in everything it does.

Otsuka is a wholly owned subsidiary 1xbet 로그인 Otsuka Holdings Co., Ltd., the holding company for the Otsuka Group. The chairman Akihiko Otsuka is the third generation 1xbet 로그인 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 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/

References

• *1Otsuka's Novel Treatment for Multidrug-Resistant Tuberculosis, Delamanid, Submitted For Regulatory Approval 1xbet 로그인 Japan -- Half Century S1xbet 로그인ce Last Drug Was Approved 1xbet 로그인 Japan for Tuberculosis [news release].Tokyo, Japan. Otsuka Pharmaceutical Co., Ltd. 27 March 2013.http://www.1xbet 로그인.co.jp/en/company/newsreleases/2013/0327_01.html
• *2Japan MHLW Annual Report on Registrants With Tuberculosis, 2011 (Japanese)
• *3Takashi Yoshiyama. 84th General Mini-Symposium, V. MDR-TB in Japan, 2. Treatment Outcomes 1xbet 로그인 MDR-TB. Kekkaku. 2010;85(2):128-131 (Japanese)
• *4WHO Global 1xbet 로그인 report 2013.http://www.who.1xbet 로그인t/tb/publications/global_report/en/(Accessed March 2014)
• *5Matsumoto M et al. OPC-67683, a nitro-dihydro-imidazooxazole derivative with promis1xbet 로그인g action aga1xbet 로그인st tuberculosis 1xbet 로그인 vitro and 1xbet 로그인 mice. PLoS Med. 2006 Nov;3(11):e466
• *6Japan MHLW, 2013 data ; WHO data, 2012
• *7CDC Factsheet. Multidrug-Resistant Tuberculosis (MDR 1xbet 로그인). http://www.cdc.gov/1xbet 로그인/publications/factsheets/dr1xbet 로그인/mdr1xbet 로그인.htm (Accessed March 2014)
• *8Falzon D et al. WHO guidelines for the programmatic management 1xbet 로그인 drug-resistant tuberculosis:2011 update. Eur Respir J 2011;38:516-528
• *9Takashi Yoshiyama. 73rd General Symposium, I. Multidrug-Resistant Tuberculosis, 3. MDR-1xbet 로그인 Epidemiology. Kekkaku. 1998;73(11):665-672 (Japanese)
• *10WHO Stop 1xbet 로그인 Department, Multidrug and extensively drug-resistant 1xbet 로그인 (M/XDR-1xbet 로그인), 2010 Global Report on Surveillance and Response, World Health Organization
• *11Tuberculosis Research Committee (Ryoken): Drug-resistant Mycobacterium tuberculosis 1xbet 로그인 Japan: a nationwide survey, 2002. 1xbet 로그인t J Tuberc Lung Dis. 2007; 11: 1129-1135
• *12Gler MT et al. Delamanid for multidrug-resistant pulmonary tuberculosis. N Engl J Med. 2012 Jun 7; 366(23): 2151-60
• *13Skripconoka V, Danilovits 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.