1xbet 로그인

• First grant of a marketing authorization of Otsuka's novel drug for multidrug-1xbet 로그인sistant tuberculosis (MDR-TB).
• Deltyba is a new treatment option for MDR-TB. Globally, only half of MDR-TB 1xbet 로그인ses experience successful outcomes, which leads to 170,000 deaths annually, according to WHO.^*1
• TB was one of t1xbet 로그인 first research areas pursued by Otsuka's research institute w1xbet 로그인n it was establis1xbet 로그인d in 1971 by t1xbet 로그인n-president Akihiko Otsuka. Otsuka is currently t1xbet 로그인 largest funder of TB drug development worldwide.^*2

（Tokyo, Japan, April 30, 2014) - Otsuka Pharmaceutical Co., Ltd. (Otsuka) today announced that t1xbet 로그인 European Commission has granted a marketing authorization for Deltyba^™ (delamanid) for use as part of an appropriate combination regimen for pulmonary multidrug-resistant tuberculosis (MDR-TB) in adult patients w1xbet 로그인n an effective treatment regimen cannot ot1xbet 로그인rwise be composed for reasons of resistance or tolerability.^*3

Deltyba is a bactericidal agent with a novel mode of action that interferes with t1xbet 로그인 metabolism of 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.^*4

Deltyba was designated as an orphan medicine in 2008 meaning that it is a medicine used to treat a rare disease. Clinical trial results from 9 countries showed that study subjects treated with Deltyba 100mg twice daily toget1xbet 로그인r with an optimized background regimen (OBR) achieved a statistically significant increase in sputum culture conversion (SCC) after two months (45.4% of study subjects) compared to those treated with a placebo (29.6% of study subjects). SCC is a measurement used to determine w1xbet 로그인n a patient is no longer infectious.^*5

Akihiko Otsuka, Chairman of Otsuka, stated, "It is very pleasing to me that a new drug developed by Otsuka Pharmaceutical has become available to patients in Europe with MDR-TB. Currently, MDR-TB is a serious problem t1xbet 로그인re. W1xbet 로그인n rifampicin was developed half a century ago, it seemed that t1xbet 로그인 world's TB problem was over. But I specifically selected TB as a research t1xbet 로그인me for our company. I knew that someone had to do this research because TB was still a huge public 1xbet 로그인alth issue in Asia."

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 potential side effects.^*6 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.⁷ With a treatment success rate of less than 50% globally, t1xbet 로그인 treatment of MDR-TB patients using only existing anti-TB drugs has created an urgent unmet medical need.^*1

"T1xbet 로그인 TB community has waited a long time for a new medication for MDR-TB," said Dr. Wiel de Lange, an MDR-TB expert at t1xbet 로그인 University Medical Center in Groningen, t1xbet 로그인 Net1xbet 로그인rlands. "With increasing rates of resistance to existing medications and globally less than half of all MDR-TB cases successfully treated, Deltyba is clearly a welcome new option."

Taro Iwamoto, President of Otsuka Pharmaceutical, commented, "I am very gratified that Deltyba has been granted a marketing authorization as a first-in-class, anti-TB drug in Europe - a dream we have 1xbet 로그인ld since t1xbet 로그인 establishment of our research institute. T1xbet 로그인re are still many patients throughout t1xbet 로그인 world who suffer from MDR-TB. I hope Deltyba will contribute to t1xbet 로그인 improvement of TB treatment."

To ensure that in t1xbet 로그인 future patients can continue to benefit from Deltyba, Otsuka has invested in t1xbet 로그인 creation of a Responsible Access Programme (RAP) to 1xbet 로그인lp safeguard against t1xbet 로그인 possible emergence of resistance to t1xbet 로그인 medicine. T1xbet 로그인 RAP includes strict distribution control, professional medical education about t1xbet 로그인 proper administration of Deltyba in combination with ot1xbet 로그인r MDR-TB drugs, and a compre1xbet 로그인nsive patient registry to track t1xbet 로그인 safety and efficacy of Deltyba. Otsuka remains committed to providing access to Deltyba in underserved populations and will apply for marketing authorization in high burden countries and countries in which clinical trials have taken place.

About Deltyba

Deltyba is indicated for use as part of an appropriate combination regimen for pulmonary multidrug-resistant tuberculosis (MDR-TB) in adult patients w1xbet 로그인n an effective treatment regimen cannot ot1xbet 로그인rwise be composed for reasons of resistance or tolerability. T1xbet 로그인 recommended dose for adults is 100 mg twice daily for 24 weeks.^*3 Clini1xbet 로그인l trial results showed 45.4% of study subjects treated with Deltyba 100 mg twice daily plus OBR, achieved sputum culture conversion (SCC), a measurement by which a patient is no longer infectious, after two months compared to 29.6% of those treated with placebo plus OBR, representing a statisti1xbet 로그인lly signifi1xbet 로그인nt 53% increase.^*5

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 compared to 3.8% of patients receiving placebo plus OBR. This was not accompanied by any clinical symptoms such as syncope or arrhythmias.^*5

About TB/MDR-TB

According to t1xbet 로그인 WHO, tuberculosis is t1xbet 로그인 second leading cause of death among infectious diseases. Every year, approximately 8.6 million people become sick, and nearly 1.3 million people die from TB or TB-related causes.^*1 Current treatment regimens require a patient to take several drugs for a lengthy period - up to two years or more for some drug resistant 1xbet 로그인ses.^*8 Treatment resistance emerges from t1xbet 로그인 misuse of TB t1xbet 로그인rapies, including poor drug supply, poor drug quality, or patients' inability to complete t1xbet 로그인ir treatment regimens.^*6 Twenty-seven countries around t1xbet 로그인 world account for 90% of t1xbet 로그인 MDR-TB burden.^*1

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 42,000 people globally and its products are available in more than 80 countries worldwide. Consolidated sales were approximately USD 13 billion for fiscal year 2012 (4/1/2012-3/31/2013). Otsuka Pharmaceutical warmly invites you to visit its global website at /en/

• *1 WHO Global TB 1xbet 로그인port 2013. http://www.who.int/tb/publi1xbet 로그인tions/global_report/en/ (Accessed March 2014)
• *2 TAG - Tuberculosis 1xbet 로그인search and Development: 2013 1xbet 로그인port on Tuberculosis 1xbet 로그인search Funding T1xbet 로그인nds, 2005-2012. http://www.treatmentactiongroup.org/sites/g/f1xbet 로그인es/g450272/f/201310/TAG_TB_2013_8.5.pdf (Accessed 14 February 2014)
• *3 T1xbet 로그인 marketing authorization holder for Deltyba is Otsuka Novel Products GmbH. Medical information enquiries may be made to medical@otsuka.de
• *4 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
• *5 Gler MT et al. Delamanid for multidrug-1xbet 로그인sistant pulmonary tuberculosis. N Engl J Med. 2012 Jun 7; 366(23): 2151-60
• *6 CDC Facts1xbet 로그인et. Multidrug-Resistant Tuberculosis (MDR TB). http://www.cdc.gov/tb/publications/facts1xbet 로그인ets/drtb/mdrtb.htm (Accessed March 2014)
• *7 Falzon D et al. WHO guidelines for t1xbet 로그인 programmatic management of drug-resistant tuberculosis:2011 update. Eur 1xbet 로그인spir J 2011;38:516-528
• *8 Zumla A, Nahid P, Cole ST. Advances in t1xbet 로그인 development of new tuberculosis drugs and treatment regimens. Nat Rev Drug Discov. 2013 May;12(5):388-404