1xbet 로그인 Pharmaceutical Co., Ltd.

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

（Tokyo, Japan, April 30, 2014) - 1xbet 로그인 Pharmaceutical Co., Ltd. (1xbet 로그인) today announced that the European Commission has granted a marketing authorization for Deltyba^™(delamanid) 1xbet 로그인 use as part of an appropriate combination regimen 1xbet 로그인 pulmonary multidrug-resistant tuberculosis (MDR-TB) in adult patients when an effective treatment regimen cannot otherwise be composed 1xbet 로그인 reasons of resistance or tolerability.^*3

Deltyba is a bactericidal agent with a novel mode of action that 1xbet 로그인terferes with the metabolism of the Mycobacterium tuberculosis (MTB) cell walls. It also has high activity 1xbet 로그인 vitro aga1xbet 로그인st various MTB stra1xbet 로그인s, 1xbet 로그인clud1xbet 로그인g those resistant to first-l1xbet 로그인e anti-TB drugs, such as isoniazid and rifampic1xbet 로그인.^*4

Deltyba was designated as an orphan medic1xbet 로그인e 1xbet 로그인 2008 mean1xbet 로그인g that it is a medic1xbet 로그인e used to treat a rare disease. Cl1xbet 로그인ical trial results from 9 countries showed that study subjects treated with Deltyba 100mg twice daily together with an optimized background regimen (OBR) achieved a statistically significant 1xbet 로그인crease 1xbet 로그인 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 determ1xbet 로그인e when a patient is no longer 1xbet 로그인fectious.^*5

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

Resistance to anti-TB drugs can occur 1xbet 로그인 a number of reasons including misuse or mismanagement, such as failure to complete a full course of treatment due to potential side effects.^*6The emergence of MDR-TB has become a major global concern imposing a burden on patients to comply with treatment regimens that can last 1xbet 로그인 a minimum of 20 months.⁷With a treatment success rate of less than 50% globally, the treatment of MDR-TB patients us1xbet 로그인g only exist1xbet 로그인g anti-TB drugs has created an urgent unmet medical need.^*1

"The TB community has waited a long time 1xbet 로그인 a new medication 1xbet 로그인 MDR-TB," said Dr. Wiel de Lange, an MDR-TB expert at the University Medical Center in Groningen, the Netherlands. "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 1xbet 로그인 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 held since the establishment of our research institute. There are still many patients throughout the world who suffer from MDR-TB. I hope Deltyba will contribute to the improvement of TB treatment."

To ensure that in the future patients can continue to benefit from Deltyba, 1xbet 로그인 has invested in the creation of a Responsible Access Programme (RAP) to help safeguard against the possible emergence of resistance to the medicine. The RAP includes strict distribution control, professional medical education about the proper administration of Deltyba in combination with other MDR-TB drugs, and a comprehensive patient registry to track the safety and efficacy of Deltyba. 1xbet 로그인 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 1xbet 로그인 use as part of an appropriate combination regimen 1xbet 로그인 pulmonary multidrug-resistant tuberculosis (MDR-TB) in adult patients when an effective treatment regimen cannot otherwise be composed 1xbet 로그인 reasons of resistance or tolerability. The recommended dose 1xbet 로그인 adults is 100 mg twice daily 1xbet 로그인 24 weeks.^*3Cl1xbet 로그인ical 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 1xbet 로그인fectious, after two months compared to 29.6% of those treated with placebo plus OBR, represent1xbet 로그인g a statistically significant 53% 1xbet 로그인crease.^*5

Cl1xbet 로그인ical trial results demonstrated that adverse events were evenly distributed 1xbet 로그인 the Deltyba and placebo treatment groups with the exception of QT prolongation. Electrocardiogram QT prolongation was reported 1xbet 로그인 9.9% of patients receiv1xbet 로그인g Deltyba as 100 mg twice daily compared to 3.8% of patients receiv1xbet 로그인g placebo plus OBR. This was not accompanied by any cl1xbet 로그인ical symptoms such as syncope or arrhythmias.^*5

About TB/MDR-TB

Accord1xbet 로그인g to the WHO, tuberculosis is the second lead1xbet 로그인g cause of death among 1xbet 로그인fectious diseases. Every year, approximately 8.6 million people become sick, and nearly 1.3 million people die from TB or TB-related causes.^*1Current treatment regimens require a patient to take several drugs 1xbet 로그인 a lengthy period - up to two years or more 1xbet 로그인 some drug resistant cases.^*8Treatment resistance emerges from the misuse of TB therapies, 1xbet 로그인clud1xbet 로그인g poor drug supply, poor drug quality, or patients' 1xbet 로그인ability to complete their treatment regimens.^*6Twenty-seven countries around the world account 1xbet 로그인 90% of the MDR-TB burden.^*1

About 1xbet 로그인 Pharmaceutical Co., Ltd.

1xbet 로그인 Pharmaceutical Co., Ltd. is a global healthcare company with the corporate philosophy: '1xbet 로그인-people creating new products for better health worldwide.' 1xbet 로그인 researches, develops, manufactures and markets innovative and original products, with a focus on pharmaceutical products for the treatment of diseases and nutraceutical products for the maintenance of everyday health. In pharmaceuticals, 1xbet 로그인 is a leading firm in the challenging area of 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 1xbet 로그인 is a "big venture" company at heart, applying a youthful spirit of creativity in everything it does.

1xbet 로그인 is a wholly owned subsidiary of 1xbet 로그인 Holdings Co., Ltd., the holding company for the 1xbet 로그인 Group. The chairman Akihiko 1xbet 로그인 is the third generation of 1xbet 로그인 family members to lead the business, whose origins date from 1921. The 1xbet 로그인 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). 1xbet 로그인 Pharmaceutical warmly invites you to visit its global website at/en/

• *1WHO Global TB report 2013.http://www.who.1xbet 로그인t/tb/publications/global_report/en/(Accessed March 2014)
• *2TAG - Tuberculosis Research and Development: 2013 Report on Tuberculosis Research Fund1xbet 로그인g Trends, 2005-2012.http://www.treatmentactiongroup.org/sites/g/files/g450272/f/201310/TAG_TB_2013_8.5.pdf(Accessed 14 February 2014)
• *3The marketing authorization holder for Deltyba is 1xbet 로그인 Novel Products GmbH. Medical information enquiries may be made to medical@1xbet 로그인.de
• *4Matsumoto Met 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
• *5Gler MTet al.Delamanid 1xbet 로그인 multidrug-resistant pulmonary tuberculosis.N Engl J Med.2012 Jun 7; 366(23): 2151-60
• *6CDC Factsheet. Multidrug-Resistant Tuberculosis (MDR TB).http://www.cdc.gov/tb/publications/factsheets/drtb/mdrtb.htm(Accessed March 2014)
• *7Falzon Det al.WHO guidelines 1xbet 로그인 the programmatic management of drug-resistant tuberculosis:2011 update.Eur Respir J2011;38:516-528
• *8Zumla A, Nahid P, Cole ST. Advances 1xbet 로그인 the development of new tuberculosis drugs and treatment regimens. Nat Rev Drug Discov. 2013 May;12(5):388-404