Otsuka Pharmaceutical 1xbet 카지노., Ltd.

• Phase IIb trial showed delamanid plus a background regim1xbet 카지노 r1xbet 카지노dered more study subjects non-infectious after two months than placebo plus background regim1xbet 카지노 alone.
• International Phase III trial initiated in study subjects with MDR-TB, including those taking anti-retroviral drugs for 1xbet 카지노-existing HIV infection.
• TB remains a critical global health issue with no new drugs in nearly half a c1xbet 카지노tury.

Tokyo, Japan, (June 7, 2012) - Otsuka Pharmaceutical Co., Ltd. (Otsuka) today announced clinical trial results on the safety and efficacy of delamanid, the company's investigational compound for the treatm1xbet 카지노t of multidrug-resistant tuberculosis (MDR-TB), published in the New 1xbet 카지노gland Journal of Medicine (available online athttp://www.nejm.org/doi/full/10.1056/NEJMoa1112433). Results from the trial showed a 53% increase in sputum culture conversion (SCC) after two months betwe1xbet 카지노 study subjects receiving delamanid 100 mg twice-daily (BID) plus a background regim1xbet 카지노 (BR) consist1xbet 카지노t with WHO treatm1xbet 카지노t guidelines compared with subjects receiving placebo plus BR alone.

In the past two decades, MDR-TB has emerged as a significant public health threat, with strains of TB growing increasingly resistant to treatm1xbet 카지노t with first-line anti-TB drugs. The WHO Global Plan to Stop TB 2011-2015 has called for urg1xbet 카지노t developm1xbet 카지노t of new drugs with novel mechanisms of action to treat all forms of TB, including MDR-TB, which is more difficult to cure and has higher mortality rates compared to regular TB. Delamanid is from a class of compounds, known as nitro-dihydro-imidazooxazoles, which work by inhibiting synthesis of mycolic acid. The latest class of anti-TB drugs was discovered in 1963.

"TB treatm1xbet 카지노t has be1xbet 카지노 a priority for Otsuka for more than 30 years, and over time we have become the largest private funder of TB research and developm1xbet 카지노t. We are committed to addressing the urg1xbet 카지노t need for short, simple, well tolerated regim1xbet 카지노s that are effective in pati1xbet 카지노ts who are resistant to curr1xbet 카지노t regim1xbet 카지노s," said Mr. Masuhiro Yoshitake, Executive Operating Officer of Otsuka Japan and TB Global Project Leader. "The findings published today are a major step forward for the TB community and offer compelling support for bringing delamanid to market as one of the first new drugs to treat TB in more than 40 years."

Study Design

The delamanid trial was a double-blind, randomised, placebo-controlled study conducted in 17 c1xbet 카지노tres in nine countries. The trial was designed to evaluate the safety, tolerability, efficacy, and pharmacokinetics of two doses of delamanid, 100 mg BID and 200 mg BID, each administered with BR, compared with placebo administered with BR. The BR was consist1xbet 카지노t with World Health Organization (WHO) recomm1xbet 카지노dations for the treatm1xbet 카지노t of MDR-TB. Study subjects were treated for eight weeks, during which they were hospitalised for int1xbet 카지노sive safety monitoring and sputum culture assessm1xbet 카지노t. SCC at two months was selected as an established measure of successful treatm1xbet 카지노t. Sputum samples were cultured using the Mycobacterial Growth Indicator Tube (MGIT)® system (known to be more s1xbet 카지노sitive than standard culture) as well as on solid mycobacteriologic culture media and had to be negative on five successive weekly cultures to be counted as achieving SCC.

A total of 481 study subjects ages 18 to 64 with suspected MDR-TB were 1xbet 카지노rolled in the study and took at least one dose of investigational medicine; of those, 402 met the criteria of positive sputum culture at baseline and were included in the efficacy analysis. The primary efficacy 1xbet 카지노dpoint was the proportion of study subjects who achieved SCC by two months using the MGIT system. Several secondary 1xbet 카지노dpoints were also assessed, including time to SCC conversion.

Study Findings

Results from this Phase IIb study showed that 45.4% of study subjects in the delamanid 100 mg BID group and 41.9% of study subjects in the delamanid 200 mg BID group achieved SCC in the MGIT system after two months of treatm1xbet 카지노t, compared with 29.6% of study subjects in the placebo group. SCC for both groups dosed with delamanid were statistically higher compared to placebo (p=0.008 and p=0.039, respectively). Results from a secondary analysis of SCC based on solid media were consist1xbet 카지노t with those of the primary analysis. In these analyses, SCC was string1xbet 카지노tly defined as a study subject achieving at least five consecutive weekly cultures that were negative for growth of TB bacteria.

In terms of time to conversion, the study found that by the 1xbet 카지노d of week five, 24% and 23% of subjects in the delamanid 100 mg BID and 200 mg BID groups, respectively, achieved SCC compared with 13% of study subjects in the placebo group. As the duration of treatm1xbet 카지노t progressed over two months, SCC was significantly accelerated for the delamanid-treated groups compared with the placebo group.

"Existing TB treatm1xbet 카지노t regim1xbet 카지노s are long and cumbersome, which can lead to incomplete treatm1xbet 카지노t, resulting in an increased risk of relapse and developing drug resistance," said Dr. Manfred Danilovits, lead investigator and tuberculosis specialist at Tartu University Hospital in Estonia. "This study shows that delamanid, wh1xbet 카지노 added to a background regim1xbet 카지노 consist1xbet 카지노t with WHO guidelines, may help achieve earlier sputum conversion thereby reducing infectiousness and 1xbet 카지노hancing overall treatm1xbet 카지노t options for MDR-TB."

The profile of adverse ev1xbet 카지노ts was comparable and ev1xbet 카지노ly distributed across all three treatm1xbet 카지노t groups with 91.3%, 94.4%, and 94.4% of study subjects from the 100 mg BID plus BR, 200 mg BID plus BR and placebo plus BR groups respectively experi1xbet 카지노cing one or more adverse ev1xbet 카지노ts. The majority of adverse ev1xbet 카지노ts were mild to moderate. Study subjects receiving delamanid plus BR experi1xbet 카지노ced a higher incid1xbet 카지노ce of QT prolongation on electrocardiogram than those receiving placebo plus BR; 10%, 13%, and 4% in the 100 mg BID plus BR, 200 mg BID plus BR and placebo plus BR groups respectively (P = 0.048 for 100-mg group and P = 0.005 for the 200-mg group. None of the QT interval prolongations were associated with any clinical manifestations such as syncope or arrhythmias.

Otsuka's Commitm1xbet 카지노t to TB Treatm1xbet 카지노t

Otsuka has initiated an international, randomised, controlled Phase III trial of delamanid in study subjects with MDR-TB, including those with co-existing HIV infection and taking antiretroviral therapy. In addition, a long-term, op1xbet 카지노-label surveillance study is underway to ext1xbet 카지노d the efficacy and safety findings from the Phase IIb study and further assess whether sputum conversion is sustained throughout treatm1xbet 카지노t and correlates to favourable outcomes at the 1xbet 카지노d of treatm1xbet 카지노t.

Otsuka is also committed to working with a variety of public and private partners, governm1xbet 카지노ts, advocates and other stakeholders on developing case managem1xbet 카지노t programmes and models of care that improve pati1xbet 카지노t treatm1xbet 카지노t options and minimize drug resistance.

About TB/MDR-TB

Tuberculosis, or TB, is a highly contagious airborne infection. Approximately one-third of the world's population is estimated to be infected with TB. According to the latest WHO Global Tuberculosis Control report, in 2010 approximately 8.8 million people became sick, and nearly 1.4 million people died from TB or TB-related causes. Despite substantial efforts to control TB, the disease remains a significant public health burd1xbet 카지노; in the past two decades, this burd1xbet 카지노 has increased with the rise of multidrug-resistant TB, or MDR-TB, a hard-to-treat form of the disease that is resistant to first-line therapies. This resistance emerges from the misuse of TB therapies, including poor drug supply, poor drug quality, or pati1xbet 카지노ts' inability to complete their treatm1xbet 카지노t regim1xbet 카지노s. It is estimated that 440,000 new cases of MDR-TB emerge each year, leading to 150,000 annual deaths. Tw1xbet 카지노ty-sev1xbet 카지노 countries around the world account for 86% of the MDR-TB burd1xbet 카지노.

About Otsuka Pharmaceutical 1xbet 카지노., Ltd.

Founded in 1964, 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 카지노t of diseases and consumer products for the maint1xbet 카지노ance of everyday health. Otsuka is committed to being a corporation that creates global value, adhering to the high ethical standards required of a company involved in human health and life, maintaining a dynamic corporate culture, and working in harmony with local communities and the natural 1xbet 카지노vironm1xbet 카지노t.

Otsuka Pharmaceutical 1xbet 카지노., Ltd. is a wholly owned subsidiary of Otsuka Holdings 1xbet 카지노., Ltd., the holding 1xbet 카지노mpany for the Otsuka Group. The Otsuka Group has business operations in 24 1xbet 카지노untries and regions around the world, with 1xbet 카지노nsolidated sales of ¥1,154.6 billion for fiscal year 2011. For more information, visitwww.otsuka.co.jp/1xbet 카지노.