Otsuka Pharmaceutical Co., Ltd. announces that on March 12, DELTYBA^® Tablets 50 mg (generic name: delamanid) received regulatory approval by the China Food and Drug Administration. Approval was granted for the manufacture and marketing of DELTYBA as a treatment for multidrug-resistant, pulmonary tuberculosis (MDR-TB) in adults.

Otsuka awarded grant to advance development of novel TB compound OPC-167832 with delamanid

TOKYO, HERTFORDSHIRE, England and PITTSBURGH, Aug. 24, 2017 -- Otsuka Pharmaceutical Co. Ltd. (Otsuka) and Mylan N.V. (NASDAQ, TASE: MYL) have entered into a license agreement between their respective subsidiaries, Otsuka Novel Products GmbH (ONPG) and Mylan Pharmaceuticals Private Limited (Mylan), to commercialize delamanid for the treatment of adults with pulmonary multidrug-resistant tuberculosis (MDR-TB) in low- and middle-income countries. Delamanid was discovered and developed, and is currently marketed by Otsuka under the brand name Deltyba™.

Otsuka Pharmaceutical Co. Ltd. (Otsuka) and the Russian pharmaceutical company R-Pharm JSC (R-Pharm) have entered into a licensing agreement to manufacture and commercialize Deltyba™ (delamanid) for the treatment of adults with pulmonary multidrug-resistant tuberculosis (MDR-TB) in the Russian Federation and the Commonwealth of Independent States (CIS).

During the 47th Union World Conference on Lung Health, Otsuka Pharmaceutical, the manufacturer of delamanid, announced the development of a second anti-TB compound in its portfolio currently in Phase 1 clinical development. The compound, OPC-167832, is intended to target both drug-susceptible as well as drug-resistant forms of TB, and has a different mechanism of action than all currently approved anti-TB drugs.  

The initiative will allow countries to access delamanid through the Stop TB Partnership’s Global Drug Facility at a price of US$ 1700 for each full-course treatment of six months’ duration.

Now in its second year, the annual programme recognises young leaders in TB research and furthers a global health partnership committed to fighting TB in high-burden regions.

23 May 2014 - Otsuka and the WHO’s Global Laboratory Initiative (GLI) working group of the Stop TB Partnership launched a new Mycobacteriology Laboratory Manual at the GLI Annual Meeting on April 30th.

-- Program fosters young leaders in TB research

-- Honorees will receive grant to attend international training in TB control strategies and showcase their research at the 45^th Union World Conference on Lung Health

Otsuka's response to open letter regarding delamanid compassionate use program.