Therapy Areas: Infectious Diseases
Otsuka signs license agreement for delamanid for treating pulmonary multidrug-resistant tuberculosis in low- and middle-income countries
24 August 2017 -

Healthcare company Otsuka Pharmaceutical Co Ltd reported on Wednesday the launch of a license agreement to commercialise delamanid for the treatment of adults with pulmonary multidrug-resistant tuberculosis (MDR-TB) in low- and middle-income countries in partnership with Mylan NV (Nasdaq:MYL)(TASE:MYL).

The license agreement for Delamanid, which was discovered and developed and is currently marketed by Otsuka under the brand name Deltyba, has been signed between the company's respective subsidiaries, Otsuka Novel Products GmbH (ONPG) and Mylan Pharmaceuticals Private Limited.

This agreement provides Mylan with an exclusive license by Otsuka to prioritize access to Deltyba in South Africa and India. The Drug Controller General of India (DCGI) has granted approval to Mylan to market Deltyba in India and registration is under way in South Africa.

Additionally, Mylan will further exercise exclusive commercial rights and registration responsibilities in additional high MDR-TB burden countries. Both companies may enter into discussions and feasibility studies for a technology transfer plan, enabling Mylan to manufacture and distribute Deltyba for these markets in the future.

Deltyba is one of two anti-tuberculosis medicines and is registered in the EU, Japan, Korea, Hong Kong, Turkey and India. The efficacy of Deltyba was studied in a large, randomised, placebo-controlled phase 2 trial that demonstrated the drug is well tolerated with adverse events evenly distributed in the Deltyba and placebo treatment groups. Electrocardiogram QT prolongation was reported in 9.9% of patients receiving in 100 mg twice daily compared to 3.8% of patients receiving placebo plus OBR.

Tuberculosis (TB), an airborne infectious disease, is among the top causes of death in the world and is the leading infectious disease killer. In 2015, nearly half a million people globally developed MDR-TB, an infection resistant to at least isoniazid and rifampicin, the two most commonly used first-line TB drugs.

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