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Novel tuberculosis drug reaches clinical trials

The drug candidate PA-824, donated royalty-free by US biotech firm Chiron in 2002, has entered phase I clinical trials for the treatment of tuberculosis through research initiated by the Global Alliance for TB Drug Development.

The Global Alliance for TB Drug Development, also called the TB Alliance, was granted exclusive worldwide rights to PA-824 and related compounds by Chiron together with a commitment to make the TB technology available royalty-free in endemic countries.

The Alliance is compiled of governments, foundations, businesses and research institutes working towards developing affordable new drug regimens. PA-824 is the first TB drug from the TB Alliance pipeline to enter clinical study. After licensing PA-824 from Chiron, the TB Alliance directed and funded the drug’s preclinical development.

PA-824 marks the first novel compound to be introduced for the treatment of TB for over 40 years.

Under the 2002 license agreement provisions were made for possible further collaboration between the parties including a grant-back option to Chiron for manufacture and commercialization of products in developed markets. The agreement also states that no royalties will be due for drugs marketed in less developed economies, including impoverished countries with a high burden of tuberculosis.

According to the Stop TB Partnership, between 2000 and 2020 an estimated one billion people will be newly infected with TB, an infection which is a leading cause of death among people living with HIV/AIDS.

“Reaching this milestone greatly enhances the chances of improved TB treatment and is an important advance in the TB community’s drive for a faster cure,” said Dr Maria Freire, president and CEO, TB Alliance. “We worked creatively and smartly with our partners, donors and contractors. The result is that an extremely promising TB compound moved from lead identification into human trials in near record time.”