A scletis announced that the company has licensed develop- ment, manufacturing and commercialization rights from Assent R&D Ireland to TMC310911, a next-generation HIV protease inhibitor (PI). The agreement provides Ascletis with exclusive rights to develop and commercialize TMC310911 in Greater China, including mainland China and Macau. Janssen will retain all rights in the rest of the world and is eligible to receive royalties based on product sales in Greater China.
“This licensing agreement for TMC310911 adds a third drug candidate in late-stage development to the Ascletis pipeline, which aims to provide innovative therapeutics for important medical needs in China,” said Jinzi J. Wu, Ph.D., Ascletis President and Chief Executive Officer. “Based on research to date, we believe that TMC310911 has the potential to offer a new standard-of-care, especially for HIV-infected patients exhibiting multi-drug resistance to current PIs.”
Published research has shown that TMC310911 offers a higher genetic barrier to the development of resistance than any existing HIV PIs. TMC310911 also exhibits broader activity against multi-PI resistant recombinant clinical isolates of HIV than any currently approved PI, including darunavir, the current standard of care. Moreover, three clinical studies completed by Janssen, including a Phase IIa study, showed TMC310911 to have a favorable safety and tolerability profile and demonstrated clinical proof-of-concept in treatment naïve, HIV positive patients.
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