Ascletis said today it obtained exclusive rights from Assent R&D Ireland to develop, manufacture, and commercialize the next-generation HIV protease inhibitor (PI) TMC310911 in greater China, including mainland China and Macau. Johnson & Johnson’s Janssen subsidiary 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,” Jinzi J. Wu, Ph.D., Ascletis’ president and CEO, said in a statement.
The other two are ASC-06 (ALN-VSP), a clinical-stage, first-in-class, systemically delivered RNAi therapeutic for the treatment of liver cancers that is being developed with Alnylam Pharmaceuticals; and ASC-08 (danoprevir), a clinical-stage hepatitis C protease inhibitor being developed with Roche. Earlier this month, Ascletis and Roche said they would collaborate to develop and commercialize Roche’s investigational drug danoprevir in China for hepatitis-C virus.
“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,” Dr. Wu said.
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. Published studies have also shown that TMC310911 offers a higher genetic barrier to the development of resistance than any existing HIV PIs; and exhibits broader activity against multi-PI resistant recombinant clinical isolates of HIV than any currently approved PI, including the current standard of care darunavir.
With operations at the National High Tech Industry Development Zone in Hangzhou, China, and at North Carolina’s Research Triangle Park and Ascletis specializes in clinical development of medicines and commercialization for the growing Chinese pharmaceutical marketplace.
On its own, Ascletis is developing the cancer drug ASC-06 (ALN-VSP), which consists of two siRNAs designed to target a pair of genes involved in the growth and development of cancer cells: vascular endothelial growth factor (VEGF) and kinesin spindle protein (KSP), also known as eglin 5 (Eg5).