HANGZHOU, China and RESEARCH TRIANGLE PARK, N.C., April 30, 2013 /PRNewswire/ -- Ascletis today announced that the company has licensed development, manufacturing and commercialization rights from Janssen 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 2a study, showed TMC310911 to have a favorable safety and tolerability profile and demonstrated clinical proof-of-concept in treatment naïve, HIV positive patients.
Ascletis is an emerging biotechnology company, dedicated to discovering, developing and commercializing important new treatments for cancer and infectious diseases. Ascletis is focused on clinical development of innovative medicines and commercialization for the growing Chinese pharmaceutical marketplace. Ascletis has assembled an entrepreneurial management and senior scientific team with a track record of successful pharmaceutical discovery and development at major global pharmaceutical and emerging biotechnology companies in the United States and Europe. To date the company has added three late-stage candidates to its product portfolio: ASC-06 (ALN-VSP), a clinical stage, first-in-class, systemically delivered RNAi therapeutic for the treatment of liver cancers partnered with Alnylam Pharmaceuticals, Inc.; ASC-08 (danoprevir), a clinical stage hepatitis C protease inhibitor partnered with Roche; and ASC-09 (TMC310911), a next-generation HIV protease inhibitor acquired from Janssen, a pharmaceutical company of Johnson & Johnson. For more information, please visit www.ascletis.com outside China or www.ascletis.com.cn inside China.