1. Date of Event: 2013/04/11
2. Content of Announcement:
(1) Microbio obtained global exclusive right of “small-molecule inhibitors DBPR110 for clinical use to treat Hepatitis C virus (HCV) and its derivatives” from the National Health Research Institutes (NHRI)
(2) DBPR110 is a small-molecule drug designed to selectively inhibit the non-structural 5A (NS5A) protein of hepatitis C virus. The preclinical development of DBPR110 has been completed and transferred to Microbio Co., Ltd. Completion of clinical trials for DBPR110 will be a milestone in the domestic drug discovery and development of new chemical entities. DBPR110 could be part of a more effective therapeutic strategy for HCV in the future.
(3) The preclinical data shows that DBPR110 has superior viral inhibition compared to the NS5A inhibitor developed by Bristol-Myers Squibb (BMS-790052). Additional preclinical data also shows that DBPR110 has superior drug stability and pharmacokinetics.
(4) Microbio has completed the CMC, preclinical toxicology, pharmacology and patent filing. Microbio is currently preparing the IND package for US FDA submission.
3. Potential Impact to Microbio:
(1) Hepatitis C virus (HCV) infection is a growing public health concern. Globally an estimated 180 million people are infected, with 32 million in the United States and 40 millions in China. The hepatitis C market is estimated to reach 20 billion in 2020.
(2) The license agreement states milestone is based on developmental and regulatory achievement; therefore, the financial risk is moderate. DBPR110 is potentially a highly positive asset for Microbio if it is successfully advanced in development.
4. Purpose of the license deal:
To develop novel small-molecule treatment for hepatitis C infection