Gilead and Boehringer Ingelheim sign license agreement for novel HIV non-catalytic integrase inhibitors

Gilead Sciences, Inc. (Nasdaq:GILD) and Boehringer Ingelheim today announced that the companies have entered into a licensing agreement, under which Boehringer Ingelheim has granted Gilead exclusive worldwide rights for the research, development and commercialization of its novel non-catalytic site integrase inhibitors (NCINIs) for HIV. This includes the lead compound BI 224436, which has been evaluated in a Phase 1a dose-escalation study to assess bioavailability and pharmacokinetics in healthy volunteers.

NCINIs target the key component of the HIV virus responsible for incorporation of the viral DNA into the human genome. NCINIs inhibit HIV integrase by binding to a novel site, distinct from the catalytic site used by the current class of integrase inhibitors, and therefore may possess a differentiated resistance profile from raltegravir or elvitegravir.

“We are very pleased to have established this licensing agreement. The Boehringer Ingelheim compounds complement our internal discovery programs and the efforts are aligned with our commitment to continue to innovate in the field of HIV,” said Norbert Bischofberger, PhD, Executive Vice President, Research and Development and Chief Scientific Officer, Gilead Sciences. “We are looking forward to progressing BI 224436 or other compounds further into clinical development.”

“Both companies’ genuine interest in advancing research and development in virology is reflected by this collaboration’s aim to address unmet patient needs,” said Prof. Dr. Klaus Dugi, Corporate Senior Vice President Medicine at Boehringer Ingelheim. “While Gilead will drive the integrase inhibitors in HIV into clinical development, we will focus our development efforts on further compounds of our virology pipeline, particularly our portfolio in hepatitis C.”

Under the terms of the agreement, Gilead will pay Boehringer Ingelheim an upfront payment. Boehringer Ingelheim could receive additional payments based upon the achievement of certain development, regulatory and commercial milestones, as well as royalties on future net sales.