Almirall, Sun Pharma Enter into a License Agreement for Psoriasis Drug Tildrakizumab in Europe
Sun Pharmaceutical Industries Ltd and Almirall will work together to develop and commercialize tildrakizumab for psoriasis in Europe.
Tildrakizumab is an investigational IL-23p19 inhibitor currently being evaluated in patients with moderate-to-severe plaque psoriasis.
Under terms of the license agreement, Almirall will pay Sun Pharma an initial upfront payment of US $50 million. Phase-3 studies of tildrakizumab have recently been completed. Sun Pharma will be eligible to receive development and regulatory milestone payments and, additionally, sales milestone payments and royalties on net sales, the terms of which are confidential.
Almirall will be able to lead European studies, and participate in larger Global clinical studies for psoriasis indication subject to the terms of the Sun Pharma – Merck agreements, as well as certain cost sharing agreements. Sun Pharma will continue to lead development of tildrakizumab for other indications, where Almirall will have right of first negotiation for certain indications in Europe.
Tildrakizumab is the first IL-23p19 inhibitor to demonstrate positive results in Phase-3 clinical trials. In May 2016, the two pivotal Phase-3 clinical trials of tildrakizumab met their primary endpoints for both evaluated doses. The co-primary efficacy endpoints were: the proportion of participants with psoriasis Area Sensitivity Index 75 (PASI 75) response at week 12 compared to placebo and the proportion of participants with a Physician's Global Assessment (PGA) score of clear or minimal with at least a 2 grade reduction from baseline at week 12 compared to placebo. The overall safety profile of tildrakizumab in both Phase-3 clinical trials was consistent with the safety data observed in previously reported studies. Additionally, the second study included an etanercept comparator arm, with a key secondary endpoint comparing tildrakizumab and etanercept on PASI 75 and PGA. Tildrakizumab 200mg was superior to etanercept on both PASI 75 and PGA endpoints at week 12, while the 100 mg dose showed superiority to etanercept on PASI 75 only.
The detailed findings from the Phase-3 clinical trials will be presented at upcoming scientific meetings.
The preparations for submission of a Biologics License Application to the U.S. Food and Drug Administration are proceeding.