Sun Pharmaceutical Industries and Almirall – the spanish giant announced a licensing agreement on the development and commercialization of tildrakizumab for psoriasis (read more below) in Europe.
Almirall is a global company based in Barcelona dedicated to providing valuable medicines and medical devices through its R&D, agreements and alliances. In 2015, Almirall revenues totaled 769 million euros and, with more than 1,800 employees.
Almirall will pay Sun Pharma an initial upfront payment of US $50 million as per the license agreement. Sun Pharma will be eligible to receive development and regulatory milestone payments, sales milestone payments and royalties on net sales. The license agreement also has a provision for possible co-promotion agreement at some point in the future. While Sun Pharma will continue to lead development of tildrakizumab for other indications, Almirall will have right of first negotiation for certain indications in Europe.
This agreement follows the recent announcement that tildrakizumab is the first IL-23p19 inhibitor to demonstrate positive results in Phase-3 clinical trials.
Tildrakizumab has the potential to help control the pathogenic cells responsible for the inflammatory process of psoriasis with limited impact on the rest of the immune system. The companies are in due process to submit a Biologics License Application to the U.S. Food and Drug Administration.
Psoriasis is a chronic immune disease that appears on the skin. It affects an estimated 7.5 million people in the U.S. and approximately 125 million people worldwide. It is a non-contagious disorder that speeds the growth cycle of skin cells and results in thick scaly areas of skin.
The most common form of psoriasis, called plaque psoriasis, appears as red, raised areas of skin covered with flaky white scales, which may be itchy and painful and can crack and bleed . Despite existing treatment options, many people with plaque psoriasis continue to struggle with the ongoing, persistent nature of this chronic disease that often has a debilitating impact not only on their bodies but their everyday lives.
In May 2016, the two pivotal Phase-3 clinical trials of tildrakizumab met their primary endpoints for both evaluated doses with topline results shared via a separate press release.
The overall safety profile of tildrakizumab in both Phase-3 clinical trials was consistent with the safety data observed in previously reported studies.
The preparations for submission of a Biologics License Application to the U.S. Food and Drug Administration are proceeding.
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