Mallinckrodt and Silence Therapeutics will collaborate to develop and commercialize RNAi drug targets designed to inhibit or ‘silence’ the complement cascade, a group of proteins that are involved in the immune system and that play a role in the development of inflammation. These proteins are known to contribute to the pathogenesis of many diseases, including autoimmune diseases.
Under the terms of the agreement, Mallinckrodt will obtain an exclusive worldwide license to Silence’s C3 complement asset, SLN500, with options to license up to two additional complement-targeted assets in Silence’s preclinical complement-directed RNAi development program. Silence will be responsible for preclinical activities, and for executing the development program of each asset until the end of Phase 1, after which Mallinckrodt will assume clinical development and responsibility for global commercialization.
Mallinckrodt will provide Silence with an upfront payment of $20 million. Silence is also eligible to receive up to $10 million in research milestones for SLN500 and for each optioned asset, in addition to funding for Phase 1 clinical development including GMP manufacturing. Silence will fund all other preclinical activities. The collaboration provides for potential added clinical and regulatory milestone payments of up to $100 million for SLN500, as well as commercial milestone payments of up to $563 million for SLN500. Should Mallinckrodt opt to license one or two additional assets, Silence could receive up to $703 million in similar clinical, regulatory, and commercial milestone payments per asset. Silence would also receive tiered, low double-digit to high-teen royalties on net sales for SLN500 and each optioned asset. Mallinckrodt has also agreed to make an equity investment of $5 million in Silence Therapeutics. The company is subscribing for a total of 5,062,167 new ordinary shares at an issue price of 79p per share, representing a 10 percent premium to Silence’s 20-day, volume-weighted average price. As part of this equity investment Mallinckrodt will take a non-executive Director seat on the Silence Board of Directors, and it has been proposed that Steven Romano, M.D., Executive Vice President and Chief Scientific Officer at Mallinckrodt fulfill this position.