Tolero Pharmaceuticals, a biopharmaceutical company focused on the discovery and development of novel therapeutics to treat cancer and other serious human diseases, and MannKind Corporation (Nasdaq: MNKD), focused on discovering, developing and commercializing therapeutic products for diabetes and cancer, today announced a license agreement granting Tolero exclusive worldwide rights to develop and commercialize compounds from MannKind's novel BTK (Bruton's tyrosine kinase) program, which are currently being developed for the treatment of hematological malignancies and inflammatory diseases.
Under the terms of the agreement, Tolero will pay MannKind upfront and milestone payments linked to the development, approval and commercialization of products, for total potential upfront and milestone payments of approximately $130 million. MannKind will also receive tiered royalties on sales of products and a percentage of sublicensing revenue. In addition, MannKind has an option to re-acquire the rights to the program at pre-specified terms until 60 days after the conclusion of the first Phase 1 study. If MannKind exercises this option, then MannKind would assume responsibility for developing and commercializing products and Tolero would become entitled to receive the milestone payments, royalties and sublicensing revenues specified in the agreement.
"We are really excited about this opportunity and pleased to be working with an experienced drug development team at MannKind that is passionate about moving this program forward. BTK currently represents one of the most exciting therapeutic targets in oncology, and we feel that our collaborative approach to targeting BTK may uncover some novel utilities not yet fully realized," said Dallin Anderson, Chairman and President of Tolero.
Dr. David Bearss, Founder of Tolero, added, "BTK has already been demonstrated to be a validated clinical target in multiple disease settings. We believe that MannKind has developed a series of novel compounds with unique mechanisms of action that may lead to important treatments for cancer and autoimmune diseases, such as rheumatoid arthritis. We are excited to be a strategic partner with MannKind."
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