Milestone fees related to development, regulatory activities, and sales could exceed $325 million.
Genentech is paying Bayhill Therapeutics $25 million up front in cash and equity for rights to its type 1 diabetes treatment. This marks Genentech’s first clinical-stage diabetes drug candidate.
BHT-3021, a DNA-based, antigen-specific immunotherapy, is currently in Phase I/II trial. If successfully developed, approved, and commercialized, Bayhill could receive over $325 million.
Under the terms of the exclusive, worldwide license, Bayhill will be responsible for completing the ongoing clinical studies, and Genentech will reimburse related expenses. Genentech will then be fully responsible for all future R&D, manufacturing, and commercialization activities.
Bayhill will also receive escalating royalties on annual net sales. The firm also retains rights to opt-in on future development and co-promote in North America.
BHT-3021 is a plasmid-encoding proinsulin, designed to target specific pathogenic immune cells responsible for the autoimmune response in type 1 diabetic patients. It is designed to induce antigen-specific tolerance by selectively turning off the errant autoimmune response attacking the pancreas.
Interim results from a randomized, blinded, placebo-controlled, dose-escalation trial showed that all patients exhibited a preservation of C-peptide, a measure of pancreatic function, compared to placebo. Patients were randomized 2:1 to receive a weekly intramuscular injection of BHT-3021 (0.3 mg, 1 mg, 3 mg, or 6 mg) or placebo for 12 weeks.
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