SOUTH SAN FRANCISCO, CA, USA I August 23, 2018 I Global Blood Therapeutics, Inc. (GBT) (NASDAQ: GBT) announced today that it has entered into an exclusive worldwide licensing agreement with F. Hoffmann-La Roche Ltd. for the development and commercialization of inclacumab, a novel fully human monoclonal antibody against P-selectin. GBT plans to develop inclacumab as a treatment for vaso-occlusive crises (VOC) in patients with sickle cell disease (SCD). Under the terms of the agreement, GBT will be responsible for all development, manufacturing, and commercialization of inclacumab worldwide. Roche will receive an upfront payment of $2.0 million from GBT and is eligible to receive up to approximately $125 million in development and commercialization milestone payments for the sickle cell disease indication. Additionally, Roche is eligible to receive tiered royalties based on net revenues for inclacumab. “We have been working diligently to diversify our product pipeline through both internal research and external business development efforts and are excited to have entered into this agreement for inclacumab,” said Ted W. Love, M.D., president and chief executive officer of GBT. “We are committed to developing transformative treatments for the SCD community and becoming the preeminent SCD company. Inclacumab is an ideal complement to voxelotor, our lead investigational oral, once-daily therapy, in Phase 3 clinical development for SCD. Like voxelotor, inclacumab has a strong scientific rationale and has the potential to provide significant clinical benefit for SCD patients.” Roche was previously developing inclacumab for patients with coronary artery disease. The pharmacokinetic, safety, and tolerability profile of inclacumab are well characterized based upon Roche’s prior clinical studies, which enrolled more than 500 patients. Roche discontinued the inclacumab program following Phase 2 clinical trials. P-selectin inhibition is a clinically validated target in SCD, known to reduce the incidence of VOCs. GBT plans to develop inclacumab for this indication and intends to leverage the safety data produced from Roche’s prior clinical studies as we proceed with our development in SCD. GBT has already begun the process of technology transfer from Roche to a contract manufacturing organization, and anticipates submitting an Investigational New Drug application to the U.S. Food and Drug Administration for inclacumab in 2021. About Inclacumab About Sickle Cell Disease About Vaso-Occlusive Crisis About GBT |
1 https://emedicine.medscape.com/article/205926-clinical. Accessed June 5, 2018.
2 van Tuijn CF, van Beers EJ, Schnog JJ, Biemond BJ. Pain rate and social circumstances rather than cumulative organ damage determine the quality of life in adults with sickle cell disease. Am J Hematol. 2010;85:532-535
3 Platt OS, Brambilla DJ, Rosse WF, et al. Mortality in sickle cell disease — life expectancy and risk factors for early death. N Engl J Med .1994;330:1639-1644.
SOURCE: Global Blood Therapeutics