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GlycoMimetics, Pfizer sign $430 million license agreement
GAITHERSBURG, Md.—GlycoMimetics, Inc. and Pfizer Inc. have announced the signing of an exclusive worldwide licensing agreement for GlycoMimetics' investigation compound GMI-1070, a pan-selectin antagonist that is currently in Phase II development as a treatment for vaso-occlusive crisis associated with sickle cell disease. The compound has received both Fast-Track designation and Orphan Drug status from the U.S. Food and Drug Administration.
"We are very pleased to partner with Pfizer for the advancement of GlycoMimetics' lead drug candidate, GMI-1070, which is initially being evaluated in patients with sickle cell disease experiencing vaso-occlusive crisis. This is a major unmet medical need," Rachel King, CEO of GlycoMimetics, said in a press release. "We value the resources and experience that Pfizer brings to the program, and recognize that the agreement is an important validation of GlycoMimetics' unique chemistry expertise in discovery of proprietary drug candidates."
Per the terms of the agreement, Pfizer will gain an exclusive worldwide license to GMI-1070 for vaso-occlusive crisis associated with sickle cell disease as well as for other diseases for which the compound might be developed. GlycoMimetics is responsible for completing the current Phase II trial under Pfizer's oversight, after which Pfizer will assume development and commercialization duties. GlycoMimetics stands to receive approximately $340 million total, including an upfront payment and development, regulatory and commercial milestones, as well as royalties on any sales.
"This partnership is an important milestone for GlycoMimetics as the company advances its clinical development program," Jim Barrett, Ph.D., Chairman of the Board of GlycoMimetics and General Partner, New Enterprise Associates, said in a press release. "It's a testament to the progress made to-date with GMI-1070, and will enhance continued development of this potential treatment for patients suffering from vaso-occlusive crisis."
Vaso-occlusive crisis is the main clinical feature of sickle cell disease and occurs when circulation is blocked by sickle-shaped blood cells, leading to ischemic injury. It results in severe pain and tissue damage, leading occasionally to patient complications and death, and as of yet, no mechanism-based therapies exist. Current treatment is limited to supportive therapy such as hydration and pain control. Vaso-occlusive crisis can last five to six days and results in over 75,000 hospitalizations a year in the United States. GMI-1070 is believed to inhibit selectin interactions, a significant step early on in the inflammatory process that leads to vaso-occlusive crisis, and in preclinical studies, the compound restored blood flow to affected blood vessels in animals with vaso-occlusive crisis.
GMI-1070 is a rationally designed glcyomimetic inhibitor of E-, P- and L-selectins that interferes with the early step in the inflammatory process that leads to leukocyte adhesion and recruitment to inflamed tissue. Two Phase I trials were completed for GMI-1070 in 2009, with no serious adverse events reported. Preclinical studies are also underway to test GMI-1070 in other diseases such as hematologic malignancies, in which selectin-mediated cell adhesion and migration is known to play a significant part in the disease process.
"Pfizer is committed to helping improve the lives of patients with rare diseases, and we see potential for GlycoMimetics' GMI-1070 to be a significant advance in the treatment of vaso-occlusive crisis of sickle cell disease," said Yvonne Greenstreet, senior vice president and head of the Medicines Development Group within Pfizer's Specialty Care business unit, in a press release. "This experimental compound and partnership are emblematic of our strategy in rare disease, targeting areas of high unmet need to deliver improved patient outcomes."
SOURCE: GlycoMimetics press release