GlycoMimetics, Inc. (NASDAQ: GLYC) announced today that Pfizer (NYSE:
PFE) has informed the company that it anticipates initiating a planned
Phase 3 clinical trial with rivipansel (GMI-1070) in mid-2015. Pfizer
has advised GlycoMimetics that the clinical supply issue which has
delayed the start of this trial has been discussed with the FDA. Based
on these discussions, Pfizer anticipates the study being able to start
enrollment in mid-2015, following FDA review of amended study documents.
Under the terms of the license agreement between the two companies,
Pfizer is scheduled to make a $20 million milestone payment to
GlycoMimetics once the first patient is dosed in the Phase 3 clinical
trial. This milestone is the second of two scheduled milestone payments
totaling $35 million upon initiation of the Phase 3 clinical trial.
Pfizer previously paid GlycoMimetics $15 million in May
2014. Rivipansel is initially being developed as a potential
treatment for vaso-occlusive crisis (VOC) of sickle cell disease. Under
the license agreement, Pfizer is responsible for the clinical
development and regulatory submission and, if approved, the
commercialization of rivipansel.
“Pfizer’s commitment to initiating the rivipansel Phase 3 clinical trial
represents a key step in the development of this potentially important
new medication for treatment of pain crisis associated with sickle cell
disease,” said Rachel
King, Chief Executive Officer, GlycoMimetics.
Rivipansel has received both Orphan Drug and Fast Track status for the
treatment of VOC from the FDA, and Orphan Product status in the European
Union.
About GlycoMimetics, Inc.
GlycoMimetics is a clinical stage biotechnology company focused on the
discovery and development of novel glycomimetic drugs to address unmet
medical needs resulting from diseases in which carbohydrate biology
plays a key role. GlycoMimetics entered into an exclusive license
agreement with Pfizer for rivipansel in October 2011. Under the license
agreement, Pfizer is responsible for the clinical development,
regulatory approval and potential commercialization of rivipansel.
A GlycoMimetics wholly-owned candidate therapy (GMI-1271) for acute
myeloid leukemia (AML) and other blood disorders is also in clinical
trials. Glycomimetics are molecules that mimic the structure of
carbohydrates involved in important biological processes. Using its
expertise in carbohydrate chemistry and knowledge of carbohydrate
biology, GlycoMimetics is developing a pipeline of glycomimetic drug
candidates that inhibit disease-related functions of carbohydrates, such
as the roles they play in inflammation, cancer and infection. Learn more
at www.glycomimetics.com.
Cautionary Note Regarding Forward-Looking Statements
This press release contains forward-looking statements regarding the
clinical development of rivipansel, including expected milestone
payments from Pfizer. Actual results may differ materially from those in
these forward-looking statements. For a further description of the risks
associated with these statements, as well as other risks facing
GlycoMimetics, please see the risk factors described in the Company’s
annual report on Form 10-K that was filed with the U.S. Securities and
Exchange Commission on March 16, 2015, and other filings the Company
makes with the SEC from time to time. Forward-looking statements speak
only as of the date of this release, and GlycoMimetics undertakes no
obligation to update or revise these statements, except as may be
required by law.
Copyright Business Wire 2015