) announced that its partner,
), has entered into an agreement with the FDA under a special
protocol assessment (SPA) for a phase III study on rivipansel
(GMI-1070). GlycoMimetics' shares jumped around 9% following the
The companies are developing rivipansel for the treatment of
patients suffering from sickle cell disease who are hospitalized
for vaso-occlusive crisis (VOC). The study is expected to start by
In May 2014, Pfizer paid $15 million to GlycoMimetics as per the
terms of the 2011 agreement between the two companies.
GlycoMimetics will receive $20 million payment following the
initiation of the phase III study. While GlycoMimetics was
responsible for phase II, Pfizer is in charge of the phase III
study on the candidate.
Last year, GlycoMimetics announced positive results from a phase II
study on rivipansel in hospitalized sickle cell disease patients
experiencing VOC. Results revealed that reductions in time to reach
resolution of VOC were observed in patients treated with rivipansel
compared to those under placebo.
GlycoMimetics and Pfizer intend to file for approval of rivipansel
in the U.S. for the VOC indication on the basis of results from the
phase III study. Rivipansel enjoys both orphan drug and fast track
designation in the U.S. for the VOC indication.
Both GlycoMimetics and Pfizer have progressed well with rivipansel.
Successful development of rivipansel is crucial for GlycoMimetics
which currently has no approved products.
GlycoMimetics currently carries a Zacks Rank #3 (Hold). Some
better-ranked stocks in the same sector include
Synergy Pharmaceuticals, Inc.
). Both stocks carry a Zacks Rank #1 (Strong Buy).
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