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GlycoMimetics' Leukemia Drug Gets Orphan Status in U.S. - Analyst Blog

Zacks Equity Research
Updated

GlycoMimetics, Inc. GLYC announced that its proprietary oncology candidate GMI-1271 received orphan drug status from the FDA for the treatment of acute myeloid leukemia (AML).

Currently, the company is evaluating the safety, pharmacokinetics and efficacy of GMI-1271 in combination with chemotherapy in a phase I/II open-label multicenter study in adults suffering from AML.

The FDA usually grants orphan drug status to promote the development of candidates it considers promising for the treatment of rare diseases that affect less than 200,000 people in the U.S. Upon the receipt of this designation, the concerned company becomes entitled to receive benefits such as a potential seven-year period of marketing exclusivity in the U.S. following approval and assistance from the FDA regarding study protocol. Additionally, the company may apply for research funding and tax credits for specific research expenses as well as request for waiving of certain regulatory fees.

GlycoMimetics believes that orphan drug status for GMI-1271 is a significant regulatory milestone for the company. Being a development-stage company, this designation should ramp up efforts on the development of GMI-1271, which is the second-most important candidate in GlycoMimetics’ pipeline.

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In addition to AML, GlycoMimetics is working in collaboration with the University of Michigan to develop GMI-1271 as a potential new class of anticoagulant for the treatment of patients at risk for venous thromboembolic disease. A phase I study on GMI-1271, being conducted in healthy volunteers by The University of Michigan in this indication is expected to be completed within ten months from the date of commencement (Dec 2014).

Meanwhile, the company is developing its lead candidate, rivipansel, for the treatment of vaso-occlusive crisis (one of the most severe complications of sickle cell disease) under collaboration with Pfizer Inc. PFE. Rivipansel enjoys both orphan drug designation and fast track designation in the U.S. for the treatment of vaso-occlusive crisis.

GlycoMimetics carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the health care sector are Valeant Pharmaceuticals International, Inc. VRX and Actelion Ltd. ALIOF. Both carry a Zacks Rank #1 (Strong Buy).

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