S*BIO Receives Orphan Drug Designation for JAK2 Inhibitor SB1518 for the Treatment of Myeloproliferative...( SINGAPORE May 13 /- S*BIO Pte Ltd...)

SINGAPORE, May 13 /PRNewswire/ -- S*BIO Pte Ltd today announced that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation to SB1518, its potent and orally-active JAK2 inhibitor for the treatment of myeloproliferative disorders (MPD). The FDA accepted S*BIO's application upon review of preclinical data which demonstrated excellent anti-proliferative and anti-tumor activity, combined with very good tolerability of the JAK2 inhibitor.

"We are pleased to receive orphan drug designation for SB1518," said Dr. Jan-Anders Karlsson, CEO of S*BIO. "There is a great need for effective treatment of MPD caused by aberrant JAK2 signaling and SB1518 could potentially address this unmet medical need. The designation will allow us to optimize our development and regulatory strategy for SB1518."

MPD is a closely related group of hematological malignancies in which the bone marrow develops and functions abnormally. MPD is characterised by an excess of blood cells and the three main disorders include polycythemia vera (excess red blood cell mass), essential thrombocythemia (excess blood platelets) and myelofibrosis.

Orphan Drug Designation in the United States

Orphan drug is a designation by the FDA indicating a therapy developed to treat diseases that affect fewer than 200,000 persons in the United States. Orphan drug designation for SB1518 will entitle S*BIO to tax credits on clinical research after designation and seven years of marketing exclusivity. Other potential benefits include regulatory fee waivers, grants for clinical research and protocol assistance.

About SB1518

SB1518 is a small molecule JAK2-selective kinase inhibitor which has high potency against both the wild type JAK2 kinase and the JAK2 kinase with the V617F mutation. The V617F mutation is found in high frequencies in certain types of hematological disorders. By targeting the JAK2 activating mutation, SB1518 has the potential to interfere w
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