SINGAPORE, May 13 S*BIO Pte Ltd today announced that theU.S. Food and Drug Administration (FDA) has granted orphan drug designation toSB1518, its potent and orally-active JAK2 inhibitor for the treatment ofmyeloproliferative disorders (MPD). The FDA accepted S*BIO's application uponreview of preclinical data which demonstrated excellent anti-proliferative andanti-tumor activity, combined with very good tolerability of the JAK2inhibitor.
"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 effectivetreatment of MPD caused by aberrant JAK2 signaling and SB1518 couldpotentially address this unmet medical need. The designation will allow us tooptimize our development and regulatory strategy for SB1518."
MPD is a closely related group of hematological malignancies in which thebone marrow develops and functions abnormally. MPD is characterised by anexcess of blood cells and the three main disorders include polycythemia vera(excess red blood cell mass), essential thrombocythemia (excess bloodplatelets) and myelofibrosis.
Orphan Drug Designation in the United States
Orphan drug is a designation by the FDA indicating a therapy developed totreat diseases that affect fewer than 200,000 persons in the United States.Orphan drug designation for SB1518 will entitle S*BIO to tax credits onclinical research after designation and seven years of marketing exclusivity.Other potential benefits include regulatory fee waivers, grants for clinicalresearch and protocol assistance.
SB1518 is a small molecule JAK2-selective kinase inhibitor which has highpotency against both the wild type JAK2 kinase and the JAK2 kinase with theV617F mutation. The V617F mutation is found in high frequencies in certaintypes of hematological disorders. By targeting the JAK2 activating mutation,SB1518 has the potential to interfere with a key mechanism driving theprogress of a variety of cancers and other hematological disorders.
About S*BIO Pte Ltd
S*BIO is a privately-held biotech company focused on the research andclinical development of novel targeted small molecule drugs for the treatmentof cancer with leading programs around histone deacetylases (HDAC) andkinases. S*BIO's lead candidate, SB939, has entered the clinic in 2007. Itrecently announced that SB1518, has been selected as a clinical candidate andthat a third compound, SB1317, is in pre-clinical development.
In line with its vision to be a leading fully-integrated oncology-focusedbiotech company in Asia Pacific, S*BIO has established a state-of-the-art R&Dinfrastructure, complemented by an experienced clinical development team.S*BIO has strong linkages with a network of medical oncologists in AsiaPacific and its investors include Bio*One Capital, Novartis Bioventures andother international funds. More information about S*BIO can be found atwww.sbio.com.S*BIO Pte Ltd: Russo Partners: Stephen Keith Rhind, Ph.D. Tony Russo +1 212-845-4251 Senior Vice President, Corporate [email protected]
Development Andreas Marathovouniotis Tel: +65 6827 5000 (Singapore) +1 212-845-4235 [email protected] [email protected]