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.
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 with a key mechanism driving the progress 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 and clinical development of novel targeted small molecule drugs for the treatment of cancer with leading programs around histone deacetylases (HDAC) and kinases. S*BIO's lead candidate, SB939, has entered the clinic in 2007. It recently announced that SB1518, has been selected as a clinical candidate and that a third compound, SB1317, is in pre-clinical development.
In line with its vision to be a leading fully-integrated
oncology-focused biotech company in Asia Pacific, S*BIO has established a
state-of-the-art R&D infrastructure, complemented by an experienced
clinical development team. S*BIO has strong linkages with a network of
medical oncologists in Asia Pacific and its investors include Bio*One
Capital, Novartis Bioventures and other international funds. More
information about S*BIO can be found at http://www.sbio.com.
S*BIO Pte Ltd: Russo Partners:
Stephen Keith Rhind, Ph.D. Tony Russo +1 212-845-4251
Senior Vice President, Corporate Tony.Russo@russopartnersllc.com
Development Andreas Marathovouniotis
Tel: +65 6827 5000 (Singapore) +1 212-845-4235
Copyright©2008 PR Newswire.
All rights reserved