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 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
Stephen_rhind@sbio.com Andreas.Marathis@russopartnersllc.com
SOURCE S*BIO
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