Navigation Links
S*BIO's JAK2 Inhibitor SB1518 Granted Orphan Drug Designation by European Commission (EC) for the Treatment of Myelofibrosis (MF)

SINGAPORE, Oct. 18 /PRNewswire/ -- S*BIO Pte Ltd today announced that the European Commission (EC) has granted orphan drug designation to SB1518, its potent and orally active JAK2 inhibitor for the treatment of primary myelofibrosis (PMF), post-polycythemia vera myelofibrosis (PPV-MF) and post-essential thrombocythemia myelofibrosis (PET-MF).  SB1518 has also received orphan drug designation from the U.S. Food and Drug Administration (FDA) for the treatment of the same disorder.

S*BIO recently reported positive safety and tolerability data from an Australian Phase 1 study in 20 patients treated with SB1518. Results were consistent with the data from SB1518's U.S.  Phase 1 trials in which safety, tolerability and activity in different disease states had been observed. S*BIO is currently in Phase 2 MF trials with SB1518, to further test its safety and efficacy.

"The orphan drug designation strengthens our regulatory strategy for SB1518 and potentially expands our marketing exclusivity in the EU after approval," said Dr. Jan-Anders Karlsson, CEO of S*BIO.  "There is a great unmet medical need in Europe and around the world for an effective and safe treatment of MF and we are confident that SB1518 has the potential to address this need."  

Orphan drug designation in the European Union (EU) is granted to drug candidates intended for the diagnosis, prevention and treatment of diseases that affect no more than five in 10,000 people within the EU and no other therapies exists or where new treatments could offer significant benefit over current therapies.  Orphan drug designation for SB1518 will entitle S*BIO to a range of incentives including protocol assistance, reduction in registration fees and eligibility for grants and initiatives supporting research and development related to this orphan designation, both at the European level, and at the level of the member states. For marketing approved products, the orphan drug status grants potential market exclusivity of up to 10 years in the EU.

MF is a serious progressive and chronic condition, whereby scar tissue develops in the bone marrow, resulting in a reduced ability to produce sufficient blood cells. Consequently, more blood cells are made in other organs, such as the liver and spleen, which are not as efficient at blood cell production as the bone marrow.  MF is characterized by an enlarged spleen and progressive anaemia.  Current therapies for MF are mostly palliative in nature and survival rates can be short.  While the actual cause of the disease is unknown, the JAK2 gene has been implicated in the development of this condition.

About S*BIO Pte LtdS*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, entered the clinic in 2007. SB1518, S*BIO's potent and orally-active JAK2 inhibitor, entered the clinic in 2008 and has received orphan drug designation from the U.S. FDA. S*BIO has entered into a development collaboration, and option & license agreement with Onyx Pharmaceuticals, Inc. to develop and commercialize SB1518 and its other novel JAK2 inhibitor, SB1578 in North America and Europe. S*BIO's SB1317, a novel multikinase inhibitor, is in preclinical development and under a worldwide exclusive license with Tragara Pharmaceuticals, Inc. for its development and commercialization.

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 a strong clinical development team. S*BIO has strong links with a network of medical oncologists in Asia Pacific and its investors include Bio*One Capital a subsidiary of EDBI (EDB Investments), Aravis Ventures, Mitsui Ventures, Novartis Bioventures and other international funds. In 2009, S*BIO received the BioSpectrum Editor's Choice, Emerging BioScience Company of Singapore Award. More information about S*BIO can be found at S*BIO Pte Ltd:Russo Partners:Stephen Keith Rhind, Ph.D.

Tony Russo +1 212-845-4251Senior Vice President, Corporate Development Tel: +65 6827 5000 (Singapore)

Andreas Marathovouniotis +1

Copyright©2010 PR Newswire.
All rights reserved

Related medicine technology :

1. For the Treatment of Rheumatoid Arthritis, Surveyed European Rheumatologists Expect Well-Established TNF-Alpha Inhibitors to Lose Considerable Patient Share to Newer Agents in This Drug Class
2. For Multiple Myeloma Treatment, More Surveyed European Clinicians Consider the Combination of Immunomodulatory Agents and Proteasome Inhibitors Promising With Respect to Efficacy Than Any Other Drug Regimen Combinations
3. N30 Pharma Initiates Phase 1 Trials of Novel Reductase Inhibitor
4. ViroPharma Announces Publication of Cinryze™ (C1 Esterase Inhibitor [Human]) Phase 3 Trial Results in Hereditary Angioedema (HAE) in the New England Journal of Medicine
5. ViroPharma Files Prior Approval Supplement (PAS) for Cinryze™ (C1 Esterase Inhibitor [Human]) Industrial Scale Manufacturing
6. FDA: Possible Fracture Risk With High Dose, Long-term Use of Proton Pump Inhibitors
7. Proton Pump Inhibitor DEXILANT(TM) (dexlansoprazole) Now Available in U.S. Pharmacies
8. Portola Pharmaceuticals Announces Initiation of Phase 1 Clinical Trial of PRT062607, an Oral, Syk-Specific Inhibitor for Chronic Inflammatory Disease Indications
9. Genomic Health Announces Publication of Study Using Oncotype DX(R) in Node-Negative and Node-Positive Breast Cancer Patients Treated With Aromatase Inhibitors
10. Takeda Announces Initiation of Trial to Study the Concomitant Use of Dexlansoprazole and Other Proton Pump Inhibitors with Plavix(R) (clopidogrel bisulfate)
11. Neurocrine Advances VMAT2 Inhibitor Program
Post Your Comments:
(Date:11/26/2015)... Research and Markets ( ) ... Future Horizons and Growth Strategies in the Italian ... Segment Forecasts, Competitive Intelligence, Emerging Opportunities" report ... --> This new 247-page report ... drug monitoring market, including emerging tests, technologies, instrumentation, ...
(Date:11/26/2015)... , November 26, 2015 /PRNewswire/ ... announced the addition of the  "2016 ... the European Cell Surface Marker Testing ... Opportunities"  report to their offering.  ... the addition of the  "2016 Future ...
(Date:11/25/2015)... , Nov. 26, 2015  The total global healthcare industry ... over 2015-2016. Latin America has the ... , (excluding Japan ), is second with ... continues to face increased healthcare expenditure. In 2013-2014, total government ... from 43.5% in 2008-2009 to 41.2% in 2013-2014. In real ...
Breaking Medicine Technology:
(Date:11/26/2015)... ... 2015 , ... PRMA Plastic Surgery is updating their record books yet again ... free flap breast reconstruction surgery! , “What an accomplishment for the PRMA team, says ... and it’s an honor to have served all of these women.” , PRMA is ...
(Date:11/26/2015)... ... November 26, 2015 , ... Pixel Film Studios brings Final ... ProTrailer: Vintage. This newly styled ProTrailer pack comes with 30 all-new vintage-inspired designs, ... giving users limitless opportunities to stylize and create designs quickly and easily, all ...
(Date:11/26/2015)... ... November 26, 2015 , ... Indosoft Inc., developer and distributor ... application server to improve system efficiency and reliability. , The new Q-Suite 6 platform ... standards, the system avoids locking itself into a specific piece of software for many ...
(Date:11/25/2015)... , ... November 25, 2015 , ... ... for all, Water For Empowerment ™ attracts volunteers together who want to ... by empowering women as key stakeholders in the process. The non-profit launched its ...
(Date:11/25/2015)... MN (PRWEB) , ... November 25, 2015 , ... Finnleo, ... through Christmas Eve on several models of traditional and far-infrared saunas. , ... Nordic Spruce is the most traditional Finnish sauna wood, and Finnleo uses only European ...
Breaking Medicine News(10 mins):