Orphan Medicinal Product Status to Active Biotech’s 57-57 project recommended
Nov 18, 2010 10:09 (CET)
Lund, Sweden, November 18, 2010 - Active Biotech AB (NASDAQ OMX Nordic: ACTI)
today announced that the COMP (Committee for Orphan Medicinal Products) adopted
a positive opinion recommending the project 57-57 for designation as orphan
medicinal product, for the indication Systemic Sclerosis (SSc), to the European
Commission.
Preparations are in progress for the launch of an explorative study in Systemic
Sclerosis during 2011.
Active Biotech AB (publ)
Tomas Leanderson
President and CEO
About EMA's Orphan Medicinal Product Designation
The EMA's "Orphan Medicinal Product Designation" is implemented to promote the
development of drugs which may provide significant benefit to patients suffering
from rare diseases identified as life-threatening or chronically debilitating.
Under EMA guidelines, Orphan Medicinal Product Designation provides 10 years of
potential market exclusivity if the product candidate is approved for marketing
in the European Union. Orphan status also permits EMA assistance in optimizing
the candidate's clinical development through participation in designing the
clinical protocol and preparing the marketing application. Additionally, a drug
candidate designated by the EMA as an Orphan Medicinal Product may qualify for a
reduction in regulatory fees as well as a European Union-funded research grant.
About 57-57
57-57 is an orally active small molecule which binds to the molecule S100A9 and
blocks its interaction with the pro-inflammatory receptors RAGE and TLR4. 57-57
interferes with early stage of immune activation and acts immunomodulatory
without causing general immune suppression. Excellent properties for oral once
daily administration has been demonstrated.
Phase I studies and a small-scale exploratory clinical study of 57-57 in SLE
patients have been conducted. This study has recently been completed. In August
2010, the company decided to initiate the development of 57-57 for the treatment
of Systemic Sclerosis.
About Systemic Sclerosis
Systemic sclerosis (SSc) is a rare autoimmune disease. SSc is characterized by
disturbances of the immune system and by overproduction and deposition of
various proteins in particular collagen leading to inflammation and abnormal
growth of the connective tissue of the skin and internal organs such as
gastrointestinal tract, lungs, heart and kidney. The disease may lead to severe
dysfunction and can be life threatening due to failure of internal organ.
There is presently no cure for SSc and existing treatments are focused on
controlling symptoms and preventing complications. There is a high unmet medical
need for new targeted therapies of SSc.
For further information, please contact
Göran Forsberg, VP IR & Business Development
Tel: +46 46 19 11 54
goran.forsberg@activebiotech.com
About Active Biotech
Active Biotech AB (NASDAQ OMX NORDIC: ACTI) is a biotechnology company with
focus on autoimmune/inflammatory diseases and cancer. Projects in or entering
pivotal phase are laquinimod, an orally administered small molecule with unique
immunomodulatory properties for the treatment of multiple sclerosis, TASQ for
prostate cancer as well as ANYARA for use in cancer targeted therapy, primarily
of renal cell cancer. In addition, laquinimod is in Phase II development for
Crohn's and Lupus. Further projects in clinical development comprise the two
orally administered compounds, 57-57 for SLE & Systemic Sclerosis and RhuDex(TM)
for RA. Please visitwww.activebiotech.comfor more information.
Active Biotech is obligated to publish the information contained in this press
release in accordance with the Swedish Securities Market Act. This information
was provided to the media for publication on November 18, 2010 at 10:00 am.
Active Biotech AB
PO Box 724, SE-220 07 Lund
Sweden
Tel: +46 (0)46-19 20 00
Fax: +46 (0)46-19 11 00
www.activebiotech.com
[HUG#1463684]
Orphan Medicinal Product Status to Active Biotech's 57-57 project recommended:
http://hugin.info/1002/R/1463684/402402pdf
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Source: Active Biotech via Thomson Reuters ONE