Active Biotech: FDA grants Orphan Drug Designation for tasquinimod for the treatment of multiple myeloma
(Thomson Reuters ONE) -
Lund 12 April 2017 - Active Biotech AB (Nasdaq Stockholm:ACTI) announces today
that Active Biotech has been granted Orphan Drug Designation by the U.S. Food
and Drug Administration (FDA) for its investigational novel agent tasquinimod,
for the treatment of multiple myeloma.
The FDA Orphan Drug Designation program provides orphan status to drugs and
biologics which are defined as those intended for the safe and effective
treatment, diagnoses or prevention of rare diseases or disorders that effect
fewer than 200,000 people in the U.S. This designation provides for a seven year
marketing exclusivity period against competition, as well as certain incentives.
About tasquinimod
Tasquinimod is an immunomodulatory, anti-metastatic and anti-angiogenic compound
that affects the tumor's ability to grow and spread. Tasquinimod acts on
immunosuppressive cells that play a key role in tumor progression in multiple
myeloma due to their capability to promote immune-escape, angiogenesis, and
metastasis. Robust results have been achieved with tasquinimod in animal models
for multiple myeloma. Tasquinimod has patent protection in multiple myeloma
until 2035. The development of tasquinimod has previously been focused on the
treatment of prostate cancer with clinical proof of concept and a good safety
profile shown in Phase 2 and 3 studies. Active Biotech is seeking a partner for
the continued development of tasquinimod in multiple myeloma.
About Multiple myeloma
Multiple myeloma is an incurable form of blood cancer where the plasma cells in
the bone marrow grow uncontrollably while other blood forming cells such as
white and red blood cells and blood platelets are suppressed. This leads to
anemia, infections, destruction of bone tissue and kidney problems since normal
plasma cells are an important part of the body's immune defense and the
production of antibodies. Despite new treatments that have greatly improved
prognosis and survival of MM patients, the biological heterogeneity of the
disease and the emergent drug resistance is a big challenge and the medical need
remains high.
Tomas Leanderson
President and CEO
For further information, please contact:
Hans Kolam, CFO
Tel. +46 46 192044
Active Biotech AB (publ) (Nasdaq Stockholm: ACTI) is a biotechnology company
with focus on Active Biotech AB (publ) (NASDAQ Stockholm: ACTI) is a
biotechnology company with focus on neurodegenerative/inflammatory diseases and
cancer. Laquinimod, an orally administered small molecule with unique
immunomodulatory properties, is in pivotal Phase 3 development for the treatment
of relapsing remitting multiple sclerosis. Also, laquinimod is in Phase 2
development for the treatment of primary progressive multiple sclerosis and
Huntington's disease. Furthermore, commercial activities are conducted for the
tasquinimod, paquinimod och SILC projects. Please visit www.activebiotech.com
for more information.
Active Biotech AB
(Corp. Reg. No. 556223-9227)
Box 724, SE-220 07 Lund, Sweden
Tel: +46 (0)46 19 20 00
This information is information that Active Biotech AB is obliged to make public
pursuant to the EU Market Abuse Regulation. This information was submitted for
publication, through the agency of the contact person set out above, at 13.30
a.m. CET on April 12, 2017.
FDA grants Orphan Drug Designation for tasquinimod:
http://hugin.info/1002/R/2095809/792814.pdf
This announcement is distributed by Nasdaq Corporate Solutions on behalf of Nasdaq Corporate Solutions clients.
The issuer of this announcement warrants that they are solely responsible for the content, accuracy and originality of the information contained therein.
Source: Active Biotech via GlobeNewswire
Unternehmensinformation / Kurzprofil:
Datum: 12.04.2017 - 13:30 Uhr
Sprache: Deutsch
News-ID 536051
Anzahl Zeichen: 4234
contact information:
Town:
LUND
Kategorie:
Business News
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