Active Biotech: FDA grants Orphan Drug Designation for tasquinimod for the treatment of multiple myeloma
April 12 2017 - 7:30AM
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
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
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