Active Biotech AB Year-end report January - December 2014
(Thomson Reuters ONE) -
Laquinimod
· The pivotal CONCERTO clinical study is continuing according to plan and
results are expected in 2016.
· In May 2014, EMA's Committee for Medicinal Products for Human Use (CHMP)
announced that the risks observed in animal studies did not prevent registration
for treatment in humans. CHMP confirmed its January 2014 risk-benefit opinion,
that is, to at this stage recommend against approval of laquinimod for the
treatment of relapsing-remitting multiple sclerosis (RRMS) in the European Union
(EU).
· In September 2014, new follow-up data was presented from the extension studies
following ALLEGRO and BRAVO. No new risks were identified and the rates of
adverse events (AEs) were lower in the open-label extensions than in the core
studies. Less than 3 percent of patients discontinued treatment due to AEs
during these extensions. The safety profile of laquinimod when used in a longer-
term setting was hence confirmed.
· In November 2014, it was announced that Teva will initiate a Phase II trial
with laquinimod for the treatment of primary progressive multiple sclerosis
(PPMS). The first patient had been screened in a Phase II trial in Huntington's
disease.
Tasquinimod
· The Phase III study 10TASQ10 is proceeding as planned; the final analysis of
progression-free survival (PFS) and overall survival (OS) is expected during the
first half of 2015.
· In February 2014, Ipsen launched a randomized, double-blind, placebo-
controlled Phase III study of tasquinimod in chemo-naive castrate-resistant
prostate cancer (CRPC) patients in Asia.
· In September 2014, Ipsen announced the preliminary results of the clinical
Phase II proof-of-concept study in four cancer indications. The study for the
treatment of hepatocellular carcinoma is continuing with results expected in
2015. The results do not support the further development of tasquinimod for the
treatment of patients with advanced ovarian, renal cell or gastric carcinomas.
The primary endpoint of the study was progression-free survival (PFS) at a
predefined time for each cohort.
ANYARA
· During the year, it was decided to only conduct commercial activities in
relation to the project. Out-licensing activities are ongoing.
Paquinimod (57-57)
· During the year, it was decided to only conduct commercial activities in
relation to the project. Out-licensing activities are ongoing.
ISI
· The project is proceeding according to plan. The selection of the first
candidate drug is planned to take place during 2015.
Financial information
· A rights issue totaling approximately SEK 225 M was completed in December
2014 and was oversubscribed by 24 percent.
Financial summary
MSEK Oct. - Dec. Jan. - Dec.
2014 2013 2014 2013
---------------------------------------------------------------
Net sales 2.9 4.0 10.4 116.0
Operating loss -55.6 -80.4 -228.5 -209.0
Loss for the period -57.0 -82.1 -231.5 -212.1
Loss per share (SEK) -0.73 -1.07 -3.02 -2.81
Cash and cash equivalents (Dec 31) 328.5 376.2
For further information, please contact:
Tomas Leanderson, President and CEO Active Biotech AB
Tel: +46 (0)46 19 20 95 (Corp. Reg. No. 556223-9227)
Box 724, SE-220 07 Lund, Sweden
Hans Kolam, CFO Tel: +46 (0)46 19 20 00
Tel: +46 (0)46 19 20 44 Fax: +46 (0)46 19 11 00
The report is also available at
www.activebiotech.com
Active Biotech AB Year-end report January - December 2014 :
http://hugin.info/1002/R/1893344/670862.pdf
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originality of the information contained therein.
Source: Active Biotech via GlobeNewswire
[HUG#1893344]
Unternehmensinformation / Kurzprofil:
Datum: 11.02.2015 - 08:30 Uhr
Sprache: Deutsch
News-ID 370753
Anzahl Zeichen: 4876
contact information:
Town:
LUND
Kategorie:
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