Laquinimod
* Teva remains committed to the development of laquinimod (NERVENTRA(®)) for
the treatment of multiple sclerosis (MS)
* On January 24, laquinimod received a negative opinion by the Committee for
Medicinal Products for Human Use (CHMP) of the European Medicines Agency
(EMA). The CHMP's opinion was based on the view that laquinimod's positive
effect on reducing relapses did not outweigh the potential risks. Although
the CHMP found that laquinimod has a positive effect on slowing disability
in MS patients, this finding had no impact on the decision. In the risk
assessment, the CHMP focused on findings in animal studies, performed in
parallel with the pivotal clinical trials, relating to the potential risk of
fetal damage and the potential increased risk of cancer. None of these
effects have been observed in the comprehensive patient material, comprising
7,490 patient years in total, with some patients being exposed for more than
seven years and tolerated treatment well.
* Teva has requested a re-examination of the CHMP's opinion.
* The ongoing pivotal Phase III study CONCERTO continues according to plan.
Results are expected 2016.
* Teva plans to initiate clinical trials in primary progressive multiple
sclerosis (PPMS).
* Analysis of data from the Phase III ALLEGRO study shows that laquinimod
provides a beneficial impact on brain tissue damage. Laquinimod-treated
patients accumulated significantly less brain tissue damage caused by
neurodegeneration.
* Data presented at ECTRIMS shows that laquinimod reduces inflammation and has
neuroprotective activity.
* At this time, Teva has decided to postpone further clinical development of
laquinimod for the treatment of Crohn's disease until a clearer clinical
strategy has been defined.
Tasquinimod
* Active Biotech received a milestone payment of EUR 12 M from Ipsen.
* Phase III 10TASQ10 study is proceeding as planned; the primary analysis of
progression-free survival (PFS) and overall survival (OS) is expected in
2014.
* In February 2014, Ipsen launched a randomized, double-blind, placebo-
controlled Phase III study of tasquinimod in chemo-naive CRPC patients in
Asia.
ANYARA
* Detailed analysis provided further support for ANYARA's efficacy in a
biomarker-defined sub-group of renal cell cancer patients. Results from the
Phase II/III study was presented at the 2013 European Cancer Congress.
* The next step is a pivotal trial to treat a biomarker-defined group of renal
cancer patients in second-line therapy, which will commence only when an
out-licensing agreement has been reached with a partner.
Paquinimod (57-57)
* Evaluation of the clinical trial in systemic sclerosis demonstrated a
favorable safety profile and effects on disease-related biomarkers.
* The next step in the development program is a Phase II study in systemic
sclerosis, which will commence only when an out-licensing agreement has been
reached with a partner.
ISI
* Project proceeding according to plan.
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
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
[HUG#1761651]
