Active Biotech AB Year-end report January - December 2013February 13, 2014 08:30 (CET)
- 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.
- 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.
- 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.
- 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.
- Project proceeding according to plan.
For further information, please contact:
| Tomas Leanderson, President and CEO |
Tel: +46 (0)46 19 20 95
Hans Kolam, CFO
Tel: +46 (0)46 19 20 44
The report is also available at www.activebiotech.com
| Active Biotech AB |
(Corp. Reg. No. 556223-9227)
Box 724, SE-220 07 Lund
Tel: +46 (0)46 19 20 00
Fax: +46 (0)46 19 11 00