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Active Biotech AB Year-end report January - December 2014

2015-02-11

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
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, Sweden
Tel: +46 (0)46 19 20 00
Fax: +46 (0)46 19 11 00

pdfActive Biotech AB Year-end report January - December 2014



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