Active Biotech AB Interim report January – March 2014

Laquinimod

• On January 24, the laquinimod (Nerventra®) market application received a negative opinion by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA).
   
• Teva has requested a re-examination of the CHMP’s opinion.
   
• In February 2014, Teva decided not to proceed with the randomization stage of the planned LIBRETTO trial for the treatment of relapsing remitting multiple sclerosis (RRMS) since the current design is no longer aligned with the regulatory strategy.
• The ongoing US pivotal clinical study CONCERTO is continuing according to plan. The results are expected in 2016.

Tasquinimod     

• In February 2014, Ipsen launched a randomized, double-blind, placebo-controlled Phase III study of tasquinimod in chemo-naive CRPC patients in Asia.
   
• The Phase III 10TASQ10 study is proceeding as planned; the primary analysis of progression-free survival (PFS) and overall survival (OS) is expected in 2014.            

Paquinimod (57-57)  

• In January 2014, paquinimod, for the treatment of systemic sclerosis, was granted orphan drug status by the US Food and Drug Administration (FDA). Orphan drug status in the US provides advantages such as market exclusivity for a period of seven years upon approval. 

Financial summary

• Net sales 2.1 (2.4) MSEK
• Operating loss -59.2 (-77.0) MSEK
• Loss for the period -60.2 (-78.0) MSEK
• Loss per share -0.80 (-1.10) SEK

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Active Biotech AB Interim report January – March 2014

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Source: Active Biotech via Globenewswire
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