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     525  0 Kommentare Biotie interim report 1 January - 30 June 2014 - Seite 2

    Timo Veromaa, Biotie's President and CEO commented, "We are now fully in control of the path forward for tozadenant. The data we have reported so far is strong and we believe this product has the potential to offer meaningful clinical benefit to patients with Parkinson's disease.  We also made steady progress with our Phase 2 assets: NIDA completed recruitment earlier than expected in the SYN117 cocaine addiction study and we were pleased to receive funding from The Michael J. Fox Foundation, after the quarter, to investigate SYN120 in Parkinson's dementia where its dual mechanism of action could play an important role in managing cognition. In the near term our focus will be on execution as we prepare to start Phase 3 trials with tozadenant in H1 2015. We await headline data from the SYN117 study in cocaine dependence around end-2014, at the same time as a Phase 2 clinical trial should begin for SYN120 in Parkinson's dementia. For our VAP-1 antibody, BTT1023, we also expect a Phase 2 study in primary sclerosing cholangitis to commence later in the year".

    Outlook for 2014 and key upcoming milestones:

    Selincro (nalmefene): Lundbeck will continue the rollout of Selincro in additional European markets during 2014. Biotie is eligible for launch milestones in France, Germany and Spain of EUR 2 million in each market, of which Biotie became eligible to the EUR 2 million for Spain on 22 July, and further royalties on sales in all markets. Due to the early phase of the launch of Selincro no guidance can be given on expected royalty revenue in 2014. The first clinical Phase 3 study under the joint Lundbeck/Otsuka development program in Japan is expected to be initiated in 2014, but will not impact Biotie's financial results.

    Tozadenant (SYN115): Biotie considers tozadenant to potentially be its most valuable asset given the high unmet medical need in Parkinson's disease and stage of development. Following the decision by UCB Pharma to return global rights to tozadenant in March 2014, Biotie has been evaluating the most suitable development strategy for this Phase 3 ready asset to maximize its value to shareholders and has concluded that this can be best achieved by continuing with the Phase 3 study within its current portfolio. Biotie is currently evaluating various options, which may include a capital increase, to support the clinical studies and a strong regulatory filing package for tozadenant.

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    Biotie interim report 1 January - 30 June 2014 - Seite 2 BIOTIE THERAPIES CORP.                       Interim Report                                            30 July, 2014 at 9.00 a.m. Biotie interim report 1 January - 30 June 2014 This is …