501 0 Kommentare Biotie interim report 1 January - 30 September 2014

BIOTIE THERAPIES CORP. Interim Report 31 October, 2014 at 9.00 a.m.

Biotie interim report 1 January - 30 September 2014

This is a summary of the interim report 1 January - 30 September 2014 published today. The complete report is attached to this release.

Company Highlights
July - September 2014

Preparations to advance tozadenant into Phase 3 development in Parkinson's disease as part of Biotie's proprietary portfolio continued during the quarter and it is expected that the Phase 3 program will be able to start recruiting patients during H1 2015, as planned.
The formal transfer process of global rights to tozadenant from UCB Pharma S.A. (UCB) to Biotie was concluded in August. The transfer agreement confirms that UCB will meet all its contractual and scientific commitments regarding the ongoing development program for tozadenant, which are expected to be fully completed by the end of 2014.
Biotie was awarded a USD 2.0 million (approximately EUR 1.6 million) grant from The Michael J. Fox Foundation (MJFF) to investigate SYN120 in a Phase 2 study in Parkinson's disease dementia, further strengthening Biotie's presence in the Parkinson's disease space. The study is currently expected to begin recruitment around the end of 2014.
A Phase 2 clinical study with Biotie's BTT1023 in primary sclerosing cholangitis (PSC) was awarded external grant funding of up to approximately EUR 1.0 million from the Efficacy and Mechanism Evaluation (EME) Programme funded and managed by the National Institute for Health Research (NIHR) in the UK. The study will be conducted in partnership with the University of Birmingham and is expected to start recruiting patients by the end of 2014.
Biotie's partner H. Lundbeck A/S (Lundbeck) continued the rollout of Selincro in European markets, and it has now been introduced in well over 20 European markets, including the five key markets for which Biotie received a launch milestone. During the quarter, Selincro was launched in Spain, Germany and France, for which Biotie received a EUR 2.0 million milestone in each market. The National Institute for Health and Care Excellence (NICE), the United Kingdom's health technology assessment authority, issued draft guidance recommending the use of Selincro (nalmefene) within the conditions of its marketing authorization in the National Health Service (NHS) in England and Wales. The final guidance is expected in November 2014.
Biotie decided not to exercise its exclusive option to acquire Neurelis, Inc. (Neurelis), a private specialty pharmaceutical company. In consideration of the timely transfer of the program to Neurelis, Biotie and Neurelis have agreed that Biotie may recover the cost of its investment to date in Neurelis' lead product NRL-1 through a share of future revenue generated by Neurelis.

Biotie's revenue in Q3 2014 was EUR 7.2 million (EUR 4.5 million) and the financial result was a net profit of EUR 2.5 million (net loss of EUR 1.8 million).
Biotie ended the third quarter on 30 September 2014 with liquid assets of EUR 35.9 million (EUR 34.0 million, 30 June 2014). Operating cash flow for the quarter was a net inflow of EUR 0.3 million (net inflow of EUR 2.7 million).