Biotie Therapies Corp. financial statement release 1 January (Biotie) - Feb 24, 2012 - Biotie exercised its right to terminate the merger plan and combination agreement for safinamide; As a result Biotie was entitled to & consequently received a break-up fee of EUR 1.5M from Newron; Biotie has granted a worldwide license to UCB Pharma for the development of the SYN115 through P3 trials & subsequent commercialization; P2b ongoing (sponsored by Biotie) with results expected H1 2013
Anticipated P2 result • Parkinson's Disease
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Biotie Therapies Corp. financial statement release 1 January - 31 December 2011
Key drivers of business progressed during 2011: internal pipeline expanded through acquisition of Synosia, partnered programs advanced towards commercialization, management team strengthened and additional cash resources secured.
SelincroTM (nalmefene) completed an extensive Phase 3 program during 2011, and in December Biotie's partner, Lundbeck, submitted a marketing authorization application (MAA) through the centralized procedure to the European Medicines Agency (EMA). The dossier has been accepted for review by the EMA.
In February, Biotie completed the acquisition of Synosia Therapeutics, a drug development specialist with operations in the US, broadening its pipeline and adding mid-stage novel CNS products. Progress with the newly expanded pipeline remained on track during integration of the companies and in April Biotie announced the start of a Phase 2b study with SYN115 in Parkinson's disease. In July, Biotie started a Phase 1 positron emission tomography (PET) imaging study with SYN120, a potential treatment for cognitive disorders, including Alzheimer's and schizophrenia. Results from an exploratory Phase 2a study of its HPPD inhibitor SYN118 in Parkinson's disease (PD) were reported in May. These data did not show a significant improvement in measures of PD motor function versus placebo and, in November, Biotie fully impaired the carrying value of this asset and UCB confirmed that it would not exercise its option to license the compound.
In March, Biotie raised EUR 27 million in a directed share issue to institutional and strategic investors, strengthening its financial position.
In September, Biotie proposed to acquire Newron Pharmaceuticals through a European Union cross-border merger. Shortly after this announcement, Merck Serono indicated that it would return to Newron the full global rights for safinamide, Newron's lead asset which is currently in Phase 3 development for Parkinson's disease. After reviewing this development, Biotie exercised its right to terminate the merger plan and combination agreement. As a result, Biotie was entitled to and consequently received a break-up fee of EUR 1.5 million from Newron.
In December, non-dilutive funding was secured through a Collaborative Research and Development Agreement with the National Institute on Drug Abuse (NIDA) at the US National Institutes of Health to investigate the safety and efficacy of nepicastat (SYN117) in the treatment of cocaine dependence.
Q4/2011 in brief:
In December, Lundbeck submitted a marketing authorization application (MAA) in the EU for SelincroTM (nalmefene).
In December, Biotie announced that the National Institute on Drug Abuse (NIDA) at the US National Institutes of Health will start a clinical study with Biotie's nepicastat (SYN117) in the treatment of cocaine dependence.
In December the Board of Directors of Biotie approved two new share-based incentive plans for the Group employees.
In November, Biotie announced that The Finnish Funding Agency for Technology and Innovation (Tekes) decided to forgive certain capital loans and accrued interest by altogether EUR 2.6 million.
In November, Biotie fully impaired the carrying value of SYN118 and confirmed that UCB would not exercise its option to license the compound.
Proposal and subsequent termination of agreement to acquire Newron Pharmaceuticals S.p.A.:
In September, Biotie proposed to acquire Newron Pharmaceuticals. Shortly after this announcement in October, Merck Serono indicated that it would return to Newron the full rights for safinamide, Newron's lead asset for Parkinson's disease. Biotie exercised its right to terminate the agreement and received a break-up fee of EUR 1.5 million from Newron.
Outlook for 2012 and key pipeline newsflow
Tozadenant (SYN115): An orally administered, potent and selective inhibitor of the adenosine 2a (A2a) receptor in Phase 2b development for the treatment of Parkinson's disease. Biotie has granted a worldwide license to UCB Pharma for the development of the compound through Phase 3 trials and subsequent commercialization. Phase 2b ongoing (sponsored by Biotie) with results expected H1 2013.
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