Biotie's first-six months conformable to expectations
Biotie Therapies Corp. has made substantial progress in the first-six months of 2011. In January, Biotie acquired Synosia Therapeutics, a drug development specialist with key operations in the US and a strategic alliance with UCB Pharma. In March, Biotie raised EUR 27 million in a directed share issue to institutional and strategic investors, strengthening its financial position. In June, Biotie's partner, Lundbeck, concluded an extensive phase 3 program for nalmefene in alcohol dependence, following initial positive data in January.
"We have made tremendous progress since the beginning of the year, with nalmefene for alcohol dependence completing Phase 3 studies and nearing the market, and with the start of a large Phase 2b trial of SYN115 in Parkinson's disease. We have conducted a thorough pipeline review to ensure that we are investing in those products that have the greatest opportunity to create value. We have also uncovered interesting new opportunities for our VAP-1 antibody in niche indications. We are confident and excited about these opportunities and believe that Biotie is ideally positioned to create value for our shareholders", says Timo Veromaa, Biotie's President and CEO.
Financial statements for January - June 2011 are not directly comparable to the same period in 2010 due to the Synosia Therapeutics acquisition and the consolidation of the new subsidiaries' results into the Biotie group's consolidated financial statements from the acquisition date 1 February 2011 onwards.
The first-six months turnover was EUR 946 000 and the net loss EUR 12,3 million. Cash and cash equivalents and short term investments totaled EUR 40.9 million on 30 June 2011. The groups' financial position has been strengthened by a private placement of EUR 27 million in March and furthermore by the liquid assets of Synosia acquired in February.
Outlook for 2011
Outlook for key development programs by the company:
Nalmefene: Small molecule opioid receptor antagonist for alcohol dependence partnered with H. Lundbeck A/S (Lundbeck). Phase 3 program complete marketing authorization application (MAA) in Europe expected by end of 2011; potential launch in 2012. Detailed efficacy and safety data expected to be submitted by Lundbeck for presentation at scientific and medical meetings in the next 12 months.
SYN115 (tozadenant): Small molecule adenosine A2a receptor antagonist for Parkinson's disease, partnered with UCB. Phase 2b ongoing (sponsored by Biotie) with results expected H1 2013.
SYN118 (nitisinone): Small molecule inhibitor of 4-hydroxyphenylpyruvate dioxygenase (HPPD). Biotie is considering development options for the compound together with its partner UCB and will announce further plans later in the year.
SYN120: Small molecule 5HT-6 receptor antagonist for cognitive disorders associated with Alzheimer's disease and schizophrenia. Phase 1 PET ("positron emission tomography") imaging study to determine therapeutic dose for subsequent phase 2 studies ongoing; expected completion H1 2012. Roche has an option to license this compound from Biotie.
SYN117 (nepicastat): Small molecule dopamine beta-hydroxylase (DBH) inhibitor in phase 2 trial in post-traumatic stress disorder (PTSD), funded by US Department of Defense; results expected in 2013. Strong scientific and medical rationale in the treatment of cocaine dependency; in discussions with US government agencies for further funding in this indication.
BTT-1023 (VAP-1 antibody): Fully human monoclonal antibody targeting Vascular Adhesion Protein-1. Manufacturing scale-up optimization program ongoing and proof-of-concept clinical studies in selected indications are planned to start H2 2012. Biotie is also in discussions with potential additional partners, outside Seikagaku's territory, for indications targeting large markets.
Ronomilast: Potential best-in-class small molecule phosphodiesterase-4 (PDE4) inhibitor for COPD; Phase1 complete. Biotie will seek a corporate partner to drive development of ronomilast and will not invest in further clinical studies without a partner.
Biotie Therapies Corp. in brief
Biotie is a specialized drug development company focused on the development of products for neurodegenerative and psychiatric disorders (Parkinson's disease, Alzheimer's disease and other cognitive disorders, alcohol and drug dependence) and inflammatory diseases. It has several innovative small molecule and biological drug candidates at different stages of clinical development. Biotie's products address diseases with high unmet medical need and significant market potential.
Partnerships with top-tier pharmaceutical partners are in place for several programs as well as a strategic collaboration with UCB Pharma S.A. Biotie's most advanced product, nalmefene for alcohol dependence, has completed Phase 3 clinical development by licensing partner H. Lundbeck A/S.
The parent company of the group is Biotie Therapies Corp. The domicile of the company is Turku, Finland. The company has two non-operational subsidiaries named Biotie Therapies GmbH, located in Radebeul, Germany and Biotie Therapies International Ltd in Finland.
Following the acquisition of Synosia Therapeutics, the company has a holding subsidiary, Biotie Therapies Holding AG, located in Basel, Switzerland, which has two operative subsidiaries, Biotie Therapies AG, located in Basel, Switzerland and Biotie Therapies, Inc. located in South San Francisco, California. During the reporting period January - June 2011, the average number of employees amounted to 41.