Biotie Therapies Corp.
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2 Biotie Therapies Corp. Timo Veromaa toimitusjohtaja Financial Results for Q May 4,
3 Disclaimer This presentation is not a prospectus and as such does not constitute an offer to sell or the solicitation of an offer to purchase securities. Investors should not subscribe for any securities referred to in this document, except on the basis of their own examination of Biotie Therapies Corp. ( Biotie ) and any offering it organized, including the merits and risks involved. This presentation does not purport to be all-inclusive or contain all information that a prospective investor may desire in investigating Biotie and no representation is made as to the accuracy, fairness or completeness of this information. This presentation is not an offer of securities for sale in the United States. Securities may not be offered or sold in the United States absent registration or an exemption from registration under the U.S. Securities Act of 1933, as amended. Biotie has not registered and does not intend to register, any securities in the United States and does not intend to conduct a public offering of securities in the United States. This presentation includes forward-looking statements. These forward-looking statements include all matters that are not historical facts, as well as all statements regarding Biotie s intentions, beliefs or current expectations concerning, among other things Biotie s results of operations, financial condition, liquidity, prospects, growth, strategies and the industry in which Biotie operates. By their nature, forward-looking statements involve risks and uncertainties because they relate to events and depend on circumstances that may or may not occur in the future and speak only as of the date they are made. Biotie cautions you that forward-looking statements are not guarantees of future performance and that its actual results of operations, financial condition and liquidity and the development of the industry in which Biotie operates may differ materially from those made in or suggested by the forward-looking statements contained in this presentation. In addition, even if Biotie's results of operations, financial condition and liquidity and the development of the industry in which Biotie operates are consistent with the forward-looking statements contained in this presentation, those results or developments may not be indicative of results or developments in future periods. Biotie does not undertake any obligation to review or confirm expectations or estimates or to release publicly any revisions to any forward-looking statements to reflect events that occur or circumstances that arise after the date of this presentation. Any offer of securities deemed to be made in any EEA member state that has implemented Directive 2003/71/EC is only addressed to qualified investors in that member state within the meaning of the directive. This document is only being distributed to and is only directed at (i) persons who are outside the United Kingdom or (ii) to investment professionals falling within Article 19(5) of the Financial Services and Markets Act 2000 (Financial Promotion) Order 2005 (the Order ) or (iii) high net worth entities and other persons to whom it may lawfully be communicated, falling within Article 49(2)(a) to (d) of the Order (all such persons together being referred to as relevant persons ). The shares are only available to and any invitation, offer or agreement to subscribe, purchase or otherwise acquire such securities will be engaged in only with, relevant persons. Any person who is not a relevant person should not act or rely on this document or any of its contents. Offers will not be made directly or indirectly in any jurisdiction where prohibited by applicable law, or where such offer would require the drawing up or registration of a prospectus, or other measures to be taken and any offer documents and related documents will not and may not be distributed, forwarded or transmitted into or from any jurisdiction where prohibited by applicable law. 3
4 Company Highlights - 1Q 2012 Phase 3 Selincro data in alcohol dependence presented at the 2012 European Congress of Psychiatry by partner Lundbeck Pipeline Successfully completed Phase 1 PET imaging study with SYN120 Clinical development projects remain on track Regained full rights to VAP-1 antibody from Seikagaku 1 R&D investment 5.8 million (4.9); key investments in SYN115, VAP-1 Financials Operative cash flow -9.3 million (-4.2) Cash, cash equivalents and liquid assets of 24.7 million 31/3/2012 Team Panu Miettinen joined as CFO and member of the management team 4 1) after reporting period
5 Balanced Product Portfolio - Late stage compounds, own investments into 2 compounds Biotie R&D Investment Phase 1 Phase 2 Phase 3 Regulatory/ commercial Selincro (nalmefene) alcohol dependence opioid antagonist MAA* in EU accepted for review 12/2011 Tozadenant (SYN115) Parkinson s disease adenosine A 2a antagonist Phase 2b ongoing; data due H ) SYN120 AD/cognitive disorders 5-HT 6 antagonist PET imaging study complete; H Ready for Phase 2 VAP-1 antibody inflammatory / fibrotic disease VAP-1 antagonist, fully human Ready for Phase 2 Seek partner for large indications Nepicastat (SYN117) 2) PTSD & 3) cocaine dependence DBH inhibitor 2) PTSD Results expected H Ronomilast COPD PDE4 inhibitor Seeking partner 1) Option agreement; 2) US Department of Defense funding and conducting clinical study 3) US National Institute on Drug Abuse (NIDA) to fund clinical study, *MAA= marketing authorization application 5
6 Selincro (nalmefene) - For alcohol dependence First treatment to target reduction of alcohol consumption Currently approved therapies target abstinence Selincro dosing targeted to drinking situations taken as needed Offers a more realistic treatment goal and removes key obstacle to starting treatment Addresses a significant social and economic problem Approx. 60 million 1 people drink harmful levels of alcohol in Europe Significantly under-diagnosed, yet causes 10% deaths and 25% of ER admissions MAA review ongoing in Europe Filed by partner Lundbeck in December 2011 Next milestones to Biotie are due upon commercial launch 6 1) World Health Organization
7 Lundbeck Phase 3 program - Consistent with prior data 1 ESENSE1 ESENSE2 Patients randomized to Selincro (18 mg) or placebo, as needed 24 weeks treatment ESENSE1 data presented at EPA 2012, March 2012: 66% reduction on average in total alcohol consumption Mean heavy drinking days reduced from 19 to 7 days/month Effects observed within first month of treatment ESENSE2 positive top-line data reported Further data to be presented at medical conference in June 2 SENSE Patients randomized to Selincro (18 mg) or placebo, as needed 52 weeks treatment Safe and well tolerated; efficacy observed through 12 months Further data to be presented at medical conference in June 1 7 1) Karhuvaara et al. Alcohol Clin Exp Res 2007; 31: ; 2) Annual Research Society on Alcoholism (RSA) Scientific Meeting, San Francisco, June 23 27
8 Tozadenant (SYN115) - First potential new mechanism of action in Parkinson s for over 20 years Parkinson s is a progressive disease 2 nd most prevalent neurodegenerative disease; afflicts ~ 1% of people >60yrs Motor symptoms: tremor, muscle rigidity, difficulty starting and sustaining movement Non-motor symptoms: dementia, depression, anxiety, and sleep disorders Current leading therapies are dopamine-based Benefit of current therapy diminishes ( wears off ) over time Need for therapies giving more symptom control, with improved side effect profile Adenosine A2a receptor antagonist represents new therapeutic class Provides new option for patients and physicians Could address motor symptoms AND associated non-motor symptoms Has potential to be neuroprotective, not just symptomatic 8
9 SYN120 5-HT 6 receptor antagonist for Alzheimer s disease and cognitive disorders Cognitive impairment represents a huge unmet medical need 1 ~ 11 million people in EU and US afflicted with Alzheimer s disease ~ 4 million people in EU and US afflicted with Schizophrenia Limited treatment options available Alzheimer s therapy impacted by poor efficacy and unfavourable side effects Cognitive disorders in Schizophrenia are not targeted by current therapies SYN120 product profile Oral, once-daily, third generation 5-HT 6 receptor antagonist Increases pro-cognitive neurotransmitters Selectively targets the brain Designed to avoid cardiovascular issues of the class (% Change) Peak Efflux ) Alzheimer s disease organization, Facts and Figures 2011 ACH GLU
10 SYN 117 and VAP-1 Nepicastat (SYN117) First-in-class dopamine β-hydroxylase inhibitor Phase 2 study in post traumatic stress disorder ongoing CRADA 1 with the US National Institute on Drug Abuse (NIDA) for study in cocaine dependency VAP-1 antibody First-in-class MAb against vascular adhesion protein-1 Successfully completed full Phase 1 clinical package, with RA and psoriasis patients Potential for use in multiple inflammatory disorders, including niche fibrotic diseases 10 1) Collaborative Research and Development Agreement
11 Outlook for 2012 and key upcoming milestones SYN120: Review of data package by Roche and option to license VAP-1 antibody: Proof-of-concept clinical studies in selected indications expected to start H SYN115: Phase 2b study data in Parkinson s disease H SYN117 - Phase 2 study data in PTSD - Start Phase 2 study in cocaine dependence Selincro: Expected European Launch Selincro: European approval expected around year end
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