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Edison Research Template Biotie Therapies Update: SYN120 rights retained Assets available for partnering Pharma & biotech Biotie’s retention of SYN120 rights after Roche decided not to opt-in to a 6 July 2012 development license means the company now has three unencumbered Phase II- Price €0.37 ready assets available for global licensing. A deal on any of these could extend Market cap €143m Biotie’s current cash runway beyond early 2013, although the company may explore other options as additional funds will likely need to be raised this year. The next key catalyst with known timing is the European approval decision for alcohol dependence Shares in issue 387.6m therapy Selincro, expected by year-end. Approval could mean a Q113 launch, which Free float N/A would trigger an undisclosed milestone payment from partner Lundbeck. Code BTH1V Primary exchange OMX Year end Revenue PBT* EPS* DPS P/E Yield Other exchanges N/A (€m) (€m) (c) (c) (x) (%) 12/10** 2.0 (8.5) (5.2) 0.0 N/A N/A Share price performance 12/11 1.0 (20.8) (3.5) 0.0 N/A N/A 12/12e 0.1 (28.0) (6.7) 0.0 N/A N/A 12/13e 0.1 (29.6) (7.5) 0.0 N/A N/A Note: *PBT and EPS are normalised, excluding intangible amortisation and exceptional items. ** Represents ‘continuing operations’. Forecasts do not assume further deal activity. SYN120: Rights returned for strategic portfolio reasons Various large pharma/CNS specialists are investigating 5-HT antagonists, which have 6 potential in cognitive impairment; Lundbeck has recently achieved proof of concept in % 1m 3m 12m Alzheimer’s disease. SYN120 is safe/well tolerated, has a wide therapeutic window Abs 12.1 (19.6) (31.5) and confirmed dosing for Phase II. Biotie has been approached by interested parties, Rel (local) 3.2 (10.3) (10.9) although deal timing is uncertain. Other Phase II-ready assets available for partnering 52-week high/low €0.6 €0.3 include BTT-1023 (H2 start of clinical studies in fibrotic disorders) and ronomilast. Business description Licensed programmes: Selincro and tozadenant Biotie Therapies is a Finnish/US biotech company with a focus on clinical Commercial success of the two partnered projects has potential to transform Biotie. programmes in CNS and niche The EMA approval decision for Selincro (alcohol dependence) by end-2012 should inflammatory diseases. Its lead project catalyse the share price; potential Q113 launch would trigger a Lundbeck milestone. Selincro, for the treatment of alcohol The next news flow for UCB-partnered tozadenant is the read-out of the Phase IIb trial dependency, is partnered with Lundbeck and pending EU approval. UCB is a in Parkinson’s disease (which recently completed enrolment) around end-2012. strategic partner. Financials: Cash into 2013 with potential for deals Next events Q1 cash of €25m represents funds into 2013 in the absence of additional receipts. Q212 results 3 August SYN117: PTSD Phase II data H212 Upfront payments on new licensing deals, milestones from existing partners Selincro: EMA approval H212 (Lundbeck on Selincro EU launch, UCB on tozadenant Phase IIb data/Phase III start), Tozadenant: Phase IIb results End-2012 and/or an equity raise in 2012 could address Biotie’s funding requirement. Selincro: Europe launch H113 Valuation: €243m rNPV, current EV of €115m Analysts Our new rNPV of €243m (previously €250m) reflects BTT-1023’s re-positioning as a Lala Gregorek +44(0)20 3077 5736 potential fibrotic disease therapy. This valuation only includes the lead indications of Robin Davison +44(0)20 3077 5737 [email protected] Biotie’s five core assets and compares with a €115m EV (excluding the Tekes financial Edison profile page liability, which is only repayable on profitability). Significant potential milestones from Lundbeck and UCB are not captured in this valuation, and thus represent upside. Biotie Therapies is a research client of Edison Investment Research Limited Biotie Therapies | 6 July 2012 Biotie Therapies: Data sheet Exhibit 1: Biotie Therapies’ R&D pipeline Product Indication/stage Partners/financial terms/notes Selincro Alcohol dependence Global deal with Lundbeck provides up to €84m in upfront and milestone payments (€12m received (nalmefene) (Phase III)/ to date) and tiered double-digit royalties. Phase III programme (20mg nalmefene on demand), pathological conducted by Lundbeck complete with positive top-line results: Selincro was effective in reducing gambling/smoking alcohol intake (less frequent heavy drinking and lower overall alcohol consumption) by >66% over six cessation months. Two 24-wk placebo-controlled Phase III studies: ESENSE1 (598-pts) and ESENSE2 (718- pts) (primary efficacy endpoints: change in baseline in the monthly number of heavy drinking days and total alcohol consumption) and SENSE (a 665-pt, 52-week safety study). Detailed Phase III data presented (by Lundbeck) at the European Congress of Psychiatry, Prague (3-6 March) and the Annual Research Society on Alcoholism (RSA) Meeting, San Francisco (23-27June). EU MAA filed and accepted (Dec 2011), potential approval late 2012, with first launches (triggering a milestone) expected from early 2013. Oral opioid receptor antagonist drug to be taken on an ‘as needed’ basis. Tozadenant/ Parkinson’s disease Partnered with UCB globally: deal included $20m equity investment with up to $370m in regulatory SYN115 (Phase II) and commercial milestones plus double-digit tiered sales royalties (with potential for collaboration expansion). UCB responsible for post-Phase IIb development and marketing. Oral: PK consistent with once-daily dosing. Well tolerated up to 480mg/day for up to 28 days. 400-pt double-blind Phase IIb (80-pts/arm: four doses and placebo) fully enrolled: primary endpoint of improvement in motor function (UPDRS OFF time) at 12 wks with non-motor secondary endpoints (results: end-2012). 30- pt Phase IIa showed dose-dependent functional activity in brain regions associated with motor function/cognition (clinical improvement in both). Activity in preclinical models of depression, cognition and anxiety. Potential neuro-protective drug. Licensed from Roche. Selective A2a antagonist. SYN120 Cognitive disorders Once-daily oral small molecule drug: can cross the BBB; no QTc (cardiovascular) side effects. Phase I associated with single and multiple ascending dose studies in 70 healthy volunteers complete (studied for up to 14 Alzheimer’s disease/ days at doses up to 600mg/day, which >10x the anticipated therapeutic dose. Wide therapeutic schizophrenia window: PET study in nine healthy volunteers established that target levels of receptor occupancy (Phase II ready) expected for efficacy could be achieved with doses an order of magnitude lower than those shown to be safe/well tolerated. Phase II enabling package complete: appropriate dosing established. Licensed from Roche, which declined to exercise one-time option to global rights. Seeking development partner. Back-up SYN-114 has completed Phase I. Oral 5HT6 receptor antagonist. BTT-1023 Fibrotic diseases Phase II-ready: manufacturing process and scale up optimisation underway. Phase II trials in select (Phase II ready) indications to start H212. Previous studies in inflammatory indications but development strategy now rheumatoid focused on fibrosis disease indications. Repeat-dose Phase I studies in 24 RA pts showed PK arthritis/psoriasis consistent with chronic use and some evidence of efficacy at higher doses (ACR50 response in (Phase I complete) several higher dose patients). Results of similar ascending multiple dose study in psoriasis showed consistent tolerability and PK, and evidence of efficacy (decrease in PASI score). New opportunity in liver inflammatory fibrotic diseases identified (patent pending). Biotie holds global rights after Asia- Pacific license with Seikagaku terminated for strategic reasons ($2.7m received under this deal). Deal discussions ongoing for large indications. Fully human monoclonal antibody targeting VAP-1. Nepicastat/ Drug dependence / 120-pt Phase II in PTSD (results: H212), funded by US Dept of Defense. 180-pt three-month Phase II SYN117 post traumatic stress cocaine dependency study to start H212; funded under a CRADA with the US NIDA. Positive 16-pt disorder (Phase II) Phase IIa study in non-treatment seeking cocaine addicts (safe, well tolerated and reduced subjective responses to cocaine). Oral dopamine β-hydroxylase inhibitor. Ronomilast COPD/asthma/ Phase II-ready. No investment in further clinical development without a partner: active deal psoriasis discussions ongoing. Repeat dose PK studies in 48 healthy volunteers up to 100mg daily showed (Phase II-ready) ronomilast was well tolerated with no serious or severe adverse events, generated highly statistically significant biomarker responses, and had PK supporting a once-daily dose regime. Total of 126-pts studied in Phase I. Once-daily oral PDE4 (phosphodiesterase-4) inhibitor (potential best-in-class: differentiated by improved side-effects [GI/CNS]). Nitisinone/ Movement disorders Fully written down (UCB declined to exercise option to global license for non-orphan indications after SYN118 (Phase II-ready) Phase IIa Parkinson’s disease study missed primary endpoint). Seeking development partner. Oral, once-daily. 21-pt randomised placebo-controlled two-wk proof-of-concept trial in RLS showed symptom improvement (RLS6 and patient diaries). Licensed from Syngenta for non-orphan diseases: marketed by Swedish Orphan Biovitrum for Hereditary Tyrosinemia Type 1 (Orfadin). HPPD inhibitor. Source: Edison Investment Research 2 Biotie Therapies
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