Pharmacy News EU

Copenhagen, 11 February 2010 – Today, at the 5th Annual CHDI Conference onHuntington’s disease, held 8 to 11 February in Palm Springs, California,NeuroSearch (NEUR.CO) presented the results from the MermaiHD study, a PhaseIII study with Huntexil (pridopidine) for the treatment of Huntington’sdisease. Top-line results from the study were announced on 3 February 2010(Announcement no. 01-10),Presenting as the featured speaker at the conference, Dr. Joakim Tedroff, Headof Clinical Science at NeuroSearch on Wednesday 10 February, 4pm to 5pm PDT(Thursday, 1am to 2am CET) presented the study results, including thefollowing:? Efficacy – Results from the MermaiHD study demonstrate that six months’ (26weeks) treatment with Huntexil (45 mg BID), in Huntington’s patientssignificantly improves both voluntary movement control, as measured on theprimary endpoint, the mMS, and also a broader range of voluntary andinvoluntary motor symptoms, including dystonia and eye movements. Measured inboth the ITT (Intention to treat) and the PP (per protocol, 82% of patients))populations, the improvements seen were highly statistically significant, andthereby the results in the PP population fully confirm the ITT analysis :Motor scale; Significance level for the PP population; Significance level forthe ITT population;Modified Motor Score, mMS; p <0.005; p <0.02;Total Motor Score, TMS; p <0.005; p <0.001;Eye Movements p <0.02 p <0.002Dystonia p <0.01 p <0.001? Cognitive testing – On one of the cognitive measures, the Trail Making test,included in the MermaiHD study as a secondary endpoint, six months treatmentwith Huntexil 45mg BID showed a significant improvement (ITT; p <0.05).? Safety and compliance – Over the six months of treatment in the study, lessthan two thirds of all patients reported adverse events. The most frequentlyobserved adverse events were falls, dizziness, Huntington’s chorea, diarrhoea,nausea, nasopharyngitis, depression, fatigue and insomnia, occurring at afrequency between 3% and 9% and equally distributed between the activetreatment groups and placebo. In total, the study had a high completion rate,and with less than 4% of patients withdrawing from the study due to adverseevents:Placebo; Huntexil 45 mg QD; Huntexil 45 mg BID;Randomised pts (ITT); 144; 148; 145;Completers; 129 (90%); 143 (97%); 131 (90%);Withdrawals due to AE; 8 (6%); 2 (1%); 7 (5%);Any adverse event; 64%; 61%; 68%;The study showed no worsening of any disease signs and symptoms, includingHuntington’s chorea, on which measure both the ITT and the PP analyses showedno difference compared to placebo.? Patient demographics – Patient randomization in the MermaiHD study wassuccessful with patients in the three study arms (Huntexil 45 mg QD; Huntexil45 mg BID; and placebo) expressing similar demographic characteristics. Atbaseline, the mean age across the study was 50.6 years, time since diagnose 4.8years and the mean CAG repeats was 44.7 (between 36 and 63). Out of the totalnumber of randomized patients, 190 (43.5%) were on antipsychotic medication,and 247 (56.5%) were not.Insight into the unique pharmacology of HuntexilHuntexil (pridopidine) exerts its pharmacological effect via induction of aunique functional modulation of dopamine D2 receptors primarily in thestriatum. This functional feature of the compound has recently been publishedin the European Journal of Pharmacology (2010, issue 628, pp 19-26 by T.Dyhring et al.; The dopaminergic stabilizers pridopidine (ACR16) and()-OSU6162 display dopamine D2 receptor antagonism and fast receptordissociation properties.Further, in vivo studies have shown that Huntexil strengthens the glutamatefunction in the cortex, an effect most likely to be mediated by the release ofdopamine and consequently D1 activation.Huntington’s disease is associated with dopaminergic dysfunction and disruptivecorticostriatal circuitry, and the combined effect of Huntexil on both thedopaminergic and glutamatergic systems is believed to account for the observedpartial normalization of motor dysfunctions in Huntington patients.Conclusions from the MermaiHD studyIn the MermaiHD study, six months’ treatment with Huntexil has shown tosignificantly improve both voluntary and involuntary motor functions,translating into a to 1 years of set-back in the natural progression ofthese disease symptoms. Importantly, this improvement is seen without any”therapeutic" disadvantages in terms of worsening of other disease signs orsymptoms and with good safety.Following the results from the MermaiHD study, NeuroSearch has undertakenfurther in-depth analysis of the results and initiated dialogue with regulatoryauthorities to discuss the study outcome and plans for market registration ofHuntexil as a novel treatment for Huntington’s disease.Flemming PedersenCEOContact persons:Flemming Pedersen, CEO, telephone: +45 4460 8214 or +45 2148 0118Hanne Leth Hillman, Vice President, Director of Investor & Capital MarketRelations, telephone: +45 4017 5103About the MermaiHD studyThe MermaiHD study is a randomised, double-blinded and placebo-controlled PhaseIII study conducted at 32 clinical centres across Europe to examine the effectsof Huntexil on a number of Huntington’s disease parameters.The study has enrolled 437 patients with Huntington’s disease from Austria,Belgium, France, Germany, Italy, Portugal, Spain and the UK. The patients havebeen randomly allocated to receive treatment with one of two Huntexil doses(45 mg QD or 45 mg BID) or placebo during a six month double-blinded phase.Hereafter, they have been offered to continue into a six month open-labelextension phase, in which they receive treatment with Huntexil 45 mg BID only.The last patient completed the double-blinded phase in November 2009, and ofthe total number of patients having completed six months of randomisedtreatment, almost 90% have chosen to continue into the open-label extensionphase.The primary study endpoint is voluntary motor function in Huntington patients,measured on the modified Motor Score (mMS), The mMS is defined as the sum scoreof voluntary motor items from the Total Motor Score (TMS), The TMS is part ofthe Unified Huntington’s Disease Rating Scale (UHDRS) and measures a broaderrange of motor symptoms, including voluntary motor function (mMS and eyemovements) and also involuntary movements such as dystonia and chorea. Furtherstudy endpoints include the TMS, cognitive function, behaviour and symptoms ofdepression and anxiety.About Huntington’s diseaseHuntington’s disease (HD) is a highly disabling, hereditary neurodegenerativegenetic disorder, which leads to damage of the nerve cells in certain areas ofthe brain including the basal ganglia and the cerebral cortex. Patientssuffering from HD experience a wide variety of symptoms typically grouped intothree categories: motor, cognitive and psychiatric symptoms. The onset ofsymptoms is typically around 35 and 45 years of age and patients hereafter havea life expectancy of 10 to 20 years.The disease occurs at a rate of about one in every 10,000 in most westerncountries with an estimated 70,000 affected patients in North America andEurope combined. In other parts of the world HD prevalence is lower, and thetotal number of patients suffering from HD outside North America and Europe isestimated at 30,000 to 35,000. The rate of diagnose also varies amonggeographic regions.After symptoms onset the disease progresses without remission and eventuallyevery person with Huntington’s disease will require full-time care.Huntington’s disease represents high unmet medical needs, as there is currentlyno cure or effective treatment available and only a limited number of noveldrugs in development.About NeuroSearch – Company profileNeuroSearch (NEUR) is a Scandinavian biopharmaceutical company listed on NASDAQOMX Copenhagen A/S. The core business of the company covers the development ofnovel pharmaceutical agents, based on a broad and well-established drugdiscovery platform, focusing on ion channels and central nervous system (CNS)disorders. A substantial share of the activities is partner financed throughstrategic alliances with Janssen Pharmaceutica, Eli Lilly and Company andGlaxoSmithKline (GSK), and a license collaboration with Abbott. The drugpipeline comprises eight clinical (Phase I-III) development programmes:Huntexil (pridopidine) for Huntington’s disease (Phase III), tesofensine forobesity (ready for Phase III), ABT-894 for ADHD (Phase II) in partnership withAbbott, ACR343 for schizophrenia (ready for Phase II), ACR325 to treatdyskinesias in Parkinson’s disease (Phase Ib), ABT-560 for the treatment ofcognitive dysfunctions (Phase I) in collaboration with Abbott, NSD-788 foranxiety/depression (Phase I) and NSD-721 for social anxiety disorder (Phase I)in partnership with GSK. In addition, NeuroSearch has a broad portfolio ofpreclinical drug candidates and holds equity interests in several biotechcompanies.Copyright © 2010 OMX AB (publ).Copyright © 2010 OMX AB (publ)