First patients dosed with new formulation of RPL554

Verona Pharma plc ("Verona Pharma" or the "Company") First patientssuccessfully dosed in clinical trial withnew commercially scalable formulation ofnebulised RPL554 Bronchodilation to be assessed in addition to study's primary aim of safety and tolerability Bothhealthy volunteers and COPD patientsto be evaluated New formulation expected to enable delivery of higher dose of drug in shorter time Results availablein second half 2015 12 January 2015, Cardiff - Verona Pharma plc (AIM: VRP.L), the drug developmentcompany focused on first-in-class medicines to treat respiratory diseases,today announces that a first cohort of healthy volunteers have beensuccessfully dosed with a new proprietary, nebulised formulation of RPL554.These volunteers are part of a combined Phase I/II clinical trial profilingthis new RPL554 formulation. The trial includes a single ascending dose studyin healthy volunteers and 5 days multiple ascending dose study in both healthyvolunteers and patients with COPD (chronic obstructive pulmonary disease). Theprimary objective of the study is to confirm safety, tolerability andbronchodilation with this new formulation. Up to 120 subjects are planned to berecruited to this study and the results are expected to be available in thesecond half of 2015. Verona Pharma is initially developing RPL554 as a nebulised treatment for acuteexacerbations in COPD patients in a hospital or home-care setting. Phase IIstudies to date with the drug, a novel PDE3/4 inhibitor, have been successfullyconducted in over 100 subjects. Results collectively show that the drug is avery potent bronchodilator with the ability to illicit a uniqueanti-inflammatory response. At the doses tested, RPL554 had a benign sideeffect profile, which compared favourably with existing standard treatments.The original nebulised formulation of the drug used in these initial studieswas devised to provide proof-of-concept data, before developing a newformulation suitable for commercial scale-up. The new proprietary formulation of RPL554 has demonstrated very attractiveproperties, in addition to being viable for commercial scale-up. Inpre-clinical testing, inhalation of this new formulation was better tolerated,producing significantly less irritation than the one used previously. It isexpected that this will result in a significantly improved therapeutic index inpatients, implying that they should be able to inhale higher doses over ashorter time interval, improving convenience and potentially compliance. Dr Jan-Anders Karlsson, Chief Executive Officerof Verona Pharma,said: "We believe that thisnew proprietary formulation for nebulised RPL554 willallow us to develop optimally and commercialise this unique drug as aneffective treatment for acute exacerbations in COPD.We look forward toreporting the results from this important clinical study, whichprofiles the newformulation in healthy volunteers and COPD patients,in the second half of2015." The study is being performed at the Medicines Evaluation Unit in Manchester (atthe same site as the previous RPL554 study) by lead investigator Professor DaveSingh, with oversight from the Company's newly appointed Chief Medical Officer,Ken Newman, who is based in Verona Pharma's subsidiary in the US. -Ends- For further information please contact: Verona Pharma plc Tel: +44 (0) 20 3283 4200 Jan-Anders Karlsson, Chief ExecutiveOfficer N+1 Singer Tel: +44 (0)20 7496 3000 Aubrey Powell / Jen Boorer FTI Consulting Tel: +44 (0)20 3727 1000 Julia Phillips / Simon Conway Notes to Editors About Verona Pharma plc Verona Pharma plc is a UK-based clinical stage biopharmaceutical companyfocused on the development of innovative prescription medicines to treatrespiratory diseases with significant unmet medical needs, such as chronicobstructive pulmonary disease (COPD), asthma and cystic fibrosis. Verona Pharma's lead drug, RPL554, is a first-in-class drug currently in PhaseII trials as a nebulised treatment for acute exacerbations of COPD in thehospital setting. The drug is a dual phosphodiesterase (PDE) 3/4 inhibitor andtherefore has both bronchodilator and anti-inflammatory effects, which areessential to the improvement of patients with COPD and asthma. Verona Pharma is also building a broader portfolio of RPL554-containingproducts to maximise its benefit to patients and its value. This includes thevery significant markets for COPD and asthma maintenance therapy. The Companyis also exploring the potential of the drug in different diseases, such ascystic fibrosis, where it is in pre-clinical testing and has recently receiveda Venture and Innovation Award from the Cystic Fibrosis Trust. About The Medicines Evaluation Unit The Medicines Evaluation Unit ("MEU") is one of the UK's leading contractresearch organisations, working in collaboration with the University Hospitalof South Manchester. The MEU specialises in performing clinical trials (fromPhase I through to IV) in respiratory/inflammatory medicine and related areas.The MEU has an outstanding reputation for performing high quality clinicalresearch complying with UK Clinical Trials legislation and EU Directives andholds MHRA Phase I accreditation. About Chronic Obstructive Pulmonary Disease (COPD) Sixty-five million people worldwide suffer from moderate to severe COPD and theWorld Health Organisation (WHO) expects COPD to be the 3rd leading cause ofdeath globally by 2020. It is the only major chronic disease with increasingmortality. Currently available drugs are aimed at long-term maintenancetherapy, with the market dominated by large pharma. Despite the wideavailability of these therapies, COPD patients suffer acute periods ofworsening symptoms (exacerbations), which cause, in the US alone, some 1.5million A&E visits, 726,000 hospitalisations and 120,000 deaths per annum. IMS Consulting Group considers bronchodilating therapy to be the standard ofcare, and agents can be administered via handheld devices such as metered doseinhaler (MDI), dry powder inhaler (DPI) and by nebulisers. The nebulisedbronchodilator market was worth about $1 billion in 2014 in the US. RPL554 isbeing developed by Verona Pharma as an add-on therapy to the "Standard of Care"with the objectives of providing rapid and pronounced improvement in lungfunction, reduced symptoms and both shortened duration of hospital stays andreduced re-admission rates 30 days after discharge from hospital. Studies todate on RPL554 have demonstrated that it has a strongly differentiated 3-waymode of action, being: (1) bronchodilation (the relaxation of smooth muscle inthe airway); (2) anti-inflammatory effects on cells and (3) ion channelactivation in epithelial cells, with increased mucociliary clearance of theairway.