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Verona Pharma Release: Clinical and Scientific Advisory Board Formed to Help Guide Future Development of RPL554



4/29/2013 9:59:25 AM

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April, 2013 -- Verona Pharma plc (AIM: VRP), the drug development company focused on “first-in-class” medicines to treat respiratory diseases, today announces the formation of a Clinical and Scientific Advisory Board (CSAB) of key opinion leaders in the fields of chronic obstructive pulmonary disease (COPD) and asthma. The objective of the Advisory Board will be to help guide and inform the future clinical development of Verona Pharma’s lead drug candidate, RPL554, a unique dual PDE3/4 inhibitor, which has so far successfully completed early Phase II clinical studies in COPD and asthma.

Following a strategic review last year, the Company intends to initially concentrate further development of RPL554, in a nebulized form, as a treatment for severe COPD, a significant unmet medical need. Verona Pharma believes this could potentially shorten the time to commercialisation of the drug and so accelerate shareholder value creation.

The members of the Clinical and Scientific Advisory Board are:

Prof. Mario Cazzola, Professor of Respiratory Medicine and Director of the Postgraduate School of Respiratory Medicine at the University of Rome ‘Tor Vergata’, Rome, Italy, where he is also Chief of the Respiratory Clinical Pharmacology Unit.

• Key focus is the pharmacology of airway diseases, particularly use of bronchodilators in COPD and the use of antimicrobial drugs in the treatment of respiratory infections. He is the author or co-author of 404 scientific papers and book chapters, editor and author of 10 monographs or books. He is also editor-in-chief or is an editorial board member of a number of journals in the respiratory field.

• Previously Chairman of the Airway Pharmacology and Treatment Group and the Secretary of the Inflammatory Airway Diseases and Clinical Allergy Assembly and is the Postgraduate Courses Director at the European Respiratory Society.

• Was Co-chairman of the European Respiratory Society/American Thoracic Society Task Force "Outcomes for COPD pharmacological trials: from lung function to biomarkers".

• Member of the steering committee of the Airway Disorders Network at the American College of Chest Physicians.

Prof. Paul O´Byrne, E. J. Moran Campbell Professor of Medicine and Chair of the Department of Medicine, McMaster University Canada. Also Executive Director of The Firestone Institute for Respiratory Health, Hamilton, Ontario, Canada. • Key focus is the mechanisms and treatment of asthma, with particular reference to the role of environmental allergens and the mechanisms by which these cause airway inflammation.

• Author of over 250 peer-reviewed papers. Has edited eight books and written more than 70 review papers and is a frequent lecturer at international meetings.

• Chair of the Executive Committee for the Global Initiative for Asthma (GINA), the WHO and NHLBI sponsored initiative to develop global guidelines for asthma diagnosis and treatment, and a member of the Executive Committee, WHO’s Global Alliance against Chronic Respiratory Diseases.

Prof. Klaus Rabe, Professor of Pulmonary Medicine at the University of Kiel, Germany and Director of the Department of Pneumology at Clinic Grosshansdorf.

• Active in various fields of Respiratory Medicine worldwide, predominantly asthma, COPD and lung cancer. His current scientific interests are related to clinical trials in COPD and asthma, the mechanisms of airway inflammation, and the endoscopic staging of lung cancer.

• Has served on various editorial boards, was the first European Associate Editor of the American Journal of Respiratory and Critical Care Medicine and was recently Chief Editor of the European Respiratory Journal.

• Immediate past-president of the European Respiratory Society. He is a member of the German and Dutch Chest Societies, the British Pharmacological Society, the American Thoracic Society and has served on the Global Initiative for Asthma (GINA) and Global Initiative for Chronic Obstructive Lung Disease (GOLD).

Jan-Anders Karlsson, CEO of Verona Pharma, commented, “We are excited to announce the formation of such a strong clinical and scientific advisory board of recognised key opinion leaders in the fields of COPD and asthma. Their insight and experience will be invaluable as we hone our plans for the further development of RPL554. The emerging therapeutic profile of the drug from the phase II trials successfully completed to date, suggest an initial focus on an indication for severe COPD, an area of significant unmet medical need. This could potentially shorten the time to commercialisation of the drug, which could enable us to accelerate shareholder value”.

For further information please contact:

Verona Pharma plc Tel: 020 7863 3300

Clive Page, Chairman

Jan-Anders Karlsson, CEO

WH Ireland Limited Tel: 020 7220 1666

Chris Fielding

Nick Field

FTI Consulting Tel: 020 7831 3113

Julia Phillips

Simon Conway

About Verona Pharma plc

Verona Pharma is developing first-in-class drugs to treat respiratory disease, such as COPD, asthma and chronic, severe cough. The Company has three drug programmes, two of which are in Phase II. The lead programme, RPL554, is an innovative dual phosphodiesterase (PDE) 3 and 4 inhibitor with both bronchodilator and anti-inflammatory properties. VRP700 is an innovative product for suppressing chronic, severe cough in patients with underlying lung disease. In its third programme, Verona Pharma is investigating novel anti-inflammatory molecules, called NAIPs, for a wide range of respiratory and inflammatory diseases.

About RPL554 for the treatment of COPD and Asthma

Verona Pharma’s lead drug, RPL554, is a dual phosphodiesterase (PDE) 3 and 4 inhibitor being developed as a novel treatment for chronic obstructive airways disease such as COPD and asthma with bronchodilator and anti-inflammatory effects. Both effects are essential to improve symptoms in patients with COPD or asthma. RPL554 is currently in phase II for both diseases.

COPD is a chronic lung disease with significant unmet need for which current treatment is far from optimal, as it often has unwanted side-effects and/or limited effectiveness. COPD is most commonly characterised by fixed airflow obstruction and chronic airways inflammation resulting from exposure to irritants like tobacco smoke. Asthma, which remains one of the most common chronic diseases in the world, is characterised by recurrent breathing problems and symptoms such as breathlessness, wheezing, chest tightness, and coughing. The market for COPD and asthma drugs is currently estimated to be GBP20 billion [source: visiongain].

About VRP700 for the treatment of Cough

VRP700 is Verona Pharma's lead drug compound for the treatment of cough, having a novel mechanism of action involving the suppression of cough initiating signals originating from cough sensory nerve endings located in the lungs. A clinical trial completed at the University of Florence, Italy in September 2011 clearly demonstrated significant anti-tussive effects with nebulised VRP700 in hospitalized patients with chronic severe cough.

Cough can be a very debilitating comorbidity reported by patients, especially those with respiratory conditions such as asthma, COPD, lung cancer, interstitial lung disease, fibrosis or lung infections. It is a neglected symptom which is often self-medicated. Consumer spending on OTC medications, including those for cough, grew by 10% over 2005-10, to reach GBP532 million [source: Mintel]. However, there is very little clinical evidence for such OTC cough medications being really effective and it is widely recognised by the medical community that there is a large need for more effective drugs to control and prevent pathologically induced coughing.



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