Mar. 23, 2011 (PR Newswire UK Disclose) -- Verona Pharma plc is a biotechnology company dedicated to discovering new drugs for the treatment of chronic respiratory diseases, such as asthma, allergic rhinitis (hay fever), chronic obstructive pulmonary disease (COPD) and cough. Today, the Company announces its unaudited preliminary results for the 12 months ended 31 December 2010.
2010 OPERATIONAL HIGHLIGHTS
* January - Filed four new patents related to novel compounds discovered under the Company’s Novel Anti-Inflammatory Polysaccharides (“NAIPs”) project.
* January - Received the final quality assured study report from the Centre for Human Drug Research (“CHDR”) at Leiden University for the Phase I/IIa trial of Verona’s lead product, RPL554, which confirmed the quality of the clinical trial and its associated analyses.
* October - Initiated the clinical trial of VRP700 in chronic cough patients at the University of Florence, Italy.
* November - Completed proof of concept experimental studies showing that RPL554 can be delivered via each of the main types of devices commonly available for inhalation therapy.
* November - Initiated the clinical trial of RPL554 at CHDR at Leiden University to evaluate the safety and bronchodilator effectiveness of higher doses of RPL554 in patients with mild asthma. 2010 FINANCIAL HIGHLIGHTS
* Loss after tax of £1.89 million or 0.79 pence per ordinary share.
* Low cash burn rate during the year and as at 31 December 2010 the Company had cash and cash equivalents of £2.00 million. SUBSEQUENT EVENT HIGHLIGHTS
* January 2011 - Applied to the Medicines and Healthcare Products Regulatory Agency (“MHRA”) for approval to conduct further clinical development of RPL554 in the UK.
* February 2011 - Successfully completed the clinical trial at CHDR at Leiden University of higher doses of RPL554 in patients with mild asthma.
* February 2011 - Received ethics approval from the Policlinico Tor Vergata, University of Rome, Italy to proceed with an exploratory Phase II trial of RPL554 in COPD patients.
CHAIRMAN AND CHIEF EXECUTIVE OFFICER’S JOINT STATEMENT
INTRODUCTION
2010 has been another busy year for Verona Pharma. The Company continues to vigorously pursue the licensing of its lead project, RPL554, to an appropriate pharmaceutical partner, as well as to achieve progress with its other programmes - VRP700 for the treatment of cough and NAIPs. The Company also continues to review potential new projects for inclusion in its pipeline in the future. The Board continues to maintain a firm control on the Company’s finances and the Company operates a proven financial model which enables it to apply its resources to maximum effect.
RPL554
Discussions are ongoing for licensing out the Company’s lead project, RPL554, a novel inhaled PDE3/4 inhibitor as a treatment for inflammatory diseases of the respiratory tract, including asthma, COPD and allergic rhinitis (hay fever). As the Company has stated previously, it is seeking the most compatible and appropriate licensing partner to develop RPL554 into a marketed medicine.
During 2010, the Company initiated further clinical trials in order to provide useful clinical data to add further value to the overall RPL554 package. The first clinical trial started in November and took place in Leiden, The Netherlands, at CHDR. The purpose of the trial was to evaluate the safety and bronchodilator effectiveness of higher doses of RPL554 in patients with mild asthma. Other objectives for this trial were to establish an appropriate dose for patients with respect to both effectiveness as a bronchodilator, and its safety. The trial was successfully completed in December 2010 and there were no withdrawals due to adverse effects. Both doses of RPL554 resulted in positive bronchodilation as assessed by the standard measure of FEV1 (Forced Expiratory Volume in 1 sec). Of particular note was the absence of any gastrointestinal symptoms related to the administration of the drug, since this is a limiting side effect for many PDE4 (phosphodiesterase type 4) inhibitors. At the highest dose given, limited cardiovascular effects were encountered. The results from this trial will allow the Company to be able to set appropriate doses for future studies. Additionally, the outcome of the trial provided further support for RPL554 as a novel treatment for patients with respiratory diseases and further strengthened the Company’s data package for discussions with potential licensees.
The second clinical trial received approval from the appropriate ethical authority in Italy in January 2011 to proceed with an exploratory Phase II trial at the Policlinico Tor Vergata in Rome. This clinical trial has been designed to test the bronchodilator effects as well as safety of RPL554 in patients with established mild to moderate COPD. The incidence of COPD globally continues to grow and it is a disease which currently has significant unmet treatment needs. The Company currently believes that RPL554 will if successful be of significant clinical value in the treatment of this debilitating condition.
In January 2011, the Company applied to the MHRA, the governmental agency in the UK with responsibility for standards of safety, quality and performance of new drug treatments, to conduct a third clinical trial in the UK. This trial will examine the safety, duration and maintenance of bronchodilator action of RPL554 when it is given at repeated doses over several days. In addition there will be exploratory observations related to possible anti-inflammatory actions of RPL554.
The Company has also been evaluating the various methods by which RPL554 can be administered to patients by oral inhalation using appropriate oral inhaler devices. Normally asthma and COPD drugs are delivered from a dry powder inhaler (“DPI”) or a pressurized metered dose inhaler (“pMDI”), although nebulizers are used in a substantial number of patients. In both the currently planned and completed trials, RPL554 has been delivered using a nebulizer. In November, the Company completed a proof of concept experimental study that showed RPL554 can be delivered via a DPI as well as by a pMDI. These experiments will assist potential licensees in deciding the most suitable administration route and type of device for the commercialisation of RPL554. Such studies will obviously add value and strengthen the Company’s position with respect to ongoing licensing discussions.
VRP700
During 2010, the Company received the necessary regulatory and ethical approvals for a clinical trial of VRP700 in patients who have an intractable cough due to underlying severe lung disease. The study was initiated in late October 2010 and is currently still going at the University of Florence, Italy. The trial has been specifically designed to demonstrate the anti-tussive (cough-suppressive) effects of VRP700 by inhalation. Progress of the trial is limited due to an unavoidable slow rate of patient recruitment. The Company currently hopes that the trial will be able to be completed in the second quarter of 2011.
NAIPs
Verona Pharma’s NAIPs project has progressed to the point that the Company has submitted four new `composition of matter’ patents for fractions that have been discovered as a result of the collaboration with Glycomar Ltd. These novel fractions have been identified from a number of marine sources and have shown anti-inflammatory actions that are of potential clinical value in a range of inflammatory diseases. The Company continues to seek other novel NAIPs from other sources via its collaboration with Glycores SpA.
FINANCIALS
The loss for the current year increased by 18% or £0.29m to £1.89m (2009: £1.60m).
Total research and development expenditure, which was expensed as incurred, was £1.15m (2009: £0.94m). The increase in research and development expenditure was primarily due to an increase in expenditures for the RPL554 programme by £0.12m to £0.94m (2009: £0.82m) and an increase in expenditure on the cough programme by £0.07m to £0.11m (2009: £0.04m). These increases were offset by a decrease in expenditure in the NAIPs programme by £0.01m to £0.07m (2009: £0.08m).
The increase in expenditure on the RPL554 programme was primarily due to costs incurred in connection with continuing to develop the RPL554 series and the experimental studies of various inhaler devices for administering RPL554. The increase in expenditure in the cough programme was due to the progression from the clinical trial planning phase in 2009 to the clinical trial implementation phase in 2010.
Administrative expenses for the year were £0.75m (2009: £0.66m). The increase of £0.09m over the previous period was primarily due to an increase in investor relations activities and costs involved with the licensing efforts for RPL554.
The income tax expense of £10,000 was capital gains tax paid by Rhinopharma Limited, during the year.
As at 31 December 2010, the Company had approximately £2 million in cash and cash equivalents.
OUTLOOK
All current evidence indicates that RPL554 has the potential to be a significant new respiratory drug that could capture a significant market share. Verona Pharma is optimistic that it will find a suitable partner to assist it in taking the drug to market. In the meantime, the higher dose trial which was successfully completed in December 2010, and the other two trials which are expected to be underway shortly, are designed to take the drug through to the next development stage and add value to our licensing package.
Progress with the VRP700 project clinical trial has been slower than hoped due to delays in patient recruitment, however, the Company expects that the trial will be completed in the second quarter of 2011.
Verona Pharma is pleased to report that it has continued to maintain a low cash burn rate. Furthermore, the Company is very positive about its progress to date and looks forward to updating the market on further developments in due course
