23rd Apr 2007 07:02
Vectura Group PLC23 April 2007 VECTURA ANNOUNCES SUCCESSFUL OUTCOME OF SECOND PHASE IIb CLINICAL STUDY ON INHALED ERECTILE DYSFUNCTION PRODUCT Chippenham, UK - 23 April, 2007: Vectura Group plc (LSE: VEC) ("Vectura") todayannounces the successful outcome of a second Phase IIb clinical study for VR004,its product for the treatment of Erectile Dysfunction (ED). The studydemonstrated that VR004 again improved erectile performance, with a rapid onsetof action, and was well tolerated. VR004 is Vectura's proprietary formulation ofapomorphine, delivered by oral inhalation to the lungs using Vectura'sAspirair(R) dry powder inhaler (DPI). The study is the second of two double-blind, placebo-controlled trials designedto assess the safety and efficacy of VR004. It evaluated three fine particledoses (100 micro g, 150 micro g (common dose with previous study) and 200micro g) and placebo in patients with mild, moderate or severe ED. Followinga four week "no treatment" run-in period, patients were randomised to eitherplacebo or VR004. On successful completion of an orthostatic challenge (quickstanding and sitting manoeuvres to expose intolerance to vasodilation), patientswere allowed home with study treatment for a period of 12 weeks. The assessment of efficacy used the Sexual Encounter Profile (SEP) questions 2and 3. SEP 2 is a measure of the ability of a patient to achieve vaginalpenetration. SEP 3 assesses the ability of a patient to maintain an erectionsuitable for successful intercourse. Changes from baseline in positive responsesto these questions were the primary endpoints of the study. The following table shows the percentage of positive answers to SEP 2 and SEP 3,and the change from baseline in positive answers to SEP 2 and SEP 3, recordedover the last 4 week period of the study, for the 241 patients who received atleast 6 doses of VR004 or placebo "at home": 100 micro g 150 micro g 200 micro g PlaceboPercentage of "positive" answers to SEP 2 71% 66% 83% 61%Percentage of "positive" answers to SEP 3 49% 45% 62% 32%Change from baseline in "positive" answers to 13%* 6%* 14%* -1%SEP 2Change from baseline in "positive" answers to 23%* 17%* 29%* 1%SEP 3 *p < 0.001 compared to placebo VR004 resulted in statistically significant improvements for SEP 2 and 3 at alldoses when compared to placebo thereby achieving the desired primary endpointsof the study. The mean onset of erectile function was dose independent, with 60% of patientswho responded to VR004 reporting onset of erection within five minutes ofdosing, and 85% responding within 10 minutes. Some patients responded within 1minute of dosing. Good safety and tolerability of patients to VR004 was demonstrated. Notreatment-related serious adverse events were reported. Headache was the mostcommon adverse event, reported by 8/98 patients at the top dose compared with 1/89 on placebo. Presentations of these results are planned at future scientific meetings. Vectura intends to seek licensing partners for VR004 prior to commencing pivotalPhase III trials and is currently in discussions with a number of companies whohave expressed interest in the product. Dr Chris Blackwell, Chief Executive of Vectura, said: "The consistency of the data reported from our Phase IIb clinical studies,involving approximately 600 patients with ED of varied aetiology and severity,further validates our belief that VR004 has potential as a rapidly-acting, safeand effective treatment. The combination of these attributes meets our targetprofile and provides an opportunity for a highly effective product capable ofmeeting the needs of patients with ED. These data strengthen the package thatsupports our on-going discussions regarding the licensing of VR004 prior toPhase III clinical evaluation." Alan Riley, MSc, MB, BS, MRCS, FFPM, recently retired Professor of SexualMedicine at Lancashire School of Health and Postgraduate Medicine, University ofCentral Lancashire, and Principal Investigator of the study, commented: "Theresults of this study clearly demonstrate that apomorphine administered byinhalation not only provides a product with therapeutic benefit in ED similar tothat seen previously with the PDE V inhibitors, but also brings clear benefitsof speed of action and spontaneity. It is particularly encouraging that suchperformance has now been demonstrated in ED patients across two separateclinical studies. In addition, as a dopamine agonist, VR004 may also play a rolein treating men unresponsive to PDE V inhibitors or those who arecontraindicated from using them." Enquiries: Vectura Group plc Tel + 44 (0) 1249 667700Chris Blackwell, Chief ExecutiveAnne Hyland, CFO Financial Dynamics Tel: + 44 (0) 207 831 3113David Yates/ John Gilbert Notes for Editors: About erectile dysfunction ED is defined as the consistent inability to achieve and/or maintain an erectionadequate for satisfactory sexual function. The condition is correlated withincreasing age, cardiovascular disease, hypertension, diabetes, obesity,hyperlipidaemia and smoking. In addition, neurogenic risk factors resulting fromradical prostatectomy, spinal cord injury and multiple sclerosis as well ascertain prescription drugs and psychogenic issues contribute to ED. ED affects more than 50 million men in the US and EU with 2006 global sales inexcess of $2.9 billion and with global sales expected to be $6.6 billion by2012. Through market research with doctors, patients and opinion leaders, webelieve that there is a clear unmet need for products with a faster onset ofaction than current oral and buccal products. Continued market growth will bedriven by a number of factors, including the ageing population, the awarenessamongst patients and their partners about the availability of effective EDtreatments and the increasing prevalence of predisposing factors such ascardiovascular disease and obesity. The market is currently dominated by the PDEV inhibitors Viagra, Cialis and Levitra. Based on the clinical trials to date, it is anticipated that apomorphinedelivered through the lungs will be more efficient; avoiding first-passmetabolism, thus requiring lower nominal doses and providing a faster onset oftherapeutic activity than drugs delivered orally, sub-lingually orintra-nasally. About the first Phase IIb VR004 study Results from the first VR004 Phase IIb study were published on 28 June 2006 andthe comparable table, for the doses used in this study, showing the percentageof positive answers to SEP 2 and SEP 3 , and the change from baseline inpositive answers to SEP 2 and SEP 3, recorded over the last 4 week period of thestudy for the 138 patients who received at least 6 doses of VR004 or placebo "athome" in this first study is as follows: 150 micro g 250 micro g 300 micro g PlaceboPercentage of "positive" answers to SEP 2 69% 87% 79% 60%Percentage of "positive" answers to SEP 3 46% 60% 62% 38%Change from baseline in "positive" answers to 8%* 30%* 25%* -4%SEP 2Change from baseline in "positive" answers to 14% 26%* 28%* 6%SEP 3 *p < 0.05 compared to placebo As with the second trial the mean onset of erectile function was doseindependent, with 50% of patients in the first trial, who responded to VR004,reporting onset of erection within five minutes of dosing, and over 80%responding within 10 minutes. About Vectura Vectura's principal focus is the development of a range of inhaled drugs for thetreatment of both lung diseases and other conditions where optimised deliveryvia the lungs can provide significant benefits, such as a rapid onset of action,improved efficacy and improved tolerability compared with current therapies. Vectura's strategy is to combine its proprietary pulmonary formulation anddevice technologies with existing, off-patent or clinically validated drugseither for use in new indications or to provide inhalation as an improved meansof administration. The Company has a portfolio of products in pre-clinical andclinical development, some of which have been licensed to major pharmaceuticalcompanies. It also generates revenue from partnerships in respect of marketedpulmonary and non-pulmonary products. Vectura also actively licenses out itsinhalation device and formulation technologies for product applications of otherpharmaceutical companies. The Company has development collaborations covering various products withBoehringer Ingelheim, Novartis, GSK and Chiesi as well as with othernon-disclosed pharmaceutical companies. The acquisition of Innovata in January2007 added further development and licensing partnerships including, Baxter, UCBand Otsuka as well as expanding its range of inhalation technologies anddevelopment programmes. For further information, please visit Vectura's websiteat www.vectura.com This information is provided by RNS The company news service from the London Stock ExchangeRelated Shares:
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