23rd May 2007 07:02
Vectura Group PLC23 May 2007 VECTURA ANNOUNCES CLINICAL PROOF OF CONCEPT FOR INHALED PREMATURE EJACULATION PRODUCT Chippenham, UK - 23 May, 2007: Vectura Group plc (LSE: VEC) ("Vectura"), thepulmonary product development Company focused on respiratory and neurologicaldiseases, today announces the successful outcome of a Phase IIa proof-of-conceptclinical study for its product VR776 for the treatment of Premature Ejaculation(PE). The data demonstrate that VR776 improves intravaginal ejaculatory latencytime (IVELT). VR776 is Vectura's proprietary formulation of a centrally-acting drug deliveredby oral inhalation using the Company's Aspirair(R) dry powder inhaler (DPI).The active component has been approved worldwide for treatment of otherindications but has never been licensed for PE. Currently no product isapproved in either the US or Europe for PE and a therapy with rapid onset ofaction could provide significant benefit for patients. PE is defined as persistent or recurrent ejaculation sooner than desired eitherbefore or shortly after penetration, typically reflecting an IVELT of twominutes or less, over which the sufferer has minimal or no control. Forty patients with PE took part in the double-blind crossover study evaluatingtwo doses of VR776 (1mg & 2mg) and placebo. Following a 21 days "no treatment"run-in period, patients were randomly assigned to receive either placebo or oneof the doses of VR776. The results demonstrate: • Statistically significant improvement of IVELT at the 2mg dose • Clinical effect achieved within 15 minutes of dosing • A minimal/no effect dose was established at 1mg • The sense of control over ejaculation felt by the patient was significantly improved • Further endorsement of patient acceptability of the Aspirair(R) inhaler VR776 was associated with side effects of a mild-to-moderate nature, the mostnotable of which was incidence of cough. There were no serious adverse eventsand all forty patients completed the study. Whilst the data demonstrate statistically significant changes in IVELT, Vecturabelieves the next stage in the development of VR776 is to establish whetherbigger improvements in IVELT can be achieved at higher doses to optimise thepotential therapeutic benefit. This may require re-formulation of the productin an attempt to reduce or eliminate associated cough. In line with theCompany's stated strategy to focus on the development of pulmonary products forthe treatment of respiratory and neurological diseases it is Vectura's intentionto out-license this product. Dr Chris Blackwell, Chief Executive of Vectura, commented: "Premature ejaculation is a common and distinct medical condition that canseverely impact quality of life, affecting the physical and emotional well-beingof patients and their partners. The initial evaluation of the results of thisstudy endorses our belief that the potential remains for VR776 to be arapidly-acting and effective treatment for PE patients. We are also verypleased that the study provides further validation of the effectiveness of ourAspirair(R) dry powder inhaler device." Vectura Group plc Tel: + 44 (0) 1249 667700Chris Blackwell, Chief ExecutiveAnne Hyland, Chief Financial OfficerJulia Wilson, Director of Investor Relations & Corporate Communications Financial Dynamics Tel: + 44 (0) 207 831 3113David Yates / John Gilbert Notes for Editors: About premature ejaculation PE is the inability to delay ejaculation long enough to have a satisfactorysexual experience. It is the most common form of sexual dysfunction in men,affecting nearly 30 per cent at some time in their lives. Most often, it is dueto nervousness or anxiety. PE is currently treated by counselling and/or the useof desensitising products. Recent studies have shown that centrally-acting oralanti-depressants can be effective, but the onset of action is slow. In spite ofthis, some are known to be used ''off label'' for the treatment of PE. Around50 million males over the age of 40 are estimated to be affected by PE in the USand EU. Vectura believes that the lack of a licensed drug that specificallyaddresses PE, the high incidence of PE and the increasing willingness ofpatients to present with this problem will mean that this is an important futuremarket for effective pharmaceutical products. About Vectura Vectura is a pulmonary drug development company focused principally on thedevelopment of a range of inhaled therapies for the treatment of respiratory andneurological diseases. The Company targets opportunities where optimiseddelivery via the lungs can provide significant benefits, such as a rapid onsetof action, improved efficacy and improved tolerability compared with currenttherapies. Vectura has eight marketed products and a portfolio of drugs in clinical andpre-clinical development, some of which have been licensed to majorpharmaceutical companies. The Company also seeks to develop certain programmesfurther through development to optimise value at a later licensing stage.Vectura also offers its formulation and inhalation capabilities to otherpharmaceutical companies on a licensing basis where this complements Vectura'sbusiness strategy. Vectura has development collaborations with a broad range of pharmaceuticalcompanies including Boehringer Ingelheim, Novartis, GSK and Chiesi. Theacquisition of Innovata in January 2007 brought established alliances with anumber of additional companies, such as Baxter, Merck KGaA, UCB and Otsuka aswell providing revenue streams, complementary products and critical mass. For further information, please visit Vectura's website at www.vectura.com About Aspirair(R) Aspirair(R) is Vectura's high performance, patent-protected single unit dose drypower inhaler, designed to allow delivery with high lung penetration and lowvariability, essential for drugs that are intended for systemic delivery.Vectura believes that the device is conveniently sized and simple to usecompared to other 'active' inhalers. Experiments to date indicate that Aspirair(R) is capable of delivering DPI formulations of both large and small molecules,either in the form of a pure drug particle or in combination with an excipient.In laboratory tests, Aspirair(R) has been shown to consistently deliver bothfine and ultra-fine particles to the deep lung regions. Aspirair(R) generates anaerosol plume, triggered by a patient's inhalation, which is significantlyslower than most spray type active inhalers currently available. Thus the amountof powder that is unintentionally deposited in the mouth and throat is reduced.Aspirair(R) is currently manufactured in pilot-scale quantities under GMPconditions by CTP Plasro, while blister filling takes place at Vectura's own GMPfacility in Chippenham. Aspirair(R) has been used in patient studies in clinicand at-home settings by more than 600 subjects. This press release contains "forward-looking statements," including statementsabout the discovery, development and commercialisation of products. Variousrisks may cause Vectura's actual results to differ materially from thoseexpressed or implied by the forward-looking statements, including adverseresults in clinical development programs; failure to obtain patent protectionfor discoveries; commercial limitations imposed by patents owned or controlledby third parties; dependence upon strategic alliance partners to develop andcommercialise products and services; difficulties or delays in obtainingregulatory approvals to market products and services resulting from developmentefforts; the requirement for substantial funding to conduct research anddevelopment and to expand commercialisation activities; and product initiativesby competitors. As a result of these factors, prospective investors arecautioned not to rely on any forward-looking statement. We disclaim anyintention or obligation to update or revise any forward-looking statements,whether as a result of new information, future events or otherwise. 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