Vectura announces clinical proof of concept for VR776
23 May 2007
Vectura announces clinical proof of concept for inhaled premature ejaculation product
Chippenham, UK - 23 May, 2007: Vectura Group plc (LSE: VEC) ("Vectura"), the pulmonary product development Company focused on respiratory and neurological diseases, today announces the successful outcome of a Phase IIa proof-of-concept clinical study for its product VR776 for the treatment of Premature Ejaculation (PE). The data demonstrate that VR776 improves intravaginal ejaculatory latency time (IVELT).
VR776 is Vectura's proprietary formulation of a centrally-acting drug delivered by oral inhalation using the Company's Aspirair(R) dry powder inhaler (DPI). The active component has been approved worldwide for treatment of other indications but has never been licensed for PE. Currently no product is approved in either the US or Europe for PE and a therapy with rapid onset of action could provide significant benefit for patients.
PE is defined as persistent or recurrent ejaculation sooner than desired either before or shortly after penetration, typically reflecting an IVELT of two minutes or less, over which the sufferer has minimal or no control.
Forty patients with PE took part in the double-blind crossover study evaluating two 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 one of 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 most notable of which was incidence of cough. There were no serious adverse events and all forty patients completed the study.
Whilst the data demonstrate statistically significant changes in IVELT, Vectura believes the next stage in the development of VR776 is to establish whether bigger improvements in IVELT can be achieved at higher doses to optimise the potential therapeutic benefit. This may require re-formulation of the product in an attempt to reduce or eliminate associated cough. In line with the Company's stated strategy to focus on the development of pulmonary products for the treatment of respiratory and neurological diseases it is Vectura's intention to out-license this product.
Dr Chris Blackwell, Chief Executive of Vectura, commented:
"Premature ejaculation is a common and distinct medical condition that can severely impact quality of life, affecting the physical and emotional well-being of patients and their partners. The initial evaluation of the results of this study endorses our belief that the potential remains for VR776 to be a rapidly-acting and effective treatment for PE patients. We are also very pleased that the study provides further validation of the effectiveness of our Aspirair(R) dry powder inhaler device."
Vectura Group plc Tel: + 44 (0) 1249 667700
Chris Blackwell, Chief Executive
Anne Hyland, Chief Financial Officer
Julia Wilson, Director of Investor Relations & Corporate
Communications
Financial Dynamics Tel: + 44 (0) 207 831 3113
David Yates / John Gilbert
Notes for Editors:
About premature ejaculation
PE is the inability to delay ejaculation long enough to have a
satisfactory sexual 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 due to nervousness or
anxiety. PE is currently treated by counselling and/or the use of
desensitising products. Recent studies have shown that
centrally-acting oral anti-depressants can be effective, but the
onset of action is slow. In spite of this, some are known to be
used ''off label'' for the treatment of PE. Around 50 million males
over the age of 40 are estimated to be affected by PE in the US and
EU. Vectura believes that the lack of a licensed drug that
specifically addresses PE, the high incidence of PE and the
increasing willingness of patients to present with this problem
will mean that this is an important future market for effective
pharmaceutical products.
About Vectura
Vectura is a pulmonary drug development company focused principally
on the development of a range of inhaled therapies for the
treatment of respiratory and neurological diseases. The Company
targets opportunities where optimised delivery via the lungs can
provide significant benefits, such as a rapid onset of action,
improved efficacy and improved tolerability compared with current
therapies.
Vectura has eight marketed products and a portfolio of drugs in clinical and pre-clinical development, some of which have been licensed to major pharmaceutical companies. The Company also seeks to develop certain programmes further through development to optimise value at a later licensing stage. Vectura also offers its formulation and inhalation capabilities to other pharmaceutical companies on a licensing basis where this complements Vectura's business strategy.
Vectura has development collaborations with a broad range of pharmaceutical companies including Boehringer Ingelheim, Novartis, GSK and Chiesi. The acquisition of Innovata in January 2007 brought established alliances with a number of additional companies, such as Baxter, Merck KGaA, UCB and Otsuka as well 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 dry power inhaler, designed to allow delivery with high
lung penetration and low variability, essential for drugs that are
intended for systemic delivery. Vectura believes that the device is
conveniently sized and simple to use compared 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 both fine and ultra-fine particles to the deep
lung regions. Aspirair(R) generates an aerosol plume, triggered by
a patient's inhalation, which is significantly slower than most
spray type active inhalers currently available. Thus the amount of
powder that is unintentionally deposited in the mouth and throat is
reduced. Aspirair(R) is currently manufactured in pilot-scale
quantities under GMP conditions by CTP Plasro, while blister
filling takes place at Vectura's own GMP facility in Chippenham.
Aspirair(R) has been used in patient studies in clinic and at-home
settings by more than 600 subjects.
This press release contains "forward-looking statements," including statements about the discovery, development and commercialisation of products. Various risks may cause Vectura's actual results to differ materially from those expressed or implied by the forward-looking statements, including adverse results in clinical development programs; failure to obtain patent protection for discoveries; commercial limitations imposed by patents owned or controlled by third parties; dependence upon strategic alliance partners to develop and commercialise products and services; difficulties or delays in obtaining regulatory approvals to market products and services resulting from development efforts; the requirement for substantial funding to conduct research and development and to expand commercialisation activities; and product initiatives by competitors. As a result of these factors, prospective investors are cautioned not to rely on any forward-looking statement. We disclaim any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.

