Vectura announces CE mark for Aspirair® inhaler
24 Jan 2007
Vectura announces CE mark FOR Aspirair® inhaler
Chippenham, UK – 24 January 2007: Vectura Group plc (LSE: VEC) ("Vectura") today announces that the Aspirair® dry powder inhaler has received CE mark certification. This certificate confirms that the Aspirair inhaler meets all regulatory requirements for a class IIb medical device within Europe . The inhaler will now bear the CE mark of an approved device.
The CE mark certificate follows on from the certification of Vectura's quality management system to the requirements of the Medical Devices Directive 93/42/EEC and ISO13485 2003.
The Aspirair inhaler is Vectura's high performance patent-protected inhaler technology, designed to allow delivery with high lung penetration and low variability, primarily for drugs that are intended for delivery into the blood stream via the lungs. The device is conveniently sized and simple to use, and in user studies to date, it has been positively received.
The Aspirair dry powder inhaler is currently used to deliver Vectura's development-stage products; VR040 for the treatment of Parkinson's disease, VR004 for erectile dysfunction and VR776 for premature ejaculation.
Dr Chris Blackwell, Chief Executive of Vectura, commented:
"Achieving CE mark approval is a critical step in the development of any medical device technology and this achievement further demonstrates Vectura's device expertise. It is particularly significant as Aspirair has already been successfully used in clinical studies in more than 600 patients. T hese studies have shown that Aspirair can be used to deliver our systemic products in an efficient, effective and patient-friendly manner."
Enquiries:
Vectura Group plc Tel: + 44 (0) 1249 667700
Chris Blackwell, Chief Executive
Anne Hyland, Chief Financial Officer
Financial Dynamics Tel: + 44 (0) 207 831 3113
David Yates
Anna Keeble
Notes for Editors:
About Vectura
Vectura's principal focus is the development of a range of inhaled drugs for the treatment of both lung diseases and other conditions 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's strategy is to combine its proprietary pulmonary formulation and device technologies with existing, off-patent or clinically validated drugs either for use in new indications or to provide inhalation as an improved means of administration. The Company has a portfolio of products in pre-clinical and clinical development, some of which have been licensed to major pharmaceutical companies. It also generates revenue from partnerships in respect of marketed pulmonary and non-pulmonary products. Vectura also actively licenses out its inhalation device and formulation technologies for product applications of other pharmaceutical companies.
The Company has development collaborations with Boehringer Ingelheim, Novartis, GSK and Chiesi as well as with other non-disclosed pharmaceutical companies. The acquisition by Vectura in January 2007 of Innovata added further development and licensing partnerships including, Baxter, UCB and Otsuka as well as expanding its range of inhalation technologies and development programmes. For further information, please visit Vectura's website at www.vectura.com
About Aspirair®
Aspirair is Vectura's high performance, patent-protected inhaler technology, designed to allow delivery with high lung penetration and low variability, essential for drugs that are intended for systemic delivery. Vectura believes that t he device is conveniently sized and simple to use compared to other 'active' inhalers. Experiments to date indicate that Aspirair 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 has been shown to consistently deliver both fine and ultra-fine particles to the deep lung regions. Aspirair generates an aerosol plume, triggered by a patient's inhalation, which is significantly slower than most spray type active inhalers curretly available. This reduces the amount of drug that is unintentionally deposited in the mouth and throat and subsequently swallowed rather than inhaled into the lungs. The Aspirair device 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 has been used in patient studies in clinic and at-home settings by more than 600 subjects.
