24th Jan 2007 07:01
Vectura Group PLC24 January 2007 VECTURA ANNOUNCES CE MARK FOR ASPIRAIR(R) INHALER Chippenham, UK - 24 January 2007: Vectura Group plc (LSE: VEC) ("Vectura") todayannounces that the Aspirair(R) dry powder inhaler has received CE markcertification. This certificate confirms that the Aspirair inhaler meets allregulatory requirements for a class IIb medical device within Europe. Theinhaler will now bear the CE mark of an approved device. The CE mark certificate follows on from the certification of Vectura's qualitymanagement system to the requirements of the Medical Devices Directive 93/42/EECand ISO13485 2003. The Aspirair inhaler is Vectura's high performance patent-protected inhalertechnology, designed to allow delivery with high lung penetration and lowvariability, primarily for drugs that are intended for delivery into the bloodstream via the lungs. The device is conveniently sized and simple to use, and inuser studies to date, it has been positively received. The Aspirair dry powder inhaler is currently used to deliver Vectura'sdevelopment-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 medicaldevice technology and this achievement further demonstrates Vectura's deviceexpertise. It is particularly significant as Aspirair has already beensuccessfully used in clinical studies in more than 600 patients. These studieshave shown that Aspirair can be used to deliver our systemic products in anefficient, effective and patient-friendly manner." Enquiries: Vectura Group plc Tel + 44 (0) 1249 667700Chris Blackwell, Chief ExecutiveAnne Hyland, Chief Financial officer Financial Dynamics Tel: + 44 (0) 207 831 3113David Yates/John Gilbert Notes for Editors: 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 with Boehringer Ingelheim, Novartis,GSK and Chiesi as well as with other non-disclosed pharmaceutical companies. Theacquisition by Vectura in January 2007 of Innovata added further development andlicensing partnerships including, Baxter, UCB and Otsuka as well as expandingits range of inhalation technologies and development programmes. For furtherinformation, please visit Vectura's website at www.vectura.com About Aspirair(R) 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 believesthat the device is conveniently sized and simple to use compared to other 'active' inhalers. Experiments to date indicate that Aspirair is capable ofdelivering DPI formulations of both large and small molecules, either in theform of a pure drug particle or in combination with an excipient. In laboratorytests, Aspirair has been shown to consistently deliver both fine and ultra-fineparticles to the deep lung regions. Aspirair generates an aerosol plume,triggered by a patient's inhalation, which is significantly slower than mostspray type active inhalers currently available. This reduces the amount of drugthat is unintentionally deposited in the mouth and throat and subsequentlyswallowed rather than inhaled into the lungs. The Aspirair device is currentlymanufactured in pilot-scale quantities under GMP conditions by CTP Plasro, whileblister 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 morethan 600 subjects. This information is provided by RNS The company news service from the London Stock ExchangeRelated Shares:
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