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Vectura announces positive data with inhaled anti-migraine product


15 April 2008

Chippenham, UK – April 15, 2008: Vectura Group plc (LSE: VEC) (“Vectura”), the pulmonary product development company, today announced positive data from an early proof of concept study of VR147, a product in development for the symptomatic treatment of migraine. VR147 is an orally inhaled triptan therapy with the potential to provide enhanced benefits to migraine patients through its rapid onset of action.

The results of the trial, a dose-escalation and cross-over pharmacokinetic and safety comparison in 12 healthy adult volunteers, showed:

  • Rapid achievement of maximum arterial plasma concentrations of VR147 four minutes after dosing, which may directly impact speed of symptomatic relief through rapid delivery to the cranial arteries
  • Rapid achievement of maximum venous plasma concentrations 8 minutes after dosing, compared with 12 minutes when the active component of VR147 is administered subcutaneously
  • Dose-dependent plasma concentrations and exposure to the active drug at levels known to be effective in patients
  • Excellent tolerability of the product, illustrated by a benign adverse event profile consistent with the active drug, and no abnormal ECG changes

The triptan market currently dominates migraine therapy, with sales in excess of $2.3 billion in 2007.

Dr Chris Blackwell, Chief Executive of Vectura, commented:

“These positive results provide us with an opportunity to create value in what we anticipate will be a very significant market.  The primary need of migraine patients is to obtain rapid onset of relief, and there is evidence to suggest that this can also have a positive impact on the severity of the migraine.  

“With the benefit of this early and compelling data, we will assess licensing options both for VR147 and for the use of our inhalation technology for the delivery of other triptans.”

- Ends -

Enquiries:

Vectura Group plc  +44 (0)1249 667700
Chris Blackwell, Chief Executive
 
Anne Hyland, Chief Financial Officer  
Financial Dynamics +44 (0)20 7831 3113
David Yates  
Ben Atwell  
Susan Quigley  

Notes for Editors:

About Migraine
Migraine is characterised by recurring attacks of throbbing headache pain, often associated with visual, auditory or gastrointestinal disturbances. Attacks range from mild to severe and can last from 4 hours to 72 hours.  In the most severe attacks, migraine sufferers are unable to pursue basic daily activities. According to the American Council for Headache Education, migraines afflict 25 million to 30 million people in the U.S. alone.  As many as 6% of all men and up to 18% of all women experience a migraine headache at some time.

About Vectura
Vectura Group plc is a pulmonary product development company focused principally on the development of a range of inhaled therapies for the treatment of respiratory and neurological diseases. Vectura develops products to treat respiratory diseases such asthma, chronic obstructive pulmonary disease (COPD) and cystic fibrosis, the market for which is forecast to achieve sales of $32 billion by 2011. Vectura also develops products for non-respiratory diseases where optimised delivery via the lungs into the blood stream 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 seeks to develop certain programmes further through development to optimise value at a later licensing stage. Vectura also offers its formulation and inhalation technologies to other pharmaceutical companies on a licensing basis where this complements Vectura’s business strategy.

Vectura has development collaborations with several pharmaceutical companies including Boehringer Ingelheim, Novartis and Chiesi. The acquisition of Innovata in January 2007 brought established alliances with a number of additional companies, such as Baxter, GlaxoSmithKline (GSK), Merck Generics (part of Mylan Inc), UCB and Otsuka, as well as providing revenue streams, complementary products and critical mass.
For further information, please visit Vectura’s website at www.vectura.com

Forward-Looking Statements
This press release contains “forward-looking statement”, 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 programmes; failure to obtain patent protection for inventions; 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.

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