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Vectura Group plc (VEC.L): FAVOLIR Regulatory Update


4/11/2014 9:54:22 AM

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Chippenham, UK – 11 April 2014: Vectura Group plc (LSE: VEC; “Vectura” or the “Company”) announces that it will initiate a pivotal study in Europe later this calendar year for FAVOLIR, its investigational product for severe, uncontrolled asthma.

This decision underlines the Company’s planned strategy for a broad European development programme for FAVOLIR, rather than a country-specific approach, and this decision follows a recent meeting with the German regulator (BfArM) regarding the local development options for the product.

Dr. Chris Blackwell, Chief Executive of Vectura:
“The feedback that we received from BfArM is in-line with our own expectations. The constructive dialogue that we have had with the BfArM has helped us in our planning for the upcoming European pivotal trial and we look forward to taking the development of FAVOLIR to the next stage. FAVOLIR is an important product and is of potentially high value to all stakeholders.”

Enquiries

Vectura Group plc +44 (0)1249 667700
Chris Blackwell, Chief Executive
Karl Keegan, Corporate Development Director

FTI Consulting +44 (0)20 3727 1000
Ben Atwell / John Dineen

About Vectura Vectura is a product development company that focuses on the development of pharmaceutical therapies for the treatment of airways-related diseases. This growing market includes asthma and chronic obstructive pulmonary disease (COPD) and is estimated to be worth in excess of $46 billion worldwide.[1]

Vectura has eight products marketed by its partners and a portfolio of drugs in clinical development, a number of which have been licensed to major pharmaceutical companies. Vectura has disclosed development collaborations and licence agreements with several pharmaceutical and biotechnology companies, including Novartis, Sandoz (the generics arm of Novartis), Baxter, GlaxoSmithKline, UCB, Ablynx, Grifols and Tianjin KingYork Group Company Limited.

Vectura seeks to develop certain programmes itself where this will optimise value. Vectura's formulation and inhalation technologies are available to other pharmaceutical companies on an out-licensing basis where this complements Vectura's business strategy. For further information, please visit Vectura's website at www.vectura.com.

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