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Vectura Group plc (VEC.L): Swedish Regulatory Authority Confirm Approval Of Airflusal® Forspiro®


1/14/2014 9:55:54 AM

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Chippenham, UK – 14 January 2014: Vectura Group plc (LSE: VEC; “Vectura” or “the Company”) confirms that our partner, Sandoz, has today received Swedish marketing authorisation for AirFluSal® Forspiro® (formerly known as VR315), an innovative new inhaler for patients with asthma and chronic obstructive pulmonary disease (COPD).

The product was first approved in Denmark on December 18th, 2013 and Germany on January 13th, 2014. The new product offers the proven combination of salmeterol (a long-acting inhaled ß2-agonist) and fluticasone (an inhaled corticosteroid) in an innovative inhalation device.

Sweden has approved the 50-500µg and 50-250µg dosage forms for the continuous treatment of patients above 12 years of age with persistent asthma or for symptomatic treatment of COPD in the same patient group. The product’s safety, efficacy and equivalence have been proven in multiple clinical trials1,2.

The receipt of the marketing authorisations in Sweden, Germany and Denmark follows the successful completion of EU decentralised procedures also including Norway for the 50-500 µg and 50-250 µg dosage forms and for the 50-500 µg dosage form Germany, Belgium, Bulgaria, Hungary, Luxembourg and Romania. We will communicate as and when further market approvals are received.

Vectura initially developed the VR315 product and created the design of the innovative inhaler, before licensing the asset to Sandoz in 2006. It was subsequently developed in collaboration with Vectura as AirFluSal® Forspiro® by Aeropharm GmbH in Rudolstadt, Germany, Sandoz’ global respiratory Center of Excellence. The innovative and intuitive to use design of the inhaler was awarded the Red Dot Product Design award in 2011, an internationally recognized quality seal awarded by the Design Zentrum Nordrhein Westfalen in Essen, Germany.

[1] P Kuna, I Gath, U Thyroff-Friesinger, S Jones. Equivalence of an innovative multidose salmeterol/fluticasone dry powder inhaler vs comparator in paediatric asthma. Submitted ERS – Reference September 2013

[2] Sandoz data on file

Enquiries
Vectura Group plc +44 (0)1249 667700
Chris Blackwell, Chief Executive

Karl Keegan, Corporate Development Director

FTI Consulting +44 (0)20 7831 3113
John Dineen / Ben Atwell

About Vectura
Vectura Group plc and its subsidiaries (“Vectura” or the “Group”) is a product development company that focuses on the development of pharmaceutical therapies for the treatment of airway-related diseases. This growing market includes asthma and chronic obstructive pulmonary disease (COPD) and is estimated to be worth in excess of $30 billion worldwide.

Vectura has seven 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 development collaborations and licence agreements with several pharmaceutical companies, including Novartis, Sandoz (the generics arm of Novartis), Baxter, GlaxoSmithKline (GSK), UCB and Tianjin King York Group Company Limited (KingYork).

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.

Victoria Foster Mitchell
Senior Consultant
Strategic Communications
F T I Consulting
+44 (0)20 3077 0486 direct
+44 (0)7816 944 230 mobile
Victoria.FosterMitchell@fticonsulting.com
Holborn Gate, 26 Southampton Buildings
London, WC2A 1PB
www.fticonsulting.com

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