Romanian approval of AirFluSal Forspiro

Vectura Group plc

Romanian Regulatory Authority confirm approval of AirFluSal® Forspiro®

Chippenham, UK - 29 January 2014: Vectura Group plc (LSE: VEC; "Vectura" or "the Company") confirms that our partner, Sandoz, has received marketing authorisation in Romania for AirFluSal® Forspiro® (formerly known as VR315), an innovative new inhaler for patients with asthma and chronic obstructive pulmonary disease (COPD). The receipt of the Romanian marketing authorisation by Sandoz triggers a milestone payment to Vectura of €1.5 million.

The product was first approved (and now launched) in Denmark on December 18th, 2013 with subsequent market authorisations received earlier in January 2014 in Germany, Sweden and Hungary. The new product offers the proven combination of salmeterol (a long-acting inhaled β2-agonist) and fluticasone (an inhaled corticosteroid) in an innovative inhalation device.

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

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] Kuna, I. Gath, U. Thyroff-Friesinger, S. Jones. Equivalence of fluticasone propionate/salmeterol delivered via new multi-dose dry powder inhaler and accuhaler™ in adolescent and adult asthma. Ajrccm conference.2013.187.1_MeetingAbstracts.A2611

[2]Sandoz data on file

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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.

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