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Vectura Group plc (VEC.L)'s AirFluSal® Forspiro® Launched In Denmark


1/20/2014 6:27:58 AM

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Chippenham, UK – 20 January 2014: Vectura Group plc (LSE: VEC; “Vectura” or “the Company”) confirms that our partner, Sandoz, has announced that it is launching AirFluSal® Forspiro® (formerly known as VR315), an innovative new inhaler for patients with asthma and/or chronic obstructive pulmonary disease (COPD), in Denmark today.

Today’s launch in Denmark follows the announcement on December 18 that Sandoz had received its first EU market authorisation for AirFluSal® Forspiro® after the completion the EU regulatory process for nine EU countries.

AirFluSal® Forspiro® offers the proven combination of salmeterol (a long-acting inhaled ß2-agonist) and fluticasone (an inhaled corticosteroid) in an innovative new inhalation device.

Denmark has approved the 50-250 µg and 50-500 µg 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 trials.1,2

More than 55,000 (2012 figures) Danish patients are currently being treated with the fixed combination of salmeterol and fluticasone propionate, according to the Danish Ministry of Health’s research institute, Statens Serum Institut.

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. The device features an innovative, patient-friendly design, including multiple feedback mechanisms:

- Visual control features which help reassure the patient about dosing
- Simple lever arm to load the dose
- Clear and accurate dose counter

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.

Besides Denmark, Sandoz has received marketing authorisations for a further three countries, including Germany, Sweden and Hungary.

[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

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.

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