• Regulatory authorities in Ireland and Czech Republic grant marketing authorisation for AirFluSal® Forspiro®
• Approval for 50-250 µg and 50-500 µg dosage forms
• AirFluSal® Forspiro® already launched in four European countries and South Korea
Chippenham, UK – 19 November 2014: Vectura Group plc (LSE: VEC; “Vectura” or “the Company”) confirms that our partner, Sandoz, has been granted marketing authorisation by the regulatory authorities in Ireland and the Czech Republic for AirFluSal® Forspiro®, an innovative new inhaler for patients with asthma and/or chronic obstructive pulmonary disease (COPD). The receipt of the Czech Republic marketing authorisation by Sandoz triggers a milestone payment to Vectura of €1.5 million.
The latest marketing authorisations by the two EU member states means that AirFluSal® Forspiro® has now been approved in a total of 15 European countries, as well as South Korea and Mexico. The product has been launched in four countries to date, including South Korea.
Ireland and the Czech Republic both approved AirFluSal Forspiro in the 50-250 µg and 50-500 µg dosage forms. AirFluSal® Forspiro® offers the proven combination of salmeterol (a long-acting inhaled ß2-agonist) and fluticasone propionate (an inhaled corticosteroid) in an innovative new device. The product’s safety, efficacy and equivalence have been proven in multiple clinical trials.
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’s 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 recognised quality seal awarded by the Design Zentrum Nordrhein Westfalen in Essen, Germany.
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Enquiries
Vectura Group plc
+44 (0)1249 667700
Chris Blackwell, Chief Executive
Karl Keegan, Chief Corporate Development Officer
FTI Consulting
44 (0)20 3727 1000
Ben Atwell / John Dineen / Ulla Lundhus
About Vectura
Vectura is a product development company that focuses on the development of pharmaceutical therapies for the treatment of airways-related diseases (airways 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 now has eight products marketed by partners with growing global royalty streams and a portfolio of drugs in clinical development, a number of which have been licensed to major pharmaceutical companies. Vectura currently has disclosed development collaborations and licence agreements with several global pharmaceutical and biotechnology companies, including Novartis, Sandoz, Baxter, GlaxoSmithKline, UCB, Ablynx, Grifols and Tianjin KingYork Group Company.
Vectura develops products for airways diseases and owns formulation and inhalation technologies that 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.
References
1 Pharmaview Commercial Landscape Series Respiratory Decision Resources 2013
Forward-looking statements
This press release contains forward-looking statements, 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 statements. 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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