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Approval in Baltics for AirFluSal Forspiro

4th Nov 2014 07:00

RNS Number : 0432W
Vectura Group plc
04 November 2014
 



Vectura Group plc

 

Approval in Baltics for innovative respiratory inhaler AirFluSal® Forspiro®

 

· Regulatory authorities in Estonia, Latvia and Lithuania grant marketing authorisations for AirFluSal® Forspiro®

· Approval for 50-250 and 50-500 µg dosage forms

· AirFluSal® Forspiro® already launched in four European countries and South Korea

 

 

Chippenham, UK - 4 November 2014: Vectura Group plc (LSE: VEC; "Vectura" or the "Company") confirms that our partner Sandoz, has been granted marketing authorisation by the pharmaceutical regulatory authorities in Estonia, Latvia and Lithuania for AirFluSal® Forspiro®, an innovative new inhaler for patients with asthma and/or chronic obstructive pulmonary disease (COPD).

These latest marketing authorisations by the three Baltic states, which are members of the European Union (EU), mean that AirFluSal® Forspiro® has now been approved in a total of 13 European countries, as well as South Korea and Mexico. The product has been launched in five countries to date, including South Korea.

The three Baltic states all approved AirFluSal® Forspiro® in the 50-250 and 50-500 µg dosage forms.

AirFluSal® Forspiro® offers the proven combination of salmeterol (a long-acting inhaled beta-2 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.

The device includes multiple feedback mechanisms such as visual control features, which help reassure the patient about dosing, a simple lever arm to load the dose, and clear and accurate feedback on remaining available doses.

-Ends-

 

 

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 has eight products marketed by 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, Baxter, GlaxoSmithKline, UCB, Ablynx, Grifols and Tianjin KingYork Group Company Limited.

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.

 

 

This information is provided by RNS
The company news service from the London Stock Exchange
 
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