18th Dec 2013 17:28
Vectura Group plc
Danish Regulatory Authority confirm approval of AirFluSal® Forspiro®
Chippenham, UK - 18 December 2013: Vectura Group plc (LSE: VEC; "Vectura" or "the Company") confirms that our partner, Sandoz, has today received Danish marketing authorisation for AirFluSal® Forspiro® (formerly known as VR315), an innovative new inhaler for patients with asthma and chronic obstructive pulmonary disease (COPD). The Danish approval follows the completion of the EU regulatory process for eight EU countries.
AirFluSal® Forspiro® offers the proven combination of salmeterol (a long-acting inhaled β2-agonist) and fluticasone (an inhaled corticosteroid) in an innovative new inhalation device. The product's safety, efficacy and equivalence have been proven in multiple clinical trials1,2. Denmark has approved both mid and high-strength dosage forms (50-250µg and 50-500µg) 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 first approval of AirFluSal® Forspiro® is a milestone that de-risks our high value respiratory generic portfolio in Europe and the Rest of the World," said Chris Blackwell, CEO of Vectura. "Once launched, we will begin to receive another new valuable royalty stream. The innovative new device is a further validation of our capabilities in respiratory drug development."
In order to improve patient experience with inhalation devices, Sandoz collaborated closely with patients during the development of AirFluSal® Forspiro®. The device features an innovative, patient-friendly design, including multiple feedback mechanisms:
· Visual control features which helps reassure the patient about dosing
· Simple lever arm to load the dose
· Clear and accurate dose counter
Vectura initially developed VR315, before licensing the asset to Sandoz in 2006, including optimising the design of an innovative inhaler. It was subsequently developed 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 vscomparator in paediatric asthma. Submitted ERS - Reference September 2013
2 Sandoz data on file
-Ends-
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) 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.
About Sandoz
Sandoz, the generic pharmaceuticals division of Novartis, is a global leader in the rapidly growing generics industry. Sandoz employs over 26,000 employees in more than 140 countries, offering broad range of over 1,000 high-quality, affordable products that are no longer protected by patents. With USD 8.7 billion in sales in 2012, Sandoz holds the #1 position globally in biosimilars as well as generic injectables, ophthalmics, dermatology and antibiotics as well as strong positions in the treatments for central nervous system disorders, gastrointestinal medicines, cardiovascular treatments, and hormone therapies. Sandoz develops, produces, and markets these medicines along with pharmaceutical and biotechnological active substances. In addition to strong organic growth since consolidating its generics businesses under the Sandoz brand name in 2003 , Sandoz has benefitted from strong growth of its acquisitions including Lek (Slovenia), Sabex (Canada), Hexal (Germany), Eon Labs (US), EBEWE Pharma (Austria), Oriel Therapeutics (US), and Fougera Pharmaceuticals (US).
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
END
Related Shares:
VEC.L