Latest GyroHayler News 4/114 Nov 2014 12:59
AirFluSal Forspiro is the direct generic replacement for GSK'S Advair, one of the four top selling drugs in the world & accounting for over $8 billion per year (25% of GSK'S global revenues) whose patents have now ended. The drug is administered by GyroHaler, a joint device development project between Vectura (VEC) & Carclo Technical Plastics & who now manufacture the inhaler. Sandoz is responsible for seeking world wide Approvals apart from USA. A major (unnamed) American pharma company were appointed for that territory & that is ongoing.
Approval in Baltics for innovative respiratory inhaler AirFluSal(R) Forspiro(R)
-- Regulatory authorities in Estonia, Latvia and Lithuania grant marketing authorisations for AirFluSal(R) Forspiro(R)
-- Approval for 50-250 and 50-500 ug dosage forms
-- AirFluSal(R) Forspiro(R) already launched in four European countries (Germany, Denmark, Sweden, Norway) and South Korea. Marketing approval has recently already been granted in Portugal & recently in Latin America (Brazil)
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(R) Forspiro(R) , 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(R) Forspiro(R) 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(R) Forspiro(R) in the 50-250 and 50-500 ug dosage forms.
AirFluSal(R) Forspiro(R) 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(R) Forspiro(R) 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.
http://uk.advfn.com/news/UKR