Regulatory authorities in Estonia, Latvia and Lithuania grant marketing authorizations for AirFluSal® Forspiro®
Approval for 50-250 and 50-500µg dosage forms
AirFluSal Forspiro already launched in four European countries and South Korea
Holzkirchen, November 4, 2014 – Sandoz announces today that the pharmaceutical regulatory authorities in Estonia, Latvia and Lithuania have all granted marketing authorizations for AirFluSal® Forspiro®, an innovative new inhaler for patients with asthma and/or chronic obstructive pulmonary disease (COPD).
The latest marketing authorizations 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 50-500µg dosage forms.
“We look forward to launching this important new product in the Baltics in the near future and making it available to a steadily growing number of people suffering from asthma and COPD,” said Jan-Torsten Tews, Sandoz’s Head of Global Respiratory. “This is an affordable and award winning new therapeutic option, developed in close collaboration with patients.”
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.
It was developed at Aeropharm GmbH in Rudolstadt, Germany, Sandoz’s global respiratory Center of Excellence. Sandoz collaborated with UK-based Vectura, a respiratory product development company, in the design and development. 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.
In order to improve patient experience with inhalation devices, Sandoz collaborated closely with patients during the development process. 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.
Sandoz, the generic pharmaceuticals division of Novartis, is a global leader in the generic pharmaceutical sector. Sandoz employs over 26,500 employees and its products are available in more than 160 countries, offering a broad range of high-quality, affordable products that are no longer protected by patents. With USD 9.2 billion in sales in 2013, Sandoz has a portfolio of approximately 1,100 molecules, and holds the #1 position globally in biosimilars as well as in generic injectables, ophthalmics, dermatology and antibiotics, complemented by leading positions in the cardiovascular, metabolism, central nervous system, pain, gastrointestinal, respiratory, and hormonal therapeutic areas. Sandoz develops, produces, and markets these medicines, as well as active pharmaceutical and biotechnological substances. Nearly half of Sandoz's portfolio is in differentiated products, which are defined as products that are more difficult to scientifically develop and manufacture than standard generics.
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, which include Lek (Slovenia), Sabex (Canada), Hexal (Germany), Eon Labs (US), EBEWE Pharma (Austria), Oriel Therapeutics (US), and Fougera Pharmaceuticals (US).