Copenhagen, January 20, 2014 - Sandoz announces that it is launching in Denmark today AirFluSal® Forspiro®, an innovative new inhaler for patients with asthma and/or chronic obstructive pulmonary disease (COPD).
The product was first approved in Denmark on December 18th, 2013 with subsequent marketing authorizations received earlier this week also in Germany and Sweden.
Today’s launch in Denmark follows the announcement on December 18 that Sandoz had received its first EU market authorization for AirFluSal® Forspiro® after the completion the EU regulatory process for nine 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.
Denmark has approved the 50-250 µg and 50-500 µg dosage forms 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 product’s safety, efficacy and equivalence have been proven in multiple clinical trials.1,2.
“The launch of AirFluSal® Forspiro® is a key element of our strategy to introduce differentiated generic medicines that address unmet needs for patients in Denmark,” said Rex Clements, Sandoz Country Head Nordics. “This innovative new respiratory device underscores Sandoz’s commitment to asthma and COPD patients in Denmark.”
"It is good news for both patients and public health care that we now have a new treatment option for Danish COPD and asthma patients", Professor Vibeke Backer, from the Department of Pulmonary Medicine, Bispebjerg Hospital, said.
More than 55,000 (2012 figures) Danish patients are currently being treated with the fixed combination of salmeterol and fluticasone propionate, according to the Danish Ministry of Health’s research institute, Statens Serum Institut.
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. The device features an innovative, patient-friendly design, including multiple feedback mechanisms:
Visual control features which help reassure the patient about dosing
Simple lever arm to load the dose
Clear and accurate dose counter
Besides Denmark, Sandoz has received marketing authorizations for a further three countries, including Germany, Sweden and Hungary.
About Sandoz Sandoz, the generic pharmaceuticals division of Novartis, is a global leader in the rapidly growing generics industry. Sandoz offers a broad range of about 1,100 high-quality, affordable products that are no longer protected by patents. With more than 26,000 employees in approximately 140 countries, Sandoz holds the #1 position globally in biosimilars, injectables, ophthalmics and dermatology as well as a strong global #5 position in inhalables. Key product groups include antibiotics, 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 and anti-infectives. In addition to strong organic growth in recent years, Sandoz has made a series of acquisitions including Lek (Slovenia), Sabex (Canada), Hexal (Germany), Eon Labs (US), EBEWE Pharma (Austria), Oriel Therapeutics (US), and Fougera Pharmaceuticals (US). In 2012, Sandoz posted sales of USD 8.7 billion.
1Kuna, I. Gath, U. Thyroff-Friesinger, S. Jones. Equivalence of fluticasone propionate/salmeterol delivered via new multi-dose dry powder inhaler and accuhaler™ in adolescent and adult asthma. Ajrccm conference.2013.187.1_MeetingAbstracts.A2611