Sandoz receives first approval for AirFluSal® Forspiro®
Novel inhaler approved for patients with asthma and COPD
Approval follows completion of EU decentralized procedure (DCP)
AirFluSal® Forspiro® strengthens Sandoz respiratory portfolio and reinforces company leadership in differentiated products
Munich, December 18, 2013 - Sandoz announced today that it has received Danish marketing authorization for AirFluSal® Forspiro®, an innovative new inhaler for patients with asthma and/or chronic obstructive pulmonary disease (COPD). The Danish approval follows the completion of EU decentralized procedures (DCP) for eight EU countries, including Denmark.
AirFluSal® Forspiro® offers the proven combination of salmeterol (a long-acting inhaled ß2-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 trials,. 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 key element of our strategy to introduce differentiated generic medicines," said Jeff George, Global Head of Sandoz. "This innovative new respiratory device underscores Novartis's commitment to asthma and COPD patients and further strengthens Sandoz' global leadership in differentiated products, which comprised 43 percent of our sales in 2012."
AirFluSal® Forspiro® was developed at Aeropharm GmbH in Rudolstadt, Germany, Sandoz' global respiratory Center of Excellence. Sandoz collaborated with UK-based Vectura, a respiratory product development company, in the design and development of the product. 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 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
 P Kuna, I Gath, U Thyroff-Friesinger, S Jones. Equivalence of an innovative multidose salmeterol/fluticasone dry powder inhaler vs comparator in paediatric asthma. Submitted ERS - Reference September 2013
 Sandoz data on file
This press release contains forward-looking statements that can be identified by terminology such as "strategy," "commitment," or similar terms, or by express or implied discussions regarding potential additional marketing approvals for AirFluSal Forspiro, or regarding potential future revenues from AirFluSal Forspiro. You should not place undue reliance on these statements. Such forward-looking statements are based on the current beliefs and expectations of management regarding future events, and are subject to significant known and unknown risks and uncertainties. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those set forth in the forward-looking statements. There can be no guarantee that AirFluSal Forspiro will be submitted or approved for sale in any additional markets, or at any particular time. Nor can there be any guarantee that AirFluSal Forspiro will receive regulatory approval or be commercially successful in the future. In particular, management's expectations regarding AirFluSal Forspiro could be affected by, among other things, the uncertainties inherent in research and development, including unexpected regulatory actions or delays or government regulation generally; unexpected clinical trial results and additional analysis of existing clinical data; general economic and industry conditions; global trends toward health care cost containment, including ongoing pricing pressures; unexpected manufacturing issues, and other risks and factors referred to in Novartis AG's current Form 20-F on file with the US Securities and Exchange Commission. Novartis is providing the information in this press release as of this date and does not undertake any obligation to update any forward-looking statements as a result of new information, future events or otherwise.
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).
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