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GSK application for preliminary injunction withdrawn just before Cologne Court of appeals was to rule in the case

  • GlaxoSmithKline withdraws application for preliminary injunction on German marketing and distribution of Sandoz’s award-winning AirFluSal® Forspiro®
  • GSK application withdrawn shortly before Cologne Court of Appeals was due to rule in the case, restoring German patient access to AirFluSal
  • Sandoz continues to roll out its innovative and cost-effective respiratory inhaler, co-developed with patients, in Europe and beyond

Holzkirchen, June 16, 2014: Pharmaceutical company GlaxoSmithKline has withdrawn its application for a preliminary injunction on German marketing and distribution of Sandoz’s innovative and cost-effective respiratory inhaler, AirFluSal® Forspiro®, shortly before the Cologne Court of Appeals was due to rule in the case.

The withdrawal means that Sandoz is now free to sell, market and distribute AirFluSal Forspiro in Germany. The latest development also comes shortly after a ruling in Sandoz’s favor by a district court in Oslo (Norway), where GSK had also sought a preliminary injunction following the launch of the Sandoz product.

Jan-Torsten Tews, Sandoz’s Head of Global Respiratory, said: “We are pleased that GSK has withdrawn this application, as its arguments referred solely to the lilac color of our device. This is a big win for patients across Germany, who now have access to our innovative, award-winning inhaler. AirFluSal Forspiro has already been approved in eight European countries, as well as South Korea, showing that we can offer patients and payors what they are looking for – tried and trusted medicines combined with innovative devices that fully meet clinical requirements.”

Sandoz subsidiary Hexal received German marketing approval in January for AirFluSal Forspiro (50/500 micrograms/dose) for the treatment of asthma and chronic obstructive pulmonary disease (COPD). The Sandoz product combines the proven active substances salmeterol and fluticasone with an innovative new inhaler, which received the prestigious 2011 Red Dot Product Design Award from the Design Center of North-Rhine Westphalia. Patients were actively involved in the development process, with a view to optimizing device handling, control and ease of use.

AirFluSal Forspiro was developed by Aeropharm, a Hexal subsidiary based in Rudolstadt, Germany. This site is Sandoz’s global Center of Excellence for the development and production of differentiated respiratory therapies.

Disclaimer

This press release contains express or implied forward-looking statements, including statements that can be identified by terminology such as “continues,” “roll out,” “can,” “view,” or similar expressions. Such forward-looking statements reflect the current views of the Group regarding future events, and involve known and unknown risks, uncertainties and other factors that may cause actual results to be materially different from any future results expressed or implied by such statements. These expectations could be affected by, among other things, risks and factors referred to in the Risk Factors section of 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 it in the future.

About Sandoz

Sandoz, the generic pharmaceuticals division of Novartis, is a global leader in the generic pharmaceutical sector. Sandoz employs over 26,500 employees across 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).

For further information, contact:

Sandoz Global Communications:
Neil Moorhouse
+49 8024 476 2597
neil.moorhouse@sandoz.com

Chris Lewis
+49 8024 476 1906
chris.lewis@sandoz.com