Princeton, New Jersey, July 14, 2014 - Sandoz today announced the US market introduction of tobramycin inhalation solution, USP, an authorized generic version of TOBI®, currently marketed by Novartis Pharmaceuticals Corporation1.
Tobramycin inhalation solution, USP is indicated for the management of cystic fibrosis patients whose lungs contain bacteria called P. aeruginosa.
Cystic fibrosis is a life-threatening genetic disease that primarily affects the lungs and digestive system. An estimated 30,000 children and adults in the United States (70,000 worldwide) have cystic fibrosis2.
"We are proud to bring the authorized generic of TOBI® to the patients with cystic fibrosis,” said Peter Goldschmidt, President of Sandoz US. “As part of the Novartis Group, we work together to increase patient access to leading treatments in the most efficient and effective way possible.”
According to IMS Health, aggregate US sales for the branded version of tobramycin inhalation solution, USP were approximately USD 241 million for the twelve months ending in April 2014. Sandoz is marketing tobramycin inhalation solution, USP in 300mg/5mL single-dose ampules, the same size and strength that is currently marketed by the brand.
Today, Sandoz announced that the European Generic medicines Association (EGA) has reelected Dr. Joerg Windisch, Chief Science Officer at Sandoz, as chair of its European Biosimilars Group (EBG).
The foregoing release contains forward-looking statements that can be identified by words such as “launches,” “introduction,” “launch,” “will,” or similar terms, or by express or implied discussions regarding potential future product approvals, or regarding potential revenues from tobramycin inhalation solution, USP or any potential future products. 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 any potential new products will receive regulatory approval in the future, or that tobramycin inhalation solution, USP or any such potential new products will be commercially successful in the future. In particular, management’s expectations could be affected by, among other things, unexpected regulatory actions or delays or government regulation generally; competition in general, including potential approval of additional versions of tobramycin inhalation solution, USP; government, industry and general public pricing pressures; unexpected patent litigation outcomes; unexpected manufacturing issues; general economic and industry conditions, 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 contained in this press release as a result of new information, future events or otherwise.
1TOBI® is a registered trademark of Novartis AG.
2Cystic Fibrosis Foundation. "About CF". 1 May 2014. Accessed 26 June 2014 from http://www.cff.org/.