Princeton, New Jersey , July 02, 2013 – Sandoz today announced the US launch of metronidazole 1% topical gel, the first generic version of METROGEL® 1%.
Metronidazole 1% topical gel is indicated for the topical treatment of inflammatory lesions of rosacea1, a condition that affects an estimated 16 million Americans.2
“This significant launch further expands our offering of high-quality, affordable dermatology medicines,” said Peter Goldschmidt, President of Sandoz US. “As the US and global leader in generic topical medicines, Sandoz is proud to be the first company to market a generic version of this important treatment option to US patients.”
Sandoz is marketing metronidazole topical gel in the 1% strength, the same strength marketed for METROGEL® 1%.
According to IMS Health, US sales for branded metronidazole 1% topical gel were USD 110 million for the 12 months ending in April 2013.
The foregoing release contains forward-looking statements that can be identified by terminology such as “launches,” “launch,” or similar expressions, or by express or implied discussions regarding potential future revenues from metronidazole 1% topical gel. You should not place undue reliance on these statements. Such forward-looking statements reflect the current views of the Company 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, performance or achievements expressed or implied by such statements. There can be no guarantee that metronidazole 1% topical gel will achieve any particular levels of revenue in the future. In particular, management’s expectations could be affected by, among other things, unexpected regulatory actions or delays or government regulation generally, including potential FDA approval of additional generic versions of metronidazole 1% topical gel; unexpected product manufacturing difficulties; competition in general; government, industry and general public pricing pressures; unexpected patent litigation outcomes; the impact that the foregoing factors could have on the values attributed to the Novartis Group’s assets and liabilities as recorded in the Group’s consolidated balance sheet, and other risks and factors referred to in Novartis AG’s current Form 20-F on file with the US Securities and Exchange Commission. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those anticipated, believed, estimated or expected. 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.
Sandoz, a Division of the Novartis group, is the second-largest generic pharmaceuticals company globally, offering a broad range of about 1,000 high-quality, affordable products that are no longer protected by patents. With approximately 25,000 employees in 140 countries, Sandoz holds the #1 position globally in biosimilars as well as generic injectables, ophthalmics, dermatology, and antibiotics. 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.