Princeton, New Jersey, September 23, 2013 – Sandoz today announced the US launch of azacitidine for injection, an authorized generic version of Celgene’s VIDAZA®.
Azacitidine for injection is indicated to treat myelodysplastic syndrome (MDS), a bone marrow disease formerly known as pre-leukemia.1
“Sandoz is pleased to make this affordable, high-quality oncology product available to patients in the US,” said Peter Goldschmidt, President of Sandoz US. “With this launch, Sandoz further strengthens its position as the global leader in differentiated generic injectable products.”
Sandoz is marketing azacitidine for injection in 100mg single-use vials, the same strength as that of the brand product.
According to IMS Health, US sales for branded azacitidine for injection were USD 373 million for the 12 months ending in May 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 azacitidine for injection. 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 azacitidine for injection 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 azacitidine for injection; 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, 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 nearly 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.