Sandoz continues to build oncology injectables portfolio with US launch of docetaxel injection, a ready-to-use version of Taxotere®
Princeton, New Jersey, August 23, 2011 - Sandoz today announced US Food and Drug
Administration (FDA) approval and the US launch of docetaxel injection, a ready-to-use version of Taxotere® injection concentrate.
The market introduction of docetaxel injection in an easy-to-use single vial formulation represents the 11th oncology injectables launch for Sandoz in the US.
"We are pleased to add this leading, customer-friendly therapy to our growing portfolio of generic oncology injectables, a key component of Sandoz's leadership in differentiated products," said Don DeGolyer, President of Sandoz Inc. "This further broadens our high-quality product offering to key oncology customers and reinforces Sandoz's commitment to increasing patient access to essential medicines."
Docetaxel injection is intended to be used alone or in combination with other medications to treat certain types of breast and non-small cell lung cancers, and in combination with other medications to treat hormone refractory prostate cancer, gastric adenocarcinoma cancer, and squamous cell carcinoma of the head and neck.
According to IMS Health, US sales for branded and generic docetaxel injection products were approximately USD 1.1 billion for the 12 months ending in June 2011. Sandoz is marketing docetaxel injection, 20 mg/2mL, 80 mg/8 mL, and 160 mg/16mL in ready-to-use vials, a dosage form requiring less handling than the Taxotere® two vial formulation.
Important Safety Information
The incidence of treatment-related mortality associated with docetaxel injection is increased in patients with abnormal liver function, in patients receiving higher doses, and in patients with non-small cell lung carcinoma and a history of prior treatment with platinum-based chemotherapy who receive docetaxel injection as a single agent at a dose of 100 mg/m².
Docetaxel should not be given if bilirubin > ULN, or if AST and/or ALT > 1.5 × ULN concomitant with alkaline phosphatase > 2.5 × ULN. LFT elevations increase risk of severe or life-threatening complications. Obtain LFTs before each treatment cycle. Docetaxel should not be given if neutrophil counts are < 1500 cells/mm³.
Page 2 of 3
Severe hypersensitivity, including very rare fatal anaphylaxis, has been reported in patients who received dexamethasone premedication. Severe reactions require immediate discontinuation of docetaxel injection and administration of appropriate therapy.
Contraindicated if history of severe hypersensitivity reactions to docetaxel injection or to drugs formulated with polysorbate 80. Severe fluid retention may occur despite dexamethasone.
For full safety information, please see the Docetaxel Injection Prescribing Information, available in the product catalogue at www.us.sandoz.com.
The foregoing release contains forward-looking statements that can be identified by terminology such as "launch," "commitment," or similar expressions, or by express or implied discussions regarding potential future launches of oncology injectable products, or regarding potential future revenues from docetaxel injection (solution for intravenous infusion) or from such potential future products. 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 Sandoz will launch any additional oncology injectable products in the future. Nor can there be any guarantees that docetaxel injection (solution for intravenous infusion), or any such other potential products 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 versions of docetaxel injection (solution for intravenous infusion); 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 a global leader in the field of generic pharmaceuticals, offering a wide array of high-quality, affordable products that are no longer protected by valid and enforceable third-party patents. Sandoz has a portfolio of approximately 1000 compounds and sells its products in about 130 countries. Key product groups include cardiovascular medicines, anti-infectives, treatments for central nervous system and alimentary tract disorders, oncology and respiratory therapies, as well as medications for blood and blood forming organ disorders. Sandoz develops, produces and markets these medicines along with pharmaceutical and biotechnological active substances. 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), and Oriel Therapeutics (US). In 2010, Sandoz employed more than 23,000 people (full-time equivalents) worldwide and achieved net sales of USD 8.5 billion for the full year.
* * *
For further information
Sandoz US Communications:
+1 609 627 5287
Sandoz Global Communications:
+49 8024 476 2550
Taxotere® is a registered trademark of Sanofi.