Sandoz launches a new, ready-to-use formulation of argatroban injection (in Sodium Chloride)
Princeton, New Jersey, May 10, 2011
Sandoz today announced the US launch of argatroban injection (in sodium chloride), the first ready-to-use alternative to Pfizer's concentrate formulation, following the US Food and Drug Administration (FDA) approval of the Sandoz New Drug Application.
Argatroban is indicated as an anticoagulant for the prophylaxis or treatment of thrombosis in patients with heparin-induced thrombocytopenia. Argatroban injection is also indicated as an anticoagulant in patients undergoing percutaneous coronary intervention (PCI) with, or who are at risk for, heparin-induced thrombocytopenia.
"Sandoz is pleased to be first to market with this ready-to-use formulation of argatroban injection," said Don DeGolyer, President of Sandoz Inc. "The launch of argatroban further expands and strengthens our injectables product line and differentiated products portfolio in the US."
According to IMS Health, US sales for Pfizer's Argatroban Injection were approximately USD 146 million for the 12 months ending in February 2011. Sandoz is marketing argatroban injection (in sodium chloride) in packages of two 125mg/125mL single-use vials.
The foregoing release contains forward-looking statements that can be identified by terminology such as "launch," "committed," "expects," or similar expressions, or by express or implied discussions regarding potential future approvals of additional oral contraceptive products, or regarding potential future revenues from Loryna or such other 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 any additional oral contraceptive products will be submitted or approved by Sandoz for sale. Nor can there be any guarantee that Loryna or any such other 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 YAZ®; unexpected product development 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.
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