Sandoz launches an authorized generic version of argatroban injection (aqueous solution for intravenous infusion)

Princeton, New Jersey, 5-3-2013 — /europawire.eu/ — Sandoz today announced the US launch of an authorized generic version of Eagle Pharmaceuticals’ ready-to-use argatroban injection 50 mg/50mL, aqueous solution (1 mg/mL).

Argatroban injection is indicated for prophylaxis or treatment of thrombosis in adult patients with heparin-induced thrombocytopenia. Argatroban is also indicated as an anticoagulant in adult patients with, or at risk of, heparin-induced thrombocytopenia while undergoing percutaneous coronary intervention.

“Argatroban injection provides healthcare professionals in institutional settings with an easy-to-use, cost-effective treatment alternative that requires less handling and that may result in less wasted product than the concentrate,” said Don DeGolyer, President of Sandoz US. “As the global leader in generic injectable products, Sandoz is proud to make this affordable, high-quality product available for patients in the US.”

Sandoz is marketing argatroban injection 50 mg/50mL, aqueous solution (1 mg/mL) in a package of ten 50 mg/50 mL single-use vials.  Sandoz also markets argatroban injection (in sodium chloride) in packages of two 125mg/125mL single-use vials.

Unlike the concentrate, both the Sandoz product and Eagle product are already diluted in sodium chloride and are ready-to-use.  The introduction of the 50mg/50mL vial can lead to increased cost savings as a result of lower wastage at hospitals.

According to IMS Health, US sales for concentrated and ready-to-use versions of argatroban injection were USD 98.7 million for calendar year 2012.
Disclaimer
The foregoing release contains forward-looking statements that can be identified by terminology such as “launches,” or similar expressions, or by express or implied discussions regarding potential future revenues from argatroban 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 argatroban 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 argatroban 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.

About Sandoz
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.

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For further information:

Sandoz US Communications
Chris Lewis
+1 609 627 5287; chris.lewis@sandoz.com

Sandoz Global Communications
Neil Moorhouse
+49 8024 476 2597; neil.moorhouse@sandoz.com