Sandoz completes US offering of generic Lovenox® line with launch of enoxaparin sodium injection, USP vials
Princeton, New Jersey, April 25, 2012 – Sandoz today announced the introduction of enoxaparin sodium injection, USP 3 mL vials, a generic version of Sanofi's Lovenox® Injection Multiple-Dose Vials, in the US.
With the addition of 300mg/3mL vials, Sandoz now markets generic versions of the full Lovenox® product line.
Enoxaparin vials, developed in collaboration with Momenta Pharmaceuticals, Inc., are indicated for use in: prophylaxis of deep vein thrombosis (DVT) in abdominal surgery, hip replacement surgery, knee replacement surgery, or medical patients with severely restricted mobility during acute illness; inpatient treatment of acute DVT with or without pulmonary embolism; outpatient treatment of acute DVT without pulmonary embolism; prophylaxis of ischemic complications of unstable angina and non-Q-wave myocardial infarction [MI]; and treatment of acute ST-segment elevation myocardial infarction [STEMI] managed medically or with subsequent percutaneous coronary intervention [PCI].
"We are proud to complete our line of this important therapy and to further expand our portfolio of complex, high-quality generic injectable products," said Don DeGolyer, President of Sandoz Inc. "Sandoz made history in 2010 by launching the first generic Lovenox®, which has resulted in savings of several hundred million dollars for US patients and payors. Today's launch of an additional form of that product reinforces our commitment to increasing access to affordable treatment options."
Enoxaparin, a low molecular weight heparin (LMWH), is an anticoagulant that helps to prevent thrombosis. Thrombosis is the formation of a blood clot in the blood vessels in the absence of bleeding. Enoxaparin is made up of a complex blend of low molecular weight substances (oligosaccharides) derived from heparin, and therefore requires sophisticated analytical methods on the part of the manufacturer to ensure highly accurate and well-controlled manufacturing processes.
Sandoz has been marketing enoxaparin sodium injection, USP in the other seven syringe dosage forms since 2010. According to IMS Health, US sales for the branded version of enoxaparin sodium injection, USP 3 mL vials were approximately USD 27.8 million for the 12 months ending in January 2012, out of a total branded and generic market of USD 2.6 billion for enoxaparin sodium injection, USP.
Important Safety Information WARNING: SPINAL/EPIDURAL HEMATOMA Epidural or spinal hematomas may occur in patients who are anticoagulated with low molecular weight heparins (LMWH) or heparinoids and are receiving neuraxial anesthesia or undergoing spinal puncture. These hematomas may result in long-term or permanent paralysis. Consider these risks when scheduling patients for spinal procedures. Factors that can increase the risk of developing epidural or spinal hematomas in these patients include: • Use of indwelling epidural catheters • Concomitant use of other drugs that affect hemostasis, such as non-steroidal anti-inflammatory drugs (NSAIDs), platelet inhibitors, other anticoagulants • A history of traumatic or repeated epidural or spinal punctures • A history of spinal deformity or spinal surgery. Monitor patients frequently for signs and symptoms of neurological impairment. If neurological compromise is noted, urgent treatment is necessary. Consider the benefits and risks before neuraxial intervention in patients anticoagulated or to be anticoagulated for thromboprophylaxis.
CONTRAINDICATIONS • Enoxaparin sodium injection, USP is contraindicated in patients with active major bleeding; thrombocytopenia with a positive in vitro test for anti-platelet antibody in the presence of enoxaparin sodium; known hypersensitivity to enoxaparin sodium, heparin, pork products, or benzyl alcohol (multi-dose formulation only)
WARNINGS AND PRECAUTIONS • Increased risk of hemorrhage: Use with caution in patients at risk • Percutaneous coronary revascularization: Obtain hemostasis at the puncture site before sheath removal • Concomitant medical conditions: Use with caution in patients with bleeding diathesis, uncontrolled arterial hypertension or history of recent gastrointestinal ulceration, diabetic retinopathy, renal dysfunction, or hemorrhage • History of heparin-induced thrombocytopenia: Use with caution • Thrombocytopenia: Monitor thrombocytopenia closely • Interchangeability with other heparins: Do not exchange with heparin or other LMWHs • Pregnant women with mechanical prosthetic heart valves and their fetuses, may be at increased risk and may need more frequent monitoring and dosage adjustment ADVERSE REACTIONS • Most common adverse reactions (>1%) were bleeding, anemia, thrombocytopenia, elevation of serum aminotransferase, diarrhea, and nausea.
Please visit www.sandoz.com/index.shtml for complete full prescribing information, including boxed Warning. Disclaimer The foregoing release contains forward-looking statements that can be identified by terminology such as "introduces," "introduction," or similar expressions, or by express or implied discussions regarding potential future revenues from enoxaparin sodium 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 enoxaparin sodium 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 versions of enoxaparin sodium injection; 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 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 2011, Sandoz employed more than 24,000 people (full-time equivalents) worldwide and achieved net sales of USD 9.5 billion for the full year. * * * For further information Sandoz US Communications: Chris Lewis +1 609 627 5287