Sandoz launches first generic high dose intravenous iron, Ferumoxytol Injection, to treat US patients with iron deficiency anemia

2021-07-16

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- Patients with iron deficiency anemia in a hospital or clinic setting now have access to an important IV iron medicine at a more affordable price - Iron deficiency anemia occurs when there is a lower than normal number of oxygen-carrying red blood cells because of too little iron1 - Immediate availability of Ferumoxytol Injection bolsters Sandoz portfolio and delivers another high-quality generic medicine to US patients [16-July-2021] PRINCETON, N.J., July 16, 2021 /PRNewswire/ -- Sandoz, a global leader in generic and biosimilar medicines, today announced the immediate US availability of generic Ferumoxytol, an intravenous medicine used to treat iron deficiency anemia (IDA). Ferumoxytol, a generic equivalent to AMAG Pharmaceuticals' Feraheme®* (ferumoxytol injection), is approved to treat IDA in adult patients who have an intolerance to oral iron or have had an unsatisfactory response to oral iron, or who have chronic kidney disease.2 The overall global IV iron market is over a one billion dollar market and continues to grow.3 "As the first generic high dose IV iron available in the US, Ferumoxytol provides patients with iron deficiency anemia a more cost-effective treatment option," said Keren Haruvi, President, Sandoz Inc. "This launch delivers on our strategy to continue to build our hospital and clinic portfolio and provide US patients access to affordable generic medicines that work as well as brand-name products." Sandoz initially plans to make its generic Ferumoxytol medicine available to patients in the hospital and clinic setting. Intravenous administration of iron has been shown to be more effective, more rapidly, than a prolonged course of oral iron therapy in patients with IDA.4 *Feraheme is a registered trademark of Covis Pharma GMBH Limited Liability Company. IMPORTANT SAFETY INFORMATION CONTRAINDICATIONS Ferumoxytol is contraindicated in patients with: Known hypersensitivity to ferumoxytol or any of its components History of allergic reaction to any intravenous iron product WARNINGS AND PRECAUTIONS Hypersensitivity Reactions: Observe for signs and symptoms of hypersensitivity for at least 30 minutes following the administration of Ferumoxytol. Hypotension: May cause hypotension. Monitor for signs and symptoms of hypotension following the administration of Ferumoxytol. Iron Overload: Regularly monitor hematologic responses during Ferumoxytol therapy. Do not administer Ferumoxytol to patients with iron overload. Magnetic Resonance Imaging: Ferumoxytol can alter magnetic resonance imaging (MRI) studies. ADVERSE REACTIONS The most common adverse reactions following the administration of Ferumoxytol are diarrhea, nausea, dizziness, hypotension, constipation, and peripheral edema. DRUG INTERACTIONS Drug-drug interaction studies with Ferumoxytol were not conducted. Ferumoxytol may reduce the absorption of concomitantly administered oral iron preparations. USE IN SPECIFIC POPULATIONS Pregnancy: There are no studies of Ferumoxytol in pregnant women. In animal studies, Ferumoxytol caused decreased fetal weights and fetal malformations at maternally toxic doses of 13-15 times the human dose. Use Ferumoxytol during pregnancy only if the potential benefit justifies the potential risk to the fetus. Nursing Mothers: It is not known whether Ferumoxytol is present in human milk. Because many drugs are excreted in human milk and because of the potential for adverse reactions in nursing infants, a decision should be made whether to discontinue nursing or to avoid Ferumoxytol, taking into account the importance of Ferumoxytol to the mother and the known benefits of nursing. Pediatric Use: The safety and effectiveness of Ferumoxytol in pediatric patients have not been established. Geriatric Use: In controlled clinical trials, 330 patients ≥ 65 years of age were treated with Ferumoxytol. No overall differences in safety and efficacy were observed between older and younger patients in these trials, but greater sensitivity of older individuals cannot be ruled out. In general, dose administration to an elderly patient should be cautious, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy. Please see full Prescribing Information for additional safety information. INDICATION Iron replacement product indicated for the treatment of iron deficiency anemia (IDA) in adult patients who have intolerance to oral iron or have had unsatisfactory response to oral iron or who have chronic kidney disease (CKD). Disclaimer This press release contains forward-looking statements within the meaning of the United States Private Securities Litigation Reform Act of 1995. Forward-looking statements can generally be identified by words such as "potential," "can," "will," "plan," "may," "could," "would," "expect," "anticipate," "look forward," "believe," "committed," "investigational," "pipeline," "launch," or similar terms, or by express or implied discussions regarding potential marketing approvals, new indications or labeling for the investigational or approved products described in this press release, or regarding potential future revenues from such products. You should not place undue reliance on these statements. Such forward-looking statements are based on our current beliefs and expectations regarding future events, and are subject to significant known and unknown risks and uncertainties. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those set forth in the forward-looking statements. There can be no guarantee that the investigational or approved products described in this press release will be submitted or approved for sale or for any additional indications or labeling in any market, or at any particular time. Neither can there be any guarantee that, if approved, such generic or biosimilar products will be approved for all indications included in the reference product's label. Nor can there be any guarantee that such products will be commercially successful in the future. In particular, our expectations regarding such products could be affected by, among other things, the uncertainties inherent in research and development, including clinical trial results and additional analysis of existing clinical data; regulatory actions or delays or government regulation generally; the particular prescribing preferences of physicians and patients; competition in general, including potential approval of additional generic or biosimilar versions of such products; global trends toward health care cost containment, including government, payor and general public pricing and reimbursement pressures and requirements for increased pricing transparency; litigation outcomes, including intellectual property disputes or other legal efforts to prevent or limit Sandoz from selling its products; general political, economic and business conditions, including the effects of and efforts to mitigate pandemic diseases such as COVID-19; safety, quality, data integrity or manufacturing issues; potential or actual data security and data privacy breaches, or disruptions of our information technology systems, and other risks and factors referred to in Novartis AG's current Form 20-F on the US Securities and Exchange Commission. 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 Novartis division, is a global leader in generic pharmaceuticals and biosimilars. Our purpose is to pioneer access for patients by developing and commercializing novel, affordable approaches that address unmet medical need. Our ambition is to be the world's leading and most valued generics company. Our broad portfolio of high-quality medicines, covering all major therapeutic areas, accounted for 2020 sales of USD 9.6 billion. Sandoz on social media LinkedIn: Twitter: Facebook: Instagram: CEO Richard Saynor on LinkedIn: References Johns Hopkins Medicine. Iron-Deficiency Anemia. Available at: . Accessed May 25, 2021. Ferumoxytol. Prescribing Information. Available at: . Accessed July 15, 2021. Grand View Research. Intravenous Iron Drug Market Size. Available at: . Accessed on May 25, 2021. Das SN, Devi A, Mohanta BB, Choudhury A, Swain A, Thatoi PK. Oral versus intravenous iron therapy in iron deficiency anemia: An observational study. J Family Med Prim Care. 2020;9(7):3619-3622. Published 2020 Jul 30. doi:10.4103/jfmpc.jfmpc_559_20

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