CHICAGO--(BUSINESS WIRE)--Meitheal Pharmaceuticals, Inc. (“Meitheal”), a fully integrated generic injectables company today announced that the US Food and Drug Administration (FDA) has approved Enoxaparin Sodium Injection, USP, the generic equivalent of Lovenox®. Meitheal licenses Enoxaparin Sodium Injection exclusively through its partnership with Nanjing King-friend Biochemical Pharmaceutical Co., Ltd. (NKF), its majority shareholder. Enoxaparin had annual sales of approximately $616M in the United States, according to IQVIA data as of MAT (Moving Annual Total) October 2019.
“We are excited to be making such progress in our mission to bridge major gaps in healthcare by guaranteeing quality, affordable generic injectables that address an array of patient needs by offering a vertically integrated enoxaparin portfolio in the US,” said Tom Shea, Chief Executive Officer of Meitheal Pharmaceuticals. “Reflecting on this past year and looking ahead to 2020, we are pleased to have closed our investment transaction with NKF, launched our heparin product, and in total, 20 FDA-approved products covering anti-infective, anesthetic, oncolytic and intensive care. We have an expanding product portfolio as we prepare to launch enoxaparin and look forward to bringing other injectable products to market next year.”
Meitheal primarily specializes in the development, manufacture, procurement, and sale of generic injectable pharmaceuticals, with 20 FDA-approved products covering indications for anesthetic, anti-infective, oncolytic and intensive care. Furthermore, Meitheal has an expanding product portfolio and robust pipeline, including single and multi-dose vials and ready-to-use prefilled syringes. At the end of December 2019, Meitheal will have 39 products in the research and development phase, 19 products under review by the FDA, and 7 products planned to be launched in the first half 2020.
Enoxaparin Sodium Injection, USP is a low molecular weight heparin (LMWH) indicated for:
- 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)
- Treatment of acute ST-segment elevation myocardial infarction (STEMI) managed medically or with subsequent percutaneous coronary intervention (PCI)
IMPORTANT SAFETY INFORMATION
WARNING: SPINAL/EPIDURAL HEMATOMAS
See full prescribing information for complete boxed warning.
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:
Monitor patients frequently for signs and symptoms of neurological impairment. If neurological compromise is noted, urgent treatment is necessary.
Enoxaparin Sodium Injection, USP is contraindicated in patients with active major bleeding, history of heparin-induced thrombocytopenia (HIT) within the past 100 days or in the presence of circulating antibodies, hypersensitivity to enoxaparin sodium and hypersensitivity to heparin or pork products.
Warnings and Precautions:
- Increased Risk of Hemorrhage
- Increased Risk of Bleeding following Percutaneous Coronary Revascularization Procedures
- Increased Risk of Bleeding in Patients with Concomitant Medical Conditions
- Risk of Heparin-Induced Thrombocytopenia with or without Thrombosis
- Interchangeability with other Heparins
- Increased Risk of Thrombosis in Pregnant Women with Mechanical Prosthetic Heart Valves
Most common adverse reactions (>1%) were bleeding, anemia, thrombocytopenia, elevation of serum aminotransferase, diarrhea, nausea, ecchymosis, fever, edema, peripheral edema, dyspnea, confusion, and injection site pain.
For additional information, please see full Prescribing Information including boxed warning.
ABOUT MEITHEAL PHARMACEUTICALS
Since 2017, Meitheal Pharmaceuticals has bridged critical gaps in the US healthcare market by supplying high quality, affordable generic injectables. Our diversified product range — from antibiotics, anticoagulants, and muscle relaxants to drugs used in chemotherapy — represents practical solutions for countless patients around the country, as well as Meitheal’s commitment to their care. Based in Chicago, Illinois, our aim each day is producing quality and ensuring affordability, using the traditional Irish guiding principle we are named for — Meitheal (Mee·hall): working together toward a common goal, for the greater good.
Learn more about who we are and what we do at www.meithealpharma.com.
ABOUT NANJING KING-FRIEND BIOCHEMICAL PHARMACEUTICAL CO., LTD. (NKF)
NKF is a China-based company principally engaged in the research and development, production and sales of Active Pharmaceutical Ingredients (API) and Finished Dosage Form (FDF). Established in 1986 as one of world leading manufacturers of heparin related APIs, NKF has grown into a fully integrated API and FDF manufacturer in multiple therapeutic areas including critical care and oncology. With three US FDA approved manufacturing sites in China and more than 500 employees, including more than 100 dedicated research and development experts, NKF strives to meet patient needs globally with market presence at US, China, EU and South America. The Company is publicly listed on Shanghai Stock Exchange with a market capitalization over $4B.
*Lovenox® is a registered trademark of Sanofi-Aventis U.S. LLC