Meitheal Pharmaceuticals Announces FDA Approval of Additional Manufacturing Capacity and Future Facility Expansion Plans for Production of Heparin Sodium Injection, USP

New manufacturing line and future expansion plans will significantly increase production capacity of heparin, amidst global supply concerns

CHICAGO–(BUSINESS WIRE)–Meitheal Pharmaceuticals (“Meitheal”), a fully integrated generic injectables company today announced that the US Food and Drug Administration (FDA) has approved a new vial manufacturing line at majority shareholder, Nanjing King-Friend Biochemical Pharmaceutical Co., Ltd.’s (NKF), Nanjing, China facility and further announced plans to expand manufacturing capacity. This approval doubles Meitheal’s FDA-approved vial capacity to supply the US market with planned expansion expected to further increase Meitheal’s supply capacity.

“We are excited to bolster our manufacturing capacity to reliably and consistently provide a vital anticoagulant for patients in the US at a time when the global heparin market faces increasing manufacturing and supply concerns,” said Tom Shea, founding Chief Executive Officer of Meitheal Pharmaceuticals.

The new line and future expansion plans (10 total manufacturing lines) supports Meitheal’s majority shareholder, NKF’s commitment to ensuring capacity to supply the US market for years to come.

Nanjing, China Facility

• The new FDA-approved vial line will have 50 million units of new capacity, adding to NKF’s existing vial line, for a combined capacity to produce 100 million units.
• A second pre-filled syringe line which is in the process of being added will have 100 million units of new capacity supplementing NKF’s existing FDA approved pre-filled syringe line for a combined capacity to produce 200 million units.
• Construction of a second Nanjing, China facility, which is currently underway, will have 4 additional manufacturing lines.

Chengdu, China Facility

• 50 million units of new capacity will be added through a second vial line with products being submitted to the FDA for approval later this year, adding to NKF’s existing vial line, for a combined capacity to produce 100 million units.

Meitheal’s majority shareholder, NKF, is an FDA-approved manufacturer of both active pharmaceutical ingredients (API) and finished dosage form (FDF), supplying 15-20% of the API heparin market worldwide. Meitheal is NKF’s exclusive commercialization arm for the US market, ensuring consistent and dedicated supply of heparin.

Heparin is an intravenous or subcutaneous anticoagulant derived from porcine intestinal mucosa used to decrease the clotting ability of blood and help prevent harmful clots from forming in blood vessels. It is indicated for:

• Prophylaxis and treatment of venous thrombosis and pulmonary embolism.
• Prevention of postoperative deep venous thrombosis and pulmonary embolism in patients undergoing major abdominothoracic surgery or who, for other reasons, are at risk of developing thromboembolic disease.
• Atrial fibrillation with embolization.
• Treatment of acute and chronic consumptive coagulopathies (disseminated intravascular coagulation).
• Prevention of clotting in arterial and cardiac surgery.
• Prophylaxis and treatment of peripheral arterial embolism.
• Use as an anticoagulant in blood transfusions, extracorporeal circulation, and dialysis procedures.

IMPORTANT SAFETY INFORMATION

Heparin Sodium Injection, USP is contraindicated in patients with history of Heparin-Induced Thrombocytopenia (HIT) and Heparin-Induced Thrombocytopenia and Thrombosis (HITT), known hypersensitivity to heparin or pork products (e.g., anaphylactoid reactions), those whom suitable blood coagulation tests, e.g., the whole blood clotting time, partial thromboplastin time, etc., cannot be performed at appropriate intervals, and patients with uncontrolled active bleeding state, except when this is due to disseminated intravascular coagulation.

Fatal Medication Errors: Do not use Heparin Sodium Injection as a “catheter lock flush” product. Heparin Sodium Injection is supplied in vials containing various strengths of heparin, including vials that contain a highly concentrated solution of 10,000 units in 1 mL. Fatal hemorrhages have occurred in pediatric patients due to medication errors in which 1 mL Heparin Sodium Injection vials were confused with 1 mL “catheter lock flush” vials. Carefully examine all Heparin Sodium Injection vials to confirm the correct vial choice prior to administration of the drug.

Hemorrhage: Avoid using heparin in the presence of major bleeding, except when the benefits of heparin therapy outweigh the potential risks.

Heparin-Induced Thrombocytopenia and Heparin-Induced Thrombocytopenia and Thrombosis: Heparin-induced thrombocytopenia (HIT) is a serious antibody-mediated reaction. HIT occurs in patients treated with heparin and is due to the development of antibodies to a platelet Factor 4-heparin complex that induce in vivo platelet aggregation. HIT may progress to the development of venous and arterial thromboses, a condition referred to as heparin-induced thrombocytopenia with thrombosis (HITT).

Thrombocytopenia: Thrombocytopenia in patients receiving heparin has been reported at frequencies up to 30%. It can occur 2 to 20 days (average 5 to 9) following the onset of heparin therapy. Obtain platelet counts before and periodically during heparin therapy. Monitor thrombocytopenia of any degree closely. If the count falls below 100,000/mm3 or if recurrent thrombosis develops, promptly discontinue heparin, evaluate for HIT and HITT, and, if necessary, administer an alternative anticoagulant.

Coagulation Testing and Monitoring: When using a full dose heparin regimen, adjust the heparin dose based on frequent blood coagulation tests. If the coagulation test is unduly prolonged or if hemorrhage occurs, discontinue heparin promptly [see Overdosage (10)]. Periodic platelet counts and hematocrits are recommended during the entire course of heparin therapy, regardless of the route of administration.

Heparin Resistance: Resistance to heparin is frequently encountered in fever, thrombosis, thrombophlebitis, infections with thrombosing tendencies, myocardial infarction, cancer, in postsurgical patients, and patients with antithrombin III deficiency. Close monitoring of coagulation tests is recommended in these cases. Adjustment of heparin doses based on anti-Factor Xa levels may be warranted.

Hypersensitivity Reactions: Patients with documented hypersensitivity to heparin should be given the drug only in clearly life- threatening situations. Because Heparin Sodium Injection is derived from animal tissue, it should be used with caution in patients with a history of allergy.

Benzyl Alcohol Toxicity: Use preservative-free heparin sodium in neonates and infants. The preservative benzyl alcohol has been associated with serious adverse events and death in pediatric patients. The minimum amount of benzyl alcohol at which toxicity may occur is not known. Premature and low-birth weight infants may be more likely to develop toxicity.

Most common adverse reactions are hemorrhage, thrombocytopenia, HIT and HITT, hypersensitivity reactions, and elevations of aminotransferase levels.

For additional information, please see full Prescribing Information.

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)

Nanjing King-Friend Biochemical Pharmaceutical Co., Ltd. (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.

Contacts

Camilla White

FTI Consulting

646 250 0050

[email protected]