Immune globulin (GC Pharma)

ARLINGTON, Texas--( BUSINESS WIRE )-- AOM Infusion , a leading provider of specialty infusion therapy, announced today that it has been selected by GC Biopharma as a limited distribution partner for ALYGLO™, an FDA-approved immunoglobulin replacement therapy indicated for the treatment of primary humoral immunodeficiency (PI). ALYGLO™ uses a novel Cation Exchange Chromatography (CEX) process, which results in extra-purified IVIG. ALYGLO™ is indicated for the treatment of primary humoral immunodeficiency (PI) in adults aged 17 years and older. This includes but is not limited to, congenital agammaglobulinemia, common variable immunodeficiency (CVID), Wiskott-Aldrich syndrome, and severe combined immunodeficiencies. Patients treated with ALYGLO™ receive one infusion every three to four weeks administered by a nurse either at home or at an infusion center. GC Biopharma selected AOM Infusion as a partner because of its national reach and its expertise in specialized care for chronic conditions. AOM Infusion serves patients with over 80 different chronic conditions, with long-term treatment managed by clinical pharmacists and administered by skilled infusion nurses. The company also provides support services, including pharmacy services, referral management, insurance verification, and patient education and training. “We are proud to have AOM Infusion as part of our ALYGLO™ network of distribution partners,” says Woo Jin Lee, chief executive officer of GC Biopharma. “The AOM team’s commitment to superior patient care and focus on providing the best treatments aligns with our company’s mission and vision.” “We’re committed to providing care that enhances people’s lives,” says Karmen Stowe, AOM Vice President of Trade Relations & Supply Chain for AOM Infusion. “We’re honored GC Biopharma entrusts AOM to offer this high-purity IVIG therapy enabling us to provide our patients with another safe and effective treatment option.” For more information about ALYGLO™, visit: https://www.alyglo.com/ For more information about AOM Infusion, visit: https://aominfusionrx.com/ About GC Biopharma USA, Inc. GC Biopharma USA, Inc., headquartered in Teaneck, NJ, established its sales, marketing, and business operations in 2018 to serve customers and patients throughout the U.S. Our foundation is built on the expertise of our parent company, GC Biopharma’s, – a leading biopharmaceutical company delivering plasma therapies and vaccines worldwide. With GC Biopharma USA, Inc., GC Biopharma further extends its footprint, bringing its expertise and legacy to the United States. For more information, please visit www.GCBiopharma.us . About AOM Infusion AOM Infusion has been a leader in infusion care for 30 years, with a pharmacy license in all 50 states. The company specializes in the care of patients with chronic conditions who may require a more complex level of treatment, and has deep experience providing therapy for over 80 chronic conditions. AOM Infusion is focused on expanding its therapy solutions and investing in innovative platforms to deliver state-of-the-art care to more patients across the country. INDICATION ALYGLO™ is indicated for the treatment of primary humoral immunodeficiency (PI) in adults aged 17 years and older. This includes, but is not limited to, congenital agammaglobulinemia, common variable immunodeficiency (CVID), Wiskott-Aldrich syndrome, and severe combined immunodeficiencies. IMPORTANT SAFETY INFORMATION Thrombosis (blood clot formation) can happen with ALYGLO. Factors that increase this risk include advanced age, prolonged immobility, certain medical conditions, and cardiovascular risk factors. ALYGLO may affect the kidneys. In some cases, it can lead to acute renal failure or death. If you’re at risk for blood clots or kidney problems, your doctor should give you ALYGLO at the lowest effective dose and infusion rate. Staying well-hydrated before treatment is essential. ALYGLO is not suitable for people who have had severe allergic reactions to immune globulin or those with IgA deficiency and a history of hypersensitivity. If you experience any signs of hypersensitivity during the infusion, treatment should be stopped and epinephrine (an emergency medication) should be administered immediately. ALYGLO may cause hyperproteinemia, increased serum viscosity, and hyponatremia (low sodium levels). Aseptic Meningitis Syndrome (AMS) is a rare condition that can occur after receiving ALYGLO, especially with high doses or rapid infusion. Symptoms usually start within a few hours to 2 days after treatment. If AMS occurs, stopping ALYGLO usually leads to improvement within several days without lasting effects. Hemolysis, a breakdown of red blood cells, may occur. Some patients may experience delayed hemolytic anemia due to increased sequestration of red blood cells. Severe hemolysis-related kidney dysfunction or disseminated intravascular coagulation has been reported. Transfusion-Related Acute Lung Injury (TRALI) is a rare complication characterized by severe respiratory distress, pulmonary edema, and fever. Patients with TRALI may need oxygen therapy and ventilator support. ALYGLO is made from human blood, which may carry a risk of transmitting infectious agents (such as viruses). After receiving ALYGLO, some antibodies from the treatment may temporarily show up in blood tests. This could lead to misleading results, so your healthcare provider will consider this when interpreting lab results. Common side effects include headache, nausea/vomiting, fatigue, nasal/sinus congestion, rash, arthralgia, diarrhea, muscle pain/aches, infusion site pain/swelling, abdominal pain/discomfort, cough, and dizziness. For more information about ALYGLO, please see full Prescribing Information .

TEANECK, N.J., Sept. 9, 2024 /PRNewswire/ -- GC Biopharma USA, Inc. announced the launch and distribution of its immunoglobulin (IG) product ALYGLO (immune globulin intravenous, human-stwk), the company's first 10% intravenous immunoglobulin therapy for the treatment of adult patients aged 17 years and older with primary humoral immunodeficiency (PI). ALYGLO is a treatment option for patients with PI. This rare and chronic disorder occurs when the body's ability to produce antibodies is impaired, affecting the immune system's ability to fight infections. ALYGLO, an immune globulin formulation, has met the primary endpoints for both safety and efficacy as established by the FDA recommended guidelines in our Phase 3 clinical trials. Its novel manufacturing process may help improve patient safety by using Cation Exchange Chromatography (CEX) to remove coagulation factor XIa (FXIa) to undetectable levels. ALYGLO was approved by the U.S. Food and Drug Administration (FDA) on Dec. 15, 2023. Dr. Eun Chul Huh, President and CEO of GC Biopharma, said, "The US launch of ALYGLO by GC Biopharma USA is a historic milestone for the company and patients with primary immunodeficiency disease. It executes GC Biopharma's mission to improve the health and lives of individuals who suffer from rare and chronic diseases globally. GC Biopharma's commitment to the US further reflects its investment in R&D and a pipeline of future products to the US marketplace that will benefit patients and healthcare professionals." ALYGLO® is available to patients and healthcare professionals through a limited distribution network of top national Specialty Pharmacy providers. These partnerships provide a national footprint, delivering high-quality patient care for the primary immune deficiency population. ALYGLO is also available through specialty distributors throughout the United States. "ALYGLO expands patients' treatment options and improves access within the US marketplace," stated Dr. Lisa Betts, Chief Operating Officer for GC Biopharma USA, Inc. "GC Biopharma is committed to providing life-saving therapies to people with rare diseases. We are excited to offer the primary immune deficiency population another immune globulin therapeutic option." Please see Important Safety Information for ALYGLO on the following pages and refer to the full Prescribing Information (PI) or visit Alyglo.com For any medical or scientific questions regarding ALYGLO, call the GC Biopharma USA medical department at 1-833-426-6426. About ALYGLO ALYGLO is a liquid solution containing 10% immunoglobulin G (100 mg/mL) for intravenous infusion, manufactured from pooled human plasma from US donors. The manufacturing process includes multiple steps to reduce the risk of virus transmission. These include fractionation, solvent/detergent treatment, and nanofiltration. ALYGLO also uses its novel Cation Exchange Chromatography (CEX) in the manufacturing process for removing FXIa to undetectable levels. About Primary Humoral Immunodeficiency (PI) refers to a group of disorders where the body's ability to produce antibodies is impaired, affecting the immune system's ability to fight infections. In PI, there's a deficiency or absence of B cells or plasma cells, which are key in producing antibodies, particularly immunoglobulin G. This leads to increased susceptibility to infection, especially bacterial infections affecting the respiratory and gastrointestinal tracts. The PI indication for ALYGLO includes, but is not limited to, congenital agammaglobulinemia, common variable immunodeficiency (CVID), Wiskott-Aldrich syndrome, and severe combined immunodeficiencies. About GC Biopharma Corp. GC Biopharma Corp. (formerly known as Green Cross Corporation) is a biopharmaceutical company that delivers lifesaving and life-sustaining protein therapeutics and vaccines. Headquartered in Yongin, South Korea, GC Biopharma is a leading global plasma protein and vaccine product manufacturer dedicated to quality healthcare solutions for over half a century. About GC Biopharma USA, Inc. GC Biopharma USA, Inc., headquartered in Teaneck, NJ, established its sales, marketing, and business operations in 2018 to serve customers and patients throughout the US. Our foundation is built on the expertise of our parent company, GC Biopharma's, expertise—a leading biopharmaceutical company delivering plasma therapies and vaccines worldwide. With GC Biopharma USA, Inc., GC Biopharma further intends to extend its footprint, bringing its expertise and legacy to the United States. Forward-Looking Statements This press release may contain forward-looking statements that express the current beliefs and expectations of GC Biopharma USA management within the meaning of the Private Securities Litigation Reform Act of 1995. We intend such forward-looking statements to be covered by the safe harbor provisions for forward-looking statements contained in Section 27A of the Securities Act of 1933, as amended and Section 21E of the Securities Exchange Act of 1934, as amended. All statements contained in this press release other than statements of historical fact should be considered forward-looking statements and do not represent any guarantee by GC Biopharma USA or its management of future performance and involve known and unknown risks, uncertainties, and other factors. When used herein, words including "anticipate," "believe," "can," "continue," "could," "designed," "estimate," "expect," "forecast," "goal," "intend," "may," "might," "plan," "possible," "potential," "predict," "project," "should," "target," "will," "would" and similar expressions are intended to identify forward-looking statements, though not all forward-looking statements use these words or expressions. In addition, any statements or information that refer to expectations, beliefs, plans, projections, objectives, performance or other characterizations of future events or circumstances, including any underlying assumptions, are forward-looking. All forward-looking statements are based upon the Company's current expectations and various assumptions. The Company believes there is a reasonable basis for its expectations and beliefs, but they are inherently uncertain. The Company may not realize its expectations, and its beliefs may not prove correct. GC Biopharma USA undertakes no obligation to update or revise any forward-looking statement contained in this press release or any other forward-looking statements it may make, except as required by law or stock exchange rule. INDICATION ALYGLO™ is indicated for the treatment of primary humoral immunodeficiency (PI) in adults aged 17 years and older. This includes, but is not limited to, congenital agammaglobulinemia, common variable immunodeficiency (CVID), Wiskott-Aldrich syndrome, and severe combined immunodeficiencies. IMPORTANT SAFETY INFORMATION Contraindications: ALYGLO is contraindicated in patients who have a history of anaphylactic or severe systemic reaction to the administration of human immune globulin and in IgA-deficient patients with antibodies to IgA and a history of hypersensitivity. Hypersensitivity: In case of hypersensitivity, discontinue infusion immediately and institute appropriate treatment. Epinephrine should be available for immediate treatment of severe acute hypersensitivity reactions. Hyperproteinemia, Increased Serum Viscosity, and Hyponatremia: Hyperproteinemia, increased serum viscosity, and hyponatremia may occur. Aseptic Meningitis Syndrome (AMS): Aseptic meningitis syndrome (AMS) may occur, especially with high doses or rapid infusion. AMS usually begins within several hours to 2 days following ALYGLO treatment. Discontinuation of treatment has resulted in remission of AMS within several days without sequelae. Hemolysis: Delayed hemolytic anemia due to enhanced red blood cell (RBC) sequestration and acute hemolysis consistent with intravascular hemolysis have been reported. Cases of severe hemolysis-related renal dysfunction/failure or disseminated intravascular coagulation have occurred following infusion of IGIV. Closely monitor patients for clinical signs and symptoms of hemolysis, particularly patients with risk factors. Transfusion-Related Acute Lung Injury: Noncardiogenic pulmonary edema (transfusion-related acute lung injury [TRALI]) may occur. TRALI is characterized by severe respiratory distress, pulmonary edema, hypoxemia, normal left ventricular function, and fever. Patients with TRALI may be managed using oxygen therapy with adequate ventilator support. Monitor patients for pulmonary adverse reactions. Transmissible Infectious Agents: Because ALYGLO is made from human blood, it may carry a risk of transmitting infectious agents (eg, viruses, the variant Creutzfeldt-Jakob disease [vCJD] agent and, theoretically, the Creutzfeldt-Jakob disease [CJD] agent). Interference with Laboratory Tests: After infusion of immunoglobulin, the transitory rise of the various passively transferred antibodies in the patient's blood may yield positive serological testing results, with the potential for a misleading interpretation. Adverse reactions (observed in ≥ 5% of study subjects) were headache, nausea/vomiting, fatigue, nasal/sinus congestion, rash, arthralgia, diarrhea, muscle pain/aches, infusion site pain/swelling, abdominal pain/discomfort, cough, and dizziness. It is recommended that ALYGLO be administered separately from other drugs or medications. ©2024 GC Biopharma USA, Inc. All rights reserved. ALYGLO is a trademark of Green Cross Corporation. SOURCE GC Biopharma USA Inc.