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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.

Researchers reported Sunday that atrial fibrillation patients who received Bayer’s experimental anticoagulant were significantly more likely to experience a stroke or systemic embolism compared to those who got Eliquis. The company in November announced that it stopped its 14,810-person OCEANIC-AF study early due to asundexian’s inferior efficacy, a concerning result for what Bayer called a landmark clinical trial program. In the Phase 3 clinical trial, 98 patients who received asundexian had a stroke or systemic embolism compared to 26 in the control arm who got the anticoagulant Eliquis, also known as apixaban. That resulted in a hazard ratio of 3.79 — an outcome that no drug developer ever wants to see. Atrial fibrillation is a type of irregular and often fast heartbeat. People with atrial fibrillation take anticoagulants as a form of stroke prevention, but the currently marketed anticoagulants — direct-acting oral anticoagulants, or DOACs — come with a risk of bleeding. Bayer and other drug companies have now turned to a class of experimental treatments called factor XI inhibitors, which they hope could provide the same level of stroke and blood clot prevention without the bleeding risk. On the safety front, 17 patients experienced major bleeds on asundexian compared to 53 on Eliquis. Johnson & Johnson and Bristol Myers Squibb are developing a factor XI inhibitor called milvexian and have put together a similarly massive clinical trial program. Meanwhile, Novartis and Blackstone-backed Anthos Therapeutics are developing a once-monthly antibody treatment also targeted at factor XI. Both are in late-stage trials. The OCEANIC-AF trial results were shared at the European Society of Cardiology’s annual meeting and published in the New England Journal of Medicine . The co-authors of the NEJM study, led by Duke professor of medicine Jonathan Piccini, floated several possibilities as to why asundexian led to higher levels of stroke or blood clots compared to Eliquis. They started with the most straightforward explanation, writing that “it is possible that factor XIa inhibition with asundexian does not lead to effective stroke prevention as compared with apixaban in patients with atrial fibrillation.” The study authors also suggested that “escape mechanisms may play an important role, especially in patients with atrial fibrillation being transitioned from ongoing oral anticoagulation.” The basis for targeting factor XI comes from data that show people with natural factor XI deficiency may have a lower risk for stroke and blood clots. Another potential explanation was that the once-daily 50 mg of asundexian is not a high enough dose. In a Phase 2 trial, the 50 mg dose led to a 92% to 94% reduction in factor XI activity, but perhaps “complete or near complete (>99%) suppression of factor XIa may be required,” the researchers wrote. They concluded by adding that the incidence of stroke in the control arm was significantly lower than predicted or seen in the key trial behind Eliquis’ approval over a decade ago. “The findings of the OCEANIC-AF trial are probably attributable to a combination of these factors,” the study authors wrote. Bayer is running a separate Phase 3 study called OCEANIC-STROKE, but announced in November it is reevaluating plans for a third Phase 3 study called OCEANIC-AFINA.

Full results from the OCEANIC-AF study reveal the extent to which Bayer's oral factor XIa inhibitor asundexian fell short when put up against leading factor Xa inhibitor Eliquis (apixaban) in preventing strokes and systemic embolism in patients with atrial fibrillation (AF). The results were unveiled at the European Society of Cardiology (ESC) Congress on Sunday.The Phase III study was stopped prematurely last year on the advice of an independent data monitoring committee due to the "inferior efficacy" of asundexian, triggering a 20% share drop for Bayer when the announcement was made in November.Higher risk of stroke, embolismPreventing strokes in AF patients using with direct-acting oral anticoagulants often comes with a risk of bleeding. It was hoped that asundexian, which targets the XIa clotting factor, might reduce the risk of strokes while causing less bleeding.The OCEANIC-AF trial included 14,810 high-risk patients with AF randomised to receive asundexian at a dose of 50 mg once daily or standard-dose Eliquis. However, according to results detailed at the ESC conference and also simultaneously published in the NEJM, stroke or systemic embolism occurred in 98 patients (1.3%) receiving asundexian, compared to just 26 patients (0.4%) on Eliquis.Cardiovascular deaths happened in 48 (0.6%) patients taking asundexian and 44 (0.6%) of those in the Eliquis arm. Deaths from any cause were slightly lower with Bayer's drug, occurring in 60 (0.8%) patients from the asundexian group and 71 (1.0%) of those given Eliquis.Lower bleeding riskAlthough then drug did appear to less likely to cause major bleeding. Seventeen (0.2%) of patients taking asundexian experienced major bleeding in the trial, versus 53 (0.7%) who had been given Eliquis."Our results show that the dose of asundexian tested was inferior for stroke or systemic embolism compared with apixaban," stated principal investigator Manesh Patel. "We could speculate that near-total factor XIa suppression may be needed to prevent thrombus formation." Prior to the presentation, Jefferies analysts also suggested that the dose of asundexian used in the trial may have been too low to achieve the necessary levels of factor XIa inhibition.Researchers writing in the NEJM paper on OCEANIC-AF highlighted an earlier trial – PACIFIC-AF – in which asundexian at a dose of 50 mg once daily resulted in a 94% reduction in factor XI activity at peak concentrations. "However, to effectively prevent thrombus formation, complete or near complete (>99%) suppression of factor XIa may be required," the authors wrote.The failure of asundexian in the OCEANIC-AF trial was a significant setback for Bayer, with analysts having suggested previously that the AF indication represented around €4 billion ($4.4 billion) of the €5.5 billion ($6.1 billion) peak sales estimate for the drug. The late-stage programme also includes the OCEANIC-STROKE trial, which is testing asundexian for preventing stroke caused by a clot in people after an acute ischaemic stroke or high-risk transient ischaemic attack, a so-called mini stroke. The study is expected to wrap in October of next year.