Ticagrelor

The BLA submission is grounded on the second interim analysis results of the Phase III REVERSE-IT trial. Credit: Michal Jarmoluk from Pixabay. The US Food and Drug Administration (FDA) has accepted the biologics licence application (BLA) of SFJ Pharmaceuticals and SERB Pharmaceuticals’ bentracimab for filing and priority review. A human monoclonal antibody fragment, bentracimab is being developed as a reversal agent for ticagrelor, a medication used to reduce the risk of stroke or heart attack. SFJ Pharmaceuticals, sponsor of the bentracimab BLA, has partnered with SERB Pharmaceuticals, which has acquired exclusive US rights to the asset. SERB Pharmaceuticals is set to commercialise bentracimab in the US market, subject to approval. The FDA decision on the approval of bentracimab is anticipated in the first quarter (Q1) of 2025. See Also: FDA approves J&J’s multiple myeloma therapy Pharmaceutical Technology Excellence Awards 2024: SecureCHEK AI The BLA submission for bentracimab is grounded on the second interim analysis results of the Phase III REVERSE-IT trial. The first interim analysis of this trial was published in 2021. SFJ president and CEO Dr Barbara White stated: “Bentracimab has the potential to be an important medical advance if approved as the first and only specific reversal agent for ticagrelor, a P2Y12 platelet inhibitor. “We are confident that the data from the planned second interim analysis will support approval of bentracimab under priority review of the BLA.” Bentracimab is designed to counteract the antiplatelet effects of ticagrelor and its active metabolite in situations where reversal is necessary, such as nondeferrable surgery or invasive procedures, or in cases of major bleeding. SERB Pharmaceuticals CEO Vanessa Wolfeler said: “This milestone of BLA filing brings us closer to delivering a breakthrough therapy for patients and marks an important step in the next stage of growth for SERB. “The approval of bentracimab would offer US hospitals a much-needed solution to reverse the antiplatelet effects of ticagrelor and rapidly restore platelet function when needed.” The product received breakthrough therapy designation from the FDA in 2019, which accelerates the development and review process for treatments that show potential for significant improvement over existing therapies.

PRINCETON, N.J., June 24, 2024 (GLOBE NEWSWIRE) -- CytoSorbents, Inc. (NASDAQ: CTSO), a leader in the treatment of life-threatening conditions in the intensive care unit and cardiac surgery using blood purification via its proprietary polymer adsorption technology, announces the regulatory approval of CytoSorb® in Taiwan by the Taiwan Food and Drug Administration (TFDA). The approved indications include the extracorporeal removal of cytokines (e.g. cytokine storm, sepsis), bilirubin (e.g. liver disease), and myoglobin (e.g. trauma) from a patient’s circulating blood. The removal of the antithrombotic drugs Brilinta® (ticagrelor, AstraZeneca) and Xarelto® (rivaroxaban, Janssen/Bayer) during cardiothoracic surgery is also approved, with the goal of reducing perioperative bleeding. CytoSorb will be distributed throughout Taiwan by Hemoscien Corporation. Ms. Bettina Sabisch, Vice President of International Distributor Sales at CytoSorbents stated, “We are thrilled to announce this milestone which underscores the value and efficacy of our CytoSorb therapy and was achieved after navigating a long and complex approval process. We look forward to collaborating with Hemoscien and leveraging their long-standing customer relationships in Taiwan to bring this innovative therapy to patients in need.” Mr. Tom Juan, Managing Director of Hemoscien Corporation emphasized, “There is an ongoing critical need for more effective therapies to combat infections and to prevent or treat organ failure. I firmly believe that advanced blood purification devices such as CytoSorb® can complement the limitations of traditional pharmaceuticals by restoring peripheral blood homeostasis and balance. Given the widespread and successful application of CytoSorb therapy in numerous countries to treat life-threatening critical illnesses, we are confident in our ability to take what has been learned and to market and support CytoSorb in Taiwan's ICU sectors through our deep critical care network to help save the lives of severely ill patients.” In addition to Taiwan, CytoSorb is approved in the European Union and distributed in 75 countries worldwide. It is an extracorporeal cytokine adsorber that reduces “cytokine storm” or “cytokine release syndrome” in common critical illnesses such as sepsis and septic shock, trauma, acute respiratory distress syndrome, burn injury, pancreatitis, and others that can lead to massive inflammation, organ failure and patient death. CytoSorb is also used as an extracorporeal liver support therapy in acute liver disease (e.g. acute on chronic liver failure, alcoholic hepatitis) and removes both liver toxins, such as bilirubin and bile acids, as well as cytokines. It is also used to treat rhabdomyolysis (e.g. trauma) and the removal of myoglobin. In these diseases, the risk of death can be extremely high, and there are few, if any, effective or practical treatments. CytoSorb is also used during and after cardiothoracic surgery to remove antithrombotic drugs and inflammatory mediators that can lead to postoperative complications, including severe bleeding and multiple organ failure. As of March 31, 2024, more than 237,000 CytoSorb devices have been used cumulatively around the world. Taiwan, with approximately 24 million inhabitants, offers universal coverage to its citizens through its National Health Insurance System and serves them through a network of nearly 400 medical centers and regional hospitals. With rising medical standards, use of advanced technology to increase administrative and provider efficiency, and access to high quality healthcare, Taiwan boasts one of the most progressive healthcare systems globally. Like many other parts of the world, critical illness including sepsis is a major problem in Taiwan. For example, there are 150,000 estimated new cases of sepsis reported each year in Taiwan with mortality rates as high as 30%, driven by diseases such as pneumonia, which is the third leading cause of death in Taiwan. About Hemoscien Corporation Hemoscien Corporation, a specialized hemo-epuration service provider, was established in 2008 as a spinoff from Smile Group Corp., originally founded in 1980. Since 1998, Hemoscien has maintained a strong partnership with Infomed S.A., a respected ICU hemo-therapy platform developer, achieving over 50% market share. The company is dedicated to its mission of addressing unmet medical needs in ICU care, as well as advancing regenerative medicine and other immune therapies. About CytoSorbents Corporation (NASDAQ: CTSO) CytoSorbents Corporation is a leader in the treatment of life-threatening conditions in the intensive care unit and in cardiac surgery through blood purification. CytoSorb, the Company’s flagship product, was originally launched in the European Union under CE mark as the first cytokine adsorber. In addition to the description in the text above, CytoSorb also received FDA Emergency Use Authorization in the United States for use in adult critically ill COVID-19 patients with impending or confirmed respiratory failure. CytoSorbents’ purification technologies are based on biocompatible, highly porous polymer beads that can actively remove toxic substances from blood and other bodily fluids by pore capture and surface adsorption. Its technologies have received non-dilutive grant, contract, and other funding of approximately $50 million from DARPA, the U.S. Department of Health and Human Services (HHS), the National Institutes of Health (NIH), National Heart, Lung, and Blood Institute (NHLBI), the U.S. Army, the U.S. Air Force, U.S. Special Operations Command (SOCOM), Air Force Material Command (USAF/AFMC), and others. The Company has numerous marketed products and products under development based upon this unique blood purification technology protected by many issued U.S. and international patents and registered trademarks, and multiple patent applications pending, including ECOS-300CY®, CytoSorb-XL™, HemoDefend-RBC™, HemoDefend-BGA™, VetResQ®, K+ontrol™, DrugSorb™, ContrastSorb, and others. For more information, please visit the Company’s websites at and or follow us on Facebook and X. Forward-Looking Statements This press release includes forward-looking statements intended to qualify for the safe harbor from liability established by the Private Securities Litigation Reform Act of 1995. These forward-looking statements include, but are not limited to, statements about our plans, objectives, future targets and outlooks for our business, statements about potential exposures resulting from our cash positions, representations and contentions, and are not historical facts and typically are identified by use of terms such as “may,” “should,” “could,” “expect,” “plan,” “anticipate,” “believe,” “estimate,” “predict,” “potential,” “continue” and similar words, although some forward-looking statements are expressed differently. You should be aware that the forward-looking statements in this press release represent management’s current judgment and expectations, but our actual results, events and performance could differ materially from those in the forward-looking statements. Factors which could cause or contribute to such differences include, but are not limited to, the risks discussed in our Annual Report on Form 10-K, filed with the SEC on March 14, 2024, as updated by the risks reported in our Quarterly Reports on Form 10-Q, and in the press releases and other communications to shareholders issued by us from time to time which attempt to advise interested parties of the risks and factors which may affect our business. We caution you not to place undue reliance upon any such forward-looking statements. We undertake no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise, other than as required under the Federal securities laws. Please Click to Follow Us on Facebook and X U.S. Company Contact: Kathleen Bloch, CFO 305 College Road East Princeton, NJ 08540 +1 (732) 398-5429 kbloch@cytosorbents.com Investor Relations Contact: Eric Ribner LifeSci Advisors, LLC 250 W 55th St, #3401 New York, NY 10019 +1 (646) 751-4363 ir@cytosorbents.com