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| Title | CoVIg-19 PLASMA ALLIANCE BUILDS STRONG MOMENTUM THROUGH EXPANDED MEMBERSHIP AND CLINICAL TRIAL COLLABORATION |
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| Date of registration | 2020-05-07 |
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| Contents | Rapidly expanding support for the Alliance is increasing donations of convalescent plasma to begin clinical production, while NIH collaboration confirms clinical trial approach Alliance urges anyone who has recovered from COVID-19 to consider donating today Alliance urges anyone who has recovered from COVID-19 to consider donating today Osaka, JAPAN, and King of Prussia, PA, USA - 7 May, 2020 - The CoVIg-19 Plasma Alliance, an unprecedented plasma industry collaboration recently established to accelerate the development of a plasma-derived hyperimmune globulin therapy for COVID-19, is rapidly building momentum. Its membership has expanded globally to include 10 plasma companies, and now also includes global organizations from outside the plasma industry who are providing vital support to encourage more people to donate plasma. In addition to those announced at its inception - Biotest, BPL, CSL Behring, LFB, Octapharma and Takeda - the Alliance welcomes new industry members ADMA Biologics, BioPharma Plasma, GC Pharma, and Sanquin. Together, these organizations will contribute specialist advisory expertise, technical guidance and/or in-kind support to contribute to the Alliance goal of accelerating development and distribution of a potential treatment option for COVID-19. In parallel, the Alliance has confirmed it will work with the National Institute of Allergy and Infectious Diseases (NIAID) at the NIH to test the safety, tolerability and efficacy of the hyperimmune therapy in adult patients with COVID-19. This global study is scheduled to start early summer. and will form the foundation for the potential regulatory approval of the hyperimmune therapy. “The hyperimmune has the potential to be one of the earliest treatment options for COVID-19 and we look forward to working with NIAID and health authorities to bring this therapy to patients as early as possible,” said Bill Mezzanotte, Executive Vice President, Head of R&D, CSL Behring and Co-leader of the CoVIg-19 Plasma Alliance. “One of the stated goals of the alliance is to be an effective partner for important institutions such as NIAID and also to develop coherent Regulatory strategies which give global health authorities the confidence to streamline the approval process of the hyperimmune.” Key to developing this potential hyperimmune globulin treatment is the collection of convalescent plasma. To amplify awareness, the Alliance has gained support from large organizations outside of the plasma industry. Examples of those offering resources to the Alliance include Microsoft and Uber Health. Microsoft is providing technology support, including the Alliance website and the Plasmabot for donor recruitment. The Plasmabot streamlines the process for a potential donor to quickly gain information about their nearest collection center from across the member network. In parallel, Uber Health has agreed to donate 25,000 round-trip rides to transport potentially eligible donors to and from plasma collection centers. These rides will be coordinated by the plasma collection center directly for individuals with confirmed appointments. “Partnership and collaboration are critical to the success of the CoVIg-19 program,” said Julie Kim, President of Plasma-Derived Therapies Business Unit, Takeda and co-leader of the CoVIg-19 Plasma Alliance. “We now have enough plasma to initiate clinical manufacturing, but more is needed to ensure both speed and scale. The growing and active involvement of leading companies from outside the plasma industry, who support this Alliance as well as convalescent plasma for transfusion initiatives - demonstrates the potential of convalescent plasma to fight this public health crisis. Together, we all share the same goal - to save lives by using the power of convalescent plasma in different ways.” The success of the CoVig-19 program depends heavily right now on the support of people across the world to donate convalescent plasma. We encourage those who have recovered from COVID-19 and who are interested in contributing to our development program - or to any other - by donating their plasma to visit the website for more information. About ADMA Biologics, Inc. (ADMA) ADMA Biologics (NASDAQ: ADMA) (“ADMA”), is an end-to-end commercial biopharmaceutical company dedicated to manufacturing, marketing and developing specialty plasma-derived biologics for the treatment of immunodeficient patients at risk for infection and others at risk for certain infectious diseases. ADMA currently manufactures and markets three United States Food and Drug Administration (FDA) approved plasma-derived biologics for the treatment of immune deficiencies and the prevention of certain infectious diseases: ASCENIV™ (immune globulin intravenous, human ? slra 10% liquid) for the treatment of primary humoral immunodeficiency (PI); BIVIGAM® (immune globulin intravenous, human) for the treatment of PI; and NABI-HB® (hepatitis B immune globulin, human) to provide enhanced immunity against the hepatitis B virus. ADMA manufactures its immune globulin products at its FDA-licensed plasma fractionation and purification facility located in Boca Raton, Florida. Through its ADMA BioCenters subsidiary, ADMA also operates as an FDA-approved source plasma collector in the U.S., which provides a portion of its blood plasma for the manufacture of its products. ADMA’s mission is to manufacture, market and develop specialty plasma-derived, human immune globulins targeted to niche patient populations for the treatment and prevention of certain infectious diseases and management of immune compromised patient populations who suffer from an underlying immune deficiency, or who may be immune compromised for other medical reasons. ADMA has received U.S. Patents: 9,107,906, 9,714,283, 9,815,886, 9,969,793 and 10,259,865 related to certain aspects of its products and product candidates. For more information, please visit www.admabiologics.com. About BioPharma Biopharma is a Ukrainian biopharmaceutical company, focused on the development and production of plasma-derived medicines . It is the only plant in Ukraine and neighboring countries that has the latest technology for manufacturing. The company was founded in 1896 and have been producing plasma-derived drugs for almost 50 years. Since 2019 Biopharma operates in a new R&D complex. The company focuses on the supply of albumins, immunoglobulins, coagulation factors to Ukraine and to over 30 countries worldwide. Also Biopharma develops national network of plasma centers. www.biopharma.ua About Biotest AG Biotest is a provider of plasma proteins and biological drugs. The corporate offices are located in Dreieich (near Frankfurt), Germany. With a value-added chain that extends from pre-clinical and clinical development to worldwide sales, Biotest has specialized primarily in the areas of clinical immunology, hematology and intensive care medicine. Biotest develops and markets immunoglobulins, coagulation factors and albumin based on human blood plasma. Biotest owns and operates 22 plasma donation centers across Europe in Germany, Hungary and Czech Republic. Biotest has more than 1,800 employees worldwide. The ordinary and preference shares of Biotest AG are listed in the Prime Standard on the German stock exchange. For more information visit http://www.biotest.com. About Bio Products Laboratory (BPL) Recognising the power of plasma and with over 60 years heritage in the industry, BPL supplies high-quality plasma derived medicines to meet the needs of clinicians, patients and customers globally. Headquartered in the United Kingdom and with plasma collection centres across the United States, we are dedicated to producing medicines for the treatment of immune deficiencies, bleeding disorders and infectious diseases as well for critical care. BPL invests in the latest R&D, technology and manufacturing methods, and continuously adapts to ensure that we continue to serve all our stakeholders effectively. For more information visit http://www.bplgroup.com. About CSL Behring CSL Behring is a global biotherapeutics leader driven by its promise to save lives. Focused on serving patients’ needs by using the latest technologies, we develop and deliver innovative therapies that are used to treat coagulation disorders, primary immune deficiencies, hereditary angioedema, inherited respiratory disease, and neurological disorders. The company’s products are also used in cardiac surgery, burn treatment and to prevent hemolytic disease of the newborn. CSL Behring operates one of the world’s largest plasma collection networks, CSL Plasma. The parent company, CSL Limited (ASX:CSL;USOTC:CSLLY), headquartered in Melbourne, Australia, employs more than 26,000 people, and delivers its life-saving therapies to people in more than 70 countries. For more information, visit www.cslbehring.com and for inspiring stories about the promise of biotechnology, visit Vita www.cslbehring.com/Vita. About GC Pharma GC Pharma (formerly known as Green Cross Corporation) is a biopharmaceutical company that delivers life-saving and life-sustaining protein therapeutics and vaccines. Headquartered in Yongin, South Korea, GC Pharma is one of the leading plasma protein product manufacturers in the world and has been dedicated to quality healthcare solutions for more than half a century. Green Cross Corporation updated its corporate brand to GC Pharma in early 2018. Green Cross Corporation remains the company's registered, legal name. About LFB LFB is a bio-pharmaceutical group that develops, manufactures and markets plasma derived products and recombinant proteins for the treatment of patients with serious and often rare diseases. LFB was founded in 1994 in France and is among the leading European bio-pharmaceutical companies providing mainly hospital-based healthcare professionals, with blood-derived therapeutics with the vision to provide treatment options to patients in three major areas: immunology, haemostasis, and intensive care. LFB currently markets 15 products in more than 30 countries. www.groupe-lfb.com About Octapharma Headquartered in Lachen, Switzerland, Octapharma is one of the largest human protein manufacturers in the world, developing and producing human proteins from human plasma and human cell lines. As a family-owned company, Octapharma believes in investing to make a difference in people’s lives and has been doing so since 1983; because it’s in our blood. At Octapharma, our passion drives us to provide new health solutions advancing human life. This is our vision. We thrive as an organisation in which people take ownership, have integrity, demonstrate grounded and confident leadership, drive sustainability, and are inspired by and eager to embrace entrepreneurship. We employ more than 9,300 people worldwide to support the treatment of patients in 118 countries with products across three therapeutic areas: Hematology; Immunotherapy and Critical care. Octapharma has seven R&D sites and six state-of-the-art manufacturing facilities in Austria, France, Germany, Mexico and Sweden, in addition to more than 140 plasma donation centres across Europe and the US. For more information visit: www.octapharma.com. About Sanquin Sanquin is responsible for the Dutch collection of both blood and plasma and consists of the Sanquin Blood Bank and its pharmaceutical entity, Sanquin Plasma Products. Through Sanquins efforts in combating SARS-COV-2, we have collected plasma donations from convalescent patients for both research purposes and the manufacturing of an anti-COVID-19 immunoglobulin. Adding to this, our research initiatives complete a spectrum of corona-related projects: from publishing the first large scale investigation on the prevalence of COVID-19 antibodies in Dutch donors up to supporting conclusive research on the effects of transfusion of hyper-immune plasma to patients. We are proud and eager to take part in the international endeavor to make anti-COVID-19 immunoglobulin available to a broad range of people in risk groups. About Takeda Pharmaceutical Company Limited Takeda Pharmaceutical Company Limited (TSE:4502/NYSE:TAK) is a global, values-based, R&D-driven biopharmaceutical leader headquartered in Japan, committed to bringing Better Health and a Brighter Future to patients by translating science into highly-innovative medicines. Takeda focuses its R&D efforts on four therapeutic areas: Oncology, Rare Diseases, Neuroscience, and Gastroenterology (GI). We also make targeted R&D investments in Plasma-Derived Therapies and Vaccines. We are focusing on developing highly innovative medicines that contribute to making a difference in people's lives by advancing the frontier of new treatment options and leveraging our enhanced collaborative R&D engine and capabilities to create a robust, modality-diverse pipeline. Our employees are committed to improving quality of life for patients and to working with our partners in health care in approximately 80 countries. For more information, visit www.takeda.com. This press release and any materials distributed in connection with this press release may contain forward-looking statements, beliefs or opinions regarding Takeda’s future business, future position and results of operations, including estimates, forecasts, targets and plans for Takeda. Without limitation, forward-looking statements often include words such as “targets”, “plans”, “believes”, “hopes”, “continues”, “expects”, “aims”, “intends”, “ensures”, “will”, “may”, “should”, “would”, “could” “anticipates”, “estimates”, “projects” or similar expressions or the negative thereof. Forward-looking statements in this document are based on Takeda’s estimates and assumptions only as of the date hereof. Such forward-looking statements do not represent any guarantee by Takeda or its management of future performance and involve known and unknown risks, uncertainties and other factors, including but not limited to: the economic circumstances surrounding Takeda’s global business, including general economic conditions in Japan and the United States; competitive pressures and developments; changes to applicable laws and regulations; the success of or failure of product development programs; decisions of regulatory authorities and the timing thereof; fluctuations in interest and currency exchange rates; claims or concerns regarding the safety or efficacy of marketed products or product candidates; the timing and impact of post-merger integration efforts with acquired companies; and the ability to divest assets that are not core to Takeda’s operations and the timing of any such divestment(s), any of which may cause Takeda’s actual results, performance, achievements or financial position to be materially different from any future results, performance, achievements or financial position expressed or implied by such forward-looking statements. For more information on these and other factors which may affect Takeda’s results, performance, achievements, or financial position, see “Item 3. Key Information?D. Risk Factors” in Takeda’s most recent Annual Report on Form 20-F and Takeda’s other reports filed with the U.S. Securities and Exchange Commission, available on Takeda’s website at: https://www.takeda.com/investors/reports/sec-filings/ or at www.sec.gov. Future results, performance, achievements or financial position of Takeda could differ materially from those expressed in or implied by the forward-looking statements. Persons receiving this press release should not rely unduly on any forward-looking statements. Takeda undertakes no obligation to update any of the forward-looking statements contained in this press release or any other forward-looking statements it may make, except as required by law or stock exchange rule. ### |
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