Alpha1-proteinase inhibitor(Grifols SA)

- 4- and 5-gram ZEMAIRA® vials may reduce the number of vials necessary for reconstitution, thereby providing convenience and lowering package waste KING OF PRUSSIA, Pa., Jan. 2, 2024 /PRNewswire/ -- CSL Behring, a business unit of global biotechnology leader CSL, today announced the availability of 4- and 5-gram vial sizes for ZEMAIRA® [Alpha1-Proteinase Inhibitor (Human)]. Previously available only in a 1-gram vial, the 4- and 5-gram packaging is significant for the Alpha-1 community as it will streamline the preparation process for ZEMAIRA and reduce waste. ZEMAIRA dosing is weight-based, so a person weighing 183 pounds would require five 1-gram vials. With the 4- and 5-gram vial sizes, healthcare professionals will need to reconstitute fewer ZEMAIRA vials per dose for their patients with Alpha-1. Room temperature storage coupled with the larger vial sizes may also help streamline preparation and administration. "We have been providing ZEMAIRA to the Alpha-1 community for 20 years and are committed to listening and addressing unmet needs through our therapies and patient programs," said Shannen Silvestrini, Director, ZEMAIRA Marketing, CSL Behring. "With the larger vial sizes, we will continue to provide a safe and effective treatment option while potentially making it easier for healthcare professionals to prepare ZEMAIRA for their patients." Lowering the number of vials patients need also positively contributes to CSL's efforts to reduce waste in the supply chain and end-to-end production, which is an area of focus of the Environmental Pillar of CSL's Sustainability Strategy. For more information on ZEMAIRA, please visit . About Alpha1 Antitrypsin Deficiency Alpha1 Antitrypsin (AAT) Deficiency is a hereditary condition that can severely affect a patient's lung function. The condition is marked by a low level or absence of AAT, a natural protein that inhibits neutrophil elastase, thereby preventing destruction of lung tissue. Severe deficiency of AAT is associated with a strong tendency for the development of emphysema, a form of chronic obstructive pulmonary disease (COPD), and can significantly impact everyday life and life expectancy. About ZEMAIRA® ZEMAIRA is a highly purified form of AAT (human) currently approved in the US, Brazil, Mexico, and Puerto Rico, where it is indicated for chronic augmentation and maintenance therapy in adults with Alpha 1 Antitrypsin Deficiency and clinical evidence of emphysema. CSL Behring markets ZEMAIRA as Respreeza® in Europe. Important Safety Information (ISI) Alpha1-Proteinase Inhibitor (Human), ZEMAIRA® is indicated to raise the plasma level of alpha1-proteinase inhibitor (A1-PI) in patients with A1-PI deficiency and related emphysema. The effect of this raised level on the frequency of pulmonary exacerbations and the progression of emphysema have not been established in clinical trials. ZEMAIRA may not be suitable for everyone; for example, people with known hypersensitivity to components used to make ZEMAIRA, those with a history of anaphylaxis or severe systemic response to A1-PI products, and those with certain IgA deficiencies. If you think any of these may apply to you, ask your doctor. Early signs of hypersensitivity reactions to ZEMAIRA include hives, rash, tightness of the chest, unusual breathing difficulty, wheezing, and feeling faint. Immediately discontinue use and consult with physician if such symptoms occur. In clinical studies, the following adverse reactions were reported in at least 5% of subjects receiving ZEMAIRA: headache, sinusitis, upper respiratory infection, bronchitis, fatigue, increased cough, fever, injection-site bleeding, nasal symptoms, sore throat, and swelled blood vessels. Because ZEMAIRA is made from human blood, the risk of transmitting infectious agents, including viruses and, theoretically, the Creutzfeldt-Jakob disease (CJD) agent and its variant (vCJD), cannot be completely eliminated. Please see full prescribing information for ZEMAIRA. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit , or call 1-800-FDA-1088. You can also report side effects to CSL Behring's Pharmacovigilance Department at 1-866-915-6958. About CSL Behring CSL Behring is a global biotherapeutics leader driven by our promise to save lives. Focused on serving patients' needs by using the latest technologies, we discover, develop and deliver innovative therapies for people living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. We use three strategic scientific platforms of plasma fractionation, recombinant protein technology, and cell and gene therapy to support continued innovation and continually refine ways in which products can address unmet medical needs and help patients lead full lives. CSL Behring operates one of the world's largest plasma collection networks, CSL Plasma. Our parent company, CSL (ASX:CSL; USOTC:CSLLY), headquartered in Melbourne, Australia, employs 32,000 people, and delivers its lifesaving therapies to people in more than 100 countries. For inspiring stories about the promise of biotechnology, visit CSLBehring.com/Vita and follow us on Twitter.com/CSLBehring. Media Contact Etanjalie Ayala Mobile: +1 610 297 1069 Email: [email protected] SOURCE CSL Behring

Availability of GLASSIA® represents significant milestone for patients with emphysema due to severe hereditary deficiency of Alpha-1 antitrypsin TORONTO, Dec. 20, 2023 /CNW/ - Takeda Canada Inc. (Takeda) has entered into a contract with Canadian Blood Services (CBS) for GLASSIA® (alpha-1 proteinase inhibitor) resulting from CBS's request for proposal for hereditary deficiency of Alpha-1 Antitrypsin Deficiency (Alpha-1). Glassia has been approved to be listed on the CBS Plasma Protein and Related Products (PPRP) formulary with specific criteria for reimbursement. This marks Takeda's entry into the Alpha-1 community in Canada, building on the company's commitment to developing innovative treatments for rare diseases. "With its landmark decision, Canadian Blood Services will ensure that all Canadians suffering the pulmonary consequences of this genetic disorder will have access to the protective benefits of augmentation therapy," said Dr. Ken Chapman, Director, Asthma & Airway Centre, University Health Network, Professor of Medicine, University of Toronto. "As a physician who has cared for many patients with alpha1 antitrypsin deficiency, I'm reassured that I will now have the tools to slow the progression of emphysema and prevent disability for all of my patients, not just a fortunate few". "The availability of treatments for patients with Alpha-1 Antitrypsin Deficiency across Canada is tremendous and welcome news," said Angela Diano, Executive Director, Alpha-1 Canada. "This is a landmark moment because until now, Canadian patients have had limited options available to them, unless they lived in one of the few provinces where treatment was accessible. We look forward to working with CBS to ensure Canadian Alpha-1 patients have the information, resources, support and now treatment, they need." GLASSIA® is a liquid medicine for infusion containing human Alpha 1-Proteinase Inhibitor (A1-PI) also known as alpha-1 antitrypsin (A1AT), which is purified from human blood. The main purpose of infusing GLASSIA® is to increase the levels of the A1AT protein in the blood. Its main function is to protect the lung tissue by limiting the action of a certain enzyme, called neutrophil elastase. Neutrophil elastase can cause damage if its action is not controlled (for example, in case you have an A1-P1 deficiency).i "We are pleased to share this positive development to support Canadians living with Alpha-1 antitrypsin deficiency that will now have a treatment option in the form of GLASSIA®," said Rute Fernandes, President & General Manager, Takeda in Canada. "We're excited about this collaboration with CBS because of the positive impact it will have on the lives of patients living with Alpha-1 antitrypsin deficiency. At Takeda, we're proud of our commitment to developing innovative treatments for rare diseases and putting patients at the centre of everything we do." About GLASSIA Health Canada issued the marketing authorization (Notice of Compliance) for GLASSIA® in November 2021 for chronic augmentation and maintenance therapy in adults with clinically evident emphysema due to severe hereditary deficiency of Alpha-1 antitrypsin. GLASSIA® increases antigenic and functional (anti-neutrophil elastase capacity, ANEC) serum levels of Alpha-1 antitrypsin. GLASSIA® has shown to be equivalent in activity and similar in safety to another marketed alpha-1 antitrypsin augmentation therapy.i For a listing of contraindications, warnings, precautions, adverse reactions, interactions, dosing, and conditions of clinical use, the Canadian product monograph should be consulted at . About Alpha-1 Alpha-1 Antitrypsin Deficiency (AATD) is a genetic condition that affects approximately 1 in 5,000 Canadians & predisposes patients to liver disease & early onset emphysema. AATD can lead to lung disease such as chronic obstructive pulmonary disease (COPD), even in non-smokers. It increases the risk of liver cirrhosis & a skin condition called panniculitis. Low serum levels of Alpha-1 Antitrypsin indicate increased risk for developing the disease.ii About Takeda Canada Inc. Takeda Canada Inc. is the Canadian organization of Takeda Pharmaceutical Company Limited (TSE: 4502/NYSE: TAK), a global, values-based, R&D-driven biopharmaceutical leader headquartered in Japan, committed to discovering and delivering life-transforming treatments, guided by our commitment to patients, our people and the planet. Takeda focuses its R&D efforts on four therapeutic areas: Oncology, Rare Genetics and Hematology, 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 and regions. For more information, visit: takeda.com/en-ca SOURCE Takeda Canada Inc. Company Codes: NYSE:TAK, Toronto:4502