alexion pharmaceuticals presentation

Corporate Overview - October 2019 1.1 MB. Serious allergic reactions can happen during the SOLIRIS infusion. An Interim Analysis of A Phase 2 Study Evaluating The Efficacy, Safety, and Pharmacokinetics of Intravenous Ravulizumab 100 mg/mL Formulation in Patients with Paroxysmal Nocturnal Hemoglobinuria. If you have not been vaccinated and SOLIRIS therapy must be initiated immediately, you should also receive two weeks of antibiotics with your vaccinations. To learn more about the regulatory status of SOLIRIS in the countries that we serve, please visit www.alexion.com. Alexion delivers therapies for people living with rare and devastating diseases. About Atypical Hemolytic Uremic Syndrome (aHUS). ULTOMIRIS 100 mg/mL is an advanced formulation of ULTOMIRIS 10 mg/mL that reduces average annual infusion time for patients with aHUS and PNH by approximately 60 percent (to approximately 45 minutes for adults in the average weight cohort). In many countries around the world, SOLIRIS is approved to treat paroxysmal nocturnal hemoglobinuria (PNH), atypical hemolytic uremic syndrome (aHUS), adults with generalized myasthenia gravis (gMG) who are acetylcholine receptor (AchR) antibody positive and/or adults with neuromyelitis optica spectrum disorder (NMOSD) who are anti-aquaporin-4 (AQP4) antibody positive. Symptoms or problems that can happen due to red blood cell breakdown include: a drop in red blood cell count, tiredness, blood in the urine, stomach-area (abdomen) pain, shortness of breath, blood clots, trouble swallowing, and erectile dysfunction (ED) in males. It is not known if ULTOMIRIS or SOLIRIS will harm an unborn baby or if these medicines pass into the breast milk. Presentations. Head of Investor Relations, We use cookies to give you the best online experience. Symptoms or problems that can happen with abnormal clotting may include: stroke, confusion, seizure, chest pain (angina), difficulty breathing, kidney problems, swelling in arms or legs, and a drop in your platelet count. IMPORTANT SAFETY INFORMATION BOSTON--(BUSINESS WIRE)--Nov. 4, 2020-- Alexion Pharmaceuticals, Inc. (NASDAQ:ALXN) today announced that six abstracts have been accepted for presentation at the 62 nd Annual Meeting and Exposition of the American Society of Hematology (ASH), taking place virtually from December 5 to 8, 2020. Alexion Pharmaceuticals, Inc. 2020 Q3 - Results - Earnings Call Presentation Oct. 29, 2020 10:02 AM ET Alexion Pharmaceuticals, Inc. (ALXN) 2 Likes SA Transcripts adults and children 1 month of age and older with a disease called atypical Hemolytic Uremic Syndrome (aHUS). aHUS occurs when the complement system—a part of the body’s immune system—over-responds, leading the body to attack its own healthy cells. Meningococcal infections may quickly become life-threatening and cause death if not recognized and treated early. BOSTON--(BUSINESS WIRE)--Jan. 30, 2020-- Alexion Pharmaceuticals, Inc. (NASDAQ:ALXN) today announced financial results for the fourth quarter and full year of 2019. This card must be carried at all times during treatment and for 8 months after the last ULTOMIRIS dose or 3 months after the last SOLIRIS dose. The most common side effects of ULTOMIRIS in people treated for PNH are upper respiratory infection and headache. aHUS can cause sudden organ failure or a slow loss of function over time—potentially resulting in the need for a transplant, and in some cases, death. Call your doctor right away if you miss an ULTOMIRIS infusion or for medical advice about side effects. The most common side effects in people with PNH treated with SOLIRIS include: headache, pain or swelling of the nose or throat (nasopharyngitis), back pain, and nausea. PNH occurs when the complement system—a part of the body’s immune system—over-responds, leading the body to attack its own red blood cells. Stopping treatment with SOLIRIS may cause breakdown of your red blood cells due to PNH. The most common side effects of ULTOMIRIS in people with aHUS are upper respiratory infection, diarrhea, nausea, vomiting, headache, high blood pressure and fever. About SOLIRIS® (eculizumab) Abstract ID #1686 – poster presentation, Dec. 6, 2020, 7:00 a.m. – 3:30 p.m. Pacific Time. 4, 2021-- Alexion Pharmaceuticals, Inc. (NASDAQ:ALXN) today announced that three abstracts have been accepted for presentation at the 73 rd annual meeting of the American Academy of Neurology (AAN), taking place virtually from April 17 through April 22, 2021. SOLIRIS is not for use in treating people with Shiga toxin E. coli related hemolytic uremic syndrome (STEC-HUS). For patients with PNH, the doctor will need to monitor the patient closely for at least 16 weeks after stopping ULTOMIRIS or 8 weeks after stopping SOLIRIS. In addition, SOLIRIS is used to treat adults with a disease called generalized myasthenia gravis (gMG) who are anti-acetylcholine receptor (AChR) antibody positive. The most common side effects in people with NMOSD treated with SOLIRIS include: common cold (upper respiratory infection), pain or swelling of your nose or throat (nasopharyngitis), diarrhea, back pain, dizziness, flu like symptoms (influenza) including fever, headache, tiredness, cough, sore throat, and body aches, join pain (arthralgia), throat irritation (pharyngitis), and bruising (contusion). Alexion Pharmaceuticals is expecting the drug to be one of the company’s 3 … Alexion Pharmaceuticals, Inc. (NASDAQ:ALXN) today announced that five abstracts have been accepted for presentation at the 25th Congress of … © 2021 Alexion Pharmaceuticals, Inc. https://www.businesswire.com/news/home/20200514005533/en/. Abstract ID #756 poster presentation, Dec. 5, 2020, 7:00 a.m. – 3:30 p.m. Pacific Time. Initiation of a Phase 1 study in adults with HPP is planned for the second quarter of 2021. ULTOMIRIS and SOLIRIS are medicines that affect the immune system. View Presentation 3.3 MB. These are not all the possible side effects of ULTOMIRIS or SOLIRIS. In the U.S., ULTOMIRIS is available in two formulations with the same mechanism of action and consistent safety and efficacy. Make sure your child receives vaccinations against Streptococcus pneumoniae and Haemophilis influenzae type b (Hib) if treated with ULTOMIRIS. - Accepted abstracts include interim Phase 2 extension data demonstrating reduced duration of infusion with ULTOMIRIS® (ravulizumab-cwvz) 100 mg/mL formulation -, - Data from five abstracts demonstrate Alexion’s continued commitment to advancing the understanding of PNH with ongoing real-world studies and emerging clinical data -. Efficacy and Safety of Concomitant Use of Ravulizumab and IST in Patients with Paroxysmal Nocturnal Hemoglobinuria up to 52 Weeks. E-poster presentation, abstract ID#: EP855. adults with a disease called generalized myasthenia gravis (gMG) who are anti-acetylcholine receptor (AChR) antibody positive. It is important that you have all recommended vaccinations before you start SOLIRIS, receive 2 weeks of antibiotics if you immediately start SOLIRIS, and stay up-to-date with all recommended vaccinations during treatment with SOLIRIS. See who Alexion Pharmaceuticals, Inc. has hired for this role. These are not all the possible side effects of SOLIRIS. The prognosis of aHUS can be poor in many cases, so a timely and accurate diagnosis—in addition to treatment—is critical to improving patient outcomes. aHUS affects both adults and children, and many patients present in critical condition, often requiring supportive care, including dialysis, in an intensive care unit. Your doctor will give you a Patient Safety Card about the risk of meningococcal infection. ULTOMIRIS is approved in the United States (U.S.), European Union (EU) and Japan as a treatment for adults with paroxysmal nocturnal hemoglobinuria (PNH). ... Alexion Pharmaceuticals, Inc. First Quarter 2020 Results. This website is intended only for residents of the United States. Tell your doctor about any side effect that bothers you or that does not go away. Please see the accompanying full Prescribing Information and Medication Guide for ULTOMIRIS, including Boxed WARNING regarding serious and life-threatening meningococcal infections/sepsis. PNH often goes unrecognized, with delays in diagnosis from one to more than five years. ULTOMIRIS can cause serious side effects including infusion reactions. The most common side effects in people with PNH treated with SOLIRIS include: headache, pain or swelling of your nose or throat (nasopharyngitis), back pain, and nausea. BOSTON--(BUSINESS WIRE)--Mar. When activated in an uncontrolled manner, the terminal complement cascade over-responds, leading the body to attack its own healthy cells. Certain people may be at risk of serious infections with gonorrhea. The most devastating consequence of chronic hemolysis is the formation of blood clots, which can occur in blood vessels throughout the body, damage vital organs, and potentially lead to premature death. Alexion focuses its research efforts on novel molecules and targets in the complement cascade and its development efforts on the core therapeutic areas of hematology, nephrology, neurology, metabolic disorders and cardiology. Meningococcal vaccines reduce but do not prevent all meningococcal infections. Meningococcal vaccines reduce the risk of meningococcal infection but do not prevent all meningococcal infections. Able to communicate the scientific "story" within Alexion and at external meetings and conferences. You may report side effects to FDA at 1-800-FDA-1088. Documents; Add Files. Call your doctor or get emergency medical care right away if you get any of these signs and symptoms of a meningococcal infection: headache with nausea or vomiting, headache and fever, headache with a stiff neck or stiff back, fever, fever and a rash, confusion, muscle aches with flu-like symptoms and eyes sensitive to light. Call your doctor right away if you have any new signs or symptoms of infection. Symptoms or problems that can happen with TMA may include: confusion or loss of consciousness, seizures, chest pain (angina), difficulty breathing and blood clots or stroke. Your doctor will decide if you need additional vaccination. Apply on company website Save. Abstract ID #2457– poster presentation, Dec. 6, 2020, 7:00 a.m. – 3:30 p.m. Pacific Time. You are encouraged to report negative side effects of prescription drugs to the FDA. Head of Investor Relations, We use cookies to give you the best online experience. Call your doctor or get emergency medical care right away if you get any of these signs and symptoms of a meningococcal infection: headache with nausea or vomiting, headache and fever, headache with a stiff neck or stiff back, fever, fever and a rash, confusion, muscle aches with flu-like symptoms, and eyes sensitive to light. The following slide deck was published by Alexion Pharmaceuticals, Inc. These are not all the possible side effects of ULTOMIRIS. If you have aHUS, your doctor will need to monitor you closely for at least 12 months after stopping treatment for signs of worsening aHUS or problems related to a type of abnormal clotting and breakdown of your red blood cells called thrombotic microangiopathy (TMA). e-poster presentation, abstract ID#: EP862. During the meeting, results will be presented from an interim analysis of the Phase 2 ULTOMIRIS® (ravulizumab-cwvz) 100 mg/mL formulation open-label study extension period. Patients should tell their doctor or nurse right away if they develop these symptoms, or any other symptoms during their ULTOMIRIS infusion that may mean they are having a serious infusion reaction, including: chest pain, trouble breathing or shortness of breath, swelling of the face, tongue, or throat, and feel faint or pass out. Risk Factors for Thrombotic Events in Patients with PNH: A Nested Case-Control Study in the International PNH Registry. ULTOMIRIS is administered intravenously every eight weeks or, for pediatric patients less than 20 kg, every four weeks, following a loading dose. In many countries around the world, SOLIRIS is approved to treat paroxysmal nocturnal hemoglobinuria (PNH), atypical hemolytic uremic syndrome (aHUS), adults with generalized myasthenia gravis (gMG) who are acetylcholine receptor (AchR) antibody positive and/or adults with neuromyelitis optica spectrum disorder (NMOSD) who are anti-aquaporin-4 (AQP4) antibody positive. To learn more about the regulatory status of ULTOMIRIS in the countries that we serve, please visit www.alexion.com. This press release contains forward-looking statements that involve risks and uncertainties relating to future events and the future performance of Alexion, including statements related to: the anticipated benefits of the ULTOMIRIS 100 mg/mL formulation (including to the patients and the healthcare system); the Company’s commitment to advancing the understanding of PNH with ongoing real-world studies and emerging clinical data; and the anticipated timing of the review and decision of regulatory agencies with respect to the potential approval of certain of our product candidates. Alexion is a global biopharmaceutical company focused on developing life-changing therapies for people living with rare disorders. Symptoms or problems that can happen due to red blood cell breakdown include: drop in the number of your red blood cell count, drop in your platelet count, confusion, kidney problems, blood clots, difficulty breathing, and chest pain. Alexion Pharmaceuticals salary trends based on salaries posted anonymously by Alexion Pharmaceuticals employees. Additional data being presented at the meeting include analyses from the ongoing, observational real-world study of SOLIRIS® (eculizumab) as a treatment for PNH, along with a study evaluating the use of ALXN2040 (danicopan, formerly ACH-4471)—an investigational, oral, factor D inhibitor—used as an add-on therapy for the small, subgroup of PNH patients who are also diagnosed with extravascular hemolysis. The following slide deck was published by Alexion Pharmaceuticals, Inc. ... Earnings Call Presentation. The most common side effects of ULTOMIRIS in people with aHUS are upper respiratory infection, diarrhea, nausea, vomiting, headache, high blood pressure and fever. INDICATIONS & IMPORTANT SAFETY INFORMATION FOR ULTOMIRIS® (ravulizumab-cwvz) AND SOLIRIS® (eculizumab). ULTOMIRIS® (ravulizumab-cwvz) is the first and only long-acting C5 complement inhibitor. For patients with aHUS, the doctor will need to monitor closely during and for at least 12 months after stopping ULTOMIRIS, or 12 weeks after stopping SOLIRIS, for signs of worsening aHUS symptoms or problems related to abnormal clotting and breakdown of red blood cells called thrombotic microangiopathy (TMA). Make sure your child receives vaccinations against Streptococcus pneumoniae and Haemophilus influenzae type b (Hib) if treated with SOLIRIS. ULTOMIRIS increases your chance of getting serious and life-threatening meningococcal infections that may quickly become life-threatening and cause death if not recognized and treated early. Stopping ULTOMIRIS may cause breakdown of your red blood cells due to PNH. Caelum Biosciences and Alexion Pharmaceuticals, Inc. (NASDAQ:ALXN) today announced that two abstracts on CAEL-101, a first-in-class amyloid fibril targeted therapy, have been accepted for presentation at the 62 nd American Society of Hematology (ASH) Annual Meeting and Exposition, taking place virtually from December 5 to 8, 2020. © 2021 Alexion Pharmaceuticals, Inc. Prescribing Information and Medication Guide, full Prescribing Information and Medication Guide, https://www.businesswire.com/news/home/20201104005504/en/. In November 2020, Alexion submitted an IND application to the FDA for ALXN1850. It is important to show this card to any doctor or nurse to help them diagnose and treat you quickly. Total revenues for the full year of 2019 were $4,991.1 million , a 21 percent increase compared to 2018. aHUS occurs when the complement system—a part of the body’s immune system—over-responds, leading the body to attack its own healthy cells. Phase 3 Study of Danicopan, an Oral Complement Factor D Inhibitor, As Add-on Therapy to a C5 Inhibitor in Patients with Paroxysmal Nocturnal Hemoglobinuria with Clinically Evident Extravascular Hemolysis. In addition, the company is developing several mid-to-late-stage therapies, including a copper-binding agent for Wilson disease, an anti-neonatal Fc receptor (FcRn) antibody for rare Immunoglobulin G (IgG)-mediated diseases and an oral Factor D inhibitor as well as several early-stage therapies, including one for light chain (AL) amyloidosis, a second oral Factor D inhibitor and a third complement inhibitor. Q4 Earnings financial workbook 32.4 KB. You may report side effects to FDA at 1-800-FDA-1088. We look forward to the opportunity to present these data during the virtually-held EHA meeting.”. What are the possible side effects of ULTOMIRIS? Tell your doctor about any side effect that bothers you or that does not go away. It is important to show this card to any doctor or nurse to help them diagnose and treat you quickly. “An interim analysis of a PNH study evaluating the higher concentration formulation showed a 78-minute reduction in infusion time for adult patients in the 60-100kg cohort (representative of the majority of patients treated for PNH), and comparable safety, pharmacokinetics, and immunogenicity to the current formulation. Before a patient can receive ULTOMIRIS or SOLIRIS, their doctor must: enroll in the corresponding ULTOMIRIS REMS or SOLIRIS REMS program; counsel the patient about the risk of meningococcal infection; give the patient information and a Patient Safety Card about the symptoms and risk of meningococcal infection (as discussed above); and make sure that the patient is vaccinated with a meningococcal vaccine. patients with a disease called Paroxysmal Nocturnal Hemoglobinuria (PNH). Alexion Pharmaceuticals, Inc. (NASDAQ:ALXN) today announced that six abstracts have been accepted for presentation at the 62nd Annual Meeting and Exposition of the American Society of Hematology (ASH), taking place virtually from December 5 to 8, 2020. Chris Stevo, 857-338-9309 To help tackle pressing social needs in our communities, we support non-profit organizations with monetary grants and harness the power of our global workforce for a Global Day of Service, during which we …

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