Vertex Announces Long-Term Access Agreement in Sweden for Cystic Fibrosis Medicine ORKAMBI® (lumacaftor/ivacaftor)
Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced that ORKAMBI® (lumacaftor/ivacaftor), the first medicine to treat the underlying cause of cystic fibrosis (CF) in people with two copies of the F508del mutation, ages six and older, will be reimbursed in Sweden after concluding the three-party negotiations with TLV and the county councils. Reimbursement is effective from July 1. The innovative, long-term access agreement also provides a framework for the assessment and access of our future CF medicines.
“We are delighted that people with CF in Sweden will join the thousands of others around the world who are already benefitting from our CF medicines,” said Simon Bedson, International General Manager at Vertex. “We commend the Swedish authorities for partnering with us on an innovative, long-term access agreement. In countries where Vertex remains actively involved in reimbursement discussions, we encourage these health authorities and governments to match the commitment to innovation shown in Sweden to secure access for all patients who may benefit.”
CF is a devastating rare disease that causes continuous damage to multiple organs from birth. In the lungs, a build-up of sticky mucus causes progressive and permanent damage, severe infections and ultimately premature death. In addition to Sweden, countries where lumacaftor/ivacaftor is available to all eligible patients include Austria, Germany, Ireland, Italy, the Netherlands and the U.S.
About Cystic Fibrosis
Cystic fibrosis is a rare, life-shortening genetic disease affecting approximately 75,000 people in North America, Europe and Australia.
CF is caused by a defective or missing CFTR protein resulting from mutations in the CFTR gene. Children must inherit two defective CFTR genes — one from each parent — to have CF. There are approximately 2,000 known mutations in the CFTR gene. Some of these mutations, which can be determined by a genetic test, or genotyping test, lead to CF by creating non-working or too few CFTR proteins at the cell surface. The defective function or absence of CFTR protein results in poor flow of salt and water into and out of the cell in a number of organs. In the lungs, this leads to the build-up of abnormally thick, sticky mucus that can cause chronic lung infections and progressive lung damage in many patients that eventually leads to death. The median age of death is in the mid-to-late 20s.
About ORKAMBI ® (lumacaftor/ivacaftor) and the F508del mutation
In people with two copies of the F508del mutation, the CFTR protein is not processed and trafficked normally within the cell, resulting in little-to-no CFTR protein at the cell surface. Patients with two copies of the F508del mutation are easily identified by a simple genetic test.
ORKAMBI is a combination of lumacaftor, which is designed to increase the amount of mature protein at the cell surface by targeting the processing and trafficking defect of the F508del-CFTR protein, and ivacaftor, which is designed to enhance the function of the CFTR protein once it reaches the cell surface. Lumacaftor/ivacaftor is available as tablets and is typically taken twice per day.
For complete product information, please see the Summary of Product Characteristics that can be found on www.ema.europa.eu.
Vertex is a global biotechnology company that invests in scientific innovation to create transformative medicines for people with serious and life-threatening diseases. In addition to clinical development programs in CF, Vertex has more than a dozen ongoing research programs focused on the underlying mechanisms of other serious diseases.
Founded in 1989 in Cambridge, Mass., Vertex's headquarters is now located in Boston's Innovation District. Today, the company has research and development sites and commercial offices in the United States, Europe, Canada and Australia. Vertex is consistently recognized as one of the industry's top places to work, including being named to Science magazine's Top Employers in the life sciences ranking for eight years in a row.
For additional information and the latest updates from the company, please visit www.vrtx.com.
Vertex Pharmaceuticals Incorporated
Michael Partridge, + 1-617-341-6108
Eric Rojas, + 1-617-961-7205
Zach Barber, + 1-617-341-6470
Heather Nichols, + 1-617-341-6992
Europe & Australia:
Marie von Seyfried, + 447933 500887
Rob Clark, + 447736 473227
Om Business Wire
(c) 2018 Business Wire, Inc., All rights reserved.
Business Wire, a Berkshire Hathaway company, is the global leader in multiplatform press release distribution.
Følg saker fra Business Wire
Registrer deg med din epostadresse under for å få de nyeste sakene fra Business Wire på epost fortløpende. Du kan melde deg av når som helst.
Siste saker fra Business Wire
Gemalto Instant Connect Signals New Era in Effortless Mobile Connectivity for Consumer eSIM-equipped Devices 26.6.2019 23:00:00 CEST | Pressemelding
Thales announces the launch of Gemalto Instant Connect, a pioneering connectivity solution to simplify the connection of eSIM-enabled devices on a mobile network. While users are spared the inconvenience of establishing a Wi-Fi or Bluetooth connection to kick-start their mobile experience, OEMs and mobile operators can now provision devices with mobile connectivity at their first use, and not during manufacturing, saving both time and cost. Connected PCs and laptops will be the first devices to integrate this faster and more efficient approach to out-of-the-box connectivity for eSIMs. Going forwards, a wide array of OEMs and mobile operators stand to benefit from the solution, which is fully compliant with the latest GSMA Remote SIM Provisioning specifications. Between 2018 and 2022, an estimated 2.3 billion eSIM-compliant consumer devices will be shipped worldwide 1 . To date, eSIM-equipped devices have had to rely on some form of primary connectivity before they are able to activate
Quanterix Announces Agreement to Acquire UmanDiagnostics, World’s Leading Neurofilament Light (Nf-L) Antibody Supplier26.6.2019 20:00:00 CEST | Pressemelding
Quanterix Corporation (NASDAQ: QTRX), a company digitizing biomarker analysis with the goal of advancing the science of precision health, today announced that it has entered into a definitive agreement to acquire privately held UmanDiagnostics AB for $22.5 million, comprised of $16 million in cash plus $6.5 million in Quanterix common stock. Uman is widely recognized to possess the leading antibodies available today to measure neurofilament light (Nf-L) and has become the provider of choice for biopharmaceutical and diagnostic applications. Uman, based in Umeå, Sweden, supplies Nf-L antibodies and ELISA kits, which are widely recognized by researchers and biopharmaceutical and diagnostics companies world-wide as the premier solution for the detection of Nf-L to advance the development of therapeutics and diagnostics for neurodegenerative conditions. Nf-L has seen a dramatic growth in the last three years since Quanterix developed the first assay using Uman’s antibodies that could relia
Elliott Statement on Bayer26.6.2019 16:44:00 CEST | Pressemelding
Elliott Advisors (UK) Limited (“Elliott”), which advises funds that collectively hold shares of Bayer A.G. (“Bayer” or “the Company”) and economic equivalents with an aggregate value of €1.1 billion, acknowledges Bayer’s announcement to create a special litigation committee of the Supervisory Board (the “Special Committee”), and the retention of Mr. John Beisner of Skadden, Arps, Slate, Meagher & Flom LLP, as legal advisor to the Supervisory Board and Special Committee. Elliott welcomes these steps, and is confident that today’s statement marks a step change in Bayer’s approach to addressing the legal challenges currently facing the Company. Elliott believes that the creation of the Special Committee will provide a new level of oversight and a fresh perspective to a litigation strategy in need of a radical overhaul, and help guide the Company towards a rational, fair and swift settlement. The appointment of Mr. John Beisner not only provides Bayer with relevant litigation expertise, bu
Louisiana Launches Hepatitis C Innovative Payment Model With Asegua Therapeutics, Aiming to Eliminate the Disease26.6.2019 15:30:00 CEST | Pressemelding
Today, Governor John Bel Edwards joined Secretary Rebekah Gee of the Louisiana Department of Health, Secretary James LeBlanc of the Louisiana Department of Corrections, and Asegua Therapeutics LLC, a wholly-owned subsidiary of Gilead Sciences, Inc. (Nasdaq: GILD), to announce a deal that will allow the implementation of an innovative payment model for hepatitis C treatment, part of Louisiana’s plan to eliminate the disease. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20190626005539/en/ “This new model has the potential to save many lives and improve the health of our citizens. It is an important day for our state, for our partner Asegua Therapeutics, for providers, but most importantly for the patients and their families who will benefit from treatment,” said Governor Edwards. “Asegua was willing to come to the table to work with us to help Louisiana residents and we are pleased to initiate this five year partnership. Ultim
Nextflow Software Introduces Nextflow Studio, Its Newest Fluid Simulation Software26.6.2019 14:00:00 CEST | Pressemelding
Nextflow Software is an Independent Software Vendor (ISV) based in Nantes, France. Nextflow Software is one of the leaders in innovative Computational Fluid Dynamics (CFD) methods. The startup exhibits at the NAFEMS World Congress in Quebec City, Canada, on June 17-20, featuring live demos if its latest product Nextflow Studio. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20190626005482/en/ Nextflow Studio conception simulation (Photo: Nextflow Software) A full environment covering all stages of CFD simulation Nextflow Studio is a software platform that covers the entire CFD flow, from pre-processing, to computation and post-processing. This environment lets engineers manage easily their simulation projects and provides a Graphical User Interface (GUI) based on the latest software technologies. Nextflow Studio offers an experience that allows users to accelerate the resolution of their field-specific design objectives. Main
BrandSafway Selects Rimini Street Application Management Services for Salesforce26.6.2019 13:00:00 CEST | Pressemelding
Rimini Street, Inc. (Nasdaq: RMNI), a global provider of enterprise software products and services, the leading third-party support provider for Oracle and SAP software products and a Salesforce partner, today announced that BrandSafway, a global leader in access, industrial services and forming and shoring solutions for the industrial, commercial and infrastructure markets, has selected Rimini Street Application Management Services (AMS) for Salesforce for its Salesforce Sales Cloud system. BrandSafway has been leveraging Rimini Street support for its Oracle Database, E-Business Suite and JD Edwards software products since 2014, and now, BrandSafway is expanding its support service scope with Rimini Street to maximize the value and business impact of Salesforce and the Salesforce Sales Cloud system. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20190626005022/en/ BrandSafway Selects Rimini Street Application Management Servi