VERTEX-PHARMA
13.12.2019 19:57:09 CET | Business Wire | Press release
Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today confirmed that, following recent collaborative discussions, it has negotiated an agreement with the Health Service Executive (HSE) in the Republic of Ireland to expand the existing long-term cystic fibrosis (CF) reimbursement agreement to include the triple combination regimen (elexacaftor, tezacaftor and ivacaftor), which is under review and pending approval by the European Medicines Agency, for all eligible patients ages 12 and older in line with the potential future licensed indication.
This expands the existing agreement which had already included access to current and future Vertex medicines for people in Ireland with CF of any age who:
- Have one of the specified mutations as included in the KALYDECO® marketing authorization (G551D, G551S, S549R, G1244E, S1251N, G1349D, S1255P, G178R or S549N ) or
- Are homozygous for the F508del mutation or
- Are heterozygous for the F508del mutation and have a specified mutation (P67L , D579G, D1152H, R117C, 711+3A→G, 2789+5G→A, L206W, S945L, 3272-26A→G, R352Q, S977F, 3849+10kbC→T, A455E or R1070W ) and people ages 18 and older and have an R117H mutation.
This innovative long-term agreement also enabled rapid access for people with these mutations if the labels of the existing medicines were expanded to cover additional age groups and if new Vertex medicines were approved for these populations.
Ludovic Fenaux, Senior Vice President, Vertex International, said, “With this expanded agreement, even more patients in the Republic of Ireland will be among the first in Europe to benefit from the triple combination treatment once the medicine is licensed.”
Triple combination treatment (elexacaftor, tezacaftor and ivacaftor) is not currently licensed for use in the European Union. Vertex submitted a Marketing Authorization Application to the European Medicines Agency on October 31, 2019.
About Vertex
Vertex is a global biotechnology company that invests in scientific innovation to create transformative medicines for people with serious diseases. The company has four approved medicines in the U.S. and three approved medicines in Europe that treat the underlying cause of cystic fibrosis (CF) — a rare, life-threatening genetic disease — and has several ongoing clinical and research programs in CF. Beyond CF, Vertex has a robust pipeline of investigational small molecule medicines in other serious diseases where it has deep insight into causal human biology, including pain, alpha-1 antitrypsin deficiency, and APOL1-mediated kidney disease. In addition, Vertex has a rapidly expanding pipeline of genetic and cell therapies for diseases such as sickle cell disease, beta thalassemia, Duchenne muscular dystrophy and type 1 diabetes mellitus.
Founded in 1989 in Cambridge, Mass., Vertex's global headquarters is now located in Boston's Innovation District and its international headquarters is in London, UK. Additionally, the company has research and development sites and commercial offices in North America, Europe, Australia and Latin America. Vertex is consistently recognized as one of the industry's top places to work, including 10 consecutive years on Science magazine's Top Employers list and top five on the 2019 Best Employers for Diversity list by Forbes.
Special Note Regarding Forward-looking Statements
This press release contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995, including, without limitation, the statements by Mr. Fenaux in the second paragraph of this press release and statements regarding the expansion of the existing long-term cystic fibrosis reimbursement agreement and Vertex’s Marketing Authorization Application submission to the European Medicines Agency. While Vertex believes the forward-looking statements contained in this press release are accurate, these forward-looking statements represent the company's beliefs only as of the date of this press release and there are a number of risks and uncertainties that could cause actual events or results to differ materially from those expressed or implied by such forward-looking statements. Those risks and uncertainties include, among other things, that data from the company's development programs may not support registration or further development of its compounds due to safety, efficacy or other reasons, obtaining approval and commercializing elexacaftor, tezacaftor and ivacaftor in Europe, developing additional medicines to treat cystic fibrosis, and other risks listed under Risk Factors in Vertex's annual report and subsequent quarterly reports filed with the Securities and Exchange Commission and available through the company's website at www.vrtx.com . Vertex disclaims any obligation to update the information contained in this press release as new information becomes available.
(VRTX-GEN)
View source version on businesswire.com: https://www.businesswire.com/news/home/20191213005435/en/
Link:
About Business Wire
Subscribe to releases from Business Wire
Subscribe to all the latest releases from Business Wire by registering your e-mail address below. You can unsubscribe at any time.
Latest releases from Business Wire
Abu Dhabi Launches TAMM Global to Bring Its AI-Native Government Platform to the World16.10.2026 16:00:00 CEST | Press release
Abu Dhabi has launched TAMM Global, a private technology company established to make the award-winning technology behind TAMM available to governments worldwide. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20261016490320/en/ Abu Dhabi Launches TAMM Global to Bring Its AI-Native Government Platform to the World (Photo: AETOSWire) It is the first time the AI-powered platform, which serves 4.7 million users and is recognized as one of the world’s most advanced digital government platforms, will be available for international licensing and deployment. The launch marks a significant milestone in Abu Dhabi’s ambition to become the world’s first AI-native government. It reflects growing international demand for proven technologies that can accelerate digital transformation while protecting sovereignty, regulatory compliance and public trust. It also demonstrates how homegrown innovation and intellectual property are creating oppor
TestMu AI Brings Real Device Testing to Kane CLI, Letting Developers Test Mobile Apps on Real Phones From Any Terminal16.10.2026 16:00:00 CEST | Press release
Plain-English mobile tests now run on real Android and iOS devices in the TestMu AI cloud from any Mac, Windows, or Linux machine, with a live view of the device on the developer's laptop TestMu AI (formerly LambdaTest), the Full Stack Agentic AI Quality Engineering platform, announced real device support in Kane CLI. Developers can now test a mobile app on a real phone or tablet in the TestMu AI cloud straight from the terminal: they type what to test in plain English, and Kane taps through the app on a real Android or iOS device. Until now, testing a mobile app on real hardware meant keeping a drawer of phones, or a separate device farm outside the developer's workflow. With real device support, Kane CLI removes that dependency again now by giving terminal-first access to the real device cloud. Kane CLI on real devices gives teams: Real Android and iOS devices from any terminal. Kane CLI opens a real device in the TestMu AI cloud and taps through the app from natural language prompts
METI and GX Acceleration Agency will hold GGX Finance Summit 202616.10.2026 15:00:00 CEST | Press release
On Monday, October 26th, the Ministry of Economy, Trade and Industry (METI) and GX Acceleration Agency will hold the GGX (Global GX) Finance Summit at Tokyo Prince Hotel and online. The Summit will advance discussions on transition finance, industry decarbonization, and the role of business and finance in driving decarbonization. It will also promote cooperation among government, industry, and the financial sector, and lead international rulemaking toward achieving both emission reductions and economic growth. Outline of GGX Finance Summit Date: October 26th, 2026 10:00 - 16:20 (JST, GMT+9:00) Venue: Tokyo Prince Hotel (Tokyo) (3-3-1 Shiba-Koen, Minato-ku, Tokyo 105-8560, Japan) Organizer: Ministry of Economy, Trade and Industry (METI), GX Acceleration Agency Co-organizer: GX Future Consortium Format: Hybrid (On-site and on-line) Language: Japanese/English (with English/Japanese simultaneous interpretation) Press Registration Please complete your registration by accessing the official
Dubai Culture: Dubai Ranks First Globally in Attracting New FDI Projects in Cultural and Creative Industries in 202516.10.2026 13:32:00 CEST | Press release
Dubai Culture and Arts Authority has revealed that Dubai retained its position as the world’s leading destination for new foreign direct investment (FDI) projects in the cultural and creative industries (CCIs) in 2025, ranking first globally for the fourth consecutive year. According to data from the Financial Times’ fDi Markets, a leading source of greenfield FDI intelligence, Dubai topped the ranking of 233 cities, ahead of London, Singapore, Riyadh and Bengaluru. The results reflect the strength of the emirate’s investment environment and its appeal to creative businesses, investors, entrepreneurs and talent from around the world. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20261016681830/en/ Dubai Culture: Dubai ranks first globally in attracting new FDI projects in cultural and creative industries in 2025 (Graphic: AETOSWire) In 2025, Dubai attracted 754 new projects in the cultural and creative industries, with greenf
Horizon3 and Pax8 Expand Partnership to Bring Autonomous Security Testing to MSPs Across Europe16.10.2026 08:03:00 CEST | Press release
NodeZero® gives partners a repeatable way to identify exploitable attack paths, guide remediation, and prove fixes worked Horizon3, the AI-Native Proactive Security Company, today announced the expansion of its Pax8 partnership across Europe, bringing the NodeZero® Proactive Security Platform to the region’s managed service providers (MSPs) through the Pax8 Marketplace. The expansion enables partners to build recurring security services that help small and midsized businesses understand how attackers could compromise their environments, prioritize corrective actions, and verify remediation. Building on the companies’ North American marketplace launch, the European expansion makes autonomous offensive security testing accessible to more MSPs and the businesses they protect. Partners can use NodeZero to deliver initial assessments, support remediation engagements, and establish ongoing testing programs without conducting every penetration test manually. “MSPs are accountable for protecti
In our pressroom you can read all our latest releases, find our press contacts, images, documents and other relevant information about us.
Visit our pressroom
