VERTEX-PHARMA
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
Doha Debates Hosts “In The Room: The Negotiators Podcast” Live at Doha Forum9.12.2025 18:09:00 CET | Press release
As the podcast enters its fifth season, global diplomacy and high-stakes negotiation take center stage. Qatar Foundation’s Doha Debates spotlighted the practice of high-stakes negotiation with a special live episode of its award-winning podcast with Foreign Policy, The Negotiators, at Doha Forum, following the launch of the podcast series’ fifth season on December 1. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20251209171106/en/ Doha Debates spotlighted the practice of high-stakes negotiation with a special live episode of its award-winning podcast with Foreign Policy, The Negotiators, at Doha Forum, following the launch of the podcast series’ fifth season on December 1. (Photo: AETOSWire) Held in collaboration with The Negotiators’ special partner for this season, the International Peace Institute (IPI), and Doha Debates’ longstanding production partner, Foreign Policy, the episode featured a compelling conversation betwee
CoMotion GLOBAL 2025 Concludes in Riyadh with Landmark Deals and Global Mobility Breakthroughs9.12.2025 18:07:00 CET | Press release
Three-day summit unveils major AI research, city-led climate initiatives, and transformative partnerships in autonomous and electric air mobility, cementing Saudi Arabia’s role as a global hub for next-generation transport CoMotion GLOBAL 2025 concluded today after three transformative days that brought together global decision-makers, industry leaders, city executives, innovators, and investors to chart the future of mobility in Saudi Arabia and worldwide. Hosted for the first time in the King Abdullah Financial District (KAFD), Riyadh, the event showcased the Kingdom’s accelerating role as a global hub for next-generation transportation, sustainability leadership, and urban innovation. With more than 100 sessions spanning three days, CoMotion GLOBAL showcased forward-looking mobility strategies, multimodal transport breakthroughs, urban digital transformation, AI applications, and the dramatic rethinking of the movement of people and goods across global cities. Key moments from the e
HTEC Momentum Recognized as a Clutch Global Honoree and Champion for Fall 20259.12.2025 17:09:00 CET | Press release
HTEC Momentum (formerly Momentum Design Lab), HTEC’s research, product design, management and innovation arm, has earned two of Clutch’s highest distinctions—Global Award honoree and Clutch Champion—reaffirming its ninth straight year as the platform’s top-rated UX agency worldwide. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20251209358771/en/ HTEC Momentum Recognized as a Clutch Global Honoree and Champion for Fall 2025 The Clutch Global Awards honorees are selected based on demonstrated industry expertise and exceptional delivery—evaluated through thousands of verified client reviews published on Clutch. Clutch’s rigorous, case-study-driven review process includes extensive verification to ensure the authenticity and depth of each submission. These distinctions further underscore HTEC Momentum’s position as a top-rated leader in UX strategy, design, and user research, reflecting the consistent satisfaction of our clients
Onego Bio Launches “The Power of Trichoderma reesei” Series to Showcase Innovation, Scale, and Real-World Applications9.12.2025 17:00:00 CET | Press release
Onego Bio, a food ingredient company producing non-animal egg protein with precision fermentation*, today announced the launch of a new expert series titled “The Power of Trichoderma reesei: Building the Future with Fungi.” This multi-part initiative reveals the full potential of Trichoderma reesei, the microbial platform behind Onego’s Bioalbumen®, by spotlighting its scientific strengths, industrial scale, and practical performance across food manufacturing. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20251209632524/en/ Headshot of Dr. Sharief Barends The first session, “Why Trichoderma reesei is Precision Fermentation’s Quiet Workhorse,” will be held on December 18, 2025, featuring Dr. Sharief Barends, Head of Research Leiden (Netherlands) and Head of Fungal Genetics at IFF, and Dr. Christopher Landowski, Co-Founder and Chief Technology Officer at Onego Bio. Together, they will explore the research legacy, strengths, and
Guinea Emerges as West Africa's New Digital Transformation Powerhouse9.12.2025 16:53:00 CET | Press release
The Republic of Guinea has reached a decisive turning point as a regional digital power. By hosting the Transform Africa Summit 2025, becoming the first francophone nation to receive this major continental event since its creation in 2013, Guinea confirmed the emergence of Conakry as a new digital innovation hub in West Africa. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20251209780892/en/ Rose Pola Pricemou, Minister of Posts, Telecommunications and Digital Economy of the Republic of Guinea (Photo: AETOSWire) The numbers break all records: over 7,000 participants from 79 countries, including 47 ministers, 1,552 government representatives, 584 business leaders, over 590 start-ups, and 14 MoUs signed. Never before in the history of the Transform Africa Summit has such mobilisation been accomplished. This unprecedented turnout demonstrates international confidence in Guinea's ability to lead Africa's digital transformation ch
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
