Vertex and Republic of Ireland Expand Long-Term Cystic Fibrosis Medicines Reimbursement Agreement to Include Triple Combination Therapy for All Eligible Patients Ages 12 and Over Once Licensed
13.12.2019 21:55:00 EET | 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)
To view this piece of content from cts.businesswire.com, please give your consent at the top of this page.
View source version on businesswire.com: https://www.businesswire.com/news/home/20191213005435/en/
Contact information
Vertex Pharmaceuticals Incorporated
UK/Irish Media: +44 20 3204 5275
MediaInfo@vrtx.com
Investors: 617-961-7163
InvestorInfo@vrtx.com
About Business Wire
For more than 50 years, Business Wire has been the global leader in press release distribution and regulatory disclosure.
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
euroAtlantic Airways Expands Long-Haul Fleet With a New Airbus A330-300 Aircraft2.9.2026 10:00:00 EEST | Press release
euroAtlantic Airways (“EAA”), a Njord Partners portfolio company and a leading Portuguese aircraft wet-leasing and charter business, is pleased to announce the induction of a new Airbus A330-300 aircraft into its fleet, further strengthening its long-haul widebody capabilities and reinforcing the Company's growth trajectory in the ACMI and charter markets. The Airbus A330-300 is leased from Jackson Square Aviation (JSA). Only 15 years old, the aircraft is configured in a three-class layout of Business, Premium Economy and Economy, accommodating a total of 290 passengers, and features full lie-flat seating in Business Class along with personal in-seat entertainment monitors fitted across the entire cabin. The aircraft, which will be registered as CS-TGI after completing its normal process of approval with authorities, has already completed its delivery journey, departing Kuala Lumpur (KUL) and arriving into Beja, Portugal (BYJ) on 17 August 2026. This aircraft type is known for its effi
Interoperability and Trust Key to AI Commerce: Alipay+ and S&P Global Report2.9.2026 09:33:00 EEST | Press release
A new report by Alipay+, the unified wallet gateway of Ant International, in partnership with S&P Global, reveals a growing "commerce digitalisation gap", with people increasingly expecting seamless mobile payments and intelligent digital assistance, yet friction – from inconsistent payment acceptance to trust in AI – still define their experience. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260901394299/en/ The study, which surveyed 6,000 consumers across nine markets in Asia, Europe and the US on their cross-border spending habits, points to a major shift underway in global commerce — one where e-wallets, AI and interoperable digital ecosystems are becoming foundational to how consumers discover, transact and engage across borders. Key findings: Travel exposes gaps in global commerce infrastructure: More than half of consumers cite uncertainty around merchant acceptance (53%) or lack of access to preferred payment metho
Kontoor Brands Unveils Helly Hansen Growth Strategy and 2030 Financial Targets2.9.2026 09:30:00 EEST | Press release
Kontoor Brands, Inc. (NYSE: KTB) today announced Helly Hansen’s long-term growth strategy and 2030 financial targets, which Kontoor Brands will present at the Helly Hansen® Investor Day later today. The plan is designed to scale Helly Hansen globally while significantly expanding its profitability through 2030. "With 150 years of technical heritage and an authentic right to win globally, Helly Hansen is a brand with tremendous long-term growth potential," said Scott Baxter, Chief Executive Officer and Chairman of the Board of Kontoor Brands. "Strong alignment between our teams has allowed us to integrate quickly and move straight to executing against the opportunity ahead. Our sustained investment in Helly Hansen will be a catalyst for its next phase of growth, and we are confident in our ability to deliver significant value for our consumers, employees and shareholders for years to come." A Focused Growth Strategy: To deliver against these targets, Helly Hansen’s growth is anchored in
Axelspace Announces Partnership with Airbus Defence and Space to Deliver Satellite Imagery to a Broader Market2.9.2026 09:30:00 EEST | Press release
Axelspace Corporation (“Axelspace”), a leading microsatellite company committed to making “Space within Your Reach,” announced today a new agreement with Airbus Defence and Space, a global leader in Earth observation including optical and radar satellite imagery, to provide mid-resolution optical images captured by Axelspace’s Earth observation microsatellites “GRUS.” Under this strategic partnership, we will develop and deliver innovative solutions that meet long-term customer needs for utilizing satellite imagery. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260901360086/en/ GRUS is Axelspace's series of approximately 100 kg-class optical Earth observation microsatellites. GRUS-1 is currently operated as a four-satellite constellation, delivering high-frequency, wide-area imagery. This imagery, together with value-added solutions derived through processing and analysis, supports a broad range of industries, including agr
Vara Receives World-First CE Certification for Autonomous AI in Breast Cancer Screening2.9.2026 09:00:00 EEST | Press release
Vara has received CE certification under the EU Medical Device Regulation (Class IIb) for autonomous triage in organised breast cancer screening – the first breast AI certified anywhere to report screening examinations as normal without radiologist review. In autonomous triage, examinations the system classifies as clearly normal can be reported by AI without a radiologist reading them; every other examination continues to be read by at least one radiologist. This deployment mode is intended for organised population screening, where a shrinking radiologist workforce is straining programmes that still read every mammogram twice. The certification has only been possible because Vara has developed a safety system that supervises the autonomous use of its AI models. "What made this possible is not the AI model alone," said Stefan Bunk, CTO and co-founder of Vara. "It is based on seven years of continuous monitoring of how our AI performs in the real world, on every single case. That experi
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