Business Wire

VERTEX-PHARMA

13.12.2019 19:57:09 CET | Business Wire | Press release

Share
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

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)

Link:

ClickThru

About Business Wire

Business Wire
Business Wire
101 California Street, 20th Floor
CA 94111 San Francisco

http://businesswire.com

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

Reply Announces a Partnership With Mistral AI to Develop Sovereign and Enterprise-grade Artificial Intelligence Solutions18.3.2026 09:00:00 CET | Press release

Reply [EXM, STAR: REY] today announced a new partnership agreementwithAI leader Mistral AI aimed at accelerating the adoption of local, customisable, secure and enterprise-grade generative AI solutions at scale. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260318232777/en/ Through this collaboration, Reply and Mistral AI provide a trusted and secure environment on European infrastructures, accelerating the adoption of advanced AI solutions while enabling organizations with stringent regulatory, privacy and data protection requirements to fully leverage generative AI. At the core of the collaboration is a shared vision of frontier AI, designed to enable organizations to adopt AI solutions while ensuring data control, protection of sensitive information, compliance with regulatory requirements and deployment on European infrastructures. By combining Mistral AI’s high-performance AI models with Reply’s expertise in designing

Samsung Bioepis Enters into Partnership Agreement with Sandoz for Up to Five Next-Generation Biosimilar Candidates18.3.2026 08:30:00 CET | Press release

The agreement covers up to five assets, including SB36, a biosimilar candidate referencing Entyvio (vedolizumab), for collaboration of development and commercialization in global markets excluding China, Hong Kong, Taiwan, Macau, and Republic of KoreaSamsung Bioepis continues to pave the way for access to life-changing medicines by advancing a biosimilar pipeline across immunology and oncology Samsung Bioepis Co., Ltd. announced today that the company has entered into a global license, development and commercialization agreement (DCA) with Sandoz for up to five biosimilar candidates under development by Samsung Bioepis, including SB36, a biosimilar candidate referencing Entyvio1 (vedolizumab). The other terms of the agreement remain confidential. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260318826412/en/ Samsung Bioepis office in Songdo, Incheon, Republic of Korea Under the terms of the agreement, Samsung Bioepis will b

Epassi Appoints Three Senior Leaders to Accelerate European Growth18.3.2026 08:00:00 CET | Press release

Epassi Group, a leading European multi-benefits technology platform, today announced the appointments of Phil Jones as Chief Revenue Officer (CRO), Ross Seychell as Chief People Officer (CPeO), and Cho Hwang as Chief Technology Officer (CTO), strengthening its leadership team as the company enters its next phase of expansion. Cho Hwang joined Epassi on December 1, 2025. He brings extensive global technology leadership experience from companies including HelloFresh, Coupang, and Nordstrom. At Epassi, Cho leads the company’s technology strategy and engineering organisation as the platform continues to scale across Europe. His experience will support Epassi’s ambition to further expand its multi-benefits ecosystem for employers, employees, and partners. Phil Jones joined Epassi on March 2. He brings extensive experience across HR technology and the full Human Capital Management lifecycle, having held senior leadership roles across Sales, Revenue Operations, and Customer Success at global

AiDEN Are Collaborating With Volvo Group Through the Innovation Hub CampX in a Proof-of-Value Project Solving Real Customer Needs18.3.2026 05:00:00 CET | Press release

In December 2024, a new regulatory requirement was introduced in Poland related to SENT (System for Electronic Transport Supervision) for tracking high-risk goods transported within the country. In regard to this, a project to validate one of AiDEN's services/products within the platform was initiated. This was done in a project with Volvo Trucks through CampX, Volvo Group’s global innovation arena for technology and business transformation. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260317838896/en/ AiDEN’s SENT GEO compliance service displayed within a Volvo truck’s in-vehicle infotainment system, enabling automated geolocation reporting for Poland’s System for Electronic Transport Supervision (SENT). Developed through a collaboration between AiDEN Automotive and Volvo Group’s CampX innovation hub, the integrated solution allows fleets to meet SENT requirements without external GPS hardware or aftermarket installations

LTM Named NVIDIA Partner Network ‘Rising Star Consulting Partner of the Year’ at NVIDIA GTC 202618.3.2026 03:30:00 CET | Press release

LTM, the Business Creativity partner to the world’s largest enterprises, has been recognized as the NVIDIA Partner Network (NPN) ‘Rising Star Consulting Partner of the Year’ at NVIDIA GTC 2026. The award recognizes LTM’s strong collaboration with NVIDIA and its growing impact in helping enterprises move from AI experimentation to scalable, enterprise-ready adoption. The NVIDIA Partner Network (NPN) brings together a global ecosystem of technology and consulting partners working closely with NVIDIA to deliver advanced AI solutions. Being an NPN partner is about collaborating deeply with NVIDIA to help clients transition from AI pilots to enterprise-scale deployments combining NVIDIA’s advanced AI technologies with LTM’s industry and domain expertise to drive real-world outcomes. The Rising Star Consulting Partner of the Year award highlights LTM’s momentum in delivering AI solutions that are production-grade, secure, and designed for enterprise scale. This NPN award is a significant rec

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
World GlobeA line styled icon from Orion Icon Library.HiddenA line styled icon from Orion Icon Library.Eye