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
DDN Selected to Modernize Research Data Infrastructure at UNSW Sydney26.10.2026 22:30:00 CET | Press release
DDN EXAScaler and Arcitecta Mediaflux will replace 11 legacy storage systems, simplifying access to research data while balancing performance and cost DDN, the global leader in AI and data intelligence solutions, today announced that UNSW Sydney has selected DDN to deliver a new research data storage environment as part of the university’s Research Data Experience (RDE) program. Working with Australian software company Arcitecta, DDN will combine its EXAScaler parallel file system with Arcitecta’s Mediaflux® data management platform to help researchers spend less time managing data and more time using it. Following an extensive 18-month evaluation, UNSW selected an integrated approach that will replace 11 legacy storage systems with a coordinated environment for high-performance storage and enterprise data management. The decision reflects a broader challenge facing research-intensive institutions: how to support rapidly expanding scientific datasets while simplifying infrastructure, i
Agent Assurance by TestMu AI Is Now Generally Available, Letting Teams Test What Their AI Agents Actually Change26.10.2026 16:15:00 CET | Press release
The trial includes 4,000 credits and four concurrent runs, so a team can generate functional and adversarial suites from its own agent's docs and endpoint, with code optional, and gate CI on evidence-backed verdicts without booking a demo. TestMu AI (formerly LambdaTest), the world's first Agentic AI-powered Quality Engineering platform, today announced the general availability of Agent Assurance. Agent Assurance tests AI agents that take actions, such as calling tools, writing files, and changing records, by checking what a run actually changed rather than what the agent says it did. Any team can now create a TestMu AI account and run it against its own agent without booking a demo first. Agent Assurance launched on August 17, 2026, behind a waitlist and a guided onboarding session. Since then, Rook, the CLI that runs Agent Assurance, has shipped a steady run of releases, shaped by feedback from early teams. Agent evaluation has mostly graded the final reply, and that reply can be wro
Actiphy Announces ImageServer for Centralized Backup Storage and Post-Backup Processing26.10.2026 16:13:00 CET | Press release
New platform combines centralized backup management, Inter-File Deduplication, automated workflows, and remote replication. Actiphy™, Inc., a provider of backup, disaster recovery, and virtualization software, today announced Actiphy ImageServer™, a centralized platform for storing, managing, verifying, and replicating backups created with ActiveImage Protector™. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20261026410729/en/ Actiphy ImageServer Console ImageServer combines the management capabilities of Actiphy ImageCenter™ with the secure storage of Actiphy StorageServer™. By moving Verify, Replication, Consolidation, and BootCheck™ to a dedicated server, ImageServer reduces processing load on protected systems and simplifies backup administration. As organizations protect more systems and retain more backup generations, storage and administrative demands grow. ImageServer addresses these challenges by centralizing backup
Dubai Chambers Launches World's First Agentic AI Marketplace by a Chamber of Commerce26.10.2026 16:06:00 CET | Press release
Dubai Chambers has launched Chamber AI Hub, the world's first Agentic AI marketplace developed by a chamber of commerce, enabling businesses in Dubai to access ready-to-use AI agents that independently perform a range of administrative and operational tasks. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20261026467531/en/ H.E. Sultan bin Saeed Al Mansoori Chairman of Dubai Chambers. (Photo: AETOSWire) The marketplace currently offers 22 specialised AI agents across seven business functions including Compliance, Procurement, Operations, Finance, Sales, Human Resources, and Logistics. The offering is set to expand to 100 agents. The initiative supports Dubai's efforts to accelerate the adoption of Agentic AI across the private sector, helping businesses enhance efficiency, strengthen competitiveness, and transform their operating models. H.E. Eng. Sultan bin Saeed Al Mansoori, Chairman of Dubai Chambers, commented: “Success in
Media Release: Allianz Beach Arena for the LA28 Olympic and Paralympic Games Joins the Allianz Family of Stadiums26.10.2026 15:37:00 CET | Press release
First Olympic and Paralympic venue in history to display the Allianz name and the eighth member of the Allianz Family of Stadiums.The nearly 15,000 seat temporary arena on the Long Beach waterfront will host Olympic Beach Volleyball and Paralympic Blind Football (Soccer).Allianz unveils its customized LA28 Games emblem, marking the start of its preparations for the LA28 Olympic and Paralympic Games. For the first time in Olympic and Paralympic history, a competition venue will carry the Allianz name. The Allianz Beach Arena in Long Beach, California, for the LA28 Olympic and Paralympic Games will become the newest member of the Allianz Family of Stadiums. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20261026919959/en/ Allianz's "custom A" emblem for LA28. From Horse Guards Parade in London to Copacabana Beach in Rio and the Eiffel Tower in Paris, Olympic Beach Volleyball has always found its home in iconic settings around th
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
