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

FuzeBox AI Named Founding Co-Author of SPUR Coalition Technical Committee on Verifying AI Content Use5.10.2026 15:00:00 CEST | Press release

A new technical committee will define how publishers can independently confirm AI companies' reports of content use. FuzeBox AI has been named by the SPUR Coalition, an international nonprofit of 37 news and media organizations, as one of four founding co-authors of its Evidence Profile Technical Committee, adopted Sept. 2, 2026, to draft an evidence profile for SPUR's Content Telemetry standard: a way for publishers to verify AI usage reports without depending on the reporting company's cooperation. Under SPUR's current standard, AI companies self-report their content use. A company that skips reporting leaves no record, and publishers can't check what they do receive. On July 10, 2026, FuzeBox proposed its Verified Provenance Telemetry Standard (VPTS): publishers seed content with detectable markers, then verify their appearance in AI outputs via an auditable ledger, with no change to SPUR's standard. Within 48 hours, three organizations filed related proposals: ProRata on usage magn

Mary Kay Introduces the K-Beauty Texture Edit5.10.2026 14:02:00 CEST | Press release

Special-Edition Korea-Made Skin Care Collection Launches In 40 Markets, Available While Supplies Last Mary Kay Inc.,the iconic beauty giant announced today the launch of the K-Beauty Texture Edit, aspecial-edition skin care collection available while supplies last. The collection builds on the momentum of the company's largest consumer-facing global brand platform, Beauty Is More Beautiful Shared™ which launched in September. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20261005600130/en/ Mary Kay's Special Edition K-Beauty Texture Edit is a trend-forward collection which includes three Korea-made products: the Mary Kay® Melt-In Cleansing Balm, Mary Kay® Snail Gel Face Patches and Mary Kay® Collagen Moisturizing Gel. (Image Credit: Mary Kay Inc.) Inspired by Korea's globally influential skin care and self-care philosophy designed to bring playful textures, innovative ingredients, and elevated beauty experiences, the K-Beauty

GE HealthCare to Acquire SOFIE Biosciences, Establishing a 'Final Mile' Footprint for PET Radiopharmaceutical Supply in the U.S.5.10.2026 14:00:00 CEST | Press release

Broadens GE HealthCare's footprint in the U.S. radiopharmaceutical industry, drives patient access to F18 labeled Positron Emission Tomography (PET) radiopharmaceuticals and enhances exposure to new high-growth areas Pharmaceutical Diagnostics (PDx) continues to partner with other established Contract Manufacturing Organizations (CMOs) to drive and expand patient access to its radiopharmaceutical portfolio, while SOFIE Biosciences continues to supply PET products from other leading radiopharmaceutical providers Provides U.S. rights to FAPI-74, a Phase III pipeline PET radiotracer with pan-cancer imaging potential, aiming to be among the first-to-launch in a large and fast-growing market1 GE HealthCare (Nasdaq: GEHC) today announced a definitive agreement to acquire SOFIE Biosciences, a leading U.S.-based CMO for PET radiopharmaceuticals, from Trilantic North America, for a purchase price of $945 million paid in cash. The transaction is expected to close in the first half of 2027, subje

Henkell Freixenet Strengthens Premium Dealcoholized Sparkling Wine Production with Solos' Patented Aroma Recovery System5.10.2026 13:24:00 CEST | Press release

The installation marks a significant step in the evolution of premium No/Low wines, where preserving aroma and sensory quality has become a defining industry priority. Henkell Freixenet is expanding its premium dealcoholized sparkling wine production capabilities through the deployment of Solos Technology's patented Aroma Recovery System (ARS) at its Wiesbaden production site, the Group’s expertise centre for alcohol-free production. The installation represents a significant investment in next-generation dealcoholized sparkling wine production, helping preserve the natural aroma and sensory identity of the original wines. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20261005959301/en/ Fürst von Metternich Riesling Alcohol-free on the bottling line, one of the first products in Henkell Freixenet’s portfolio developed in collaboration with Solos Technology. The project combines Henkell Freixenet's longstanding winemaking exper

Croma-Pharma Expands Its Portfolio in Canada With saypha® lips Lidocaine and Exprecell™5.10.2026 13:12:00 CEST | Press release

Croma-Pharma continues to build its portfolio in Canada, adding saypha® lips Lidocaine, a hyaluronic acid filler for lip augmentation,1 and Exprecell™, a medical device for the preparation of autologous PRP | Fluid-PRF.2 Both are distributed by Renellence, Croma's partner in Canada since 2025. The two additions reflect Croma's broader approach: pairing established hyaluronic acid expertise with autologous, regenerative technologies. Together, they give practitioners options across both aesthetic and regenerative treatment categories, from a single trusted source. "With saypha® lips Lidocaine and Exprecell™, we're giving Canadian practitioners a wider set of tools for facial aesthetics and regenerative treatments, each held to the same standard of precision and safety," said Andreas Prinz, Chief Executive Officer of Croma-Pharma GmbH. Renellence has distributed Croma's Saypha® hyaluronic acid filler range in Canada since October 2025, alongside medical education and training for Canadia

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