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

Sofinnova Partners Announces Myricx Bio Agrees to Be Acquired by Novartis6.7.2026 07:15:00 CEST | Press release

Sofinnova Partners co-led the seed investment in 2019 and has supported the company from founding through to exitThe proposed acquisition combines the oncology expertise of Novartis with Myricx Bio’s novel ADC assets and platform having broad potential across multiple solid tumor typesMyricx Bio's first-in-class NMTi payload platform is designed to improve the therapeutic index of ADCs, offering the potential for more effective and better-tolerated treatment options for cancer patientsThe transaction valued at up to $1.5 billion including $1.1 billion cash upfront Sofinnova Partners, a leading European life sciences venture capital firm, today announced that its portfolio company Myricx Bio (“Myricx”) has reached agreement to be acquired by Novartis, for up to $1.5 billion including $1.1 billion cash upfront plus potential milestone payments. This marks Sofinnova Partners' seventh exit in three years. Myricx Bio is a UK-headquartered transatlantic biotech company focused on the discove

Global New Material International Wins Technology Innovation Best Practice Award at Sino-European ESG Conference6.7.2026 05:59:00 CEST | Press release

Global New Material International Holdings Ltd. has received the Technology Innovation Best Practice Award at the Third Sino-European Corporate ESG Best Practice Conference recently in Mainz, Germany, in recognition of its efforts to advance sustainable development through material innovation. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260705533555/en/ Thorsten Giehler (L), Director of the Economic, Social Development and Employment Division of The German Society for International Cooperation (GIZ), delivered the award to Zhou Fangchao, Executive Director and Vice President of Global New Material International. The annual conference, initiated by the Chinese Consulate General in Frankfurt and jointly organized with Chinese and European partners, recognizes corporate best practices in environmental, social and governance (ESG) performance. This year's event brought together government officials, business leaders and exper

Access Advance Welcomes Samsung and Sharp to the VVC Advance Patent Pool6.7.2026 02:00:00 CEST | Press release

Access Advance LLC today announced significant additions to the VVC Advance Patent Pool, including Samsung Electronics and Sharp Corporation joining as both Licensors and Licensees. The additions strengthen Access Advance's position in VVC licensing, bringing two of the world's largest video codec patent holders into the program on both sides of the license. "The growth we are seeing in VVC Advance reflects the broad range of industries and companies that are moving toward VVC as the next standard for video delivery," said Peter Moller, CEO of Access Advance. "Samsung and Sharp joining as both Licensors and Licensees is significant, but so is the participation of leading smartphone brands and the range of consumer electronics and technology companies now executing licenses. We are building a program that reflects where the video market is actually heading." The following companies have joined the VVC Advance Patent Pool as Licensees since the beginning of 2026: American Future Technolo

Kioxia and Sandisk Begin Production of 10th-Generation 3D Flash Memory Products atKitakami Plant Fab23.7.2026 12:19:00 CEST | Press release

Companies Showcase Ongoing Buildout of Manufacturing Infrastructure at K2 to Address Growing Demand for NAND Flash Kioxia Corporation, a subsidiary of Kioxia Holdings Corporation (TOKYO: 285A) and Sandisk Corporation (Nasdaq: SNDK) today announced the start of production for their 10th-generation 3D Flash memory technology at Fab2 (K2) at the Kitakami Plant in Iwate Prefecture in Japan. The milestone comes as the companies continue to drive meaningful, multi-year bit growth to address the strong demand for their innovative flash memory technology. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260702296115/en/ Unveiling ceremony for the K2 facility In conjunction with the start of production, the companies held an unveiling ceremony for the K2 facility. Opening in September 2025, the facility has produced the companies’ 8th-generation 3D flash memory products and will begin to scale production with the introduction of their

VeriSilicon Introduces CPP2000 Camera Post-Processing IP for Embodied Robotics and Mobile Vision Applications3.7.2026 12:02:00 CEST | Press release

Enhancing image quality and visual perception for moving-camera systems VeriSilicon (688521.SH) today announced its high-performance CPP2000 Camera Post-Processing (CPP) IP, expanding the company’s Image Signal Processing (ISP) solutions with advanced post-processing capabilities. By improving image quality and visual perception in mobile imaging scenarios, CPP2000 enables more reliable vision performance in robotics, drones, and other mobile vision applications. CPP2000 integrates multiple image processing technologies and can further optimize YUV images output from image signal processors. The IP supports image and video processing at up to 8K resolution and offers multiple hardware configuration options to meet diverse requirements in Power, Performance, Area (PPA), and latency across different applications. CPP2000 leverages the combined operation of multiple image processing technologies, including motion-compensated temporal filtering, advanced spatial noise reduction, chroma adj

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