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

Montrose Environmental Group Is Now Onterris21.4.2026 22:05:00 CEST | Press release

Earth Day launch of new, unified brand highlights commitment “For Planet & Progress” Montrose Environmental Group (NYSE: MEG, changing to ONT May 4, 2026) will mark Earth Day by rebranding to Onterris. The new, unified brand reflects a purpose and broader role in tackling complex environmental challenges with scientific rigor, operational quality and precise execution. It also aligns expertise and market awareness to position the Company for its next phase of growth. Founded 14 years ago and operating across the U.S., Canada and Australia, the Company is a leading pure-play environmental solutions provider. While the name is new, the mission remains unchanged: advancing our way of life without compromising the integrity of our environment. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260420842892/en/ At the heart of the new brand is a guiding principle: For Planet & Progress. “Onterris is more than a new name. This brand r

SBC Medical Announces Closing of Previously Announced Secondary Public Offering of 3.1 million shares of Common Stock21.4.2026 22:00:00 CEST | Press release

SBC Medical Group Holdings Incorporated (Nasdaq: SBC) (“the Company”), a Management Service Organization operating a wide range of franchise businesses across diverse medical fields, today announced the closing of its previously announced underwritten secondary public offering of 3,100,000 shares of the Company’s common stock by Dr. Yoshiyuki Aikawa (the “Selling Stockholder”) at the public offering price of $3.25 per share. The proceeds from the offering to the Selling Stockholder were approximately $10.1 million, before deducting underwriting discounts and commissions. The Company did not sell any shares of its common stock in the offering. The Selling Stockholder received all of the proceeds from the offering. Maxim Group LLC acted as the sole book-running manager and Roth Capital Partners acted as the co-manager for the offering. The offering was made pursuant to the Company’s effective shelf registration statement on Form S-3, including a base prospectus, filed with the U.S. Secur

NetApp Wins 2026 Google Cloud Infrastructure Modernization Partner of the Year for Storage21.4.2026 21:00:00 CEST | Press release

NetApp® (NASDAQ: NTAP), the Intelligent Data Infrastructure company, today announced that it has received the 2026 Google Cloud Infrastructure Modernization Partner of the Year for Storage Award. NetApp is being recognized for its achievements in the Google Cloud ecosystem, helping joint customers modernize their infrastructure and run enterprise workloads on Google Cloud using Google Cloud NetApp Volumes. “The Google Cloud Partner Awards honor the strategic innovation and measurable value our partners bring to customers,” said Kevin Ichhpurani, President, Global Partner Ecosystem and Channels, Google Cloud. “We are proud to name NetApp a 2026 Google Cloud Partner Award winner, celebrating their role in driving customer success over the last year.” The Google Cloud Infrastructure Modernization Partner of the Year for Storage Award recognizes partners that have helped their customers modernize their infrastructure by leveraging Google Cloud's innovative solutions, resulting in increased

Adtran and GLDS expand partnership to deliver billing-driven, zero-touch automation for subscriber lifecycle management21.4.2026 20:00:00 CEST | Press release

News summary: Service providers need simpler, billing-integrated automation to streamline activation, manage Wi-Fi and cut operational complexity Adtran’s Intellifi® managed Wi-Fi works with GLDS BroadHub®, enabling zero-touch automation from order entry through lifecycle management Solution reduces operational complexity, accelerates time to revenue and preserves operator control within an open ecosystem Adtran today announced a new phase in its long-standing partnership with GLDS, delivering billing-driven, zero-touch automation for subscriber lifecycle management. As broadband and managed Wi-Fi services scale, manual hand-offs between billing, OSS and in-home networking systems are no longer sustainable. By enabling GLDS BroadHub® to orchestrate subscriber creation, service activation and ongoing lifecycle changes across access and the connected home, the solution streamlines operations, accelerates time to revenue and reduces operational complexity. This approach gives broadband pr

Unleashing GEN4: a New Era of High-performance, Sustainable Electric Racing Begins21.4.2026 17:54:00 CEST | Press release

The debut of the GEN4 race car underlines a step change in electric racing performance. Set for its competitive debut in the 2026/27 Season, the GEN4 machine has a 71% increase in power. More road-relevant than ever, many of the biggest OEMs will take these innovations from track to road. The Fédération Internationale de l'Automobile (FIA) and Formula E have unleashed the GEN4 car on track in its debut run in the South of France, signalling the beginning of a new era for electric motor sport. This all-new car will be raced in the 2026/27 Season of the ABB FIA Formula E World Championship. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260421618886/en/ Unleashing GEN4: A new era of high-performance, sustainable electric racing begins Capable of speeds over 335kph (208mph), 0-100kph in approximately 1.8s, and 0-200kph in just 4.4s - 1.5s faster than its predecessor. GEN4 produces up to 600kW of power, a 71% increase in base ou

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