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
Bureau Veritas Confirms LEAP | 28 Ambition, Upgrades Total Revenue Growth to Double-Digit in 2027 – 20281 and Targets EUR1 Billion Revenue in AI-Driven Markets and Services by 203022.9.2026 07:30:00 CEST | Press release
Bureau Veritas (BOURSE:BVI): CAPITAL MARKETS DAY 2026 Today, Bureau Veritas hosts its Capital Markets Day. The Company will present an update on the progress of its LEAP | 28 strategy, building on three years of successful execution. › 2024-2026 achievements:Proven track record: mid-to-high single-digit organic revenue growth (7-8%) delivered across 2023–2026e2, with 115 basis points of adjusted operating margin improvement3; Portfolio transformation on track: c. 21.0% of the portfolio rotated since LEAP | 28 launch, with EUR1.2 billion of revenue acquired, sold or to be exited through 24 acquisitions, 4 divestments and 1 exit; New operating model: the active portfolio management delivered allowed the Company to create a new operating model that simplifies its growth algorithm. Combined with a simplified organization with four divisions and ten Product Lines, it sharpens Bureau Veritas’ position as a focused multi-specialist Company; Driving growth and profitability: through Portfolio
OPM Biosciences Launches Integrated Cell Culture Media-to-Manufacturing Platform for Biosimilar Development22.9.2026 07:00:00 CEST | Press release
New portfolio combines high-performance cell culture media, molecule-specific CQA optimization, and integrated CDMO capabilities to help biosimilar developers accelerate the path to analytical similarity and improve process economics. OPM Biosciences, a cell culture media and bioprocess solutions company, today announced two new offerings that extend its OPM-CHO™ platform into biosimilar development and manufacturing: the Biosimilar Media Optimization Service and the Sureness™ Biosimilar Platform. Cell culture media can significantly influence cell growth, productivity, and critical quality attributes (CQAs), making media strategy an important component of biosimilar process development. OPM-CHO, the company’s portfolio of chemically defined cell culture media for CHO-based biomanufacturing, has supported more than 390 molecules in clinical and commercial stages worldwide, including biosimilars. Across 35 side-by-side evaluations, OPM-CHO media delivered an average titer improvement of
H2SITE Secures €3.4 Million (NOK 39.1 million) in Enova Funding to Scale Onboard Ammonia-To-Power for Commercial Maritime Applications22.9.2026 06:00:00 CEST | Press release
The 700 kW system builds on H2SITE’s previous maritime deployments and is designed as a modular, replicable solution for auxiliary power onboard vessels H2SITE has secured €3.4 million (NOK 39.1 million) in funding from Enova for HydraNord Power, a project that will develop and validate a commercial-scale onboard ammonia-to-power system for the maritime sector. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260921324898/en/ Enova is one of the Norwegian government's primary instruments for accelerating the country's climate and energy transition. Its primary responsibility is to manage the Climate and Energy Fund on behalf of the Norwegian government. For H2SITE, Enova’s support is a major milestone in the commercialisation of its onboard ammonia cracking technology, enabling the company to scale from proven maritime demonstrations to replicable commercial solutions for the global shipping industry. Led by H2SITE, HydraNord
EcoOnline Recognised as a Leader in Verdantix Green Quadrant: EHS Software 2026 for Third Time21.9.2026 18:43:00 CEST | Press release
EcoOnline achieved highest score for Safety Management and ranked among the top three vendors for Chemicals Management, Training and Contractor Safety with Lone Worker Protection a key differentiator. EcoOnline, the global provider of software that transforms how organisations protect people and the planet, has been recognised for the third consecutive time as a Leader in the independent Verdantix Green Quadrant: EHS Software 2026 report, with market-leading strength in Safety Management. The assessment evaluated leading vendors of environmental, health and safety software vendors across a range of capabilities and customer buying signals. Verdantix recognised EcoOnline’s strength in the areas organisations rely on to protect workers every day: Safety Management, Chemicals Management, AI-enabled Training and Contractor Safety. It reflects the changing needs of EHS buyers, who are increasingly looking for integrated platforms that connect everyday safety with broader operational risk an
rhode Announces the Return of Limited Edition Favorites and New Exclusives at Sephora Across Europe and the U.K.21.9.2026 15:00:00 CEST | Press release
rhode, the beauty brand founded by Hailey Rhode Bieber and part of e.l.f. Beauty (NYSE: ELF), has announced that two community-favorite Peptide Lip Tints and a new Sephora-exclusive bag will launch at Sephora across Europe and the U.K. to celebrate the brand’s launch into Sephora in Europe on September 30, 2026. These items will join the brand’s assortment of high-performance skincare and hybrid makeup. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260921199856/en/ rhode announces the return of limited edition favorites and new exclusives at Sephora across Europe and the U.K. To mark the occasion with Sephora across Europe and the U.K., rhode is offering early access to purchase fan-favorite, previously limited edition Peptide Lip Tint in Pretzel at Sephora in Europe and the U.K. on the brand’s launch date September 30, before the product joins rhode’s permanent assortment globally on rhodeskin.com on October 1 and at all r
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
