Business Wire

VERTEX-PHARMACEUTICALS

21.4.2020 08:02:52 CEST | Business Wire | Press release

Share
Vertex Announces Innovative Reimbursement Agreement in Switzerland for ORKAMBI® (lumacaftor/ivacaftor) and SYMDEKO® (tezacaftor/ivacaftor and ivacaftor) for Eligible Cystic Fibrosis Patients

Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced that it has reached an agreement with the Swiss Federal Office of Public Health (FOPH) and the Swiss Federal Social Insurance Office (FSIO) for the reimbursement of ORKAMBI® (lumacaftor/ivacaftor) and SYMDEKO® (tezacaftor/ivacaftor and ivacaftor) for eligible patients in Switzerland living with cystic fibrosis (CF).

Under the terms of the agreement announced today, eligible patients ages two years and older with CF who have two copies of the F508del mutation in the cystic fibrosis transmembrane conductance regulator (CFTR ) gene can be treated with ORKAMBI® . Eligible patients ages 12 years and older who either have two copies of the F508del mutation, or one copy of the F508del mutation and another responsive residual function mutation in the CFTR gene, can be treated with SYMDEKO® . The agreement also includes any future indication extensions for patients of different ages for SYMDEKO® .

This agreement also enables the possibility for rapid patient access to a potential future triple combination regimen (elexacaftor/tezacaftor/ivacaftor and ivacaftor) pending marketing authorization from Swissmedic, the Swiss Agency for Therapeutic Products. Vertex submitted an application to Swissmedic on March 24, 2020.

Commenting about today’s news in Switzerland, Ludovic Fenaux, Senior Vice President, Vertex International, said, “This agreement is an important milestone for the cystic fibrosis community in Switzerland. Access to Orkambi and Symdeko is especially important at this time given the COVID-19 outbreak and that people with CF are vulnerable to infections. We are pleased that Vertex and the Swiss authorities have been able to work closely and flexibly to enable this agreement, so that almost 400 eligible Swiss patients will now have access to CFTR modulators to treat the underlying cause of their disease.”

Vertex’s CF medicines are reimbursed in more than 20 countries around the world including Australia, France, Germany, the Republic of Ireland, Italy, the Netherlands, Spain, Sweden, the UK and the U.S.

About Cystic Fibrosis

Cystic Fibrosis (CF) is a rare, life-shortening genetic disease affecting approximately 75,000 people worldwide. CF is a progressive, multi-system disease that affects the lungs, liver, GI tract, sinuses, sweat glands, pancreas and reproductive tract. CF is caused by a defective and/or missing CFTR protein resulting from certain mutations in the CFTR gene. Children must inherit two defective CFTR genes — one from each parent — to have CF. While there are many different types of CFTR mutations that can cause the disease, the vast majority of all people with CF have at least one F508del mutation. These mutations, which can be determined by a genetic test, or genotyping test, lead to CF by creating non-working and/or too few CFTR proteins at the cell surface. The defective function and/or absence of CFTR protein results in poor flow of salt and water into and out of the cells in a number of organs. In the lungs, this leads to the buildup of abnormally thick, sticky mucus that can cause chronic lung infections and progressive lung damage in many patients that eventually leads to death. The median age of death is in the early 30s.

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 multiple approved medicines 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 diseases. 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 this press release, statements regarding our expectations for the patient populations that will be able to access Vertex’s medicines and the timing of such access, and statements about our plans to submit a marketing authorization application for the triple combination regimen to Swissmedic. 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/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

Mirum Pharmaceuticals and Incyte Announce U.S. FDA Approval of Atebrioz™ (zilurgisertib) for Adult and Pediatric Patients with Fibrodysplasia Ossificans Progressiva26.9.2026 01:00:00 CEST | Press release

-Once-daily oral ALK2 inhibitor approved to reduce the volume of total new heterotopic ossification in patients aged 12 years and older with FOP-Atebrioz expected to be available in the United States in October through Mirum Access Plus (MAP), with eligible patients paying as little as $0 per month-PROGRESS pediatric development program continues to evaluate zilurgisertib in children aged 2 to <12 years Mirum Pharmaceuticals, Inc. (Nasdaq:MIRM) and Incyte (Nasdaq:INCY) today announced that the U.S. Food and Drug Administration (FDA) has approved Atebrioz™ (zilurgisertib) tablets to reduce the volume of total new heterotopic ossification (HO) in adult and pediatric patients aged 12 years and older with fibrodysplasia ossificans progressiva (FOP). The recommended dose of Atebrioz is 100 mg administered orally, once daily. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260925436454/en/ “Today marks an important milestone for pe

Digital Reef Signs Offtake Agreement with Oreasoc Agriculture to Mitigate the Environmental Footprint of Data Centre Growth Through Rainforest Protection, Appointing Xange.com as Digital MRV Partner25.9.2026 21:19:00 CEST | Press release

The offtake agreement connects Digital Reef’s 3.3 GW data centre pipeline with environmental assets from more than 30 million hectares of Amazon rainforest across South America, where Oreasoc Agriculture works directly on the ground alongside local communities to develop sustainable economies and safeguard their territories. Xange.com’s digital MRV technology monitors both the data centres and the rainforest. At Climate Week NYC, Digital Reef and Oreasoc Agriculture Inc. sign an offtake agreement connecting Digital Reef’s 3.3 GW data centre pipeline with environmental assets exceeding 30 million hectares of South American Amazon rainforest, mitigating the environmental footprint of data centre growth through rainforest protection and restoration where Oreasoc works alongside local communities to protect biodiversity, develop sustainable economies and safeguard their territories. Xange.com are appointed as digital MRV technology partner to monitor the data centres and rainforest where D

NetApp Announces Intent to Acquire PEAK:AIO to Advance Scalable AI Infrastructure Architecture25.9.2026 15:00:00 CEST | Press release

Planned acquisition strengthens NetApp's position in the rapidly growing AI infrastructure market by bringing differentiated metadata innovation and parallel file architecture designed for AI NetApp® (NASDAQ: NTAP), the intelligent data infrastructure company, today announced its intent to acquire PEAK:AIO, a pioneer in next-generation metadata architecture and high-performance parallel file systems. The planned acquisition is expected to accelerate NetApp's AI infrastructure roadmap by augmenting metadata services and parallel namespace innovation designed to help AI clouds scale shared storage alongside growing GPU clusters. As AI becomes embedded in every enterprise workload, organizations are confronting a new challenge: traditional storage architectures were not designed for the unprecedented scale, concurrency, and performance requirements of AI factories, AI clouds, and next-generation data-intensive applications. NetApp is building an architecture that disaggregates metadata fr

MultiBank Group Secures Two Awards at Forex Expo Dubai 202625.9.2026 14:57:00 CEST | Press release

The Group was recognised for the strength of its global institutional ecosystem and its contribution to financial markets innovation and community impact MultiBank Group, one of the world’s largest financial derivatives institutions, received two awards during its participation at Forex Expo Dubai 2026, held on 22 and 23 September at Dubai World Trade Centre. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260925539591/en/ MultiBank Group was named “Best Global Institutional Financial Ecosystem of the Year” and received the award for “Excellence in Global Financial Markets Innovation and Community Impact.” The Group was named “Best Global Institutional Financial Ecosystem of the Year” and received the award for “Excellence in Global Financial Markets Innovation and Community Impact.” The first award recognised the strength and breadth of MultiBank Group’s global institutional offering, which brings together trading, liquidity

Croma-Pharma Introduces saypha® volume prime Lidocaine25.9.2026 14:04:00 CEST | Press release

New cross-linked hyaluronic acid filler replaces saypha® volume Lidocaine, offering physicians a more versatile solution for both midface volumization and nasolabial folds Croma-Pharma introduces saypha® volume prime Lidocaine, a cross-linked hyaluronic acid dermal filler that replaces saypha® volume Lidocaine within the company's saypha® portfolio. The new product offers physicians a more versatile solution with expanded indications for both midface volumization and nasolabial folds, backed by strong clinical data. 1,2 saypha® volume prime Lidocaine demonstrated non-inferiority to comparatora in a randomized, subject- and evaluator-blinded, controlled, non-inferiority multicenter, parallel group comparison study with almost 500 patients.2 In the clinical evaluation, a high patient satisfaction highlights improved midface fullness, smoothness and contour, consistent with a rheologic profile designed to provide volumization in the mobile midface.b,2 With saypha® volume prime Lidocaine,

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