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

LTM Expands Collaboration with Google Cloud to Help Accelerate Gemini Enterprise Adoption at Scale7.10.2026 10:30:00 CEST | Press release

Collaboration brings together a dedicated Gemini Enterprise CoE and Customer Experience Center LTM, a Business Creativity partner to the world’s largest enterprises, today announced an expanded collaboration with Google Cloud to help accelerate adoption of Google Cloud’s Gemini Enterprise. The collaboration will help organizations build, deploy, and scale AI-powered solutions by combining Gemini Enterprise capabilities with LTM's deep industry expertise, engineering talent, and global delivery capabilities. As part of this collaboration, LTM is making significant investments to strengthen its Gemini Enterprise capabilities through a dedicated Gemini Enterprise Center of Excellence (CoE), Specialized Talent and Delivery Capabilities and the development of Industry-Focused AI Solutions that will be showcased at the upcoming, state-of-the-art Gemini EnterpriseCustomer Experience Center. These efforts are designed to help organizations drive enterprise-wide AI adoption, operationalize inte

Gemcorp and Fonds Souverain Malagasy Announce Strategic Partnership to Support Investment in Madagascar7.10.2026 10:00:00 CEST | Press release

Gemcorp and the Fonds Souverain Malagasy (“FSM”) signed a strategic partnership during the 81st United Nations General Assembly (“UNGA”) in New York, establishing a framework to support investment and the development of Madagascar’s strategic assets. Under the leadership of His Excellency Michael Randrianirina, President of the Republic of Madagascar and guided by his vision to “transform the potential and endowments of the country into tangible impacts for the people,” the partnership will support FSM and the Government of Madagascar in advancing the country’s growth and investment agenda. This includes a particular focus on unlocking the value of Madagascar’s mineral resources, alongside its broader assets across mining, energy and infrastructure. As part of this partnership, FSM and the Government of Madagascar will set the strategic direction and priorities, with Gemcorp supporting FSM in structuring projects, developing investment and financing solutions, and connecting projects w

High Awareness, Low Adoption: New Survey Reveals Nearly Half of Security Professionals Still Rely on Passwords7.10.2026 09:01:00 CEST | Press release

Global study from Yubico and Okta highlights a critical execution gap in enterprise security, shows how modern identity controls can eliminate password dependency. A new survey from Yubico (NASDAQ STOCKHOLM: YUBICO), the pioneer of phishing-resistant authentication and creator of the original passkey, the YubiKey, and Okta, Inc., reveals a significant gap between security knowledge and everyday practice. While security leaders overwhelmingly recognize phishing-resistant passkeys as more secure than passwords, nearly half still rely on vulnerable login methods in their daily work. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20261007969823/en/ Conducted by Talker Research, the annual 2026 Global State of Authentication* report surveyed nearly 2,000 cybersecurity and IT professionals across nine countries. The report highlights that cybersecurity's primary vulnerability is no longer a lack of education or awareness, but a stru

Wolters Kluwer brings AI-powered drafting directly into the Libra legal workspace7.10.2026 09:01:00 CEST | Press release

In addition to Libra’s existing Word Add-in, Drafting in Libra gives customers the flexibility to choose the drafting environment that best suits their workflow, while automatically applying their firm’s existing templates Wolters Kluwer Legal & Regulatory today announced the launch of Drafting, a major new capability within Libra by Wolters Kluwer, the company’s legal AI workspace. Drafting enables legal professionals to create, edit, review, and collaborate on Word documents directly within the workspace, reducing the need to switch between separate applications throughout the drafting process. Together with Libra's existing Word Add-in, which is already widely used by legal professionals today, the new capability provides customers with a second, fully integrated way to draft their documents. Depending on their preferences and workflow, they can either remain within the Microsoft Word environment or work end-to-end in the Libra legal AI workspace. At the core of Drafting is the Libr

ClaroNav Kolahi Inc. Announces EU MDR Certification for Navient Surgical Navigation System7.10.2026 09:00:00 CEST | Press release

ClaroNav Kolahi Inc. (CKI), a global developer and manufacturer of surgical navigation technologies, today announced that its Navient Surgical Navigation System has received certification under the European Union Medical Device Regulation, EU MDR. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20261007890668/en/ ClaroNav Kolahi Inc. Announces EU MDR Certification for Navient Surgical Navigation System The certification covers the Navient Image Guided Navigation System and its reusable surgical instruments, allowing CKI to continue offering Navient throughout the European Union under the EU MDR regulatory framework. “EU MDR certification is an important milestone for CKI and demonstrates our continued commitment to meeting the highest standards for safety, quality, and regulatory compliance,” said Ahmad Kolahi, CEO of CKI. Navient was previously certified under EU MDD and has received regulatory approvals including US FDA, Heal

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