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

2PointZero Group Signals Global Scale With Revenue Surge to AED 21.9 Billion and Net Profit of AED 7.7 Billion in H1 202631.7.2026 13:42:00 CEST | Press release

Group revenue growth supported by stable gross profit margin of 29%, and adjusted EBITDA of AED 5.0 billionGlobal expansion milestones include the completed sale of TAQA stake, and the acquisition of Traverse Midstream Partners in North America, Baobab Group in Africa, and 60.8% of ISEM in ItalyTIME ranks the Group 36th on the World’s Growth Leaders list for 2026, highlighting market stability, operational scale and disciplined approach to capital 2PointZero Group (ADX: 2POINTZERO), a leading Abu Dhabi-based investment holding firm, announced its financial results for the first half of 2026, reporting revenue of AED 21.9 billion and delivering a Group Net Profit of AED 7.7 billion. This robust performance is reflected in the Group’s adjusted EBITDA, which reached AED 5.0 billion after excluding fair value changes and one-offs. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260731538982/en/ Samia Bouazza, CEO of 2PointZero (P

Datroway® Approved in the EU as Only TROP2 Directed Medicine with Overall Survival Benefit for the First-Line Treatment of Patients with Metastatic TNBC Who Are Not Candidates for Immunotherapy31.7.2026 08:30:00 CEST | Press release

Approval based on TROPION-Breast02 phase 3 trial results where Daiichi Sankyo and AstraZeneca’s Datroway showed a statistically significant and clinically meaningful improvement for the dual primary endpoints of overall survival and progression-free survival Datroway now approved for two breast cancer indications in the EU Datroway® (datopotamab deruxtecan) has been approved in the European Union (EU) as monotherapy for the first-line treatment of adult patients with unresectable or metastatic triple negative breast cancer (TNBC) who are not candidates for PD-1/PD-L1 inhibitor therapy. Datroway is a specifically engineered TROP2 directed DXd antibody drug conjugate (ADC) discovered by Daiichi Sankyo (TSE: 4568) and being jointly developed and commercialized by Daiichi Sankyo and AstraZeneca (LSE/STO/NYSE: AZN). The approval by the European Commission follows the positive opinionof the Committee for Medicinal Products for Human Use of the European Medicines Agency and is based on result

Polpharma Biologics Announces FDA and EMA Acceptance for Review of PB016 Vedolizumab Biosimilar Candidate31.7.2026 08:30:00 CEST | Press release

Polpharma Biologics International AG today announces that the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) have accepted for review the Biologics License Application (BLA) and Marketing Authorisation Application (MAA), respectively, for PB016, a proposed vedolizumab biosimilar candidate to Takeda’s reference product Entyvio®* (vedolizumab) lyophilized vial for intravenous (IV) administration for the treatment of adults with moderately to severely active ulcerative colitis and Crohn's disease. The BLA and MAA acceptances represent significant milestones in Polpharma Biologics' development program and underscore the company's commitment to advancing high-quality biosimilars and expanding global access to affordable biologic medicines. "FDA and EMA acceptances for review of our IV vedolizumab biosimilar candidate mark a major achievement for Polpharma Biologics and validate our deep scientific expertise in biosimilar development and manufacturing," said

SES: Disclosure of Share Buyback Transactions31.7.2026 07:30:00 CEST | Press release

In the time period from June 2, 2026 until and including June 23, 2026, a number of 213,167 shares were bought back within the framework of the share buyback of SES to meet obligations under SES’s Equity Based Compensation Plan (EBCP). Shares were bought back as follows: Day of purchase Aggregated volume in shares Daily weighted average acquisition price of shares (EUR) Market June 2, 2026 27,097 8.8727 DXE June 2, 2026 72,903 8.8556 ENX June 5, 2026 16,624 8.3723 DXE June 5, 2026 31,510 8.4266 ENX June 15, 2026 26,451 7.8423 XPAR June 17, 2026 26,812 7.3910 XPAR June 23, 2026 11,770 7.2200 XPAR The transactions in a detailed form are published on SES’s website: https://www.ses.com/investors/shareholder-information/share-buy-backs. Follow us on: Twitter | Facebook | YouTube | LinkedIn | Instagram Read our Blogs > Visit the Media Gallery > About SES At SES, we believe that space has the power to make a difference. That’s why we design space solutions that help governments protect, busin

Half-Year Report on SES’s Liquidity Contract31.7.2026 07:30:00 CEST | Press release

Pursuant to the liquidity contract entered into by SES with BNP Paribas as of 7 April 2026, please see the below update on the progress of the liquidity services. When the liquidity services were implemented as of 7 April 2026, the following assets were in the liquidity account: € 2,500,000 As of 30 June 2026, the following assets appeared on the liquidity account: 228,186 shares; € 816,880. Over the period from 7 April 2026 to 30 June 2026, the following transactions were executed: 1,082 buy transactions; 1,308 sales transactions. Over this same period, the volumes traded represented: 1,093,335 shares and € 8,485,986 on the buy side; 873,399 shares and € 6,860,843 on the sell side. Follow us on: LinkedIn | Facebook | YouTube | X | Instagram Read our Blogs > Visit the Media Gallery > About SES At SES, we believe that space has the power to make a difference. That’s why we design space solutions that help governments protect, businesses grow, and people stay connected—no matter where th

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