Vertex Announces Access Contract in Denmark for Current and Future Cystic Fibrosis Medicines
Vertex Pharmaceuticals (Europe) Limited today announced it has entered into an innovative access contract with the Danish pharmaceutical and procurement organization, Amgros. Effective from today, this first-of-its-kind contract includes current and future CFTR modulator medicines, and means eligible Danish cystic fibrosis (CF) patients will have access to all current medicines as well as future medicines after regulatory approval.
“We’re delighted to have collaborated with Amgros to finalize this pioneering contract,” said Ludovic Fenaux, Senior Vice President, International Commercial Operations at Vertex. “Our medicines have fundamentally changed the way CF is treated and we share the community’s sense of urgency for rapid access. This contract also allows Danes with CF to be among the first in the world to access our future CFTR modulator medicines.”
“I would like to thank Vertex for its will and engagement to make this deal. Most of all, I’m happy that we have made it possible to offer a group of patients the newest treatments. And naturally, I’m also enthusiastic that this new kind of contract gives the Danish hospitals and their owners in the regions much more predictable budgets – at times of rising costs of hospital medicines,” said Flemming Sonne, CEO at Amgros.
Earlier this month, an agreement in Austria was also secured to provide access to ORKAMBI® (lumacaftor/ivacaftor) for all children with CF ages 6 through 11 with two copies of the F508del mutation. This agreement is also effective from today.
Austrians and Danes with CF join patients in other countries around the world who have access to CFTR modulator treatments, including Australia, Germany, Ireland, Italy, the Netherlands, Sweden and the U.S.
Cystic fibrosis is a rare, life-shortening genetic disease affecting approximately 75,000 people in North America, Europe and Australia.
CF is caused by a defective or missing cystic fibrosis transmembrane conductance regulator (CFTR) protein resulting from mutations in the CFTR gene. Children must inherit two defective CFTR genes — one from each parent — to have CF. There are approximately 2,000 known mutations in the CFTR gene. Some of these mutations, which can be determined by a genetic test, or genotyping test, lead to CF by creating non-working or too few CFTR proteins at the cell surface. The defective function or absence of CFTR protein results in poor flow of salt and water into and out of the cell in a number of organs. In the lungs, this leads to the build-up 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 mid-to-late 20s.
About ORKAMBI ® (lumacaftor/ivacaftor) and the F508del mutation
In people with two copies of the F508del mutation, the CFTR protein is not processed and trafficked normally within the cell, resulting in little-to-no CFTR protein at the cell surface. Patients with two copies of the F508del mutation are easily identified by a simple genetic test.
ORKAMBI ® is a combination of lumacaftor, which is designed to increase the amount of mature protein at the cell surface by targeting the processing and trafficking defect of the F508del-CFTR protein, and ivacaftor, which is designed to enhance the function of the CFTR protein once it reaches the cell surface. Lumacaftor/ivacaftor is available as tablets and is typically taken twice per day.
For complete product information, please see the Summary of Product Characteristics that can be found on www.ema.europa.eu.
Vertex is a global biotechnology company that invests in scientific innovation to create transformative medicines for people with serious and life-threatening diseases. In addition to clinical development programs in CF, Vertex has more than a dozen ongoing research programs focused on the underlying mechanisms of other serious diseases.
Founded in 1989 in Cambridge, Mass., Vertex's headquarters is now located in Boston's Innovation District. Today, the company has research and development sites and commercial offices in the United States, Europe, Canada, Australia and Brazil. Vertex is consistently recognized as one of the industry's top places to work, including being named to Science magazine's Top Employers in the life sciences ranking for eight years in a row.
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 in the second and third paragraphs of this press release. While Vertex believes the forward-looking statements contained in this press release are accurate, there are a number of factors that could cause actual events or results to differ materially from those indicated by such forward-looking statements. Those risks and uncertainties include, among other things, risks related to commercializing our products and the other risks listed under Risk Factors in Vertex's annual report and quarterly reports filed with the Securities and Exchange Commission. Vertex disclaims any obligation to update the information contained in this press release as new information becomes available.
Vertex Pharmaceuticals Incorporated
Michael Partridge, +1-617-341-6108
Eric Rojas, +1-617-961-7205
Zach Barber, +1-617-341-6470
Heather Nichols, + 1-617-341-6992
Europe & Australia:
Rob Clark, +44 7736 473 227
Om Business Wire
(c) 2018 Business Wire, Inc., All rights reserved.
Business Wire, a Berkshire Hathaway company, is the global leader in multiplatform press release distribution.
Følg saker fra Business Wire
Registrer deg med din epostadresse under for å få de nyeste sakene fra Business Wire på epost fortløpende. Du kan melde deg av når som helst.
Siste saker fra Business Wire
KOKUYO's "360° Gliding Chair ing" Wins FRAME Awards ORGATEC 2018 in Two Categories10.12.2018 09:00 | Pressemelding
KOKUYO Co., Ltd. (TOKYO:7984), a leading provider of office design and furniture in Japan, won FRAME Awards for "360º Gliding Chair ing" in two categories at ORGATEC 2018, “Trade Fair Stand of the Year” and “Best Use of Light,” which is organized by the Dutch interior design magazine "FRAME." This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20181210005248/en/ KOKUYO's "360° Gliding Chair ing" Wins FRAME Awards ORGATEC 2018 (Photo: Business Wire) ORGATEC 2018, the largest International Trade Fair for Furnishing and Management of Offices and Office Facilities was held from October 23 to 27 in Cologne, Germany. Internationally renowned creators and critics from Amsterdam, Berlin, and elsewhere in Europe were the judges of FRAME Awards critiquing global furniture manufacturer booths in four categories: Best Use of Colour, Best Use of Light, Best Use of Material, and Trade Fair Stand of the Year. Winners in these categories will be h
SIAE MICROELETTRONICA Outperforms Telefónica 10Gbps E-band Tests to Power 5G Backhauling10.12.2018 08:00 | Pressemelding
Telefónica a global leader mobile operator and SIAE MICROELETTRONICA a leader in wireless transport technology have put to the test the high capacity 10Gbps wireless links to enhance the backhauling network for the future advent of 5G. The millimetre-wave point-to-point radio operating at 80GHz E band carrier, offers the lowest transport latency and the highest wireless capacity of 10Gbps over a single channel, satisfying the strict 5G requirements. Telefónica successfully field tested SIAE MICROELETTRONICA millimetre-wave radio solution in two use cases: 10Gbps point-to-point links addressing urban applications and the multicarrier link aggregation addressing the sub-urban applications, pushing high capacity connectivity to longer distances. “SIAE MICROELETTRONICA and Telefónica have cooperated over multiple projects all aiming to satisfy the 5G backhaul requirements. From microwave SDN applications to the introduction of state of the art millimetre-wave radio, once again crossing tog
Fishawack Acquires Creative Consultancy Blue Latitude Health10.12.2018 07:00 | Pressemelding
The Fishawack Group of Companies, one of the world’s largest independent medical communications and medical marketing organizations, has acquired Blue Latitude Health, based in London, UK, and New York, USA. Blue Latitude Health is a creative consultancy combining the commercial focus of a consultancy with the creative vision of an agency. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20181209005023/en/ Dominic Miller, Fred Bassett, Oliver Dennis (back row from left to right), Martin Brass, Gail Flockhart (front row from left to right). (Photo: Business Wire) “In 2016, we set out our vision to form a major new force in the global creative agency space that would make us as strong in the creative arena as we already are in medical communications,” explained Oliver Dennis , Chief Executive Officer of the Fishawack Group. “With three acquisitions in this space in the last 16 months, I think we’ve firmly announced our intention t
Gilead Sciences Names Daniel O’Day Chairman and Chief Executive Officer10.12.2018 06:00 | Pressemelding
Gilead Sciences, Inc. (Nasdaq: GILD) announced today that its Board of Directors has named Daniel O’Day Chairman of the Board and Chief Executive Officer, effective March 1, 2019. Mr. O’Day is currently the CEO of Roche Pharmaceuticals. He has held the position since 2012, and prior to that led Roche Diagnostics. His career spans three decades of diverse leadership roles across North America, Asia Pacific and Europe. The Board has also appointed Gregg Alton as interim Chief Executive Officer for the period of January 1, 2019 until Mr. O’Day’s start date of March 1, 2019. Mr. Alton has held a number of executive positions at Gilead over the past 20 years, with experience in legal, medical affairs, policy and commercial. He previously served as general counsel and in August of this year, was appointed Chief Patient Officer. “Following a comprehensive search, the Board became convinced that Dan is the right leader to bring Gilead into the future,” said John C. Martin, PhD, Chairman, Gilea
Samsung Bioepis Announces Results of Additional One-Year Follow-Up Study Comparing Event-Free Survival of SB3 Trastuzumab Biosimilar Candidate to Reference Trastuzumab by ADCC Activity8.12.2018 14:10 | Pressemelding
Samsung Bioepis Co., Ltd. today announced the results of an additional one-year follow-up study comparing event-free survival (EFS) of SB3, a biosimilar candidate referencing HERCEPTIN® 1 (trastuzumab), to reference trastuzumab (TRZ) by antibody-dependent cell-mediated cytotoxicity (ADCC) activity. ADCC is a key mechanism of action for trastuzumab. The study results are being presented at the 2018 San Antonio Breast Cancer Symposium® (SABCS) which is being held December 4-8, 2018 in San Antonio, Texas. For the study, patients with HER2 positive early or locally advanced breast cancer were randomly assigned to receive SB3 or TRZ concurrently with chemotherapy. Patients then underwent surgery followed by treatment with SB3 or TRZ. Following completion of such therapy, 367 patients participated in a long-term follow-up study, 186 of whom were treated with SB3 and 181 of whom were treated with TRZ. Within the group of 181 patients who received TRZ, 126 patients who were exposed to at least
Harvest Health & Recreation, Inc. to hold Conference Call to Discuss Q3 2018 Results and Performance Outlook7.12.2018 19:00 | Pressemelding
Harvest Health & Recreation, Inc. (HARV: CSE) will hold its Third Quarter 2018 earnings conference call on: Tuesday, December 11, 2018 8:30 AM (Eastern Time) Participating on the call to review Harvest Health & Recreation’s Third Quarter 2018 financial and operating results will be Jason Vedadi, Executive Chairman, Steve White, Chief Executive Officer, and Steve Gutterman, President. Third quarter results are available at www.harvestinc.com/news. To participate in the conference call, please dial: US toll free +1-866-777-2509 Canada toll free +1-866-605-3852 UK toll free +44-080-823-89064 International dial in +1-412-317-5413 Registration is required; please dial in at least ten minutes prior to the scheduled start time. Webcast: https://services.choruscall.com/links/harv181211.html The conference call will be available for replay for 3 months at: https://services.choruscall.com/links/harv181211.html. About Harvest Health & Recreation, Inc. Harvest Health & Recreation, Inc. is one of t