Vertex Announces Access Contract in Denmark for Current and Future Cystic Fibrosis Medicines
October 01 2018 - 8:02AM
Business Wire
- First-of-its-kind contract with the Danish
pharmaceutical and procurement organization, Amgros, is effective
from today -
- Vertex also announces reimbursement in
Austria for ORKAMBI® (lumacaftor/ivacaftor) to treat patients ages
6 through 11 with two copies of the F508del mutation -
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.
About CF
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.
About Vertex
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.
(VRTX-GEN)
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+1-617-341-6108orEric Rojas, +1-617-961-7205orZach Barber,
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