Agreement Readies Denmark, Austria for Approval of Vertex CF Therapies

Agreement Readies Denmark, Austria for Approval of Vertex CF Therapies

Vertex Pharmaceuticals has entered a partnership with the Danish pharmaceutical organization Amgros to one day make Vertex’s cystic fibrosis (CF) therapies available for Danish patients.

The collaboration was made through an access contract, a first-of-its-kind contract that gives Danish CF patients access to all Vertex’s current and future CF drugs after their regulatory approval. The contract was  effective Oct. 1.

“We’re delighted to have collaborated with Amgros to finalize this pioneering contract,” Ludovic Fenaux, senior vice president of international commercial operations at Vertex, said in a press release.

Amgros is a public-sector pharmaceutical and procurement organization dedicated to ensuring the necessary amount of medicines in Danish public hospitals, at the lowest possible prices. The company is responsible for purchasing 99 percent of the pharmaceuticals used by public hospitals in Denmark.

“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,” Fenaux said.

Boston-based Vertex is a global biotechnology company focused on the development of therapies for a range of life-threatening diseases, including CF.

Vertex’s CF program includes three modulators of the CFTR gene (the gene that is defective in CF patients), among other investigational medicines. The three CFTR modulators — Kalydeco (ivacaftor), Orkambi (lumacaftor/ivacaftor), and Symdeko (tezacaftor/ivacaftor and ivacaftor) — are approved in the U.S.

Kalydeco and Orkambi also are approved in Europe, but Symdeko (known as Symkevi in Europe) is not yet approved.

“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.

Vertex also has established an agreement in Austria to provide access to Orkambi for all CF children ages six through 11 with two copies of the CFTR F508del mutation, the most common mutation associated with CF. The agreement also was effective from Oct. 1.

With these two agreements, Denmark and Austria join the list of countries around the world that provide their patients access to CFTR modulator therapies, including the U.S., Australia, Germany, the Netherlands, Ireland, Italy, and Sweden.

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