August 27, 2018 / 7:05 AM / 25 days ago

UPDATE 2-Novartis wins EU approval for blood cancer therapy Kymriah

* Cell therapy wins EU approval in two indications

* Swiss drugmaker says still working out pricing

* Novartis investing 90 mln Sfr in new Swiss manufacturing site (Adds comment from Novartis official, details about manufacturing)

By John Miller

ZURICH, Aug 27 (Reuters) - Novartis has received European approval for Kymriah, its gene-modifying therapy for blood cancer, but said its introduction would vary from country to country as the Swiss drugmaker works out payment details and builds manufacturing capacity.

The company aims initially to use the therapy in Europe for young people up to 25 years of age with B-cell acute lymphoblastic leukemia (ALL), and later for adult patients with diffuse large B-cell lymphoma (DLBCL).

The one-time therapy -- which works by removing disease fighting T-cells from individual patients, modifying them to attack cancer, and then re-infusing them -- is approved in both indications in the United States, where it costs $475,000 for patients with ALL and $373,000 for DLBCL.

The treatment is aimed at patients who have not been helped by other drugs.

Novartis is investing 90 million Swiss francs ($90.4 million) in a new Swiss facility to produce Kymriah, and expects this site to deliver the therapy to European patients by the start of 2020.

Additionally, it has a deal with French contract manufacturer CELLforCURE as well as Germany's Frauenhofer Institute, which, along with Novartis's existing site in New Jersey, will support manufacture of the custom-made therapy for European patients.

"This is an individualised therapy made for one patient only," Pascal Touchon, Novartis's global head of cell and gene therapies, said in an interview.

"It creates unique challenges from a capacity ramp-up point of view that do not exist with other types of drugs."

He declined to say how many patients the company hopes to have capacity to treat by 2020.

In the first half, Kymriah had $28 million in sales in the United States, although the company hopes it will eventually exceed $1 billion in annual revenue as use of the medicine expands.

In the United States, Novartis has worked out agreements in which it is reimbursed for Kymriah only if young patients with ALL are still responding by the end of the first month.

For European pricing Touchon said it was too early to say whether there would be similar types of systems or processes as the one Novartis has in the United States. "We are extremely open," he said.

When the U.S. Food and Drug Administration approved it in August 2017, Kymriah was hailed as the first of a new type of gene-modifying immunotherapy for blood cancer.

It now has a competitor, Gilead Sciences' Yescarta, for patients with lymphoma in the United States, with European approval pending. ($1 = 0.9957 Swiss francs) (Reporting by John Miller, Editing by Sherry Jacob-Phillips, Louise Heavens and Jane Merriman)

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