Europe's top biotech expects delays from drugs watchdog's HQ move

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[November 30, 2017] LONDON (Reuters) - Europe's biggest biotechnology company, Denmark's Genmab, expects some delays to regional drug approvals as the European Medicines Agency is uprooted from London to Amsterdam.

The drugs watchdog has to move by March 2019 as London will no longer be in the European Union once Britain leaves the bloc.

Genmab CEO Jan van de Winkel is braced for disruption, although the choice of the Amsterdam is arguably the least disruptive option, since four out of five members of the EMA's staff have expressed a willingness to move to the Dutch city.

"Of course you are going to see disturbance when you are moving around 1,000 super-qualified experts from London to Amsterdam," van de Winkel told Reuters in an interview.

"It's not good for Europe. I cannot imagine that everything goes without at least some slight delay in the drug approval processes. It would be a miracle if that wouldn't happen."

Maintaining timely approvals for new drugs is vital for drugmakers, since there are dozens of drug approval applications awaiting assessment by the EU regulator in the next few years.

In Genmab's case, this includes new uses for its top-selling blood cancer drug Darzalex, which is marketed through a partnership with Johnson & Johnson.

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The relocation of the EU drugs agency is one of a number of Brexit headaches facing the pharmaceuticals industry.

Drugs firms are also preparing to transfer UK product licenses to EU-based entities to comply with post-Brexit rules and set up new testing facilities in mainland Europe.

(Reporting by Ben Hirschler; editing by Alexander Smith)

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