This Biotech Is Worried Brexit Will Hit the Brakes on Drug Approvals

  • Danish drugmaker sees potential ‘hiccups’ in short term
  • Agency’s shift from London may lead to delays, CEO says

The Brexit-induced relocation of the European medicines regulator to Amsterdam may slow product approvals, hurting some drugmakers, Genmab A/S Chief Executive Officer Jan van de Winkel said.

The European Medicines Agency’s shift may cause at least “temporary hiccups and a deprioritization of some processes or programs, which wouldn’t be good for patients in Europe,” he said Wednesday in an interview in London. “I’m worried.”

Moving the watchdog, located in London for 22 years, has triggered concerns about disruptions in work by the EMA, Europe’s equivalent to the U.S. Food and Drug Administration. Amsterdam was seen as the location least likely to spur staff departures, and the EU last week picked the Dutch capital over 18 other contenders as the agency’s new home.

Amsterdam is “one of the least disruptive locations you can think of -- but it is still potentially disruptive,” van de Winkel said. Longer term, he said he’s not worried, yet the transition could slow “the introduction of a really important drug by several months,” the Danish drugmaker’s chief said.

The agency, which employs almost 900 employees and attracts some 36,000 annual visits from experts each year, must move as the U.K. prepares to leave the EU in March 2019. The agency’s departure is a “tragedy for the U.K.,” the Genmab CEO said.

The Genmab chief also said yesterday that he wants to retain at least 50 percent of drug ownership in future deals, now that the company has income flowing in from myeloma drug Darzalex and relies less on upfront payments.

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