June 26, 2009 / 10:22 AM / 11 years ago

UPDATE 2-UCB arthritis drug Cimzia wins EU watchdog approval

(Adds share price, analyst comment, detail)

By Antonia van de Velde

BRUSSELS, June 26 (Reuters) - Europe’s drug watchdog has recommended EU approval of UCB SA’s (UCB.BR) Cimzia drug as a treatment for rheumatoid arthritis, the Belgian company said on Friday, clearing the way for it to be prescribed later this year.

UCB said Cimzia would be made available in the European Union for treatment of the condition before the end of 2009 and was now only awaiting marketing authorisation from the EU. The drug is already available in the United States.

UCB has a collaboration on Cimzia with U.S.-based Nektar Therapeutics (NKTR.O) and will pay the smaller company royalties on sales.

UCB shares initially rose more than 3 percent to a 2-1/2 week high of 23.07 euros on news of the recommendation, but later pared gains to be up 0.5 percent rise by 1125 GMT.

Some analysts said the EU clearance had been expected and was already reflected in UCB’s stock market valuation.

“The approval was anticipated. It would have been a surprise if the European regulators hadn’t followed that,” an analyst who declined to be named said.

Cimzia belongs to a class of drugs that block an inflammatory protein known as a tumour necrosis factor, or TNF.

The first TNF blockers were launched 10 years ago and Cimzia is the fourth to reach the market as an arthritis treatment, behind Amgen’s (AMGN.O) Enbrel, Johnson & Johnson’s (JNJ.N) Remicade and Abbott Laboratories’ (ABT.N) Humira.

U.S. regulators cleared Cimzia in May, sending UCB shares sharply higher at the time. The company had suffered a setback when the U.S. Food and Drug Administration’s (FDA) requested further safety data in January before approving the drug.

UCB is looking to Cimzia to replace sales of older products lost to generic rivals. (Reporting by Antonia van de Velde; Editing by John Stonestreet and David Holmes)

0 : 0
  • narrow-browser-and-phone
  • medium-browser-and-portrait-tablet
  • landscape-tablet
  • medium-wide-browser
  • wide-browser-and-larger
  • medium-browser-and-landscape-tablet
  • medium-wide-browser-and-larger
  • above-phone
  • portrait-tablet-and-above
  • above-portrait-tablet
  • landscape-tablet-and-above
  • landscape-tablet-and-medium-wide-browser
  • portrait-tablet-and-below
  • landscape-tablet-and-below