• Most Popular
  • Most Shared

UPDATE 2-UCB arthritis drug Cimzia wins EU watchdog approval

Fri Jun 26, 2009 8:18am EDT

Stocks

   

(Adds share price, analyst comment, detail)

Stocks

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)



More from Reuters

Photo

Euro zone holds intensive talks about Greek rescue

BERLIN/ATHENS (Reuters) - Euro zone countries were holding intensive talks on Wednesday about a possible financial rescue for debt-stricken Greece as civil servants staged the first major strike against Athens' crisis-driven austerity plan.

 A protester marches next to a banner during an anti-government rally in Athens February 10, 2010. REUTERS/John Kolesidis
Analysis:

Will IMF step in on Greece?

Europe is loathe to turn to the International Monetary Fund to help bail out Greece but it may have little choice.  Full Article 

A worker drives a Toyota Motor Corp's newly assembled Prius hybrid vehicle onto a trailer near the company's plant in Toyota, central Japan February 9, 2010.REUTERS/Yuriko Nakao
Reuters Breakingviews:

Toyota's troubles in overdrive

The cost of Toyota's recall nightmare is nothing compared to the price of fixing its battered reputation.  Commentary