this may be part of reason for xoma's short term slide... XOMA has licensing agreement with UCB on Cimzia..
UCB’s Cimzia for Crohn’s Disease Delayed Until 2008
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Fri Mar 23, 2007 4:21 AM ET
By Philip Blenkinsop
BRUSSELS, March 23 (Reuters) - Belgian pharmaceutical group UCB could face a long delay for the launch of potential blockbuster drug Cimzia after it announced on Friday it would conduct an extra study to be completed late in 2008.
UCB shares dropped as much as 10.4 percent to 42.16 euros, their lowest level since June 2006. At 0820 GMT, they were off 5.4 percent at 44.60 euros, compared with a 0.3 percent decline of the Dow Jones Stoxx European health index <.SXDP>.
UCB had hoped for approval from the U.S. Food and Drug Administration (FDA) in the first half of this year for Cimzia to treat bowel disorder Crohn's disease, but said on Friday it now planned an additional short-term clinical study.
"UCB expects the results from this additional clinical study with Cimzia in Crohn's disease in the second half of 2008," the company said.
UCB's statement follows a meeting with the FDA this month in response to a letter the FDA sent to UCB in December requesting additional information and clarification on data submitted in UCB's application.
UCB said on Friday it would respond fully to the FDA's letter by the end of April and added it was unclear whether Cimzia could be approved for Crohn's before the extra study results were known.
"We do not know whether it is a pre-approval requirement of a post-approval commitment," a UCB spokesman said, adding the FDA could be expected to give an answer by the end of the second quarter.
UCB shares have fallen some 15 percent from a near seven-year high set on Dec. 18 on fears Cimzia's approval might be delayed.
"It's obviously not good news. The stock has already come down. For us, it means a delay and it could be until 2009. It can be expected to hit the stock," said Wim Lewi, analyst at Fortis.
The Belgian company is already behind Abbott Laboratories Inc <ABT>, whose rival product Humira received U.S. clearance for Crohn's at the end of February.
Cimzia is being touted as a potential $1 billion-a-year-plus product. UCB is also hoping European Union regulators will approve its use for treatment of Crohn's in the second half of this year.
Cimzia is also designed to treat other autoimmune conditions such as rheumatoid arthritis (RA) and psoriasis. UCB said on Friday it planned to file a U.S. licence application for Cimzia to treat RA by the end of this year.
UCB needs Cimzia, as it will lose patent protection on hayfever drug Zyrtec in 2007 and epilepsy drug Keppra in 2009. |
