March 20, 2008 / 7:15 AM / 10 years ago

UCB recalls Parkinson's patch, reviews 2008 outlook

BRUSSELS (Reuters) - Belgian drugmaker UCB said on Thursday it was recalling its Parkinson’s patch Neupro in the United States and some batches from Europe, prompting a review of its 2008 forecast.

UCB shares dropped as much as 18.4 percent to 21.60 euros, their lowest level since August 2003, as investors took a dim view of the latest in a series of setbacks to hit the group.

This month, U.S. health officials warned its prescription cough medicine Tussionex could be fatal for young children if taken frequently, though it is not approved for those aged under six.

UCB has also yet to convince regulators its would-be blockbuster Cimzia should be cleared for treating the bowel disorder Crohn’s disease. The European Medicines Agency on Thursday reaffirmed its view that Cimzia should not be approved.

Last year, UCB achieved net sales of 52 million euros ($81.7 million) from Neupro, a relatively new product.

“Depending on the resolution timeline of this issue, the full effect on UCB’s business is not yet known. Therefore, UCB’s 2008 financial outlook is under review and will be updated as soon as possible,” the company said in a statement.

UCB said the recall decision was not the result of contamination or toxicity but that the clinical performance of some samples on the market was not as required.

“As a result, there will be an out-of-stock situation with Neupro in the United States in late April 2008. In the European Union and most other regions, Neupro supply is sufficient,” it continued.

A spokeswoman said it was not clear how long UCB would be out of stock in the U.S. and likewise when it would be able to give a new 2008 outlook.

KBC Securities said in a research note it had reduced its forecast for Neupro sales this year to 88 million euros from 110 million, as well as its peak annual sales estimates and cut its target price to 33.50 euros from 35.00 euros.

“This disruption comes at a crucial time in the launch phase of this important franchise,” Deutsche Bank wrote, adding Neupro’s launch for restless legs could be significantly delayed by regulators’ insistence that quality problems be resolved.

Neupro, delivered to patients in the form of patches stuck on the skin, is approved to treat early-stage Parkinson’s in the U.S. and early and late stages of the disease in Europe.

The patches were launched in Europe in 2006 and in the U.S. in July 2007.

It filed for approval to treat restless legs syndrome in the United States and Europe in December.

UCB last month forecast revenue would decrease to about 3.4 billion euros in 2008 from 3.6 billion last year. Recurring core profit (EBITDA) would be about 650 million euros and net profit was expected to exceed 100 million.

Additional reporting by Ben Hirschler in London, editing by Will Waterman and David Hulmes

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