BRUSSELS, March 16 (Reuters) - Belgian biotech company TiGenix G9U.BR said on Tuesday that U.S. health regulators asked for an additional trial of its leading cartilage regeneration product, ChondroCelect.
The company received approval last October to launch the product within the European Union, although EU regulators did ask for an extra confirmatory trial to be carried out.
TiGenix said it believed that the outline of this test would also meet the demands of the U.S. Food and Drug Administration.
“The path will be longer than anticipated, but we believe that our eight years of clinical trial experience with ChondroCelect will help us to remain at the forefront of the field,” Chief Executive Gil Beyen said in a statement.
TiGenix said enrollment in the EU confirmatory study would begin at the end of 2010.
Separately on Tuesday, the company released full-year results. Its operating loss narrowed to 14.4 million euros ($19.68 million) from 16.5 million euros in 2008, with increased revenue and lower R&D costs.
The company said it had cash and cash equivalents of 24.7 million euros at the end of 2009, with 25.3 million euros from share issues almost balancing out the company’s cash burn.
TiGenix said it expected gradual uptake of treatment in the second half of the year as health authorities in key EU target markets approved reimbursement for ChondroCelect. (Reporting by Philip Blenkinsop; Editing by Steve Orlofsky)
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