UPDATE 2-Dutch Crucell's rabies drug on fast-track, shares up
(Adds analysts comment, details, shares)
AMSTERDAM, Nov 13 (Reuters) - Dutch biotechnology firm Crucell (CRCL.AS)(CRXL.O) said its rabies monoclonal antibody drug had been granted fast-track designation by the U.S. Food and Drug Administration, sending shares to a three-week high.
The decision by the U.S. government agency is expected to speed up procedures to get approval for introducing the drug, a key product in Crucell's portfolio, for treating the viral disease usually spread by the bite of an infected animal. "Based on market needs, peak sales for Crucell's cocktail are expected to exceed $300 million," Crucell said in a statement.
Crucell shares rose as much as 7 percent to 13.85 euros, the highest level since Oct. 24. Shares were up 5 percent at 13.54 by 0900 GMT, outperforming a 0.6 percent fall in the Amsterdam midcap-index .AMX.
"This (the fast-track status) should bring market launch six months earlier than expected. We expect that the company could announce a partnership on this product later next year," analysts SNS Securities said in a client note.
Crucell also reported quarterly results and said its loss in the third quarter narrowed to 4.5 million euros ($6.6 million) from 21.7 million euros a year earlier.
The result was better than the average analyst expectation for a loss of 10 million euros in a Reuters survey of six analysts, with individual estimates ranging from a 14 million euro loss to an 8 million loss.
Third-quarter revenue more than doubled to 62.6 million euros on increased vaccine sales and acquisition, but was slightly below average analyst expectations of 64 million euros.
Crucell reiterated it expected 2007 total revenue and total other operating income of between 220 million euros to 225 million. It also kept its outlook to break-even in its cashflow at the end of 2007.
Crucell develops its antibody cocktail using its PER.C6 technology, which offers large-scale manufacturing capabilities and production under serum-free culture conditions. (Reporting by Harro ten Wolde; Editing by Matthew Tostevin)
