UK's NICE turns down Zeltia's Yondelis on lack of evidence for ovarian cancer drug

14 March 2011

Following a negative opinion last year, and despite the company offering a funding deal, the UK drugs watchdog the National Institute for Health and Clinical Excellence (NICE) says its expert independent advisory committee has not recommended Spanish drug firm Zeltia’s (ZEL: MC) Yondelis (trabectedin, developed by its PharmaMar unit) in combination with pegylated liposomal doxorubicin (PLDH) as a treatment for ovarian cancer because of concerns over how well it works compared with the most commonly-used treatments.

Zeltia shares fell 4.7% to 2.84 euros on the news, with the stock already down 26% this year. Yondelis, with 2010 sales of 43.8 million euros ($61.3 million), up 64.6% year-on-year, makes up nearly a third of the group’s turnover.

This draft guidance is now with consultees who have the opportunity to appeal against the proposed recommendation. NICE has not yet issued final guidance to the National Health Service.

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