U.S. anaemia drug curbs weigh on Roche-analysts

By Sam Cage

ZURICH, May 11 (Reuters) - A U.S recommendation to restrict further a group of anaemia drugs widely used by cancer patients could hit Switzerland's Roche Holding AG (ROG.VX), which expects an approval decision on its Mircera drug this month.

U.S. approval of anaemia treatment Mircera for use in dialysis is still seen by mid-year, analysts said on Friday, but any label changes may have a greater effect on Roche's existing NeoRecormon anaemia drug.

As bank Vontobel does not see approval in cancer uses until 2010, analyst Karl-Heinz Koch does not expect a significant impact from Thursday's FDA recommendation on Mircera.

"The label changes based on unfavourable clinical evidence is also likely to lead to a more restrictive prescribing behaviour in Europe and as such could affect sales of Roche's NeoRecormon, which generated sales of CHF 1.5 billion in 2006," Koch said in a note.

Roche participation certificates, its most widely traded form of equity, were 1.1 percent lower at 226 Swiss francs by 0920 GMT, compared to a 0.6 percent drop in the Dow Jones European healthcare index .SXDP.

Andrew Fellows, analyst at brokerage Helvea, noted NeoRecormon sales were likely slowing regardless and are mainly in dialysis indications, and so the FDA recommendations are unlikely to affect his Roche models.

"I don't really see any major impact there, we basically see that product moderately declining as we go forward and then faster as it's replaced by newer entries," Fellows said.

RENAL ANAEMIA TARGET

A U.S. Food and Drug Administration panel of outside experts on Thursday urged more study of the drugs, known as epoetins, and panellists overwhelmingly said continued marketing should require more clinical trials and additional label changes.

"Initially Roche is targeting Mircera on the renal anaemia side, so it doesn't really mean too much," said Fellows, who anticipates approval and launch in the United States later this year.

The FDA had already imposed a "black box" warning on Amgen Inc.'s (AMGN.O) Aranesp and Epogen and Johnson & Johnson's (JNJ.N) Procrit in March after studies showed an increased risk of death in cancer patients not on chemotherapy.

All three drugs, as well as Mircera, are man-made forms of the natural protein erythropoietin, or EPO, which spurs the body to produce more red blood cells.

Roche had suspended enrolment in a mid-stage trial for Mircera -- known as Cera in the United States -- in anaemic lung cancer earlier this year due to safety concerns.

Mircera is a key new product for Roche and analysts believe it could become a multibillion-dollar-a-year seller. Amgen, however, has sued Roche, alleging infringement of six U.S. patents involving Epogen.