Replies to post #27372 on Biotech Values

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DD - any opinion/guess on the time required to resolve dispute and outcome? tia

[DewDiligence]

Roche Anemia Drug CERA Works as Monthly Dose

[CERA is a direct competitor to AMGN’s Aranesp as well as the first-generation erythropoietin products from AMGN and JNJ.]

http://yahoo.reuters.com/news/articlehybrid.aspx?storyID=urn:newsml:reuters.com:20060716:MTFH69729_2...

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ZURICH, July 16 (Reuters) - Swiss pharmaceutical group Roche Holding AG <ROG.VX> on Sunday said late-stage studies of its new anaemia drug CERA showed the drug worked on a once-monthly dose for dialysis patients. CERA -- which stands for continuous erythropoietin receptor activator -- acts to increase the production of red blood cells.

Existing anti-anaemia treatments require dialysis patients to be treated as frequently as several times a week.

Roche said that for the first time clinical research, presented at a medical conference in Glasgow, Scotland, showed dialysis patients treated with short-acting and frequently administered epoetin anti-anaemia drugs could be directly switched to a once-monthly treatment.

"Roche's once-monthly CERA could have a positive impact on the management of anaemia in dialysis patients by reducing work loads and offering greater efficiencies," the group said in a statement.

The results are part of Phase III studies on the drug.

Roche is developing CERA as a follow-up product to NeoRecormon, its second-best selling drug in 2005 with sales of 2.3 billion Swiss francs ($1.87 billion). Industry analysts had been eagerly awaiting the latest test results, since many believe CERA could generate global sales of over $2 billion annually.

Bear Stearns recently forecast 2010 CERA sales of $1.25 billion, not including potential revenues of $1.08 billion in the United States, where Roche faces a patent dispute with Amgen < AMGN >.

In April, Roche asked U.S. and European regulators for approval to market CERA as a treatment for renal anaemia associated with chronic kidney disease in patients who are on dialysis as well as those who are not. Results from the remaining Phase III studies will be announced later this year, Roche said.

At the conference in Glasgow, studies also showed that CERA had a unique mode of action for treatment of renal anaemia, which allowed it to work for longer in the body. "We found that CERA has a loose interaction with these receptors, which turns out to be an advantage as it enables the drug to stimulate red blood cell production for longer," Anton Haselbeck, a scientist from Roche's biotechnology centre in Penzberg, Germany, said in a statement.
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