Mircera?































http://www.renalbusiness.com/news/2009/12/roche-could-start-selling-mircera-in-u-s-in-mid-2.aspx

Approved years ago by FDA. Roche lost in court. Earliest would be mid 2014 if Roche even decides to pursue this. Nothing has been said publicly in years.

To elaborate, Roche lost a patent infringement case tro Amgen. Mircera is available in Europe but not in the US. It is FDA approved, so theoretically Roche could launch in the US whenever it wants to. The problem is they could be liable for triple damages (3x the amount sold) to Amgen unless they work out some sort of agreement. Depending on the theoretical agreement amount demanded by Amgen, its not worth selling Mircera.
 






I believe that the legal case preventing Mircera to be sold in the US expires sometime iin the first half of 2014. Wouldn't it make sense to launch it? It could potentially be promoted to dialysis, CKD (pre dialysis) and onc. If a contract could be signed with Fresenius dialysis centers, then it would be well worth it for this market segment.
 






I believe that the legal case preventing Mircera to be sold in the US expires sometime iin the first half of 2014. Wouldn't it make sense to launch it? It could potentially be promoted to dialysis, CKD (pre dialysis) and onc. If a contract could be signed with Fresenius dialysis centers, then it would be well worth it for this market segment.

Are you saying that the patent that we infringed upon expires then?
 




































The market is dead. Sure there is a need for epo products. But, Medicare bundled the payment for the drug(s) in with the dialysis procedure. This makes the epo products a commodity, which leads to price wars. Why bother fighting it out? Resources better deployed elsewhere, where profit margins are higher.