Replies to post #123550 on Biotech Values

[DewDiligence]

Thanks for that PR—a scorecard comes in handy here: Teva has two knockoffs of Neulasta (one from CoGenesys and one from Ratiopharm) and two knockoffs of Neupogen (one from Ratiopharm and one developed by Teva itself).

Teva’s recent settlement with AMGN covers two of these four drugs: the Neulasta knockoff from CoGenesys and the Neupogen knockoff developed by Teva itself.

Only one of the two Neupogen knockoffs is being pursued in the US (the one Teva developed itself). Whether Teva will seek US approval for both Neulasta knockoffs is unclear to me. However, I think it’s reasonable to surmise that the Neulasta knockoff from Ratiopharm will not be brought to market in the US during the next few years; otherwise, it presumably would have been included in some form in the AMGN settlement.

[genisi]

Obviously, Neugranin [from CoGenesys], which is albumin based, will be non-infringing.

I don't think so. CoGenesys's albumin fusion technology makes Neugranin a long-acting form of G-CSF (by increasing its bio-availability and half life), but it would still infringe Amgen's 5,580,755 and 5,582,823 patents (running until Dec. 2013), because the first covers all sequences coding for amino acid residues of hpG-CSF (the native as well as its analogs) and the other covers methods for treating patients with these protein sequences. I believe that is why Teva settled.