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December 26, 2007

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Kevin, I'm curious - I understand that ranibizumab (Lucentis) is a genetically modified version of the Fab fragment from the bevacizumab (Avastin) antibody that, unlike Avastin, is produced in a non-glycosylating system. However, neither drug appears to be listed in the Orange Book, so I assume Genentech's ability to price the two products differently is due to either (a) the more recent FDA approval of Lucentis and the concomitant 5-year exclusivity per TRIPs Article 39.3 (codified somewhere in the U.S.C. that I don't recall at the moment), (b) the fact that these are biologics and therefore difficult if not impossible under present regulations for generic manufacturers to knock off, or (c) both. Is this correct?

Of course Genentech isn't going to support a study that compares the efficacy of Avastin to Lucentis - they've got nothing to gain and everything to lose. If it's shown that the two are equally efficacious (or even close), then there will again be an uproar about the price difference. If it's shown that Avastin really is better, well, that's been their line all along; what would they then do, increase the price difference?

Dear Cynic:

I suspect the answer is #2 in your comment, combined with the difficulties in getting regulatory approval and the traditional patent remedies.

As for helping the NEI, you are correct, of course, that it is not in their best interests, but given the black eye the company has received over its mishandling of this issue from the beginning, there is some merit in the idea that they "go along" with the trial with their fingers crossed, since the "Lucentis is better" answer might spur FDA to impose a ban on using the reformulted Avastin, and the company avoids being the bad guy. If there really is no difference, I don't think things will change much; Genentech certainly won't have any incentive to change the regulatory picture by applying for approval for Avastin for treating AMD, and any such result would further immunize them from liability for adverse incidents occurring from use of reformulated Avastin (at least to the extent that any such problems would be more easily blamed on the physician who administered the drug or the pharmacy who reformulated it, if the drug itself was as safe and effective as Lucentis in the NEI study).

Thanks for the comment.

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