Re: Economics of GTC-Leo collaboration for CABG/HR (or another second acquired-deficiency indication)
>when LEO want to do development work in Europe on the development of ATryn as a supplement to restore heparin responsiveness in heparin resistant patients do they have to pay GTC for it?<
There are several components to the answer:
1. Leo pays GTC for ATryn used in clinical trials, regardless of the indication.
2. The GTC-Leo collaboration struck in Oct 2006 specifies $38M in clinical/regulatory milestones and $30M in sales milestones for the DIC indication. If the DIC indication were abandoned (because the phase-2 trial failed), then the above milestones would switch over to an alternate acquired-deficiency indication agreed to by the companies, which could be CABG/HR.
3. If Leo pursues the CABG/HR indication in addition to DIC, then no milestone payments accrue from the CABG/HR indication unless ATryn achieves approval for marketing in one of Leo’s territories for CABG/HR before it achieves approval for DIC.
4. On commercial sales, Leo pays GTC a royalty on sales and a mark-up on GTC’s manufacturing costs irrespective of the indication. The combined royalty and manufacturing mark-up is in the mid-to-high teens as a percentage of Leo’s end-user sales.
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