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iwfal

07/09/12 1:52 AM

#9344 RE: io_io #9326

"the Tercica-INSM case, in which INSM paid Tercica a 20% royalty on sales" per this .... Now, knowing that the Tercica and INSM drugs were not only branded drugs, but also ORPHAN branded drugs, and you are aware that ORPHAN branded drugs typically have 90% or higher GM, don't you feel it a gross distortion that this 'example' remains in the RMF?



Sure, it isn't a great example. But:

a) the problem is that it is difficult to find comparable examples. E.g. name another generic launch with potentially 12+ years of solid patent protection (too lazy to look up the exact numbers) and significant barriers to entry by competitors (in the case of Lovenox the FDA is likely to slow things substantially).

b) Given that without competition the margins on mL were high 60's before the entry of aL I would suggest your position of expecting only 2% is even more incompatible. E.g. With competition for Tercica assume the margins drop to 80% and they were willing to pay 1/4 of those in a license deal. For the same logic on aL, and even with your expected degradation of GM, you'd still expect 7 or 8%.