<<For a non-US deal this is about as best as could be expected.>>
That is somehow my point. By retaining US right and single ex-US package (with good milestones) they hold (based on development cost sharing structure) 60% (55% with Japan) of the drug economic. I see no reason why will Ortho pay more (in percentage) in development cost than they may receive later as profit. This is marketing deal, not development sharing. The price that MLNM pay for this deal is smallest *option* license (15 M is not true upfront, cover of the development cost, first marketing milestone is when drug is approved) and near term milestones. In may view majority of the ~$500M in milestones is for front line(second line) and larger cancer market.
<< There is an awful lot of temptation for many countries to just "steal" new drugs by allowing generics/knock-offs quickly, patents notwithstanding.>>
EU recently expanded data exclusivity from 6 to 8 years (in some cases 11 years), and East E. countries that are joining EU mast comply with this rule. Also, rule for generic are more restricted (more demanding), so I do not see danger that EU (except Russia, but there is also way to intervene) will not comply with patent protection. Asia (China and India as major generic manufacturers) is different story, but this country will be left out of promising new biologic drug if they continue with uncontrolled copyright philosophy.
Profit from US may be (and for now is) bigger than from other countries (except few in EU and Japan). Velcade is very expensive. 2.5 mg in sterile solution cost $950 (what it may cost to produce this? Few bucks! Profit = <geze>), or ~$30K/year. Add to that one or two chemo, supportive care, MDs fee, hospital,…and it come to $60-70K. Who can afford this price in developing countries? Governments? No way! Individuals? Very few! In Croatia it is average 10 years salary! Price mush came down to acceptable level. As you can calculate, even with ½ price profit is huge, and market will expand. IMW, faster than in US.
But for healthy drug price one need healthy medical benefit. MLNM is heavily banking that Velcade will be successful beyond MM and it will generate large profit in US. I somehow agree that Velcate will be effective in multiple indications, but so far can not say how competitive will be relative to other or similar drugs. This is risk that I was talking.
Analog is much broad than derivative, however it does not cover all proteosome inhibitors.
Miljenko
PS: Doxil id from ALZA (SEQU) |
