Dr. Lowe, from In the Pipeline, writes an update on a story we covered earlier this year:
You may recall Marathon Pharmaceuticals, the small company that announced plans to sell a long-used steroid treatment (Emflaza, deflazacort) in the US to Duchenne muscular dystrophy patients. The price was set to go up steeply, since the company was awarded years of market exclusivity by the FDA (under their program to reward orphan-drug indications like this one).
This business model is the same one followed by a number of other small outfits (see that link above for more), and it's infuriating. Generic drugs are off patent, by definition, and they're supposed to be cheap. Taking advantage of regulatory loopholes and perverse incentives to jack their prices up is shameful, unproductive, and expensive.
[...] Marathon itself appears to be about to disappear. And why not? They've turned a quick buck. Endpts, who have been doing a great job on this story, couldn't find anyone who thought that the company had spent more than $70 million on the drug's approval, and it was probably a lot less. So $140 million, plus milestones and royalties, is a nice return. But there's more money coming than just that – the company got a priority review voucher from the FDA for bringing a rare pediatric disease drug to the market, and they can sell that on the open market. I'd guess that it could bring in another $100 million or so
http://blogs.sciencemag.org/pipeline/archives/2017/04/25/marathon-pharmaceuticals-cashes-out
https://en.wikipedia.org/wiki/Deflazacort
The priority review voucher is an incentive program that provides companies, that get a drug approval for a neglected or rare disease, a voucher that entitles them to a more speedy review (under six months instead of ~10 months) for a future drug. This is a great program; however, Marathon Pharmaceuticals deliberately exploited this program by conducting a very small trial using a generic drug (another loophole).
Previous Story: https://soylentnews.org/article.pl?sid=17/02/11/2116252
(Score: 2) by kaszz on Wednesday April 26 2017, @05:57PM
So why is it the government regulation in the US usually results in crap like this?
Answer: Who pays for politicians? :-)