Marathon Pharma, which immediately ran into backlash for an $89,000 price tag on a decades-old drug just approved for Duchenne muscular disorder, is pressing “pause” on the launch before it even begins. The news comes as pressure mounts on the drugmaker, notably on Monday from frequent pharma critics Sen. Bernie Sanders, I-Vt., and Rep. Elijah Cummings, D-Md.
The company hasn't sold any new product, CEO Jeffrey Aronin said in a Monday statement, and is "pausing" the Emflaza commercial rollout following last week's FDA approval. Marathon is keeping its expanded access program, Aronin said.
The announcement came the same day congressional pharma watchdogs Sen. Sanders and Rep. Cummings castigated the company’s decision to attach an $89,000 price tag to the old corticosteroid, known generically as deflazacor. As the lawmakers point out, Marathon didn’t develop the drug.
Instead, it acquired rights to trial data from the 1990s and “completed some additional analyses to gain approval … to sell the drug in the United States.”
Deflazacort has been available in Canada and the European Union “for many years,” Sanders and Cumming pointed out in their letter (PDF) to Aronin. It’s priced at about $1,000 per year in the U.K. and Canada.
“We remain gravely concerned about these recurring abuses in the pharmaceutical industry,” the congressmen wrote, urging Marathon to lower the price and calling the company’s move “unconscionable.”
Defending his company, Aronin said Marathon sought approval for the drug "to improve access."
Sanders and Cummings want to learn more about Marathon’s costs, Emflaza revenue projections, communications with payers and patient assistance programs.
By winning the orphan drug approval, Marathon gets seven years of exclusivity and a valuable priority review voucher, which have sold for hundreds of millions of dollars in recent years.
The congressmen believe the Emflaza episode is an example of a drugmaker exploiting U.S. orphan drug laws, put in place more than 30 years ago to spur development in rare disease areas. That’s an area another congressional pharma watchdog, Sen. Chuck Grassley, R-Iowa, plans to examine.
For its part, leading pharmacy benefit manager Express Scripts called Marathon’s move an example of “egregious pricing for an old drug that is available elsewhere for much less.” Its experts are reviewing the data and will make a recommendation about clinical need.
Marathon previously implemented “staggering” hikes on heart meds Isuprel and Nitropress, Sanders and Cummings wrote, before offloading the drugs to the Valeant Pharmaceuticals, now notorious for its pricing and sales strategies. Valeant then pushed the prices up even higher.