Marathon pauses Duchenne drug launch amid price outcry

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By Toni Clarke | WASHINGTON

WASHINGTON Marathon Pharmaceuticals LLC said on
Monday it was “pausing” the launch of its Duchenne muscular
dystrophy drug after U.S. lawmakers questioned why the company
priced it at $89,000 a year when patients had been able to
import it for as little as $1,000.

In a statement posted on the patient advocacy website Cure
Duchenne, Marathon’s chief executive, Jeffrey Aronin, said the
company was pausing the launch amid “concerns about how the
pricing and reimbursement details will affect individual
patients and caregivers.”

The company said it would maintain its “expanded access
program” under which 800 patients currently receive the drug for
nothing. It said patients currently importing the drug from
overseas would continue to be able to do so.

The furore is the latest in a series related to U.S. drug
prices, including Mylan NV’s emergency EpiPen allergy
treatment, that have drawn the ire of patients and lawmakers of
all political stripes.

Marathon’s drug, Emflaza, known generically as deflazacort,
is a steroid, one of a class of drugs commonly used to treat
Duchenne’s that patients could import for personal use because
it was not available in the United States. Last week it won U.S.
approval, in theory closing off that option.

Earlier on Monday independent Senator Bernie Sanders of
Vermont and Democratic congressman Elijah Cummings of Maryland,
called on privately held Marathon to justify the price of the
drug by documenting the cost involved in bringing it to market.

Marathon, the lawmakers wrote in a letter to Aronin, did not
after all develop the product, which has been around for
decades. The company acquired rights to two clinical trials that
had already been completed. And it conducted further toxicology
and other tests to bring it through the U.S. regulatory process.

Marathon argues that the studies it conducted had value in
determining proper dosing, potential side effects and
drug-to-drug interactions, allowing physicians to prescribe “with confidence.”

In a separate statement, Marathon said it appreciated the
opportunity to discuss “the value of an FDA approval of a
medicine” with Sanders and Cummings “and futhering our shared
goal that every patient who needs this drug receives it.”

U.S. President Donald Trump has said he wants to lower drug
prices and increase competition though he has not spelled out
how.

The Food and Drug Administration approved Emflaza under its “orphan” drug program that provides incentives to drugmakers to
develop treatments for diseases with small patient populations.
The incentives include seven years of market exclusivity.
Duchenne’s, a devastating muscle-wasting disease, affects some
15,000 patients in the United States, mostly young boys.

“Marathon will have a monopoly on deflazacort for years to
come, preventing less expensive generic competitors from
entering the market, despite the fact that this drug is already
available in generic form in other countries,” Sanders and
Cummings wrote.



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