Another Shkreli-like drug price controversy? Leadiant finds itself in the spotlight after 500-fold price hike — FT

Martin Shkreli may be cooling his heels in a federal prison, but the pharma pricing strategy he pursued that got him into an intense national controversy appears to be alive and well in Europe this week.

The Financial Times concentrated its attention over the weekend on the case of a drug called chenodeoxycholic acid, or CDCA. Leadiant Biosciences, earlier known as Sigma-Tau, gained control of the cheap, old drug, once used to treat gallstones, after it had become routinely used off-label to treat a rare condition called cerebrotendinous xanthomatosis.

The biotech pulled it off the market and then gained an EMA OK for the therapy. And then they jacked the price from €300 a year to more than €150,000, according to the FT.

In the US, that kind of price hike may be controversial, but it’s perfectly legal. (Shkreli’s prison sentence was for defrauding hedge fund investors.) Marathon Pharmaceuticals confirmed that when it bought a cheap old steroid and jacked the price after getting it approved specifically for Duchenne muscular dystrophy, largely on the basis of some old trial data it acquired. After that scandal erupted, though, Marathon backed off and then sold the drug to PTC, which has maintained a high price without gaining the same notoriety.

Wilbert Bannenberg

In Europe, though, we hear that the Dutch Pharmaceutical Accountability Foundation is set to file claims of market power abuse with regulators.

“Some companies are misusing the system to get higher profits, and patients are being affected when cheap, affordable old products are no longer available,” foundation chief Wilbert Bannenberg told the Financial Times. “This may be legal but it’s not socially acceptable.”

Leadiant, which is led by CEO Marco Brughera, says it’s open to dialogue on the subject of price. 

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Sr. Manager, Regulatory Affairs, CMC
CytomX Therapeutics San Francisco, CA
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