Legal, People

Deflating R&D claims, prosecutors say an impatient Martin Shkreli conducted bogus drug study in Cyprus

For Martin Shkreli, the first line of defense against his most savage critics — which now includes a group of federal prosecutors who would like Judge Kiyo Matsumoto to throw the book at him for three felony convictions — was his work developing new drugs for rare diseases.

But the feds say that too was nothing but a sham, arguing that the biotech exec launched an unsupervised trial of one of his drugs in Cyprus so he could tout cherry picked results to investors in an SEC filing.

In a long running indictment of Shkreli’s often bizarre behavior, which includes all the harsh, mocking opinions the biotech exec would offer on lawmakers, the courts and practically everyone that attracted his hair-trigger scorn, the feds had this to say in a partially redacted filing about one of his clinical “studies” at Retrophin for RE-0024:

Shkreli was unable to simply give the drug directly to patients as he had promised. Instead, he—as with any other drug developer—needed to secure a series of approvals from the FDA, a process that can be long and painstaking. Shkreli, however, did not want to wait for that process to play out and instead launched an unmonitored drug trial in Cyprus. Because that trial did not have controls and its operation was unacceptable to the FDA, the trial itself was not (as Shkreli has claimed) part of Retrophin’s ‘efforts to receive FDA approval,’ but instead a way to get single-patient results that could be—and were subsequently—reported in Retrophin’s 8-K filings. Retrophin’s 8-K filing dated August 11, 2014…. (detailing clinical data for a period of less than three months from two individuals in the RE-0024 study; the 8-K does not disclose that the study is being undertaken in Cyprus). By the time Shkreli left Retrophin, no pre-clinical work that would qualify for FDA approval had been done to advance RE-0024. Ultimately, all steps towards the development for RE-0024 for FDA approval were taken after Shkreli’s departure from the company.

The New York Post reported on this earlier.

We’ve already heard how Shkreli relished telling associates about the quick scores available in rare disease drug development and marketing. For prosecutors, running an unsupervised study was another way of painting Shkreli as an unrepentant villain who was willing to lie, lie and lie again when it came to making money.

They want the judge to give Shkreli a minimum 15 year sentence, after she ordered that Shkreli should forfeit $7.4 million in assets.

We’ll find out Friday how effective they were.


Image: Martin Shkreli leaves federal court in June, 2017. Shutterstock


The best place to read Endpoints News? In your inbox.

Comprehensive daily news report for those who discover, develop, and market drugs. Join 31,600+ biopharma pros who read Endpoints News by email every day.

Free Subscription

Rational Combinations 360

The UK Biopharma Research & Development Summit

Data Architect/Engineer
Camp4 Therapeutics Cambridge, MA
Chief Medical Officer
Skyhawk Therapeutics Waltham, MA
Chief of Staff, North America
Ipsen Biopharmaceuticals Cambridge, MA
Senior Director, NA Digital Customer Interaction
Ipsen Biopharmaceuticals Cambridge, MA

Visit Endpoints Careers ->