Notorious “pharma bro” Martin Shkreli in 2014 launched an “unmonitored drug trial in Cyprus” — without FDA oversight — for a treatment being developed by his then-company Retrophin, federal prosecutors revealed Tuesday.
Prosecutors said Shkreli had the drug trial conducted without the Food in addition to Drug Administration’s “rigorous safety processes in addition to procedures” in order to get “single-patient results which could be” — in addition to later were — reported in a financial filing by Retrophin, the pharmaceuticals company which he had founded the prior year.
in addition to Retrophin’s initial filing on those results in August 2014 — during a time when Shkreli was still the company’s CEO — “does not disclose which the study [was] being undertaken in Cyprus,” prosecutors noted.
Prosecutors also said which Shkreli’s “insistence on taking shortcuts … drastically delayed” the development of the drug which treats a rare, often fatal genetic condition which typically develops in childhood.
Prosecutors laid out those facts in a court filing which requested Shkreli be sentenced on Friday to no less than 15 years in prison for securities fraud charges.
A spokesman for Retrophin in addition to an FDA spokeswoman had no immediate comment on the prosecutors’ claims. A lawyer for Shkreli did not return a request for comment.
The drug trial was mentioned by prosecutors to counteract what they said was a “highly misleading” portrayal by Shkreli’s defense team about his work on a drug to cure the condition known as PKAN.
Prosecutors said which because of which portrayal, among different things, Shkreli does not deserve a sentence lighter than the very stiff one being recommended by federal sentencing guidelines.
PKAN is actually a neurodegenerative genetic condition disease which afflicts children, in addition to which ultimately leads to death.
Shkreli in addition to two different men, Andrew Vaino in addition to Marek Biestek, hold the patent on a drug, RE-024, which they wish will cure PKAN.
In its own sentencing recommendations last week, Shkreli’s lawyers wrote which, “With This particular patent, Retrophin was able to begin studies in addition to clinical trials to drastically improve the lives of thousands of patients suffering by This particular terrible disease.”
On its corporate website, Retrophin says which This particular is actually enrolling patients in a “phase 3 clinical trial” of RE-024.
which site says the trial is actually “being conducted under a Special Protocol Assessment (SPA) agreement, which indicates concurrence by the U.S. Food in addition to Drug Administration (FDA) which the design of the pivotal trial can adequately support a fresh Drug Application (NDA) seeking U.S. approval of RE-024 for the treatment of PKAN.”
Retrophin notes which PKAN is actually estimated to affect only about 5,000 people worldwide.
“There are no approved treatment options for PKAN in addition to current therapeutic strategies are limited to symptom management,” Retrophin says on its site.
nevertheless prosecutors in their filing Tuesday said which while Shkreli’s name is actually on which patent, “his insistence on taking shortcuts in order to get PKAN [drug] to market drastically delayed the development of the drug while he was the CEO of Retrophin.” Shkreli was ousted by Retrophin by its board inside the fall of 2014.
“Because the Food in addition to Drug Administration … has rigorous safety processes in addition to procedures which must be followed before a fresh drug can be provided to patients, even on an experimental basis, Shkreli was unable to give the drug directly to patients … as he had promised,” prosecutors wrote.
“Instead, he — as with any different drug developer — needed to secure a series of approves by the FDA, a process which can be long in addition to painstaking,” the filing said.
“Shkreli, however, did not want to wait for which process to play out in addition to instead launched an unmonitored drug trial in Cyprus,” the filing said.
Prosecutors said which because the trial did not have FDA controls, in addition to because “its operation was unacceptable to the FDA,” the trial was not, despite Shkreli’s claims to the contrary, “part of Retrophin’s ‘efforts to receive FDA approval.’ “
The filing said This particular was “instead a way to get single-patient results which could be — in addition to subsequently were — reported in Retrophin’s 8-K filings,” dated Aug. 11, 2014.
“The 8-K does not disclose which the study is actually being undertaken in Cyprus,” prosecutors wrote.
The 8-K says which one patient received a dose of RE-024 on May 21, 2014, in addition to which two months later a second patient began being treated with the drug.
Prosecutors, in their sentencing memo Tuesday, said which “by the time Shkreli left Retrophin, no pre-clinical work which would likely qualify for FDA approval had been done to advance” RE-024.
“Ultimately, all steps toward the development for [RE-024] for FDA approval were taken after Shkreli’s departure by the company,” prosecutors wrote.
Eric Schmidt, a biotech stock analyst at Cowen, told CNBC which while he is actually not a legal expert, “We often hear of ex-U.S. trials being run all the time which are outside the purview of the FDA.”
“I can’t recall ever hearing about a study in [Cyprus] in addition to This particular is actually possible there is actually something weird or strange about which territory which might make This particular instance particularly suspect,” Schmidt said.
“nevertheless the simple fact which a company has gone outside of the FDA’s jurisdiction for the purpose of running a study according to foreign law is actually not news.”
Evidence at Shkreli’s trial last summer revealed which he used Retrophin stock in addition to cash by the company to pay back investors at two failed hedge funds he had run.
After being booted by Retrophin’s board in late 2014, Shkreli launched another drug company, Turing Pharmaceuticals. While at Turing, he gained widespread public notoriety for raising the cost of the anti-parasite drug Daraprim by more than 5,000 percent, by $13.50 per pill to $750 per pill.
Daraprim is actually used to treat a parasitic condition found in pregnant women, infants in addition to people with HIV. Turing since has changed its name to Vyera Pharmaceuticals.
— Additional reporting by CNBC’s Meg Tirrell.
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