Price-gouging Turing gets fast-track status for new epilepsy drug
Turing, the pharma company condemned for the huge 4,000 per cent price increase on its drug Darapim, has just announced FDA fast-track status for a new epilepsy drug it is developing.
The timing of the announcement will please Turing Pharma's now notorious chief executive Martin Shkreli, as it shows that his firm does more than simply acquire licences for existing off-patent drugs, as it did with toxoplasmosis Daraprim (pyrimethamine).
FDA fast-track status signals the drug treats an area of high unmet need.
Nevertheless, Shkreli is unlikely to win over any sceptics with this news, who are likely to remain suspicious about the firm's business model, despite its investment in clinical trials.
Shkreli had claimed the huge Daraprim price increase was necessary to underwrite its R&D efforts, although the firm offers few details about how much it is investing in research.
The firm has one other drug already on the market, Vecamyl for hypertension, with a further 13 research programmes underway across a range of specialist therapy areas.
The FDA has given fast-track status to TUR-004 for treatment of epileptic encephalopathies, and the compound will now enter phase I studies for safety, tolerability and pharmacokinetics.
Martin Shkreli, founder and chief executive officer of Turing Pharmaceuticals said, "With our first investigational candidate moving into the clinic, this is a very exciting moment at Turing Pharmaceuticals. We are pleased that FDA has granted Fast Track status for TUR-004 providing for an accelerated development and regulatory review pathway."
TUR-004 is being developed as adjunctive therapy for refractory generalised seizures in patients with epileptic encephalopathies. Epileptic encephalopathies are a diverse group of severe epilepsy disorders in which uncontrolled epileptic activity contributes to a progressive decline in cognitive and motor function.
Individuals with epileptic encephalopathies face a higher incidence of sudden, unexplained death, status epilepticus and severely diminished quality of life.
The company's head of research is Eliseo Salinas, who joined the company in June from another speciality start-up firm, Remalda Therapeutics.
Salinas said the firm's R&D team has been working hard during the past six months to advance TUR-004 through the IND application process and to provide new treatment options for the devastating disorders.
The uproar caused by the Daraprim price increase led to Martin Shkreli agreeing to cut its price in late September, but hasn't yet fulfilled his promise.
In the last few days, another firm, Imprimis Pharmaceuticals has pledged to launch its own $1-a-pill version of the toxoplasmosis treatment.
The outrage sparked by Turing has raised pharma pricing high up the political agenda, and put pressure on other speciality firms such as Valeant, and big pharma, despite their efforts to distance themselves from Shkreli's tactics and business model.
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