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Sarepta seeks new CEO but says eteplirsen is on track

Garabedian will be temporarily replaced by CMO Ed Kaye

Sarepta 

Sarepta Therapeutics' chief executive Chris Garabedian has stepped down just as its lead drug for Duchenne muscular dystrophy (DMD) is about to be submitted for approval in the US.

Garabedian will be replaced on an interim basis by Sarepta's chief medical officer Ed Kaye while a search for a replacement gets underway, said the company, which insisted its plan to file eteplirsen for DMD remains on track.

The abrupt resignation came after the remainder of Sarepta's board told Garabedian it had lost confidence in his leadership, and particularly his dealings with the FDA, according to a Wall Street Journal report. 

Garabedian fell out with Sarepta's former chairman William Goolsbee over the way the company was interacting with the FDA last year, and was blocked from attending FDA meetings, although that decision was subsequently overturned. Goolsbee resigned shortly afterwards, to be replaced by John Hodgman, with the company's board publicly stating its confidence in the CEO.

A few weeks later in October, Sarepta disappointed investors by saying it would have to file for approval of exon-skipping therapy eteplirsen several months later than expected, giving rival Prosensa an opportunity to bring its drisapersen candidate in front of the US regulator first.

It has been suggested that Garabedian had been pushing hard for eteplirsen to be given accelerated approval - on the condition that additional clinical data backed up its early studies - but the FDA was not comfortable with the results in hand and had concerns about the design of the 12-patient study supporting eteplirsen's efficacy.

Similarly, preliminary meetings with the EMA also made it clear that the company would need data from additional trials before it could file for approval in Europe, where another DMD therapy - PTC Therapeutics' Translarna (ataluren) - is already approved and backed by a much larger patient dataset.

Hodgman said the handover "will facilitate the company's clinical and regulatory discussions and relationships", pointing to the interim CEOs "excellent relationships with the clinical, regulatory and patient advocacy communities."

"We remain on track in collecting and analysing the data requested by the FDA necessary for us to submit the eteplirsen New Drug Application in the middle of this year as planned," said Kaye.

Drisapersen is thought to work via a process called 'exon skipping', producing a semi-functional version of the dystrophin protein that is abnormal in DMD.

Article by
Phil Taylor

2nd April 2015

From: Regulatory

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