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Sarepta shrinks as execs wait for FDA's decision on Duchenne drug

March 10, 2016
Life sciences

With its closely watched Duchenne muscular dystrophy drug eteplirsen facing an uncertain fate at the hands of the FDA, Cambridge, MA-based Sarepta Therapeutics said it is consolidating operations and shuttering a research facility in Corvallis, OR.

On Tuesday evening, the biotech, which moved from Seattle to Cambridge a little more than three years ago, noted that it will close its West Coast location for early research as well as research manufacturing. Some of the staffers and their projects will be relocated to Cambridge, but not everyone is headed east.

“There will be 30 layoffs,” noted a spokesperson for Sarepta in an email to me, “but those jobs are expected to be filled in 2017 assuming the drug gets approved.”

The consolidation will be staggered in four moves between May and the end of the year.

“For a biotechnology company of our size and stage of development, it is operationally important to centralize our facilities and focus our efforts on the R&D, manufacturing, and pre-commercialization of eteplirsen,” said Edward Kaye, Sarepta’s interim chief executive officer and chief medical officer. “To that end, we will consolidate operations to Massachusetts over the coming year to optimize the efficiency of our R&D and manufacturing teams.”

Sarepta was dealt a blow earlier in the year when the FDA offered a scathing review of its application for eteplirsen, noting that it had yet to offer any real evidence of its efficacy from a tiny, single arm study. An attempt to compare the data with a review of expected results from past studies was also gunned down. The review sent the company’s shares into a tailspin, from which it has yet to recover.

Quite a few analysts have given up any significant hope of an approval, but a winter storm indefinitely delayed an FDA panel review and the agency later said it would use additional time to review more data on the drug–offering up a glimmer of hope that the company may yet come out on top. DMD advocates have also been preparing to voice their support for an approval.

In its release Tuesday the company says that there’s still no new firm date for the advisory committee meeting but expects it will be scheduled for a day before the FDA’s May 26 deadline.

The DMD community in the U.S. has been dealt a series of setbacks in recent months. In addition to the Sarepta chastisement at the hand of regulators, BioMarin’s drug was rejected and PTC Therapeutics’ was handed a refuse-to-file notice for its application, after the agency determined that its data didn’t cut the agency’s standards.

By John Carroll

Source: Fierce Biotech

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