A year ago Ironshore Pharmaceuticals execs trumpeted the news that they had lined up $200 million in financing to launch a new ADHD drug that would wow the field — destined to become a new standard of care. They started lining up veteran commercial and scientific hires, anticipating an OK by the July 30 PDUFA date.
And then as the deadline came and went the company was suddenly as quiet as the grave, declining to say what the FDA had decided as the agency maintained the same silence it reserves for all company matters.
The launch plans gathered dust and at least one key executive — Shire vet Barry Herman, the newly hired head of medical affairs — left in the fall, according to his LinkedIn profile.
Today, the CEO confirmed the essence of what I had been hearing on the grapevine: The company closed down after Christmas, the rest of the staff was laid off, and its drug remains in an unexplained limbo.
In an email, David Lickrish wrote:
Having spent the last 18 months assembling an all-star cast of highly skilled pharmaceutical executives to launch HLD200, the decision to close down our commercial operations was incredibly difficult. We do not have clarity on when the launch of HLD200 may occur and as such we were left without any choice in the matter. HLD200 has a unique value proposition and we look forward to working with the FDA to determine what additional steps may be necessary to secure approval for the benefit of patients and families affected by ADHD.
The FDA’s new commissioner, Scott Gottlieb, has promised lawmakers and the industry that he would push to publish CRLs, or most of them. But so far, nothing has come of that promised piece of reform. So whatever the agency’s objections were, they remain a secret.
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