Back at the beginning of this year, the folks at Toronto-based Highland Therapeutics celebrated a $200 million financing completed through Morgan Stanley. That cash, they said, would go to commercializing their ADHD drug HLD200 through their wholly owned subsidiary Ironshore, touting a drug they have frequently heralded as a breakthrough in the field as it faced a July 30 PDUFA date. They even hired some Shire vets to help grab market share.
But that PDUFA deadline has come and gone and there’s no word on what the FDA has done with it. And the company CEO tells me there isn’t going to be.
Contacted by phone, David Lickrish told me earlier today that “we’re still in discussions with the agency.” Pressed that the FDA would either reject the drug, OK it or delay the decision — pick one — Lickrish told me I’d caught him at a bad time and he’d get back to me.
In an email, he stuck with no comment.
With respect to the filing, as a privately held company, and for competitive reasons, we are not commenting on the status of our NDA. Having said that our package contained 10 trials including two pivotal studies which attempt to evaluate ADHD during both the early morning routine and evening routine periods, using rating scales not currently in Clinical Outcomes and Assessment Compendium. Beyond this we won’t be commenting further on the ongoing interactions with the Agency.
I asked the FDA for comment, which has stuck with a strict no comment policy of its own before Scott Gottlieb arrived and advocated publishing the CRLs.
They haven’t changed — yet. Their response:
Please understand that information about an application is confidential unless it has been publicly disclosed by a sponsor.
At the time of the financing in January, Craig Lewis, president of Ironshore Pharmaceuticals, celebrated the company’s looming transformation from an R&D company to a full-fledged operation with a commercialization wing. HLD200, he said in a statement, was on its way to becoming a standard therapy for ADHD. He added: “Our commercial organization is being purpose-built with this objective in mind.”
In the meantime, the company also heralded the arrival of two Shire veterans — Barry K. Herman as SVP, head of medical affairs and Paul J. Casanova as SVP of sales. Shire has a major ADHD franchise.
I would suspect that after all the buildup, an approval would have been shouted from the roof tops. So there may well have been at least been a snag in their plans. Or worse. The way the rules work now, a private company is free to say whatever it likes. Or nothing at all.
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