Almost one year after filing a NDA for an ADHD drug and less than one year after announcing it secured $200M in financing, Ironshore Pharma has closed its doors.
Almost one year after filing a New Drug Application for an ADHD drug and less than one year after announcing it secured $200 million in financing, Ironshore Pharmaceuticals has closed its doors.
The company, based in the Cayman Islands and a subsidiary of Canada-based Highland Therapeutics, shuttered its operations at the end of December Chief Executive Officer David Lickrish told Endpoints News. It is as yet unknown exactly how many staff were impacted by the closure.
In addition to the number of staff, there are multiple questions left unanswered by the closing. First and foremost what happened to the company’s Attention-Deficit/Hyperactivity Disorder (ADHD) drug HLD200? Ironshore announced in December 2016 that the FDA had accepted its NDA. The company was given a PDUFA (Prescription Drug User Fee Act) date of July 30, 2017.
Ironshore’s HLD200 is a delayed-release and extended-release methylphenidate capsule that was designed to be taken before bedtime in order to control ADHD symptoms.
That PDUFA date was six months ago and the company has made no announcements about the fate of the drug. Presumably, the FDA rejected the product, but no Complete Response Letter appears to be available.
Endpoints News had tracked the progress of the drug in its reporting and noted in August that the PDUFA date had passed and the company kept mum about its status. Lickrish told Endpoints at the time that it was not providing an update on the drug as the company was still in negotiations with the FDA over the presumed fate of the drug. This week though Lickrish broke his silence.
In an email to Endpoints, Lickrish confirmed the closure of the company. He said Ironshore spent 18 months “assembling an all-star cast of highly skilled pharmaceutical executives” in anticipation of the launch of HLD200. Those additions included two Shire plc veterans. Barry Herman was tapped to head Medical Affairs at the company, and Paul Casanova was brought on board to lead the company’s sales team. Shire has a noted presence in the ADHD market. Herman spent 10 months at Ironshore before departing. Since October 2017, he has served as chief medical officer for New Jersey-based Tris Pharma, according to his LinkedIn profile.
Bringing on industry vets who know the field wasn’t enough without an approved product. Lickrish went on in his email to say the company does “not have clarity on when the launch of HLD200 may occur and as such, we were left without any choice in the matter.”
Lickrish though did say that there was still hope for HLD200. In his email, he said they (presumably Highland Therapeutics) will continue to work with the FDA to secure approval of the drug.
