At several points last year, Toronto-based Highland Therapeutics spotlighted data from a pair of pivotal Phase III studies of Benjorna (HLD-200) which they say provided clear evidence that a nightly dose of the drug upped the performance of kids with ADHD from morning through night. Now, staring down a July 30 PDUFA date with the FDA, the low-profile biotech has raised $200 million to fund the commercial ramp-up, confident that they’re now a few short steps from shaking up a major market.
The money comes from Morgan Stanley, which sold senior secured notes due in 2024 for a wholly owned subsidiary of Highland’s — Ironshore Pharmaceuticals & Development. Investors are gambling that the biotech can make the difficult switch from drug developer to commercialization group, while facing off against heavyweight players in the field, with plans to market the drug to a big market throughout the US.
In the second Phase III study of 161 kids aged 6 to 12, investigators said that they had tracked an average 44% improvement in symptoms compared to a placebo. But it’s the full-day benefit they touted the hardest. Their “before school” rating achieved a 59% improvement, making it easier for the kids to get ready for their day, without a lot of parental help. In the evening, there was a 44% improvement.
That’s key for the field, where leaders like Shire have been working on new second-gen drugs that can offer a single daily therapy with consistent benefits.
Just days ago Shire had its long-delayed SHP465 accepted for a review at the FDA. Originally filed way back in 2006, but subsequently rejected, the drug has the same active ingredient as the now generic Adderall XR, but reformulated, investigators say, to make it a once-daily therapy, boosting its efficacy from 12 hours to 16 hours.
Just what payers may thing about these drugs, though, has yet to be seen. Insurers have honed their skills at keeping members on cheap generic drugs, regardless of dosing benefits. And these followup drugs may face a tough fight.
Highland, though, believes it’s on the verge of a big breakthrough.
Craig Lewis, president of Ironshore Pharmaceuticals Inc., said:
“As a science-based, patient- centric organization, we believe HLD200 has the potential to become the standard of care in the treatment of ADHD.
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