David Lickrish took time to speak with BioSpace about the companies’ new drug, Jornay PM (methylphenidate HCL Extended-Release CLL Capsules), and how it fits into the overall ADHD therapeutic market.
For any families, the morning routine can be tough, with everyone on a schedule and time short. But for families with children with attention deficit hyperactivity disorder (ADHD), the morning routine is notoriously difficult. But now there’s a new medication, specifically formulated to help alleviate this problem.
David Lickrish, president, founder and chief executive officer of Highland Therapeutics and Ironshore Therapeutics, took time to speak with BioSpace about the companies’ new drug, Jornay PM (methylphenidate HCL Extended-Release CLL Capsules), and how it fits into the overall ADHD therapeutic market.
Prior to becoming a biotech executive, Lickrish worked on Wall Street as an equity research analyst. Back in 2007, Shire Pharmaceuticals acquired New River Pharmaceuticals for $2.6 billion, which gave Shire control over Vyvanse, a drug for pediatric ADHD. When Lickrish was working on Wall Street, he helped take New River public.
“All those stimulant medications were dosed in the morning and would take a couple hours before they had meaningful effect,” Lickrish said. “I thought, that’s got to be the most difficult time of day for most people. In today’s day and age, with drug delivery technologies, we should be able to create a pharmacokinetic profile that would allow you to dose the drug the night before so the kids would wake up ready to go with their symptoms already under control, then throughout the day and into the evening.”
That led to Lickrish consulting with experts at Massachusetts General Hospital, leaders in the category. They assured him that the morning routine was a significant problem affecting anywhere from one-third to one-half of patients. And if he could make it work, what he noted was a “big if,” that would be a gamechanger in treating ADHD.
He was settling in Toronto, when his wife, who works in the reinsurance business, took a position in the Cayman Islands. As a result, he set up the company in the Caymans. Highland is the first company, and Ironshore is a fully-owned subsidiary.
Jornay PM is a methyphenidate-based formulation using the company’s Delexis technology, a proprietary drug delivery platform. It has delayed-release properties that keep the drug from being released overnight as well as extended-release mechanisms that control the release of drugs throughout the following day. In short, it allows ADHD children to take the medication before going to bed and it kicking in before they wake.
“Pharmacokinetics are critically important in this clinical category,” Lickrish said. “You see evidence of that in the scientific literature, but also in FDA actions. There were generic versions of Concerta [Johnson & Johnson’s ADHD medication, also an extended-release methylphenidate HCL] that were bioequivalent to Concerta but were reclassified as therapeutically equivalent. The pharmacokinetics were off and the FDA established new guidelines for generic equivalents of Concert because, again, pharmacokinetics is critical in this category.”
Journay PM is approved by the FDA to treat ADHD in patients six years of age or older. Lickrish says it is clinically proven to control ADHD symptoms from the time the patient wakes up and to continue working throughout the day. It was approved in August 2018 and became available in June 2019.
“I’m overwhelmed by the response of physicians,” Lickrish said. “We’ve logged over 20,000 details with physicians who are all receptive to the value proposition of Jornay PM. I would say there’s been a substantial amount of pent-up demand over 11 years. People have gotten to know us and gotten to understand what we’re trying to achieve and recognize how it can help patients.”
Lickrish points out there haven’t been big changes in the ADHD market since about 2000 or 2001 when the Concerta and Adderall XR (which is an amphetamine formulation) and similar drugs were approved.
“Those are really the last gamechangers in ADHD,” Lickrish says. “Vyvance has been an interesting product, but its benefits are on the margin. I think Jornay PM is unique and distinct from everything that’s come before it. It really is the only product that can address not just the academic day but the bookends that have been the source of some friction in households, in the morning, when it can be chaotic and everyone’s trying to get out of the house on time and to work or school.”
Shire was acquired by Takeda Pharmaceutical in 2018, and as a result, now controls Vyvanse. Lickrish says it’s not clear what Takeda plans to do with that franchise, “but it would certainly appear they’re in the twilight of the ADHD era with the patents on Vyvance expiring in 2023.”
Highland and Ironshore, on the other hand, have 15 patents issued that go out to 2032.
The ADHD market is loosely split into stimulant and non-stimulant drugs. Stimulant drugs include amphetamine, methylphenidate, lisdexamfetamine and dexmethylphenidate. Non-stimulant drugs include atomoxetine, guanfacine, clonidine, and bupropion. The stimulant segment is the largest proportion of the market and expected to stay that way, largely because of high demand because of their effectiveness, ongoing clinical trials and government support for its use for mental health disorders.
According to Grand View Research, the global ADHD market will be about $24.9 billion by 2025, showing about a 6.4% CAGR during the forecast period. A study by the National Health Interview Survey found that the prevalence of ADHD in children and adolescents in the U.S. rose from 6.1% in the 1997-1998 period to 10.2% in 2015-2016.
Lickrish is convinced that Jornay PM and Highland Therapeutics will be on the leading edge of that market.
“When we talk to physicians, directly or through surveys we’ve conducted, 80 to 90% say they fully intend to use this product and describe it as a gamechanger in the treatment of ADHD. That remains to be seen over time, but if the early reception from the medical community is a leading indicator, it may already be a foregone conclusion. The product is something that will challenge the leading branded medications in the ADHD market. And I think this is great news for patients and those physicians who treat them.”
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