Cayman is globally renowned for its tourism and financial services, but is not known for having a pharmaceutical industry.
That could change soon, however, if all goes according to plans that have been long in the works by the Cayman-registered company Ironshore Pharmaceuticals.
Working out of a third-story office at Camana Bay, Ironshore Pharmaceuticals’ seven staff members are working to bring to market a new drug that treats Attention Deficit Hyperactivity Disorder (ADHD).
The company’s drug, JORNAY PM, would allow for treatments to be administered at night, with the medication kicking in first thing the next morning. Currently, ADHD medication has to be dosed in the morning, and the consumer has to wait before he or she feels the effects of the drug.
In other words, this drug would help those who have ADHD with the all-important morning routine, said Ironshore CEO David Lickrish.
It could be another year before JORNAY PM hits the shelves, Lickrish said. But when that happens, there could be a big payoff.
ADHD treatment is a roughly $18 billion market in North America. Lickrish said he expects JORNAY PM to capture double-digit shares of that market, meaning that it could be worth more than $1.8 billion.
When JORNAY PM hits the shelves, it will also mark a milestone for the territory, as it would likely be the first U.S. Food and Drug Administration-approved drug developed by a Cayman-registered company, according to Ironshore.
It’s been a 10-plus year road to get to this point, Lickrish said.
The Ironshore CEO started his career on Wall Street as a senior analyst, covering pharmaceutical companies. There, he noticed that there was no ADHD medicine that could be dosed in the evening.
At the time, many industry professionals did not think it was possible to develop such a treatment. When the financial crisis hit, Lickrish decided to leave Wall Street and set his sights on a new industry. Ironshore’s parent company, Highland Therapeutics Inc, was founded in 2008 in Toronto, Canada.
Ironshore Pharmaceuticals & Development, Inc., the research and development arm of the company, was set up as a subsidiary in Cayman two years later.
Eventually, Lickrish and some top pharma researchers were able to marry the methylphenidate – the central nervous stimulant used to treat ADHD – with the “technology” that allows the drug to be released in the body in a manner that allows for nighttime dosing.
The technology developed contains two film coatings around the drug: The first layer delays the initial release of the drug for up to 10 hours while the second layer helps to control the rate of release of the active pharmaceutical ingredient throughout the day.
After establishing the feasibility of nighttime dosing, Ironshore embarked on the enourmously complex, years-long process of obtaining FDA approval for the drug. The approval process includes multiple rounds of testing on volunteers, small groups of patients, and then larger groups of patients – among many other requirements.
About seven years ago, Lickrish established Ironshore in Cayman when his then-girlfriend – now his wife – was hired at a reinsurance company here.
Walking into the Ironshore office, one may expect to find beakers, Bunsen burners and other laboratory equipment, but is instead encountered with two rows of computers.
The Ironshore CEO explained that the headquarters serve as Ironshore’s “nerve center,” where the business conducted includes devising testing methodologies and other research methods.
From here, the actual testing is outsourced to top universities and hospitals around the world.
“A lot of the laboratory testing is done in areas outside of Cayman. A lot of the design of the experiments and the directions of how to conduct the experiments is done here. But we have partners in the U.S. that conduct the experiments on our behalf. You go wherever the best people are,” he said. “We’ve partnered with Harvard Medical School, Massachusetts General Hospital, University of Texas [at] Austin, distinguished professors in many institutions.
“Our external manufacturing is done in the U.S., but we manage those processes here.”
Operating out of Cayman offers Ironshore financial benefits, including the tax breaks associated with domiciling its intellectual property here. But one of Lickrish’s concerns was attracting top talent to a jurisdiction that – unlike Ireland and to a lesser extent, Barbados and Bermuda – is not known as a pharmaceutical hotbed.
Luckily, Lickrish said, attracting and keeping top talent has not been much of an issue.
“As the company grew and opportunities built, we knew we needed more resources. One of the early concerns was the ability to attract and retain top talent. Drug delivery [is a] very difficult and lengthy process. We needed to offer them best-in-class lifestyle that would encourage them to stay. We needed longer commitments than a year or two,” he said. “But we knew that they would fall in love with Cayman just like I did, and that’s what has happened.”
Lickrish said he thinks Cayman is missing out on a huge opportunity by not marketing itself as a potential home for other pharma companies. Many of them are going to places like Barbados and Bermuda, but Cayman has the best infrastructure and amenities in the Caribbean, he said.
“Cayman should be equally competitive,” he said. “It’s a nicer place, with unbelievable infrastructure and all the amenities, including great education – which is crucial.”
Lickrish said that major financial institutions agree with him that Cayman is a legitimate place for pharma companies to do business.
“We’ve had our location clearly vetted by a host of attorneys. We’ve just gone through a recent round of financing; top Wall Street banks vetted us as well,” he said, referring to Ironshore recently raising $143 million to support the commercial launch of JORNAY PM. “Many folks were interested in why we came here and if we’d recommend it.”
As an exempt company, Ironshore is limited to doing business outside of Cayman. Eventually, Lickrish said he sees his company getting involved in the community – offering treatments here at discounted rates and helping support local charities.
Right now, however, Lickrish is focusing on finishing what’s been a decade-long journey. He said his company is in the process of bringing on board three more people that work in Cayman, as well as some 400 sales and marketing people in North America to prepare for when JORNAY PM hits the shelves.
“This is the exciting part because we get to talk to parents, caregivers and patients,” he said. “There’s a tremendous amount of excitement.”