HiTech Health, which recently became the first Irish company to secure a licence to contract manufacture cell and gene therapies, is planning a multimillion-euro equity and debt fundraising to expand after opening a facility in Galway this month.
Cell and gene therapies offer revolutionary treatments to repair, replace, regenerate and re-engineer genes, cells and tissue to restore normal function or enhance their ability to fight diseases such as cancer.
Brian Harrison, a former executive with US drugmaker Bristol Myers Squibb, set up HiTech a decade ago. For most of its existence, the company has provided outsourced services to companies developing treatments, focusing increasingly on advanced therapies
The company is now moving into the area of contract manufacturing of cell and gene therapies, having recently secured a contract manufacturing licence from the Irish Health Products Regulatory Authority.
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The new Galway facility, which Mr Harrison said cost between €5 million and €10 million to develop, contains a number of so-called clean rooms that will allow it to manufacture therapies for clients.
“We have projects that in our [research and development] lab and are hoping to go into a clean room soon. With a bit of luck we’ll see the first patient being treated by the end of this year,” he said. “We are also now actively talking to companies with the hope of winning more projects.”
Mr Harrison said the company was open to manufacturing therapies for individuals or ones that could be used for multiple patients.
While cell and gene therapies are very expensive, they are often dwarfed by the lifetime cost of treating a patient with a disease or disorder.
For example, a gene therapy developed by US drugmaker BioMarin last year for the most common form of haemophilia, the inherited blood-clotting disorder that can lead to bleeding after minor injuries or scrapes, has a list price of $2.9 million (€2.7 million). A US study in 2021 put the lifetime costs per patient with severe and moderate haemophilia at more than $20 million.
“The ambition is to expand further. We see significant opportunities,” said Mr Harrison. “The number of clean rooms that we have will get it so far, but if a company has a number of [therapies] in clinical trials they want to be with a partner that can supply them perhaps on a global basis. So we will need to expand to get to that stage. That needs investment and we’re talking to many different parties about that at the moment.”
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