Chitogel inks heads of agreement with big pharma for US launch
New Zealand medical science company Chitogel has signed a heads of agreement with a US-based pharmaceutical multinational after getting greenlit by the US Food and Drug Administration for its wound-healing gel.
"We just signed the deal yesterday. They are the largest or second largest in the US in the ears, nose and throat space," says chief executive Phil Royal. He declined to name the company but said it would be Chitogel's distributor for the ENT gel in the US. Chitogel is aiming to capture 20 percent to 30 percent of the US market by 2020 and Royal said he was confident that was possible. Now the company has regulatory approval from the FDA, he expects the first commercial shipments to begin in the middle of next year.
Royal said the company currently has the capacity at its new manufacturing plant in Lower Hutt's Gracefield Innovation Quarter to meet demand from the US but would then have to expand as it moves into other markets and other products.
The gel, which has been 12 years in the making, is used post-operatively in endoscopic sinus surgery, performed approximately 500,000 times each year in the US alone. The clear gel is a topical medical treatment that reduces bleeding, scarring and infection resulting from sinus operations, according to the company. Among other things, the dissolvable clear gel dressings replace the need for gauze bandages, improving the recovery.
"It's very effective material," said Lyall Hanton, a chemistry professor at Otago University and one of the developers of the project. While Chitogel does have some competition in the ENT space he is confident the gel offers a better outcome for patients.
Hanton said the company is submitting applications to secure FDA clearance for post-surgery use in spinal and abdominal surgeries, likely focusing on spinal use first. According to Royal, human testing just kicked off today in Adelaide for spinal use.
The company also has global patents in place and will look to get regulatory approval in several markets outside the US. "Every market is slightly different in terms of how you approach it and the cost of approaching it," said Hanton.
(BusinessDesk receives assistance from Callaghan Innovation to cover the commercialisation of innovation)