Australian Financial Review, 9 June 2018
A couple of Australian woolgrowers are taking on the world of big pharma with pain relief technology they developed for sheep that is now being trialled for use in humans.
The technology was borne out of a crisis in the now-booming wool industry when animal welfare activists targeted mulesing, a procedure where farmers remove skin from around the tail area of lambs to reduce the risk of fly strike.
With the activists gaining support for a designer and consumer boycott of Australian wool in Europe in 2004, Meredith Sheil, Charles Olsson and Alan Giffard fought back.
They came up with Tri-Solfen, protected by 35 patents globally, and funded its development through their start-up company Medical Ethics.
Their company is now valued at $54 million based on the recent sale of a cornerstone stake UK-based veterinary products company Dechra Pharmaceuticals.
The royalties flow, which already includes a deal with German life sciences giant Bayer covering use in animals in Australia and New Zealand, is set to skyrocket if Tri-Solfen is approved for use in humans.
Tri-Solfen has already been used to treat about 70 million sheep in Australia under the product licensing deal with Bayer and was approved for use in calves in 2016.
International experts in wound care in humans, including Professor Keith Harding at Cardiff University and the Wales Wound Institute, now see potential for it to be adapted for use in humans.
Potential for adaptation to humans
Medical Ethics is investing $5.3 million in a phase two study on use on humans that will begin in Cardiff next month.
The company has a three- to five-year target to expand into human applications and is already assessing potential partners among big pharma.
The move comes less than 12 months after Dechra Pharmaceuticals paid $18 million for 33 per cent stake in Medical Ethics.
The Dechra deal is seen as a gateway into livestock applications in the northern hemisphere, where it is slated for use in sheep, cattle, pigs and other animals.
In addition to being a woolgrower, Dr Sheil is a specialist paediatrician with clinical and medical research experience.
Mr Olsson is a leading farmer and current director and former chairman of the Australia Wool Growers Association.
Mr Giffard has a long history in the development and commercialisation of animal products and is now chief executive of Medical Ethics.
The details of their deal with Bayer are confidential but involves what Mr Giffard said were “attractive” royalty streams and milestone payments.
‘Enormous’ market penetration
Mr Giffard said Bayer figures showed more than 70 per cent of Australian farmers now used the spray-and-stay topical anesthetic in mulesing, castration and tail docking.
“That market penetration from a Bayer perspective, or any pharmaceuticals perspective, is enormous,” he said.
“The same uptake is starting to happen in the cattle industry. We are confident when our registration occurs in other markets the same thing is going to occur.
Dr Sheil was a relative newcomer to farming in 2004 when she sat around a BBQ with Mr Olsson and talk turned to the outcry over mulesing.
“He said to me ‘you’re a doctor, surely there is some sort of anesthetic that could be developed for this’,” she said.
“That is when I started to switch my head from research in children over to how we could start to address pain relief for farm animals.”
Dr Sheil said she was driven by a sense of injustice and compassion in inventing Tri-Solfen.
“I felt the claims that were being made against Australian sheep farmers being made that they were barbaric were unjustified,” she said.
“The procedure [mulesing] is done to protect the health of their animals and all the sheep farmers that I had met were the most amazingly dedicated people who had nothing but the welfare of their sheep at heart.
“They had no way of treating pain in their animals, there were no products available.
“I don’t see a lot of difference between infant humans and lambs in the sense of potential for suffering from wounds and it was clear to me that they needed some sort of treatment to address the pain and other risks.”
‘Receiving better treatment than a lot of humans in the world’
Dr Sheil said it was always in the back of her mind that the technology could be applied in humans.
Working as a paediatrician in hospital emergency departments, she would treat children with big cuts.
The treatment involved injecting anesthetic directly in the cut so it could be cleaned and then stitched up.
Dr Sheil began soaking the wounds in local anesthetic first and saw how much it helped in the treatment of children.
“One of the things I’ve said to people at times is that the infant animals that are getting treated with this product now for wounds are receiving better treatment than a lot of humans in the world that have no access to products like this,” she said.
“At the moment there is nothing you can use like this, which is a spray anesthetic and antiseptic together, in an acute wounds situation.”
Dr Sheil sees potential applications in war zones and natural disaster situations as well as in post-operative care.
Welsh researchers looked at its effectiveness in allowing the aggressive treatment of leg ulcers in dairy cattle and saw how it might apply to the treatment of venous and diabetic ulcers in humans.
Mr Giffard said Medical Ethics had invested heavily in patent protection to guard against copycats.
“It helps having big brothers like Bayer and Dechra behind you as well,” he said.