Israeli bio-pharmaceutical company Mileutis is preparing for the final commercialization stages for Imilac, a solution that helps dairy cows avoid antibiotic resistance. The company forecasts that future applications of its solution can reduce the usage of antibiotics in dairy farms by up to 90 percent.
The active ingredient in Mileutis’s Imilac, is a unique proprietary immunomodulator – a collection of peptides derived from natural bovine casein hydrolysate (bCNH), the main protein in cow milk.
It is spoken that David Javier Iscovich, Mileutis’ CEO and co-founder, about the regulatory track and launch of the company’s lead product.
“Imilac and its claims are backed by controlled clinical studies and independently published research on the pathophysiological benefits obCNH treatments in dairy cows,” he remarks. “Currently antibiotics is still the dominant strategy for treating and preventing mastitis.”
There are certain non-antibiotic treatments that aim to help cows reduce the risk of mastitis by physically “sealing” the teat end, he notes. “However, those are not intended to replace antibiotics but to provide an additional layer of protection.”
“To the best of our knowledge, there are no other antibiotic-free science-based alternatives with clinical trials to support the above referenced claims.”
The global potential sales revenues for Mileutis are conservatively estimated to be US$1 billion.
Significant savings for dairy sector
Antibiotics are widely used to treat bovine mastitis, which is the most frequent disease in dairy herds worldwide, and the most costly.
“It is a biologically sourced, safe, residual-free offering for the management of mastitis at the dry period (the period at the end of the lactation and before the next calving), during the lactation period and for increased milk yield,” Iscovich explains.
Based on Mileutis’ patented transformational technology, the solution is administered at the “dry-off date” – when a cow has stopped lactating – using an intramammary syringe in a similar way to the current antibiotics treatments. It can potentially reduce the use of antibiotics by up to 50 percent on this application alone.
Clinically backed efficacies
Imilac and its claims are backed by controlled clinical studies and independently published research on the pathophysiological benefits of bCNH treatments in dairy cows.
“Clinical studies show bCNH has efficacy equal to or better than the currently used antibiotic treatments in specific indications,” Iscovich notes.
“It significantly expedites the cessation of milk secretion from the milk-producing cells in the udder which shortens the drying (‘involution’) of the cow from up to 21 days to three to five days,” he explains.
“This has a very positive effect on the cow’s well-being as it leads to the shortening of the dry-off period.”
Clinical trials conducted with bCNH showed that dairy cows that have been treated with Imilac produced up to 9 percent more milk in the following lactation.
Mitigating the threat to humans
Since many pathogens are common to animals and humans, the broad usage of antibiotics in animals poses a very significant risk of development of antibiotic resistant strains which will affect human health directly.
“The prevalence of antimicrobial usage and hence its consequences on antimicrobial resistance, varies by region and country,” notes Iscovich. “However, we know that it is the direct consequence of irresponsible and overuse of antibiotics and that this is measured by several organizations worldwide.”
Specifically, animal agriculture accounts for an estimated 70 percent of total global antimicrobial use, according to the recent State of the Industry Report by the collaborative investment network FAIRR.
“Antibiotics are consumed in vast numbers by farm animals for prevention and blanket treatments,” highlights Iscovich.
Route to commercialization
Mileutis has a medium-scale production unit in its 11,000 sq. ft. headquarters based in Israel, south of Tel Aviv, near the Weizmann Institute of Science. The company is now working on a global supply chain and distributed production to cover the main worldwide markets (North America, EU and selected additional countries).
Moreover, the company is preparing for the final regulatory track and launch of its product in several markets. The product will be launched first in Israel, the US and the EU.
“A request for approval has been submitted to the Israeli authorities,” says Iscovich.
“The company got very positive feedback from regulatory authorities in the US and has been deemed so safe by the European Medicine Agency, that it does not require a Maximum Residue Limit (MRL) evaluation.”
Bovine mastitis remains a key target area for agri-food-tech innovators. Among prominent developments in this space, APC Microbiome Ireland has developed microbiome-derived solutions to treat bovine mastitis, while studying bioengineering antimicrobial peptides for increased efficacy.
DSM’s nutritional solutions, meanwhile, help combat mastitis as well as ketosis and lameness, while helping optimize cows’ skeletal development, health, nutrient utilization and fertility.
