US-based NovaQuest Capital Management has announced a US$20 million product financing agreement with Mileutis, an Israeli biopharmaceutical company, to mitigate the use of antibiotics in animals. Mileutis’ protein-based therapeutics, such as Imilac, seeks to naturally manage bovine mastitis – the most prevalent and costly disease in the dairy industry.

The management, treatment and prevention of bovine mastitis at dry-off has estimated potential annual revenue of above US$1 billion globally, according to Mileutis. 

NovaQuest’s investment will drive the continued development and commercialization of Mileutis’ biologically sourced and residue-free therapies, which aim to revolutionize the way mastitis and other diseases are treated. 

“We believe Mileutis’ product line and technology platform represent a paradigm shift that is much needed in industry. It will not only improve animal and human health by enabling more sustainable milk production, but will also enhance the well-being of dairy cows,” explains Brian Axe, NovaQuest principal.  

The cost of mastitis
The global losses caused by bovine mastitis are estimated to result in US$19.7 billion to US$30 billion in annual financial burden, according to the University of Glasgow. 

Mastitis is a serious medical disorder in dairy cattle involving the mammary gland and udder tissue in dairy cows. The disease can impair milk-secreting tissues in the cattle, which leads to lower milk production, lower quality of milk and the loss of dairy cows. 

Currently, antibiotics are the main therapy used in treating mastitis and are routinely administered once a year in the beginning of the dry period. Mileutis is in advanced stages of development in the US, EU, and Israel for the therapeutics. 

Using peptides to keep cows healthy
The first line of products is comprised of peptides and specific protein fragments that have a positive impact on health conditions and may reduce antibiotic use in animal health management. 

“Our platform, which acts by stimulating the immune system, will pave the way toward the development of additional therapies for both animal health and human health,” says David Javier Iscovich, CEO and co-founder of Mileutis.

New therapies in development
The line of natural biopharmaceuticals is based on early research conducted at Israel’s Agricultural Research Organization (Volcani Center) and at Mileutis. 

Mileutis’ claims are supported by statistically significant results in a number of randomized, multi-center clinical trials, according to the company. 

The European Medicines Agency (EMA) recently issued a positive opinion on the safety of Mileutis’ leading product and platform. 

EMA recognized that Mileutis’ product, which consists of casein hydrolysate, does not require a Maximum Residue Limit (MRL) evaluation. Mileutis’ first line of therapeutics is comprised of peptides and specific protein fragments shown to have a positive impact on health conditions. 

This is viewed as an important milestone on the path to replacing the use of antibiotics in the dairy industry.

The risk of antibiotics overuse for humans
Antimicrobial resistance and the overuse of antibiotics have led researchers, regulators, policymakers and communities worldwide to look for new and safer treatments.

The World Health Organization states that using antibiotics in food animals may also have a negative impact on human health by inducing the spread of antimicrobial-resistant pathogens that may spread to people, which is seen as a major health threat. 

“By replacing antibiotics in animals such as dairy cows with safer biopharmaceuticals, we will protect animals and save people from the health damages associated with the development of antibiotic resistance,” adds Iscovich.

While consumer awareness has increased in recent years and put pressure on industry for greater transparency in antibiotic use, safety claims touting “no use of antibiotics” can be mere producer assertions rather than validations, according to the food-testing start-up Food In-Depth. 

Antibiotic resistance is a major global health problem and causes one death every 15 minutes in the US alone, according to the Center for Disease Control. 

Worldwide, it is estimated that antimicrobial resistance is responsible for causing 700,000 deaths each year globally and predicted to rise to 10 million. 

As a result of death and productivity losses, the antimicrobial resistance threat could cost US$100 trillion globally by 2050 if no action is taken, according to a report published by the UK government.