Elanco Gets FDA Nod on Biological Drug for Dairy Cows

Xconomy Indiana — 

A mastitis diagnosis in a cow spells trouble for a dairy farmer, who faces certain loss in milk production and possible loss of the cow. Antibiotics can treat this infection of the udder, but these drugs have fallen out of favor due to growing drug resistance.

Soon, though, U.S. farmers will have a biological alternative to antibiotics. The FDA has approved a new biological drug developed by Elanco, the animal health division of Indianapolis-based Eli Lilly (NYSE: LLY). Pegbovigrastim (Imrestor), an injectable drug, is a protein that boosts a dairy cow’s immune system when she is calving—a critical time when cows are vulnerable to mastitis infection. Rather than taking an infection head on the way antibiotics do, Elanco says its drug works by supporting production of the cow’s own bacteria-fighting cells and in doing so, preventing the onset of mastitis in the first place.

Mastitis is prevalent throughout the dairy industry. Elanco points to analysis of the National Animal Health Monitoring Systems Dairy 2014 study, which found that nearly 25 percent of cows were affected by mastitis the previous year. While most of those cows recovered, some were sold and a small percentage died. Dairy farmers whose cows are diagnosed with mastitis face multiple financial blows. Milk from infected cows must be dumped, and these cows must also be removed from the herd while they are treated with antibiotics because milk containing antibiotics is barred from the food supply.

Mastitis costs are measured in medication expenses, lost production, and cows culled from the herd. Dollar estimates are hard to pin down but many researchers point to figures from the National Mastitis Council pegging the annual costs to the U.S. dairy industry at somewhere between $1.7 billion and $2 billion a year—more than $200 per cow. That impact is felt in the nation’s top dairy states. California’s 1.7 million cows are the most of any state, according to 2014 U.S. Department of Agriculture figures, the most recent data available. The Golden State is the nation’s top milk producer, accounting for more than 20 percent of overall U.S. production, followed by Wisconsin at 13.5 percent.

Elanco’s drug is intended to be administered at a critical point in time for a cow. Calving makes dairy cows and heifers vulnerable to infection because of a decline in neutrophils, a type of white blood cell key to recognizing and fighting harmful bacteria, Elanco says. Pegbovigrastim is what’s called a colony-stimulating factor, a type of medicine that stimulates the body’s production of infection-fighting white blood cells.

The Elanco drug’s biotech roots are in Southern California. Pegbovigrastim was originally developed by Ambrx, a La Jolla, CA-based company that has developed technology to attach molecules to specific sites within proteins. Ambrx describes its approach as … Next Page »

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