Merck, Lilly and others seek alternatives to antibiotics
Voluntrary FDA guidelines become mandatory in early 2017
A sparkling and sprawling 48,000-square-foot two-story structure, decorated with artwork of animals etched onto interior glass walls, recently opened its doors 23 miles outside Indianapolis with one sole purpose: to keep the globe’s 70 billion farm animals healthy.
That increasingly means less reliance on antibiotics for animals. So the new research center, built and operated by Elanco LLC, a unit Eli Lilly & Co., is focused exclusively on developing vaccines as alternatives. It’s all part of a broader effort by the drug industry to join forces with the medical establishment to reduce use of antibiotics, as resistant superbugs become more prevalent in hospitals, nursing homes and other public spaces. Weaning animals from antibiotics in favor of vaccines has become central to that effort. Farm animals are fed about 80 percent of the antibiotics in the U.S., which make their way into the human body.
“We see a world where there is less need for shared-use antibiotics,” said Elanco President Jeff Simmons. “There are going to be more alternatives than ever before.”
Scientists say there is an intimate link between the health of the planet’s livestock and the human population. An estimated 700,000 people die annually from drug-resistant infections, with millions more falling sick. The prevalent use of antibiotics in animals plays a role in those deaths because they allow super-bugs to flourish.
Farmers and ranchers aren’t eager to give up antibiotics because the drugs are cheap and easy to administer. But change is coming as voluntary Food and Drug Administration rules become mandatory in January. Those include prohibiting labels that claim antibiotic use promotes growth and requiring veterinarians to administer most of the drugs. Vets also will oversee drugs that are currently bought over the counter.
The deadline has prompted the $30 billion animal-health and drug industry to embark on a campaign to educate agribusiness and farmers that vaccines can do just as credible a job protecting animals.
“The companies see that change is going to have to come,” said Laura Rogers, deputy director of the Antibiotic Resistance Action Center at George Washington University in Washington.
A 2015 study estimated the global animal-vaccine market will be worth $7.2 billion by 2020, up from $5.5 billion in 2010. Already, about one-third of the industry’s revenue is from vaccines, according to company and industry officials. A summit in Washington, D.C., planned for September will gather drugmakers, government officials and nonprofit groups to discuss antibiotic resistance.
Elanco plans to unveil several new vaccines this year and will invest two-thirds of the budget for its food-animal unit in alternatives to antibiotics; vaccines will help the unit outpace the industry’s annual growth rate of 4 percent to 5 percent.
The company expects European approval to market Clynav, a DNA vaccine for north Atlantic salmon to fight pancreas diseases. The company is also working on a new vaccine for bovine respiratory disease, said Aaron Schact, Elanco’s research and development chief.
Elanco has plenty of company. At New Jersey-based Zoetis Inc., vaccines accounted for almost half the company’s product approvals last year. It received a license in 2013 for Fostera PCV MH, which helps control porcine circovirus and enzootic pneumonia. This year, regulators granted the company a conditional license for its vaccine to help prevent disease caused by avian influenza H5N1 in chickens.
Merck Animal Health, also in New Jersey, last year introduced Porcilis Ileitis, a vaccine for bacterial intestinal infections in pigs. And the Merck & Co. units COCCIVAC-B52 vaccine prevents intestinal disease in chickens. Last year, Merck acquired Harrisvaccines Inc., an Iowa-based biotech company that develops vaccines.
“The future of our company is heavily grounded in vaccine development,” said Rick Sibbel, a veterinarian who runs the company’s technical services for cattle, poultry and swine.
Experts stress vaccines alone won’t resolve antimicrobial resistance problems. Vaccines can’t replace all antibiotics since they effectively treat some diseases but not all. For example, calves transported in groups can develop shipping-fever pneumonia that may require antibiotics. There is no similarly effective vaccine because the cause of the illness isn’t clear, said David Wallinga, a physician with the National Resources Defense Council.
That helps explain why chains like McDonald’s Corp. and Perdue Farms Inc. vow to switch to antibiotic-free poultry but aren’t making similar commitments with their beef or pork. Cattle and pigs also have longer life spans than chickens and change owners more frequently, making antibiotics a more sure bet in eradicating such illnesses as pneumonia and mastitis, a common inflammatory disease.
“Animals are still going to get sick,” said Gail Hansen, a veterinarian who has consulted for animal-health companies and public agencies. “What the drug companies are looking at is vaccines that are basically cheaper to give to the animals en masse than to treat them if and when they get sick.”
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