Shares of the company were down 2.4 per cent before the bell on Tuesday even as it beat profit estimates.

Global sales fell 1.5 per cent in the third quarter, the biggest decline in four years, compared with analysts’ average estimate of a 0.72 per cent fall, according to data compiled by LSEG.

Last week, McDonald’s temporarily paused serving Quarter Pounders in a fifth of its 14,000 U.S. restaurants in an E. coli outbreak that has killed at least one person. Shares declined nearly seven per cent last week as infections rose to 75 people. Quarter Pounders were being added back to the menu this week.

Slivered onions used in the hamburgers are likely to be the source of the infection, with the Colorado Department of Agriculture over the weekend ruling out beef patties as the possible cause.

Customer visits in the U.S. fell 6.4 per cent, 9.1 per cent and 9.5 per cent year-over-year on October 23, 24 and 25, respectively, according to a Gordon Haskett note. The company’s conference call on earnings is expected to focus on any fallout from the outbreak.

The outbreak likely has thrown a near term “monkey wrench” into the U.S. sales recovery when coupled with mixed third-quarter results, Citi analyst Jon Tower said.

The fast-food chain has been hit by slowing customer visits across the U.S., France, UK, Middle East and China as price-conscious shoppers looked for cheaper meals and cooked more at home.

International markets struggle

Sales in international markets fell 2.1 per cent, driven by weakness in France and Britain, compared with estimates of a 1.21 per cent drop.

Weaker consumer spending in China and impacts of the Middle East conflict have dented McDonald’s business segment where restaurants are operated by local partners, with sales dipping 3.5 per cent compared with a 10.5 per cent rise a year earlier.

“We believe European economies remain under pressure with potential for softer traffic from concerns with war in the Middle East, especially in urban markets, and some pressure on costs from a stronger dollar,” Jim Sanderson, analyst with Northcoast Research.

Western fast-food chains such as McDonald’s and Starbucks have seen boycott campaigns over their perceived pro-Israeli stance and alleged financial ties to Israel.

U.S. comparable sales grew 0.3 per cent, reversing the previous quarter’s drop, aided by promotions.

Overall sluggish demand has prompted fast-food chains including McDonald’s, Wendy’s, Burger King and Taco Bell to lean into meal bundles and limited-time offers in a bid to revive traffic, especially among lower-income customers.

McDonald’s CEO Chris Kempczinski said the company was focused on affordability as customers continue to be mindful about spending.

The Chicago-based company earned $3.23 per share on an adjusted basis, above analysts’ estimates of $3.20.

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“We remain very confident that any contaminated product related to this outbreak has been removed from our supply chain and is out of all McDonald’s restaurants,” the fast-food chain’s Chief Supply Chain Officer Cesar Pina said in a statement.

The Colorado Department of Agriculture said that all subsamples from multiple lots of McDonald’s brand fresh and frozen beef patties had tested negative for E. coli, adding that it had completed beef testing and does not anticipate receiving further samples.

McDonald’s said it would resume distribution of fresh supplies of the Quarter Pounder and that it is expected to be available in all restaurants in the coming week, according to the statement.

Regulators had been investigating whether McDonald’s beef patties could be affected.

The U.S. Food and Drug Administration and the U.S. Department of Agriculture didn’t immediately respond to a Reuters request for comment.

E. coli is killed in beef when cooked properly. The McDonald’s Quarter Pounder is served with raw, slivered onions; affected restaurants will serve the burgers without such onions.

U.S. fast-food chains have pulled fresh onions out of their menu items after the vegetable was named as the likely source of an E. coli outbreak.

McDonald’s has pulled the Quarter Pounder from about one-fifth of its U.S. restaurants, including in Colorado, Kansas, Utah and Wyoming, and in parts of Idaho, Iowa, Missouri, Montana, Nebraska, Nevada, New Mexico and Oklahoma.

Past E. coli outbreaks have hampered sales at big fast-food restaurants as customers avoid affected chains.

— Reporting by Kanjyik Ghosh

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Restaurant Brands International, parent of McDonald’s rival Burger King, and Yum Brands said they were removing fresh onions from menu items. Roughly five per cent of Burger King locations have removed onions from the menu, a Burger King spokesperson said in a statement.

McDonald’s said on Thursday that Taylor Farms was the supplier of the sliced onions that have been removed. Taylor Farms did not immediately respond to a request for comment. The company has recalled several batches of yellow onions produced in a Colorado facility, according to a recall memo on Wednesday by US Foods, one of the largest U.S. suppliers of food service operations.

About five per cent of Burger King stores also get supplies from Taylor Farms, but a company spokesperson said Burger King has not been contacted yet from health authorities or had any illnesses. Yum, which operates KFC, Pizza Hut and the Taco Bell chains, said it was removing onions “out of an abundance of caution.”

The U.S. Department of Agriculture said late on Wednesday that fresh onions were the likely source of the outbreak. The U.S. Food and Drug Administration said it is looking at all possible sources of the outbreak and has not determined the cause.

Past E. coli outbreaks have hampered sales at big fast-food restaurants as customers avoid the affected chains for fear of illness. Regulators are still investigating whether McDonald’s beef patties could be affected, but E. coli is killed in beef when cooked properly, whereas the McDonald’s Quarter Pounder is served with raw, slivered onions.

McDonald’s has pulled the Quarter Pounder from about one-fifth of its U.S. restaurants, including in Colorado, Kansas, Utah and Wyoming, and in parts of Idaho, Iowa, Missouri, Montana, Nebraska, Nevada, New Mexico and Oklahoma.

“We’ve been told by corporate to not use any onions going forward for the foreseeable future,” Maria Gonzales, the on-duty manager inside a Burger King in Longmont, Colorado, said on Wednesday. “They’re off our menu.”

McDonald’s did not immediately respond to a request for comment on Thursday.

McDonald’s has moved quickly to try to contain the damage while also trying to reassure customers of its efforts. That may be critical – previous outbreaks in 2015 at Chipotle Mexican Grill CMG.N and in 1993 at Jack in the Box caused sales at those companies to drop sharply for several quarters.

David Tarantino, an analyst at Baird Equity Research, downgraded McDonald’s shares to “neutral” late on Wednesday. “We are concerned that reports of an E. coli outbreak linked to McDonald’s restaurants in multiple U.S. states could pose a major threat to consumer sentiment” and thus hurt U.S. comparable-store sales, he said.

Plenty of customers

In the immediate aftermath of the McDonald’s outbreak, plenty of people in Colorado were still eating at the U.S. giant, according to checks by Reuters. Some were avoiding the hamburgers.

Charity Atkinson was munching on a 20-piece box of Chicken McNuggets in a McDonald’s parking lot in Longmont on Wednesday afternoon, about 30 miles (48 km) north of Denver.

Atkinson said she was not worried about the outbreak, but she did note that for now she was avoiding the burgers.

“I’m hoping everything gets taken care of really soon, because my mom loves the Quarter Pounders with cheese,” Atkinson said. “Hopefully they’ll have better sanitary protections soon.”

At Burger King, Monica and Jesus Martinez were digging in to a bag of burgers and fries while sitting inside their car, and said they had decided to frequent Burger King in large part because of the outbreak at McDonald’s.

“I’m worried! I like the Quarter Pounder but I’m really worried,” Monica Martinez said. “It will definitely influence my choices of where we eat going forward.”

The outbreak of E. coli was first reported to the U.S. Centers for Disease Control and Prevention in late September.

The USDA on Wednesday said that one of its state partners was also testing samples of beef for E. coli.

—Additional reporting by Siddharth Cavale in New York and Aishwarya Venugopal in Bengaluru

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The outbreak has sickened people across the U.S. West and Midwest, with 10 hospitalized due to serious complications, according to the U.S. Centers for Disease Control and Prevention (CDC), which is investigating the outbreak. A McDonald’s spokesperson said the outbreak is limited to the United States.

“We fully expect to see more cases,” said CDC spokesman Tom Skinner. “McDonald’s has moved rather quickly to take action to, hopefully, prevent as many cases as possible.”

Previous E. coli outbreaks at big U.S. fast-food chains have caused consumers to shun those chains for months. McDonald’s USA President Joe Erlinger on Wednesday said the fast-food chain needs to rebuild trust with the public after it pulled the item off its menu at a fifth of its 14,000 U.S. restaurants.

The company pulled the Quarter Pounder from its menu at McDonald’s locations in Colorado, Kansas, Utah and Wyoming, and in parts of Idaho, Iowa, Missouri, Montana, Nebraska, Nevada, New Mexico and Oklahoma.

The CDC and McDonald’s are scrutinizing the Chicago-based company’s supplies of slivered onions and beef patties as they try to determine the cause of the outbreak, the company said.

The U.S. Department of Agriculture said late on Wednesday that the onions used were the likely source of the illness, though one of its state partners is testing samples of the beef for E. coli.

The company’s stock closed down 5.1 per cent at $298.57 on Wednesday. Shares hit an intraday low of $290.88.

‘Very serious disease’

The E. coli O157:H7 strain that led to the McDonald’s outbreak is the same as a strain linked to a 1993 incident at Jack in the Box that killed four children. It can cause “very serious disease,” especially for the elderly, children and people who are immunocompromised, said Shari Shea, director of food safety at the Association of Public Health Laboratories.

McDonald’s suppliers test their products frequently and did so in the date range the CDC gave for the outbreak, and none of them identified this E. coli strain, company spokespeople said.

U.S. food safety attorney Bill Marler, who represented a victim in the Jack in the Box outbreak, said this is a relatively large and serious outbreak for which McDonald’s will face “a lot” of liability for the contamination.

“We’re still in the early stages of how McDonald’s is going to handle this,” he said. “But getting the supplier of the onions out – if they’re confident that’s the source of it – is going to be really important.”

Marler said that in the 1990s, he dealt almost exclusively with lawsuits involving contaminated beef, but in recent years E. coli outbreaks have been almost solely limited to produce contaminated through irrigation or flooding with feces from nearby cattle. E. coli is a natural pathogen in the guts of cows.

Jim Lewis, who was a franchisee in New York City for more than 30 years before exiting the system in 2019, said when E. coli became a major concern decades ago, McDonald’s was adamant about its protections for its beef supply chain.

“They were over the top to make sure it would never happen,” he said.

He said McDonald’s has historically been the “safest, strongest food chain in the world. So this is devastating to us internally.”

Analysts flagged the outbreak as a potential black eye for McDonald’s ahead of earnings.

“The worst-case scenario is if more people get sick or multiple ingredients or suppliers are impacted, which could be a longer-lasting issue that could also tarnish the brand,” CFRA Research analyst Arun Sundaram said.

During an appearance on NBC’s “Today” show on Wednesday, McDonald’s USA chief Erlinger pointed to the company’s steps to quickly pull the Quarter Pounder from its menu in areas where the outbreak occurred.

“Given the recent events of the past 24 hours, our priority is to reinforce the confidence of American consumers,” he said.

In the past, two notable E. coli outbreaks – at Chipotle Mexican Grill in 2015 and Jack in the Box in 1993 – significantly hurt sales at those chains.

Chipotle took a year-and-a-half to stabilize, while Jack in the Box sales declined for four straight quarters, Raymond James analyst Brian Vaccaro said.

Chipotle shares fell nearly 50 per cent during the 2015-2018 period when cases of norovirus infections were reported after the E. coli outbreak.

Analysts said McDonald’s fourth-quarter sales could experience some pressure from the outbreak, but it was too early to say whether it would be worse than the previous two E. coli cases.

— Additional reporting by Aishwarya Venugopal in Bengaluru and Julie Steenhuysen and Tom Polansek in Chicago

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The work began more than five years ago after Agriculture and Agri-Food Canada (AAFC) research scientist Dr. Rima Menassa learned about E. coli contamination in an Alberta meat processing plant. She knew of the Belgian team’s efforts to bio-engineer an antibody that will grow within the cell structure of a plant, and secured three years of AAFC funding to explore the possibility of using the same technology to bio-engineer E. coli 0157:H7, a bacterial pathogen of significant concern in the pork sector.

Why it matters: Preventing E. coli in hog barns has direct economic benefits to the farmers by promoting healthy pigs, but the pathogen can also be transmitted through manure and present both human health and food safety risks.

“I was very impressed by the work (the Belgian team) did and we took a very similar approach,” Menassa told Farmtario.

During the first three years of the study Menassa, based at AAFC’s London Research and Development Centre, worked with a form of antibody with a single-chain DNA that’s unique to llamas and camels. The single-chain proteins, called “nanobodies,” are characterized by very strong binding to the target cell.

Llama-derived nanobodies are well-known for their potential in medical research, including much ongoing work targeting COVID-19.

Through bio-engineering, she fused nanobodies that had been exposed to E. coli with antibodies typically found in pigs. Further engineering created antibodies that will grow within the cell structure of plants.

The purpose, according to an AAFC release, is to create a plant-based feed additive with the plants growing the antibody. “Cell walls of plant matter can protect the antibody during digestion,” it said. “This helps the antibodies reach the gut, where they bind to E. coli bacteria and can prevent further colonization of the pathogen in the digestive tract.”

“This is a novel approach,” Menassa said of the plant-grown antibody. “This is not something that occurs in nature.” In the first three years of the study, she published three scientific papers explaining her work.

A plant biologist without experience with livestock, Menassa knew after this preliminary work that she would need to bring in animal expertise. She was able to attract the interest of the biotech start-up PlantForm, which then applied for follow-up funding through OMAFRA. That’s what’s paying for the upcoming trials in mice, and Menassa is confident additional funding will be secured to continue with trials in pigs.

PlantForm, she explained, has been exploring similar therapeutics for use in humans. But getting approval for trials in humans can be more difficult than getting approvals for use in animals. And conducting those trials can be significantly more expensive in humans than in animals.

The start-up saw the opportunity to join forces with Menassa and begin its explorations through the pork antibody. Menassa and PlantForm then developed a partnership with Dr. Patti Kiser, a veterinary pathologist at Western University, to begin looking at testing this antibody specifically for E. coli in pigs. 

The trials, she says, should be straightforward. 

“You feed the animal the antibodies and then you challenge the animal with the pathogen. Then you collect the excrement and see if E. coli continues to be present.” 

After the end of the experiment, Kiser will examine the mouse intestines for signs of colonization by E. coli bacteria.

“It shouldn’t take too long. It just depends on how many results we need to acquire to make sure they’re accurate.”

Kiser will lead the trials. The aim, said Menassa, “is to determine if the antibody can prevent E. coli colonization in mice and/or prevent E. coli shedding from colonized mice.” 

The team hopes to “establish a baseline for the minimum dosage requirement for efficacy. The more antibodies that survive the digestive tract in the animal, the smaller the dosage required to achieve the desired outcomes of preventing colonization and shedding,” she said. 

Menassa hasn’t spoken directly with any representatives of Canada’s pork sector about the team’s work but she expects interest will grow as they move towards trials in pigs. And if those go well, there will be enthusiasm to see a feed additive commercialized.

“Feeding the antibody directly to livestock using a plant-based feed additive, rather than through a purified, injected formula, will have cost-related benefits for the industry,” she said, adding that purifying and formulating a treatment of this kind in an injectable form could make up to 80 to 90 per cent of the total cost of the drug.

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PlantForm Corporation has launched a new research project with Agriculture and Agri-Food Canada (AAFC) and Western University in London to target E.coli infection in pigs, specifically O157:H7, through a feed additive.

Why it matters: O157:H7 is a strain of E.coli that is harmless to most animals but can be dangerous and even deadly to humans. It occurs naturally in the gut of animals like cattle and pigs and is shed into the environment through their manure.

“What we’re trying to do is reduce the prevalence and shedding of E.coli, so the idea is to come up with a feed additive that can be given before slaughter, a powder administered in the feed that is a low-cost solution,” says PlantForm CEO Don Stewart.

Although E.coli O157:H7 is not a new challenge, it made particular headlines in Canada about two decades ago when the town of Walkerton’s water supply became contaminated, causing six deaths and making hundreds more sick.

That helped spur the development of a vaccine for cattle to reduce prevalence of the pathogen in the animals, but it did not see wide uptake. According to the Beef Cattle Research Council, it is not currently available.

E.coli contamination results in expensive – and often extensive — recalls of meat products, but can also cause food safety issues in produce if vegetables in the field come into contact with water containing the pathogen.

PlantForm’s vivoXPRESS platform uses genetically modified tobacco plants to ‘grow’ biopharmaceuticals (plant-based antibodies and vaccines), making it a faster and more cost-effective alternative to the commonly used fermentation systems for biopharmaceutical production. It’s technology originally developed at the University of Guelph by one of PlantForm’s founders, Chris Hall.

Dr. Rima Menassa is a research scientist in plant biotechnology at AAFC in London, who has developed plant-based bovine antibodies that prevent E.coli’s ability to colonize in the gut wall.

With this new project, she is looking to prove her concept in animals, starting with mice trials and then moving into pigs. Although O157:H7 is more commonly associated with cattle, it is carried by pigs and she hopes the outcomes will be easier to accomplish on monogastric or single stomach animals like pigs, where digestion is a faster and simpler process than in ruminant animals.

Pig uptake could be simpler than ruminants

“We are hoping that with pigs, who have only one stomach and digestion taking two to four hours, the antibodies can pass through and get to the intestine without being degraded. It is more complicated with ruminants, so we decided to take the first step in a pig and then maybe go to ruminants,” she explains.

The goal is to see whether the antibodies that work in the lab setting will translate to animals, both in preventing O157:H7 from growing in the gut and in preventing shedding if an animal already has the pathogen.

This new, two-year project is supported through the Ontario Ministry of Agriculture, Food and Rural Affairs’ Ontario Agri-Food Research Initiative, which is funded by the Canadian Agricultural Partnership. It is part of wider efforts to find low-cost, practical ways to prevent infection and transmission of pathogens that impact human and animal health.

Although this is work with a food safety focus, Menassa and PlantForm are also working on a project with direct animal health implications — a vaccine for Porcine Epidemic Diarrhea virus (PEDv). It causes severe dehydration and diarrhea in pigs, and although older animals can recover, the virus is generally fatal in young piglets.

“The idea is to vaccinate pregnant sows, so they generate the antibodies that are transferred to the piglets and they in turn become protected,” says Stewart.

The first case of PED in Ontario was identified in January 2014 and since then, the industry has been actively working to manage and ultimately eliminate the disease from the province.

According to Menassa, the PED project is still in early stages, but if early results are promising, she hopes to move into a study with pigs later this year.

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The Canadian Food Inspection Agency said Friday it will begin next week to require importers to provide proof that their U.S.-grown romaine didn’t come from certain California counties.

Otherwise, importers will need to provide an official certificate of analysis from an accredited lab confirming the romaine has “below-detectable levels” of E. coli.

The counties CFIA specifies include Santa Cruz, Santa Clara, San Benito and Monterey, which form central California’s Salinas Valley, a region dubbed by some in the food industry as “the salad bowl of the world.”

Romaine lettuce from the Salinas Valley was identified in food safety investigations as a “recurring source” of outbreaks of E. coli O157:H7-related illness in both the U.S. and Canada from 2016 to 2019, CFIA said Friday.

To “mitigate risk in the event of another outbreak this fall,” CFIA’s new certification and testing rules will apply to romaine lettuce as well as mixed salads containing romaine, and will be required on shipments arriving in Canada starting Wednesday (Oct. 7) until Dec. 31 this year.

The rules will apply to all U.S. shipments of romaine or salad mixes sold in bags, in bulk, or combined with other food items, in a fresh state, and to all varieties of mature and baby romaine.

Between June last year and July this year, 50,000 shipments of romaine lettuce or salad mixes containing romaine were imported into Canada, CFIA said.

In Canada alone, the agency said, there have been seven documented outbreaks of illnesses associated with romaine, and 16 E. coli-related recalls of romaine or products containing romaine lettuce between 2010 and 2019.

Romaine, best known as the main ingredient in caesar salad, is generally grown in open fields and thus is “associated with elevated food safety risks,” CFIA said.

Food-borne pathogens in such systems are known to come from sources such as irrigation water, manure used for fertilizer, runoff from livestock operations, wildlife feces and/or insects. — Glacier FarmMedia Network

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The cancellation, announced Monday, indefinitely prolongs what was already described as “critical processing capacity shortage” for the province’s cattle producers, leaving them to seek other markets and feed cattle far longer than anticipated.

The Canadian Food Inspection Agency said Monday it made the decision to cancel the licenses for Ryding-Regency Meat Packers, Canadian Select Meats and The Beef Boutique — the latter two operating under the St. Ann’s Foods banner — all of which were already suspended in September as part of an E. coli food safety investigation.

The companies’ licenses were suspended separately in mid-September because they “failed to implement effective control measures” at the facilities, CFIA said at the time.

However, during its investigation, CFIA said Monday, it also “identified (it) had received false or misleading information from the licence holders concerning E. coli lab results.”

Effective immediately, CFIA said, the companies in question “are no longer able to slaughter food animals or prepare meat products for export or to be sent from one province or territory to another.”

Beef Farmers of Ontario for weeks had been calling for “an expedited process to assist (Ryding-Regency) in rectifying the noted gaps in food safety protocols” that led to the suspensions.

“Given the uncertainties that exist, we strongly advise members to seek alternative harvesting arrangements for existing inventory, if arrangements have not already been made at other establishments,” BFO said in a statement Nov. 11.

The cattle producer organization said members should contact its office “if you are experiencing difficulty” making such arrangements.

In a statement posted in September on its website following the license suspensions, Ryding-Regency had said it “continue(s) to co-operate with the CFIA to ensure that all requirements are being met, and that improvements are being implemented to strengthen our daily business practices.”

Through the investigation, the company said on its site, it “concluded, that on isolated production days, we experienced breakdowns in our operating procedures,” and announced voluntary product recalls from those days as a result.

Ryding-Regency said at the time it “did not knowingly release any contaminated products, and there have been no complaints from industry.”

‘Uncertainty and duress’

CFIA’s announcement comes in the wake of what the Ontario Federation of Agriculture had described separately Thursday as “a state of uncertainty and duress” for the province’s cattle producers that has so far lasted “more than a year.”

Losses on beef cattle operations in Ontario and Quebec combined have risen above $150 million since January 2019, a situation OFA said Thursday is “not sustainable.”

OFA on Thursday cited “depressed market prices, trade and market access barriers, a shortage of processing capacity and most recently, the prolonged licence suspension for Ryding-Regency Meat Packers, a significant player in beef processing for Eastern Canada” — a situation the group said at the time “needs to be resolved immediately.”

The OFA said the resulting “critical processing capacity shortage — combined with a serious competitiveness crisis — is costing the sector millions of dollars in lost income, threatening the viability of Ontario beef farms, livestock truckers, auction barns, processors and other associated industries that make this billion-dollar sector thrive.”

Processing backlogs, OFA said Thursday, “are becoming more frequent and severe, requiring farmers to feed cattle at increased costs for longer periods, resulting in producers being penalized for overweight animals when they finally secure processing space.”

With beef farmers having “no immediate recourse to address these challenges,” OFA and other groups on Thursday called for “immediate government action to aid in the resolution of the mounting threats facing Ontario farmers.”

BFO and Les Producteurs de bovins du Quebec in September called on governments to set up a national emergency beef cattle investment and assistance program to help farmers in Ontario and Quebec “mitigate market losses and the disturbances of recent trade and market disruptions,” OFA noted.

Longer-term, OFA said, “a plan to support the expansion of processing capacity to service Ontario and Eastern Canada is needed. Too many processors have exited the sector in recent years, leaving too few processors to place bids on cattle to ensure a competitive, healthy marketplace.” — Glacier FarmMedia Network

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The Toronto company, along with St. Ann’s Food, announced a recall Tuesday of a long list of its products because of concerns with E. coli O157:H7. More products were added to the recall on Thursday.

The Canadian Food Inspection Agency (CFIA) says it suspended the licence of the company because the beef processor “failed to implement effective control measures in accordance with Part 4 of the Safe Food for Canadians Regulations (SFCR).” Part 4 describes controls that have to be applied in order to reduce risks.

Why it matters: Ontario farmers already have limited options for selling their beef cattle for processing. One less makes the market even tighter.

CFIA says the plant’s original licence suspension, in late September, related to ground pork, ground beef and burger products that were recalled by Alpha Meat Packers/Salaison Alpha at Anjou, Que.

The company got the affected products from Ryding-Regency Meat Packers.

“While Beef Farmers of Ontario (BFO) is very concerned about this situation and the impact on Ontario beef producers, we have full confidence in our regulatory system and will be reviewing the findings of the CFIA investigation when they become available,” the organization said in a statement.

“We have been assured by the leadership at Ryding-Regency that they are actively working with CFIA to resolve the issues that have been identified, with the goal of minimizing time out of the market.”

BFO encourages beef producers who ship to Ryding-Regency to contact the buyer they deal with.

— John Greig is editor of Farmtario.

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Indianapolis-based Elanco announced Thursday it has paid $78.5 million to buy Prevtec Microbia, which is headquartered in Montreal with facilities in St-Hyacinthe.

The Coliprotec line is meant to help protect pigs against post-weaning diarrhea (PWD) and related symptoms of infection with pathogenic E. coli bacteria.

Weanlings are at risk of E. coli exposure due to relocation, commingling, loss of maternal antibodies and the shift to a solid diet, Elanco said. Symptoms of E. coli infection such as PWD typically appear five to 15 days after weaning and can last three weeks or more.

Prevtec’s vaccine products are “particularly important in Europe given the (European Union’s) direction to phase out the use of the antibiotic colistin and zinc oxide, both among the ways producers’ protect against E. coli today,” Elanco said.

“Offering a full range of alternative solutions is particularly important given alternatives do not typically have the same broad spectrum of activity antibiotics deliver.”

Regulators have been weighing the availability of colistin to livestock producers since the 2015 discovery of a gene that makes bacteria highly resistant to the polymyxin class of antibiotics.

Colistin, a member of that class, is used in both human and veterinary medicine. In Canada, the federal health department’s Veterinary Drugs Directorate places polymyxins in Category I (“very high importance”) of its list of antimicrobials based on importance in human medicine.

As for zinc oxide, the EU in 2017 announced it would withdraw authorizations for the product’s use as a PWD treatment, citing risks from environmental accumulations of zinc.

Elanco, already the exclusive distributor for Coliprotec in Canada and Europe, said it will now “look to expand registration to other key geographies” and will bring Prevtec’s research and development programs into its own pipeline.

Elanco’s work with Prevtec so far “has been very successful and has resulted in delivery of an important non-antibiotic solution for swine producers,” Ramiro Cabral, executive vice-president for Elanco’s international business, said in a release.

“Our distribution agreement thus culminates in this exciting opportunity to provide actual and future vaccines to the animal health industry,” Prevtec CEO Michel Fortin said Thursday in a separate release.

Prevtec’s swine E. coli vaccine Coliprotec F4 has been sold across Canada since 2007, later picking up approvals in Brazil (2010), the EU (2015) and the United States (2018). Coliprotec F18 has been distributed in Canada since 2015.

Authorizations were granted in 2017 for the combination product Coliprotec F4/F18 in the EU and Canada and later in Russia and CIS countries.

Elanco noted Thursday it has taken other steps in the past year to “advance the company for greater success in the swine industry,” including the launch of Prevacent porcine reproductive and respiratory syndrome (PRRS) vaccine and a deal with AgBiome to develop probiotic products for gut health issues.

The deal announced Thursday with Prevtec also calls for a contingent payment of up to $21.5 million to Prevtec’s now-former shareholders in the first quarter of 2022 if “certain sales milestones” are hit in 2021. — Glacier FarmMedia

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