The trials, conducted by the U.S. Department of Agriculture’s (USDA) Agricultural Research Service, are the first step in a lengthy process toward the possible first use of vaccines to protect U.S. poultry from the lethal virus.

Bird flu, also known as highly pathogenic avian influenza (HPAI), has killed hundreds of millions of birds around the world, raising interest in vaccines. The virus is largely spread by wild birds that transmit it to poultry.

USDA is testing one vaccine from Zoetis, one from Merck Animal Health and two developed by the department’s Agricultural Research Service (ARS).

Zoetis said it previously supplied its vaccine to a USDA stockpile in 2016, following a massive 2015 outbreak, but it was never used.

Initial data from a study using a single dose of a vaccine are expected in May, while results from studies on two-dose vaccine regimens are expected in June, USDA said.

If the trials are successful and USDA decides to continue development, it would take at least 18-24 months for a vaccine that matches the current virus to be commercially available, the agency said.

The government needs to ensure vaccinations would not disrupt trading with major buyers, said Greg Tyler, president of the industry group USA Poultry + Egg Export Council.

Governments have previously focused on culling infected flocks to control the virus due to concerns importers would block shipments of vaccinated poultry to avoid the risk of infections.

USDA said on Friday its “current strategy of stamping out and eradicating HPAI… continues to be the most effective strategy because it works.”

Outbreaks in U.S. commercial and backyard poultry flocks have led to the deaths or culls of an estimated 58.65 million birds across 47 states since the high-path virus’ current run through the U.S. began in early 2022.

In Canada, as of Tuesday, an estimated 7.3 million commercial and backyard birds have been similarly impacted by the virus since late 2021.

France said last week it was launching an order for 80 million doses of vaccines to use in ducks in the autumn if final trial results are positive, the first EU member to start such a plan.

— Tom Polansek reports on agriculture and ag commodities for Reuters from Chicago. Includes files from Glacier FarmMedia Network staff.

The post U.S. begins testing bird flu vaccines for poultry after record outbreak appeared first on Country Guide.

The move affirms the drugmaker’s commitment to the business, which Wall Street analysts have long seen value in separating just as rival drugmakers Eli Lilly and Pfizer did.

Pfizer’s Zoetis raised US$2.2 billion in a 2013 IPO, while Elanco, the former animal health business at Lilly, raised US$1.51 billion from an IPO in September.

Merck CEO Kenneth Frazier had said in October that the company was a “good owner” of its animal health unit.

“We believe that we run this business very well inside the company compared to our competitors,” he had said.

Merck’s unit has been a big player in the animal health segment, bringing in sales of US$3.88 billion in 2017. Zoetis recorded US$5.31 billion in revenue, while Elanco brought Lilly US$3.09 billion in sales the same year.

Merck said Antelliq will be a wholly owned and separately operated subsidiary within its animal health division.

Antelliq has been the brand name since February for the Allflex Group, whose brands include Allflex, SCR, Biomark and Sure Petcare.

Antelliq’s products, which brought in 360 million euros (C$546.3 million) in sales in the year ended Sept. 30, provide veterinarians, farmers and pet owners with digital technology that monitors animals and predicts disease in them.

These products allow access to real-time, actionable information to help improve livestock management and health outcomes, Merck said in a statement.

Merck will assume Antelliq’s debt of 1.15 billion euros (C$1.75 billion), which it intends to repay shortly after the closing of the deal, expected in the second quarter of 2019.

Private equity firm BC Partners currently owns a majority stake in Antelliq.

— Reporting for Reuters by Tamara Mathias in Bangalore.

The post Merck bolsters animal health unit with Allflex deal appeared first on Country Guide.

“Animal Health is a business that we have been trying for many years to strengthen strategically, that is to say inorganically. That is still our goal,” strategy chief Werner Baumann, who is to take over as CEO on May 1, said at a media briefing late Monday.

“Should we not succeed at that in the end, we will have to ask the strategic question, as is the case with all our businesses, are these businesses well placed with us as best owner or can these businesses perhaps progress better in a different environment, with different access to resources?”

He declined to say for how much longer Bayer would continue to scout for takeover targets for the veterinary drugs unit, which saw revenue increase 13 per cent to 1.5 billion euros (C$2.2 billion) last year.

Baumann added there had been a dearth of targets in the past because tie-ups in animal health had typically taken place as part of larger deals in healthcare.

In animal health Bayer is set to become a second-tier player behind four clear market leaders following a series of major consolidation moves in the sector, capped by exclusive talks unveiled in December between Sanofi and Boehringer Ingelheim to combine some businesses.

Apart from Bayer, pharma majors such as Eli Lilly and Merck run animal health operations, applying some remedies originally developed for humans.

Baumann added Bayer was under no pressure to act because the animal health industry was very attractive and Bayer had a strong product line-up and development pipeline, citing as examples its flea and tick collars for dogs and work on developing drugs to boost farm animals’ immune system.

He said the business had a core profit margin of over 20 per cent last year and expected sales to rise in line with market growth of about five per cent in 2016.

Speaking about the group as a whole, which makes prescription drugs, consumer care products, crop chemicals and seeds, Baumann said he should not be expected to change the overall strategic course set by outgoing CEO Marijn Dekkers.

— Ludwig Burger is a Reuters correspondent based in Frankfurt.

The post Bayer to consider shedding animal health unit appeared first on Country Guide.

Financial details were not disclosed.

The deal, which is expected to close by year-end, follows rival Zoetis’ agreement, announced on Nov. 2, to buy Pharmaq, a market leader in vaccines for farmed fish, for US$765 million.

Harrisvaccines, based in Ames, Iowa, is best known for developing a vaccine called “iPED” in 2013 to fight porcine epidemic diarrhea virus (PEDv).

It was one of the first U.S. companies to develop a vaccine to fight the disease, which wiped out an estimated 10 per cent of the U.S. pig population over two years. It also received the first conditional license from the U.S. Department of Agriculture (USDA) to sell its vaccine to veterinarians and swine farmers.

Merck Animal Health’s project to develop a PEDv vaccine is ongoing, the company said on Thursday.

Zoetis also has been granted a conditional license from the USDA to sell its PEDv vaccine.

In October, Harrisvaccines was one of two drug firms to be awarded a USDA contract to manufacture doses of avian influenza vaccine for poultry, in preparation for the potential return of the fast-spreading virus later this year.

— P.J. Huffstutter reports on agriculture and ag markets for Reuters from Chicago.

The post Merck to buy Harrisvaccines to boost livestock portfolio appeared first on Country Guide.

Merck Animal Health on Friday announced approval from Health Canada’s Veterinary Drugs Directorate (VDD) to update the growth-promoting additive’s label to include component feeding.

The update allows for a lower targeted dose of 60 milligrams of the drug’s active ingredient, zilpaterol hydrochloride, per head per day through “one of multiple daily feedings,” such as in a morning or evening feeding, Merck said.

The new method, which the U.S. Food and Drug Administration approved for Zilmax last fall, gives Canadian cattle feeders “an alternative option to deliver the appropriate dose of Zilmax to cattle every day,” the company said.

Merck said the VDD has also approved a revision to the “complete feed” information on the Zilmax label.

The complete feed label dose for zilpaterol is 8.3 grams per tonne (100 per cent dry matter basis) to provide 60 to 90 mg of active ingredient per head per day, Merck said.

The label will now include an “updated caution statement” that emphasizes cattle shouldn’t be fed Zilmax beyond a 90 mg dose per head per day.

If pen consumption of complete feed exceeds 10.8 kilograms per head per day (100 per cent dry matter basis), Zilmax “should not be fed in complete feed,” the company said.

Zilpaterol, a beta-agonist drug, is prescribed for “increased carcass leanness, increased dressing percent, improved rate of body weight grain and improved feed efficiency” in feedlot cattle during the animal’s last 20-40 days on feed.

The drug’s label specifies it should be used only in feedlots and only in cattle weighing at least 450 kg (992 pounds). The label requires it be thoroughly mixed into manufactured feeds, and never used undiluted or as top-dressing on feed.

“Enhanced language”

Merck in 2013 suspended sales of the drug, nicknamed “Vitamin Z” in some feedlots, in both Canada and the U.S. after packers Tyson Foods and Cargill stopped accepting Zilmax-treated cattle.

Tyson said at the time its decision followed observations that some animals arriving at its packing plants were having trouble walking or moving.

A Reuters news agency review in late 2013 of reports submitted by Merck and others to the U.S. Food and Drug Administration (FDA) showed at least 285 cattle to have died unexpectedly or been destroyed in the U.S. after being fed Zilmax since the drug was introduced in 2007.

Reuters said the reports showed at least 75 animals lost hooves and were euthanized after being fed Zilmax over the past two years. The reports show pneumonia was a factor in 94 cases and listed bloat as a cause in 41.

Of the animals that died, 113 were fed either an antibiotic, a different growth-promoting drug or both, along with Zilmax, Reuters said. Some experts have said there is no proof Zilmax was the chief cause of any cattle deaths.

Merck said at the time it would retrain and certify beef producers in administering the drug to cattle, and run a “scientific audit,” following Zilmax-fed cattle from feed yards to packing plants, to determine potential causes of lameness and other mobility issues.

Merck said Friday it has run “an extensive assessment and analysis of existing as well as new product data” and sought input from industry experts, business partners and customers about Zilmax and its use.

“The totality of the comprehensive review supported that (Zilmax) is safe when used according to the product label and in conjunction with sound animal husbandry practices,” the company said Friday.

Merck said in November its research results and industry data showed “cattle weights, and thus feed consumption rates, have been steadily increasing over time.”

That fact, Merck said, “created the possibility that certain cattle could consume feed quantities that result in ingestion of Zilmax in an amount that exceeds the approved dose.”

Merck said its review also found “enhanced label language” along with certification requirements for the drug’s users and a “thorough best practices program” would make sure Zilmax use “remains compliant with the label.”

Under the certification rules, every feedlot worker, distributor, feed mill, nutritionist and veterinarian using Zilmax or consulting on its use must complete the Zilmax training program and yearly retraining on its use. — AGCanada.com Network

The post Zilmax cleared for component feeding in Canada appeared first on Country Guide.

Nearly 18 months after Merck pulled the drug from U.S. and Canadian markets after videos and photographs surfaced showing Zilmax-fed cattle turning up in a distressed state, either lame or with hooves missing at slaughterhouses, scientists at Texas Tech University are testing beef carcasses taken from cattle fed different concentrations of Zilmax.

The Merck-funded field study and lab work, which have not previously been reported, are designed to test Zilmax at its currently approved dosage of 6.8 grams per ton of feed for a 20-day period prior to slaughter, as well as dosages at about 60 per cent and nearly 80 per cent of that level, according to the title of the study.

At the time Merck pulled Zilmax off the market, it had only one dosage level approved by the U.S. Food and Drug Administration (FDA).

Merck awarded US$1.85 million to the Texas Tech team in October to conduct the research, the university mentioned at the time in a newsletter that got little attention outside of the school. The research is ongoing and the specific time frame of the study was not clear.

“This study is an example of the company’s ongoing research efforts to provide additional data on the use of Zilmax,” the company said in a statement to Reuters.

Merck, which says it still sells Zilmax in Mexico and South Africa, declined to comment on why it was testing these particular levels or whether it was collecting data to submit to the FDA. Merck also declined to say how many cattle are being fed Zilmax as part of the tests, or where the animals are being raised or slaughtered. It declined to give any further details.

An FDA spokeswoman declined to comment on the study, citing confidentiality regarding drug applications.

Texas Tech did not respond to requests for comment.

In November, federal regulators approved changes proposed by the company in the way the drug is administered. The company has also been working with cattle feed lot operators on how best to administer the drug.

“It looks to me like they’re doing studies to determine if the lower dosages are efficacious in improving feed efficiency, growth rate and carcass leanness,” said David Anderson, former head of swine research at Elanco Animal Health, when Reuters told him about the study.

A similar product called Optaflexx, made by Elanco, “has captured the market,” said Arizona cattle rancher Harvey Dietrich, co-founder of advocacy group Beef Additive Alert, which is critical of growth-promotants such as Zilmax. “Merck wants their market share back,” he added.

At the time the videos of the distressed cattle surfaced in 2013, some veterinarians argued that a key problem was that the drug, at its approved dosage, was too potent for some animals.

The drug company does not need federal approval to return Zilmax to the market. But all four of the nation’s largest beef packers and many meat producers have told Reuters they won’t accept Zilmax until Merck can scientifically prove the drug doesn’t cause the animal welfare issues seen in the past.

One option, say industry experts, would be for Merck to show the FDA that Zilmax is effective and safe at helping cattle gain weight at lower dosages, and petition the agency to alter the product’s usage label.

The multi-site study Merck is funding could provide the data needed to make such a petition, according to industry experts. Current labeling covers both dosage and details about its effectiveness on cattle.

Major meat packers such as Cargill and Tyson Foods say they are not processing any meat from Merck’s study or slaughtering cattle fed with Zilmax. Spokesmen for Cargill, Tyson, National Beef Packing and JBS USA said their companies were not participating in the study.

— P.J. Huffstutter and Tom Polansek report on agriculture and agribusiness for Reuters from Chicago.

The post Merck funds tests of lower Zilmax doses appeared first on Country Guide.