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Ouro Fino suffers from Brazil’s depression as year ends with double-digit drop

BY JOSEPH HARVEY

Brazilian animal health leader Ouro Fino Saúde Animale will be glad to see the back of 2016 as the firm faced strong pressures from both external and internal forces.

However, the firm is forecasting a more resilient 2017 as the Brazilian economy emerges from its worst ever depression and several of Ouro Fino’s growth-stimulating initiatives take hold.

The company recorded a 40% decline in fourth-quarter revenues to R$98.5 million ($31.9 million). Ouro Fino recorded an operating loss of R$7.8m in Q4, compared to a profit of R$33.5m during the same quarter of 2015.

The full year witnessed a 14.5% drop in sales to R$456.6m, while operating profit was down 81% to R$18.8m.

“2016 was one of the most challenging years in the history of Ouro Fino,” explained the firm’s new chief executive Jardel Massari. “Externally, we faced strong pressure from adverse macroeconomic and market conditions. Internally, we made difficult decisions to adjust the path that should lead to better results in 2017 and subsequent years.”

The Cravinhos-based company has previously communicated its struggles with the macroeconomic situation in Brazil.

In the fourth quarter of the year, Ouro Fino put into action its plan to revive growth and profitability. This strategy includes a sales rationalization process, which resulted in a substantial drop in revenues during the most recent quarter.

“We are aware the results achieved in the year were significantly below everyone’s expectations but we are certain these decisions are aligned with the long-term interests of the company and its stockholders,” said Mr Massari.

In 2017, Ouro Fino expects to benefit from: a new sales incentive program tied to an increase in gross margin; a decrease in exposure in the poultry segment; rationalization of its cattle product portfolio; and a progressive reestablishment of lower inventory levels, which is designed to improve working capital.

“We reaffirm our confidence in the animal health industry and the actions taken to make the company better prepared to take advantage of the gradual resumption of Brazil’s economic growth, which is expected to take place during 2017,” Mr Massari added. “Our long-term projects, including our investments in R&D, remain unaltered. Therefore, we reinforce our confidence in the company’s sustainable growth.”

Ouro Fino to fall out of top 20The decline in sales during 2016 will almost certainly result in Ouro Fino dropping out of Animal Pharm’s top 20 ranking for the global animal health industry. However, it should retain its standing as the leading domestic animal health firm in Brazil.

With one of the world’s largest populations of food-producing animals and a booming pet industry, Brazil is still a highly attractive animal health market. While local firms have been suffering the pains of a fiscal downturn, many international businesses have been making Brazilian purchases in recent months.

A closer look at the financial resultsOuro Fino suffered declines across the board in Q4. Sales of products for food-producing animals (-43% to R$76.6m) and companion animals (-21% to R$11.6m) both fell, while international operations dipped 31% to R$10.3m).

Despite revenues from production animals (-17% to R$359.7m) and pets (-13% to R$54.5m) dipping over the full year, there was one bright spot for Ouro Fino in 2016 – its international sales grew 18% to R$42.4m. This shows the company is globalizing and making its long-term growth plan less reliant on the domestic market.

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Ouro Fino said its production animal segment was impacted by a drop in the price of its foot-and-mouth disease vaccine, as well as price and volume losses on poultry and pig products, especially poultry products. The company said it also suffered a decrease in the volume of sales from most of its cattle products, aside from gains in reproduction products.

The firm said it recorded price and volume losses for companion animal ectoparasiticides, due to an increase in the sales of tablets by the other market players. “These results were partially offset by price and volume gains in wormers, and price gains in the remaining therapeutic classes,” Ouro Fino noted.

Product launches 2016The company launched nine new products on the Brazilian market during 2016.

The new products for food animals were: Ourovac Raiva, a vaccine against rabies in cattle; Resolutor, an antibiotic for the treatment of respiratory diseases in animals; Evol (ivermectin and albendazole sulfoxide), a broad-spectrum endectocide for cattle; Saligold and Nicargold, antibiotics for controlling coccidiosis; Gallipro, a probiotic additive to maintain the equilibrium of the intestinal flora, weight gain and improvement of the feed efficiency of broilers and breeding chickens; Mgold 20 and Mgold 40, antimicrobials for preventing coccidiosis in broilers and replacement pullets.

The one product launched for companion animals in 2016 was Nulli, a tramadol-based pain reliever for dogs and cats in an oral form.

Latin America opportunities: Small can be beautiful too

BY THIERRY GOZLAN

While Brazil is the dominant animal health market in Latin America, there are many other countries that pose enticing opportunities. Industry consultant Thierry Gozlan puts a marker down for some of the continent’s smaller markets and looks at the qualities that make Uruguay a viable opportunity.

When thinking of Latin America, most business people would think of Brazil and they are right. Brazil is the continent’s largest economy and accounts for 60% of the Latin American animal health market. Brazil is the third-largest animal health market after the US and China.

Brazil is a vast country blessed with enormous natural resources. However, it is not an easy place to make money. Administrative expenses are 50-100% higher than average costs because of the country’s multilayer tax system, according to a Deloitte study.

Competition is fierce in Brazil, which is pulling product prices down. The Brazilian real/US dollar ups and downs, as well as interest rates, are driving chief financial officers crazy. Brazil is attractive because of the size and diversity of the market – not to mention its wonderful beaches and unique racial mix of inhabitants.

But are there attractive options outside Brazil for animal health players?

Take Uruguay and Paraguay for instance. They are small but stable countries with no mining and without oil. The main income for Uruguay and Paraguay comes from their dynamic and modern agricultural markets. For example, Paraguay has one of the highest rates of embryo transfer per head of cattle worldwide.

Uruguay has an excellent educational network for agricultural sciences, including Universidad de la Republica, Instituto Clemente and Institut Pasteur (Latin American branch). The country has extremely professionally-operated meat exporters – ‘frigorificos’ – sending Hereford and Angus meat, as well as live sheep, to more than 130 markets worldwide. This is thanks to Montevideo’s port and its airport’s modern infrastructure.

One of the sophisticated and oldest milk cooperatives in Latin America is in Uruguay. Conaprole collects and processes milk. It sells finished products domestically and worldwide. As a pioneer cooperative, it inspired Colombia’s Colanta and Costa Rica’s Dos Pinos.

Prolesa (Productores de Leche Sociedad Anonima) belongs to Conaprole. It provides products and services to milk producers.

Ganaderos and creasUruguay also benefits from a network of highly-qualified extensive farmers or ‘ganaderos’, who share best practices through an original system called a ‘crea’.

Right after the World War II, French farmers trying to rebuild devastated agriculture, particularly in Normandy and Brittany, had the idea of organizing regular meetings on farms to gather individual expertise and knowledge. Best-in-class Uruguayan producers are still operating this way.

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Thierry GozlanThierry Gozlan was Virbac’s Latin America area director from 2003 to 2015. During this time, he was based in Guadalajara, Mexico, and Buenos Aires, Argentina.He now runs Thiego, a firm that provides various services to the animal health industry, particularly those looking for developing business in Latin America.

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The country is also supported by a public campaign called Uruguay Natural, which emphasizes ‘green meat’ coming from free range, non-implanted British breed cattle.

The veterinarians and technicians at organizations such as Conaprole and Prolesa – and across the whole of Uruguay – often complete their training in Argentina or New Zealand.

While Southern Brazil, Argentina and Paraguay are not only very close geographically, they share the same ‘gaucho’ culture – a mixture of strong bonds with nature and wildlife, virility and friendship.

The aforementioned countries also belong to the Mercosur regional bloc and recognize each member state regulation. This means no custom fees apply to trade between these countries.

Business-friendlyBusiness-wise, Uruguay is one of the friendliest countries in the region. It has a simple tax system, international banks, first class accountants and legal offices available in Montevideo. There are no hurdles when moving capital in and out of the country. You can even invoice your domestic sales in US dollars.

The only drawback is the country is small and it is a cattle-only market.

In 2015, Merial decided to shut down its Montevideo vaccine plant. However, in the same year, Virbac invested $10 million in a new production facility. This came only a couple of years after the firm completed the acquisition of Santa Elena, the local leader in cattle vaccines established in 1957 by Professor Gonzalo Leaniz – a veterinarian and microbiologist.

Brazil is huge but unpredictable. It is a very competitive and complex country, where size means everything. If you have no critical mass in Brazil, you will struggle to achieve profit and growth.

Mid-sized or smaller animal health entrepreneurs may look for less obvious options to create a base and grow their Latin American businesses – Uruguay could represent a good start.

African swine fever research breakthrough in China

BY MALCOLM FLANAGAN

Chinese researchers have discovered the unique enzyme structure of African swine fever virus (ASFV) may allow drug development to counter the disease.

Research by Dr Yiqing Chen and colleagues at Fudan University in Shanghai found the enzyme contains a unique binding pocket for the building blocks of DNA (nucleotides), not seen in related enzymes in other organisms. They also found several other unusual structural features, including a pair of hydrophobic amino acids that interact with incoming nucleotides, and a platform created by two basic amino acids that stabilizes a mismatched nucleotide pair.

These characteristics increase the rate of incorporation of erroneous nucleotides into the DNA chain during the repair process. “Together these features give the polymerase its unique character of a high rate of DNA replication combined with a high copying error rate,” said Dr Chen.

The researchers said blocking the binding pocket with a drug may be a valuable strategy to treat ASFV infection. Viral replication depends in part on a polymerase enzyme, AsfvPolX, that repairs breaks in the DNA, but the structure of this enzyme has not been determined in detail. The authors used X-ray diffraction and nuclear magnetic resonance to solve the structure at atomic resolution. The Shanghai study can be read in detail here.

Dr Chen said: “Exploiting this unique structural feature to attack the virus may offer a rapid route to develop treatments for this important agricultural virus. However, the high error rate of the AsfvPolX polymerase enzyme means that the virus mutates rapidly, and therefore may evolve resistance to drugs designed to block it.”

The ASFV is the only virus with a double-stranded DNA genome transmitted by arthropods. The virus causes a lethal hemorraghic disease in domestic pigs. Some isolates can cause death of animals within as quickly as a week after infection. In all other species, the virus causes no obvious disease. ASFV is endemic to sub-Saharan Africa and exists in the wild through a cycle of infection between ticks and wild pigs, bush pigs plus warthogs.

Outside Africa, an outbreak occurred at the beginning of 2007 in Georgia, and subsequently spread to Armenia, Azerbaijan, Iran, Russia, Ukraine and Belarus, raising concerns that ASFV may spread further geographically and have negative economic effects on the swine industry.

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A spreading threatASFV is spreading slowly in the Baltic countries and Poland, according to the latest epidemiological data analysed by EU member states and the European Food Safety Authority (EFSA).

The disease is spreading at about 2km a month in Latvia and Estonia, and 1km a month in Lithuania and Poland. In addition, the number of infected animals found among hunted wild boar is very low (up to 3%). The outbreaks in wild boar in the Baltic countries and Poland can therefore be defined as a “small-scale epidemic”.

The EFSA report covers cases reported between 2014 and 2016. EFSA, in cooperation with member states, will publish a second report in the fall of 2017 which will provide updated epidemiological analysis and a review of management options for wild boar.

In June 2016, a Spanish veterinary expert said the eradication of ASFV in Europe is possible but will not be an easy task. Professor Jose Manuel Sánchez-Vizcaino, professor of animal health at Universidad Complutense de Madrid, was speaking at IFAH-Europe’s annual conference in Brussels. Prof Sánchez-Vizcaino said currently there is “no effective or safe vaccine against ASF because it is a complex virus with great variability”.

He said while animal health companies have shown interest in developing a vaccine against ASFV, innovation has been sparse due to the complexity of the virus. Prof Sánchez-Vizcaino also noted that ASFV is not a worldwide concern, which also limits the amount of interest from the industry.

US companion animal spending hits record high in 2016

BY SIAN LAZELL

The American Pet Products Association (APPA) has revealed US spending on pets in 2016 exceeded the previous year by over $6 billion.

Spending on pets hit a record high in 2016 at a $66.7bn – up 10.7% from spending in 2015 of $60.3bn.

The APPA’s annual statistics are derived from pet spending on food, supplies/over-the-counter (OTC) medications, veterinary care, live animal purchases and other services.

Pet food spending was up 22.6% to $28.2bn. The APPA largely attributed the increase to the inclusion of new data from the US Bureau of Labor Statistics (US BLS). The bureau indicated previous spending figures released may have been too conservative.

The APPA said the increase in pet food spending now accurately reflects the steady growth this particular sector has experienced all along. It added high end, premium pet food and treats continue to be a key driver of growth.

Bob Vetere, president and chief executive of the APPA, said: “While this shows a significant increase over last year, it is more reflective of an adjustment in data reporting than actual growth. Actual growth when compared to previous reporting methods is closer to 4%.

“We do still expect growth in the category, although the growth percentage will level out again as we continue to access updated analytics from the same data report.”

Veterinary care remained the second biggest source of spending in the pet industry, totalling $16bn. The APPA said although routine veterinary visits have not necessarily increased, advances in health care and services may have contributed to the 3.4% growth.

The third-highest source of spending in 2016 was supplies and OTC medications, which went up 3% to $14.7bn. Supplies included beds, collars, leashes, toys, travel items, clothing, food and water bowls, and other accessories.

However, live animal purchases continued to decrease for the third year in a row. Spending in this sector was down 0.9% to $2.1bn.

Mr Vetere said: “Now that millennials have officially taken the reins as the primary demographic of pet owners, they stand to further develop the humanization of pets trend.

“We’ve been anxious to see how this new group of pet owners will affect the industry, and now that they’re here and industry spending is higher than ever, it’s a promising sign that our country’s pets are in good hands.”

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In September last year, a report by the National Bureau of Economic Research found a “fairly strong” correlation between income and spending, with households in the highest income category (annual income above $70,000) spending around 114% more on pets than those in the lowest income category. It also found spending on pets in 2012 was 60% higher in North America than it was in 1996 while spending on human healthcare grew 50% during the same period.

Outside of the US, India, China and Brazil have all been identified as potential opportunities for firms working in the companion animal space, as the countries’ respective pet populations continue to boom.

European industry welcomes progress made on vaccine availability

BY JOSEPH HARVEY

IFAH-Europe has commended progress made regarding regulators’ efforts to improve the availability of veterinary vaccines.

Frederic Descamps, vice-chair of IFAH-Europe’s biologicals working party, said momentum has been created in tackling issues surrounding the regulatory framework supporting vaccine availability. However, he also said ongoing dialog between industry and regulators is paramount for timely progress.

Over the last year, the European Medicines Agency (EMA) has begun to implement its action plan to improve the availability of veterinary vaccines. The action plan was the result of a joint EMA/HMA and industry workshop in 2015, which enabled regulators to ask industry experts their opinions regarding the regulatory and technical hurdles hindering the availability of veterinary vaccines.

Speaking at the recent annual EMA/IFAH-Europe Info Day in London, Dr Descamps said: “The industry welcomes the progress made and is keen to move forward. It is now two years since the workshop. Industry is prepared and willing to contribute, where relevant.”

He praised the increased visibility of the EMA project and noted good progress on proposals for field trials.

In fact, Dr Descamps said efficacy field trials are the industry’s leading focus in the area of vaccine regulations. He stated: “Field efficacy trials are complex, demanding, long, costly and unpredictable by nature. Because vaccines are preventative medicines, field trials must be conducted in healthy animals and you just hope the disease arrives on that farm so you can demonstrate efficacy.”

Dr Descamps said there is a need for the EMA working party to clarify the requirements of field efficacy trials for vaccines and reconsider the regulatory approach.

The second most important topic on IFAH-Europe’s agenda regarding vaccines is serology. Dr Descamps called for a re-investigation of the requirements on the use of serology “and possibly other immune parameters”.

Regarding IFAH-Europe’s concerns on field efficacy trials, the EMA’s Dr Faye Ioannou said there will be a forthcoming stakeholders focus group on field efficacy trials in June 2017.

In the case of serology, she said the industry needs to “provide a clearer problem statement with examples to be reviewed against current guidance and we will decide whether there is space for flexibility and a need to follow up with the focus group”.

Communication vitalDr Descamps, who is also associate director of regulatory affairs for biologicals at Zoetis, concluded: “Good dialog and coordination will be key for success. Regular and timely updates from the action plan steering group would be beneficial.

“The earlier involvement of industry, which can share experience and data, will result in better guidance. We need to look at the issue with fresh eyes and develop smarter ways to move forward.

“Industry and regulators share the same goal: the improved availability of safe and efficacious vaccines to protect animal health.”

Amongst a number of next steps for the EMA is the implementation of a communication strategy with stakeholders, according to Dr Ioannou.

EMA resource constraintsAt the Info Day, Dr Ioannou stated the EMA’s key message: “Availability of veterinary vaccines remains important for EU regulators but be mindful of EMA resource constraints – there is a need for expectation management.”

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Under the terms of the “very ambitious action plan”, Dr Ioannou highlighted the progress made concerning vaccine availability.

The EMA has set up a steering group to oversee and monitor progress against the action plan comprised of representatives from the HMA and EMA. It has also reviewed a list of issues identified by industry, as well as established a web page to promote communication on its veterinary vaccine availability initiative.

A group of members from the EMA’s Committee for Medicinal Products for Veterinary Use has been created to identify, prioritize and make public plans in the area of vaccine availability. The EMA has also provided support to the development of new vaccines and associated technology through existing mechanisms such as scientific advice and its innovation task force.

Dr Ioannou said the EMA’s ongoing tasks include: the development of guidance on standards for manufacturing autogenous vaccines; identification of veterinary vaccine training opportunities; finalization of minor uses/minor species guidelines; reflection on existing measures to promote availability of vaccines for epizootic diseases; and the establishment of ways to take into account the different types of vaccine and various situations for authorization, such as normal vs exceptional situations.

CVMP hoping number of scientific opinions will increase in 2017

BY JOSEPH HARVEY

Each year, the European Medicines Agency’s (EMA) Committee for Medicinal Products for Veterinary Use (CVMP) gives an overview of its achievements for the prior 12 months. Animal Pharm attended this briefing to find out the latest on positive opinions, adverse events reporting and MUMS designations.

European regulatory authorities forecast a rise in the number of scientific opinions issued for veterinary medicines in 2017.

Last year, the CVMP issued 18 scientific opinions. According to Dr David Murphy, chair of the CVMP, this total is less than previous years. In the past three years, he said around 28-34 scientific opinions are adopted by the CVMP.

“We are hopeful for an improvement in 2017 based on the submissions we’ve received at the beginning of this year,” he told delegates to the annual EMA/IFAH-Europe Info Day in London.

The CVMP has adopted eight scientific opinions so far this year, which puts it in line with the average amount for years prior to 2016.

This brighter outlook from Dr Murphy bodes well for the European animal health industry. Last year, there was a slump in new products approvals through the region’s centralized procedure as R&D budgets turned more towards generic products.

Last year, the CVMP issued 16 positive opinions. Of these, six were for pharmaceuticals, four were for generic drugs and six were for immunologicals. The committee also offered negative opinions on one pharmaceutical and one immunological.

Dr Murphy, who was appointed to his role last year, said the scientific opinions adopted by the CVMP in 2016 covered novel innovations and extensions on existing products.

CVMP scientific opinions in 2016

Product name Developer Product type Species CVMP scientific opinion

Bravecto MSD Animal Health Pharmaceutical Cats and dogs Positive

Draxxin Zoetis Pharmaceutical Sheep Positive

Metacam Boehringer Ingerlheim Pharmaceutical Cattle Positive

Varromed BeeVital Pharmaceutical Honey bees Positive

Stronghold Plus Zoetis Pharmaceutical Cats Positive

Equioxx Merial Pharmaceutical Horses Positive

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Draxxin Zoetis Pharmaceutical Sheep Negative

Sevocalm Chanelle Generic Dogs Positive

Sedadex Le Vet Pharma Generic Dogs and cats Positive

Halagon Emdoka Generic Calves Positive

Cepedex CP-Pharma Handelsgesellschaft Generic Dogs and cats Positive

Evalon Hipra Immunological Chickens Positive

Letifend Laboratorios Leti Immunological Dogs Positive

Poulvac E coli Zoetis Immunological Turkeys Positive

Clynav Elanco Immunological Aquaculture Positive

Eravac Hipra Immunological Rabbits Positive

Coliprotec F4/F18 Prevtec Microbia Immunological Pigs Positive

Respiporc FLUpan H1N1 IDT Biologika Immunological Pigs Negative

Source: EMA

Dr Murphy hailed three notable scientific opinions adopted by the CVMP recently: Clynav, the first DNA vaccine in the EU; Cytopoint from Zoetis, the first monoclonal antibody veterinary medicine, which received its positive opinion at the beginning of 2017; and Varromed, a new medicine to protect honey bees against a serious parasitic infestation.

The two products receiving negative opinions in 2016 have both seen this decision reversed and have since gained positive opinions from the CVMP.

Under-reported food animal adverse eventsDr Murphy said a total of 18,413 adverse safety events were reported relating to companion animal products. He said this figure reflected under-reporting of adverse events for food-producing animals – 82% of all reported adverse events related to products for cats or dogs.

He noted a focus group has been established by the CVMP to deal with the promotion of pharmacovigilance reporting for food animals.

MUMS updateIn 2016, the CVMP received 25 requests for minor uses/minor species (MUMS) designations for existing products. Of these, 18 were classified as MUMS or limited market products, while four were reclassified for the same designation.

The five MUMS approvals in the table above are Letifend, Poulvac E Coli, Clynav, Eravac and Varromed.

Dr Murphy said there was continued “considerable interest in MUMS classifications in 2016”. The number of MUMS classifications last year were down slightly from 2015. However, the total for 2016 was still more than double the amount of MUMS classifications registered in 2009.

This highlights the animal health industry’s increasing interest in developing and registering products for niche opportunities.

CVMP MUMS classifications and reclassifications in 2016

Year 2009 2010 2011 2012 2013* 2014 2015 2016

MUMS classifications with financial incentives 5 11 8 16 10 2 7 1

MUMS reclassifications with financial incentives 0 0 0 0 0 0 1 1

MUMS classifications without financial incentives 4 6 10 4 10 20 16 17

MUMS reclassifications without financial incentives 0 0 0 0 0 0 0 3

Not MUMS 1 3 3 1 3 7 5 3

Total 10 20 21 21 23 29 29 25

Source: EMA; * Restriction of financial incentives to food-producing animals only from September 2013

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More data needed to address anthelmintic resistance problem

BY JOSEPH HARVEY

European regulatory authorities have highlighted a lack of insightful data concerning the increasing threat of anthelmintic resistance.

Dr Gesine Hahn of Germany’s Federal Office of Consumer Protection and Food Safety is also part of a working party that received a mandate from the European Medicines Agency’s Committee for Medicinal Products for Veterinary Use (CVMP) to prepare a reflection paper on anthelmintic resistance.

Dr Hahn told delegates at the recent EMA/IFAH-Europe Info Day in London: “Anthelmintic resistance is an emerging threat for livestock production and animal health. Not only is there a loss of efficacy of many products but also there is limited introduction of innovative products or new substances. Most problems are linked to the development of anthelmintic resistance in small ruminants (such as sheep and goats), cattle and horses.”

Dr Hahn said the reflection paper attempted to provide an overview of the current resistance situation in Europe for different helminths and anthelmintic classes for food-producing animals. She said this was a difficult estimate “because anthelmintic resistance is not systematically documented throughout Europe”.

She added: “Resistance mechanisms in helminths are complex. There are very few suitable methods of detecting and evaluating resistance.”

Dr Hahn pointed out there are only a handful of locally-organized monitoring programs in Europe, with the continent’s surveillance systems more focused on antimicrobial resistance.

When evaluating current monitoring systems for anthelmintic resistance, Dr Hahn said in vivo tests are labor intensive, high cost, not species-specific, have low sensitivity and have no established cut-off levels for resistance. Additionally, she said in vitro assays are very specific but are only validated for some worms.

Speaking at the info day on behalf of the working party, Dr Hahn called on industry and academia to continue research into resistance mechanisms and develop suitable tests for detection of resistance, as well as better monitoring tools.

She said industry should continue to research management strategies and biological alternatives in the anthelmintic space. The reflection paper also highlights the need for companies to “educate and enhance awareness of anthelmintic resistance amongst veterinarians and animal owners”.

The paper also calls for industry and academia to: further explore the benefits and risks of multi-active anthelmintics; establish an EU reference laboratory for anthelmintics resistance; and develop more narrow-spectrum anthelmintics with short withdrawal periods.

Dr Hahn also urged investigation of resistance in companion animals and aquaculture.

Management suggestionsA revised draft of this reflection paper will be adopted by the CVMP in April, after which it will be published for public viewing. As well as calling for improved surveillance of anthelmintic resistance, the reflection paper also highlighted strategies designed to better manage the use of anthelmintics.

The paper calls for targeted selective treatment of helminths, correct dosing of anthelmintics, use of good nutritional products, improved quarantine protocols and implementation of biological control methods.

Dr Hahn said the CVMP’s responsibilities going forward include: promotion of targeted selective treatment; improvement of pharmacovigilance reporting; harmonization of prudent use warnings; guidance on the resistance data that should be included in a dossier and on how to characterize and confirm suspected resistance in a helminth strain; and promotion of increased availability of anthelmintics for minor species.

IDT vaccine gets positive opinion after re-examination

BY JOSEPH HARVEY

A swine flu vaccine developed by German company IDT Biologika is set for European approval after previously facing obstacles.

The European Medicines Agency’s Committee for Medicinal Products for Veterinary Use (CVMP) has adopted a positive final opinion for Respiporc FLUpan H1N1 and has recommended the product for marketing authorization.

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In December 2016, the CVMP adopted a negative opinion for the vaccine. The committee said the benefit-risk balance for Respiporc FLUpan H1N1 was not demonstrated to be favorable by the quality, safety and efficacy data submitted by IDT.

The inactivated vaccine is for active immunization of pigs against swine influenza caused by pandemic subtype H1N1. Respiporc FLUpan H1N1 provides immunization of pigs from the age of eight weeks onwards against pandemic H1N1 porcine influenza virus to reduce viral lung load and viral excretion.

The pending approval of the vaccine would add to IDT’s Respiporc portfolio in Europe. The Dessau-based company sells Respiporc Art+EP (an inactivated vaccine against atrophic rhinitis and enzootic pneumonia) and Respiporc Flu3 (an inactivated influenza vaccine with three subtypes: H1N1, H3N2 and H1N2) in Europe.

In a similar vein to the CVMP’s re-examination of Respiporc FLUpan H1N1, Zoetis also recently saw a negative opinion turned around. In May last year, the committee adopted a negative opinion for the proposed extension of the existing authorization for Draxxin (tulathromycin). This extension aimed for the inclusion of sheep as a new target species for the antibiotic. However, in September of the same year, the CVMP issued a positive opinion for this extension.

CVMP positive opinion for Ceva BRD product

BY JOSEPH HARVEY

An injectable antibiotic developed by Ceva Santé Animale for the treatment of bovine respiratory disease (BRD) has moved a step closer to marketing authorization in Europe.

The European Medicines Agency’s Committee for Medicinal Products for Veterinary Use (CVMP) adopted a positive opinion for Zeleris, an injectable solution containing a fixed combination of florfenicol and meloxicam as active substances.

Zeleris treats BRD associated with pyrexia, due to infection caused by Mannheimia haemolytica, Pasteurella multocida and/or Histophilus somni susceptible to florfenicol. According to the CVMP: “Very commonly seen adverse reactions were transient reactions at the injection site following subcutaneous administration and moderate pain during injection.”

BRD is a complex multi-factorial disease, which can have a significant impact of cattle weight. Antibiotics and anti-inflammatory drugs are widely used to treat BRD.

As a preventative measure, Merial launched the Bovalto Respi range of vaccines in Europe last year to provide protection against the bacterial and viral causes of BRD.

Also in 2016, Bayer Animal Health released a study showing significant reductions in feedlot cattle mortality can be achieved when an immunostimulant is used to combat BRD. The previous year, Bayer launched an immunostimulant for the reduction of BRD in the US. The company’s Zelnate offers end users a non-vaccine, non-antibiotic approach to tackling BRD.

Delegates to the 8th Antimicrobial Agents in Veterinary Medicine Conference in 2016, were told stimulation of the innate immune system is an area with great potential to address infectious livestock diseases, including BRD.

Annual sales growth strengthens for Japanese animal health products

BY DR ATSUO HATA

Sales of animal health products in Japan increased by around 8% in 2015, according to latest official statistics.

The Japanese Ministry of Agriculture, Forestry and Fisheries (JMAFF) and the National Veterinary Assay Laboratory (NVAL) reported total sales of animal health products for 2015 came to ¥103,173 billion ($909 million).

The growth rate was more than double that of the previous year. From 2011 to 2013, the Japanese animal health sector saw no meaningful growth as sales of antibiotics stayed flat. However, the last two years have now witnessed healthy gains as biologicals, antibiotics and anthelmintics have returned to growth.

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In 2015, veterinary drug sales increased by 11% to ¥92bn. The largest category of veterinary products is biologicals (around 35% of total sales), while antimicrobials and anthelmintics represent the second-largest segment (29%).

Out of veterinary vaccines, two-thirds of these products are used for food-producing animals. Dog and cat vaccine sales are about 16% of total sales of vaccines.

Annual sales of animal health products in Japan (Yen million)

Classification 2011 2012 2013 2014 2015 % change 2014 vs 2015

Animal drugs 85,094 85,983 80,719 83,199 92,080 +10.7

Quasi animal drugs 2,724 2,259 2,421 2,888 2,184 -34.4

Medical devices 7,266 8,033 9,959 8,768 8,908 +1.6

Total 95,084 96,276 93,099 95,855 103,173 +7.6Figures may not add up due to rounding: Source: JMFF/NVAL

Sales of animal drugs including quasi animal drugs classified by pharmacological action (Yen million)

Classification 2013 2014 2015 (%) % change 2014 vs 2015

Biologicals 31,604 31,984 33,109 3.5

Antimicrobials & anthelmintics 24,724 24,782 27,247 9.9

Non-therapeutic agents 10,903 13,240 14,804 11.8

Drugs for external use 3,749 3,432 3,474 1.2

Metabolic drugs 3,283 3,901 4,035 3.4

Reproductive drugs 2,431 2,576 2,635 2.3

Circulatory/respiratory/urinary 2,431 2,739 4,157 51.8

Digestive tract drugs 2,187 2,274 2,436 7.1

Nervous drugs 1,828 2,160 2,367 9.6

Total 83,140 87,087 94,264 8.2Figures may not add up due to rounding; Source: JMAFF/NVAL

Annual sales of veterinary biologicals by species (Yen million)

Classification 2013 2014 2015 % change 2014 vs 2015

Pig vaccine 11,625 11,792 12,356 4.8

Poultry vaccine 8,374 8,307 8,872 6.8

Cattle vaccine 3,112 3,339 3,408 2.1

Horse vaccine 361 369 356 -3.5

Fish vaccine 639 818 854 4.4

Dog vaccine 4,177 4,202 4,049 -3.6

Cat vaccine 1,247 1,148 1,265 10.2

Tetanus toxoid 2 4 4 0

Diagnostic products 2,066 2,000 1,946 -2.7

Total 31,604 31,984 33,109 3.5Figures may not add up due to rounding; Source: JMAFF/NVAL

Annual sales of antimicrobials and anthelmintics for 2015The NVAL also reported the Japanese sales figures for antibiotics, synthetic antibacterials, anthelmintics and anti-protozoan animal drugs for 2015. Sales of antibiotic animal drugs rose by 8% to ¥15.16bn compared to 2014. Cefovecin, Ampicillin, Doxycycline and Cefthioful contributed to growth of the sales.

Sales of synthetic antibacterials increased by 5% to ¥7.5bn. Main products were fluoroquinolones and Florfenicol, accounting for 78% of this category. Total sales of antimicrobials increased by 7% to ¥22.6bn.

Sales of anthelmintic animal drugs rose by 30% to ¥9.6bn compared to 2014. Major products were avermectin products including Ivermectin, Epriomectin, Selamectin, Doramectin, Milbemycin and Moxidectin, accounting for 73% of total sales. Revenue from anti-protozoan animal drugs was similar to the previous year.

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Annual sales of antimicrobial animal drugs in Japan (Yen million)

Antibiotics 2013 2014 2015 % change 2014 vs 2015

Aminoglycocides (Apramycin, Kanamycin, Gentamicin, Dihydrostreptomycin, Streptomycin) 1,317 1,282 1,369 6.2

Cephalosporins (Cefazolin, Cefapirin, Cefalexin, Cefalonium, Cefovecin, Cefroxime, Cefpodoxime) 4,043 3,811 3,861 1.3

Tetracyclines (Oxytetracycline, Chlortetracycline, Doxycycline) 1,868 1,774 1,915 7.9

Penicillins (Amoxicillin, Ampicillin, Cloxacillin, Dicloxacillin, Nafcillin, Benzylpenicillin, Mecillinum) 2,728 2,700 2,751 1.9

Peptides (Thiostrepton, Colistin) 340 293 336 14.7

Macrolides (Erythromycin, Spiramycin, Josamycin, Tylosin, Tilmicosin, Mirosamycin, Tulathromycin) 2,024 2,451 2,663 29.8

Lincosamides (Lincomycin, Clindamycin) 463 533 487 -8.6

Antifungals (Nystatin, Nanafrocin, Clotrimazole, Ktoconazole, Miconazole, Pimaicin) 895 963 1,134 17.8

Other antibiotics (Chloramphenicol, Tiamulin, Valnemline, Fosfomycin) 539 604 647 7.1

Total of antibiotics 14,217 14,011 15,155 8.2Synthetic antibacterialsQuinolones (Oxolinic aid) 49 85 74 -12.9

Sulfonamides (Sulfachlorpyridazine, Sulfadiazine, Sulfadimidine, Sulfadimethoxine, Sulfadoxine, Sulfamethoxazole, Sulfamoyldepsone, Sulfaisozole, Homosulfamine)

1,041 1,038 806 -22.4

Thiamphenicols (Thiamphenicol, Florfenicol) 1,285 1,750 2,138 22.2

Nitrofurans (Nitrofurzone, Nifurstyrenic acid) 218 100 69 -31

Fluoroqunolones (Enrofloxacin, Ofloxacin, Orbifloxacin, Difloxacin, Norfloxacin, Marbofloxacin, Danofloxacin, Lomefloxacin) 3,377 3,467 3,881 11.9

Other synthetic antibacterials (Ormethoprim, Trimethoprim) 634 634 487 -8.8

Total of synthetic antibacterials 6,604 7,074 7,455 5.4Total of antimicrobials 20,821 21,085 22,610 7.2Figures may not add up due to rounding; Source: NVAL

Annual sales of anthelmintic animal drugs in Japan (Yen million)

Anthelmintics 2013 2014 2015 % change 2015 vs 2015

Avermectins (Ivermectin, Eprinomectin, Selamectin, Doramectin, Milbemaycin, Moxidectin) 4,211 5,249 6,965 32.7

Benzimidazoles (Fenbendazole, Flubendazole, Triclabendazole) 231 252 268 6.3

Piperazin salts (Piperazin citrate, Piperazin phosphate) 25 24 24 0

Other anthelmintics (Emodepside, Levamizole, Kamala, Santonin, Dichlorophen, Pyrantel, Phenothiazine, Bromofenofos, Febantel, Praziquantel, Macri)

2,467 1,815 2,314 27.5

Total anthelmintics 6,934 7,340 9,571 30.4Figures may not add up due to rounding; Source: NVAL

Annual sales anti-protozoan animal dugs in Japan (Yen million)

Anti-protozoan animal drugs 2013 2014 2015 % change 2014 vs 2015

(Glycarbylamide, Antimony sodium gluconate, Dinitolmide, Dimidazene aceturate, Toltrazril, Nicarbazin, Pyrimethamine) 702 714 715 0.1

Total of anti-protozoan animal drugs 702 714 715 0.1Figures may not add up due to rounding; Source: NVAL

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Taiwan to produce its own avian flu vaccines

BY MALCOLM FLANAGAN

Taiwan will not buy avian flu vaccines from overseas but will produce them itself in the future, according to local media.

The Taiwanese government’s Council of Agriculture (COA) said its animal health authorities “had squandered a lot of money buying imported vaccines, only to end up destroying them after they reached their expiration date”.

COA minister Lin Tsung-hsien said his organization had shelved plans to buy any further foreign animal vaccines this year. He made the remarks in a report to a legislative committee meeting in Taipei this week on the situation regarding nation’s avian flu outbreaks and subsequent quarantine measures.

Mr Lin said the stored animal vaccines are aimed mainly at outbreaks of avian flu plus some other diseases such as rabies and the foot and mouth virus. He stressed that other Asian counties are have adopted the same approach of storing animal vaccines for possible use in an emergency.

According to vice agriculture minister Huang Chin-Cheng, if a farm is infected with avian flu the birds in surrounding poultry farms can be vaccinated. He added “it was normal to reserve vaccines for such possible use”.

He also said the COA has decided to stop buying vaccines from overseas, but will commission the Animal Health Research Institute (ATRI) under the COA to produce vaccines for “emergency and preventive use”.

Mr Huang said self-production is not necessarily cheaper, but the main reason for stopping purchases from overseas is because Taiwan previously bought vaccines from Mexico, which targets a different strain of the avian flu virus H5N2. Mr Huang claimed avian flu vaccines for emergency use are expected to be produced domestically within the next six months.

The COA said 88 poultry farms had been confirmed recently to be affected with highly pathogenic avian influenza viruses and 739,757 birds had been culled as a result. Of the 88 Taiwanese farms, 12 were hit by the virulent H5N6 strain, which can be transmitted to humans. Those 12 farms were in Hualien, Tainan, Yunlin and Chiayi counties.

In February this year Animal Pharm interviewed Romney Jackson, a representative of Taiwan’s ATRI. The UK veterinary research specialist said ATRI is expanding its commercial horizons, as it seeks to achieve international status as an in-demand commercial research organization and livestock vaccines inventor. After many years of dealing only with domestic animal health companies and academic institutions in Taiwan, ATRI is now determined to expand into mainland Asia and further afield.

ATRI has the backing of the COA in its ambitions and is actively searching out foreign companies and other research organizations which wish to use its newly installed laboratories, state-of-the-art veterinary equipment and expanding English-speaking workforce.

ATRI was originally created in 1970 as the Pig Research Institute Taiwan. During the past 46 years of its gradual evolution, Taiwanese scientists and veterinary medicine experts have supported the country’s farm animal production and biomedical projects in Taiwan. In 2014, the research facility was officially re-branded as ATRI and re-equipped to attract new business. Since then, a total of 113 research projects have been undertaken by ATRI with the support of the COA.

US tackles chronic rural vet shortagesBY MALCOLM FLANAGAN

The American Veterinary Medical Association (AVMA) has welcomed a move by the US House of Representatives to make it easier for newly qualified veterinarians to work in rural areas of the country currently suffering a chronic shortage of veterinary professionals.

The AVMA welcomes the introduction of S. 487, the Veterinary Medicine Loan Repayment Program Enhancement Act (VMLRPEA), promoted by senators Mike Crapo (R-Idaho) and Debbie Stabenow (D-Michigan).

This bill will increase funding available for grants through the Veterinary Medicine Loan Repayment Program (VMLRP), which implements loan forgiveness for veterinarians who commit to serving in federally designated veterinary shortage areas. Representatives Adrian Smith (R-Nebraska) and Ron Kind (D-Wisconsin) introduced companion legislation, H.R. 1268, in the US House of Representatives.

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Student loan debt for graduates of veterinary colleges in 2015 topped $140,000 on average. This significant debt can make starting a veterinary practice in a rural shortage area cost prohibitive for recent graduates. As a result, many new graduates are unable to practice in underserved areas of the US where they are most needed. These are usually in livestock producing areas where diseases may initially go unnoticed.

The VMLRP makes practice in rural underserved areas more financially feasible for recent graduates by providing up to $75,000 in loan repayments in exchange for at least three years of service in designated veterinary shortage areas. Since the program’s implementation in 2010, more than 350 veterinarians have participated across 45 US states, Puerto Rico and federal lands.

Withholding taxHowever, a 39% income withholding tax is applied to each award, which significantly lowers the number of awards the USDA can make each year. If this tax had been removed, more than 100 additional veterinarians – and rural communities – could have benefitted from the VMLRP. If passed, the VMLRPEA will implement this important pivotal change. The legislation has broad support from more than 160 veterinary, commodity and agriculture-related organizations.

AVMA president Dr Tom Meyer said: “The VMLRP is a win-win for veterinarians and rural economies because it provides loan relief while also helping alleviate veterinary shortages in areas that lack adequate access to veterinary services for livestock animals.

“Unfortunately, the heavy tax applied to VMLRP awards decreases the number of awards that can be made and the number of rural communities that can benefit from increased services. We’re grateful our leaders in Congress are again supporting legislation to remove this tax and maximize the effectiveness of the VMLRP. The AVMA played a key role in implementing the VMLRP and will continue our strong support of the VMLRPEA during 2017.”

Senator Crapo said: “Access to animal care is critical to Idaho’s agricultural economy. But too often, ranchers and farmers can’t access the care they need because they live in areas where demand for veterinary services exceeds availability. This legislation will increase the number of veterinarians able to serve in the areas where they are needed most, which will help strengthen rural economies and protect the safety of our food supply.”

Senator Stabenow said: “Veterinarians are vital to animal welfare and our nation’s agricultural economy. Unfortunately, many small towns and rural communities in Michigan and across the country don’t have access to the veterinary services they need most. This bill creates important incentives for veterinarians to practice in underserved areas, where quality veterinary care is needed to ensure healthy livestock and a safe food supply.”

Representative Smith added: “Animal health is critical to maintaining the US’ world-leading standards for food safety, with veterinarians and producers working together to ensure livestock are appropriately cared for. However, shortages of large-animal veterinarians in many of the rural areas where our meat, poultry, eggs, and dairy are produced make this work more challenging.

“This legislation addresses an inconsistency in our tax code involving the treatment of student loan repayment programs while ensuring the VMLRP’s limited funding is more directly focused on bringing animal health providers to the areas where they are most needed.”

In December last year, The Texas Animal Health Commission (TAHC) said it was accepting nominations for areas of Texas experiencing a severe shortage of veterinarians that work in food animal medicine, rural private practice or public practice.

Any veterinarian who successfully applies to work in a veterinary-deprived area of Texas in 2017 will receive $25,000 worth of student debt paid-off annually by the Austin-based TAHC. The TAHC vet inducement scheme is part of the VMLRP scheme and will last for three years.

Erber opens pig health research center in Thailand

BY MALCOLM FLANAGAN

The Austrian Erber Group has opened a new pig health research center in Thailand at Kasetsart University in Nakhon Pathom province, which is in the central eastern part of the country.

A signing ceremony to mark the development was held at the recent VIV Asia 2017 animal health exhibition in Bangkok.

Getzersdorf-headquartered Erber, which also owns feed additive specialist Biomin, said the purpose of the research project is “to promote the application of technology and innovation in animal nutrition and animal health”.

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The Asian initiative includes a new 2,300-square-meter research center based on a design concept created by Erber swine expert Dr Ferry Entenfellner, in collaboration with Dr Kai Grathwohl, of Sanphar Asia. Construction is set to begin later this year.

The state-of-the-art facilities will be the first of their kind in Asia outside of China and Korea, and will be equipped with advanced filter ventilation and waste disinfection systems. Research will have a particular focus on biosecurity and development of innovative technologies.

Erber and Biomin founder Dr Erich Erber said: “The Erber Group family of companies can look forward to close collaboration with eminent Thai specialists and professors on animal health to address key issues for safe and sustainable food and swine health in Asia.”

In 2015, Erber subsidiary Biomin also joined forces with Kasetsart University and opened a feed research center. Biomin said the purpose of the center, with its modern trial facilities, is to enable the application and testing of new innovative solutions for the animal feed industry in Thailand and the South East Asian region.

The two-year-old Biomin center is the sixth investment in a global network of ‘Biomin Centers for Applied Nutrition’. The 466-square-meter research center boasts a unique design inspired by the traditional Chinese farmhouse courtyard with a mixture of Thai and European features.

Boehringer to extend PCV vaccine rangeBY JOSEPH HARVEY

European authorities have recommended the granting of a marketing authorization for Ingelvac PCV FLEX.

The product, developed by Boehringer Ingelheim, is a suspension for injection for active immunization of pigs against porcine circovirus type 2 (PCV2).

The European Medicines Agency’s Committee for Medicinal Products for Veterinary Use (CVMP) adopted a positive opinion for the inactivated vaccine, bringing it one step closer to approval. Ingelvac PCV FLEX is administered once via the intramuscular route to seronegative pigs from two weeks of age.

According to the CVMP: “The benefits of Ingelvac PCV FLEX are its capability of reducing mortality, clinical signs and lesions in lymphoid tissues associated with PCV2-related diseases in seronegative animals in addition to a reduction of PCV2 nasal shedding, viral load in blood and lymphoid tissues, and duration of viremia.

“The onset of protection is two weeks post-vaccination and the duration of protection is at least 17 weeks. The most common side effect is a mild and transient hyperthermia on the day of vaccination. On very rare occasions anaphylactic reactions may occur that should be treated symptomatically.”

Boehringer’s Ingelvac swine vaccines are significant products for the firm globally. Ingelvac CircoFlex and Ingelvac PRRS MLV are Boehringer’s top-selling products. In fact, the company estimate one billion pigs and sows have been protected against porcine reproductive and respiratory syndrome by Ingelvac PRRS MLV since it was launched 22 years ago.

In 2015, MSD Animal Health received EU approval for Porcilis PCV ID, an intradermal vaccine against PCV2.

Australia tests out superfast BRD detectors

BY MALCOLM FLANAGAN

Australian feedlot owners will test out a new cutting edge system for identifying bovine respiratory disease (BRD) in newly-arrived cattle.

Australian cattle industry body Meat and Livestock Australia (MLA) said BRD is the biggest source of economic losses for feedlot owners and meat producers in the country.

The expert charged with introducing the state-of-the art BRD testing strategy is MLA project manager Dr Joe McMeniman, who said the new automated system would identify diseased cattle immediately. Producers will then be able to diagnose and treat livestock more efficiently.

The BRD system was originally conceived by the University of Kansas and US company Precision Animal Solutions. It has been successfully implemented and trialled at feedlots in the US and Canada over the last three years.

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The new BRD system is known as the Remote Early Disease Identification System (REDI). The technology is due to be trialled at two feedlots in South Australia shortly. Experts will test out the efficacy of the system compared to traditional methods used by Australian beef and dairy producers to test for BRD.

REDI uses ultra-wide band ear tags and receivers to monitor animal movements throughout the feedlot pen and processing center. The REDI ear tag is slightly larger than typical cattle ear tags but is applied in a similar way.

Dr McMeniman said: “The REDI system has enable early identification and diagnosis of BRD to take place. It has promoted judicious antimicrobial use in North America and we expect the same in Australia.

“The system identifies things we cannot see with the human eye because we don’t have time to watch every individual animal 24 hours a day, seven days a week. That’s where the technology is a real benefit – it gives us the opportunity to constantly collect data and augment what the feedlot pen rider sees.”

In September last year, Australia said it was conducting a long-term study into the efficacy of vaccines to protect against BRD in pasture and feedlot situations.

MLA is supporting the BRD vaccine research to determine the effect of ‘backgrounding’ vaccination regimens on feedlot performance and health. Backgrounding is a beef cattle production system, which incorporates maximum use of pasture and forages from the time calves are weaned until they are in a feedlot.

The outcomes measured include morbidity, treatment, mortality and growth rates, to give feedlot operators objective measurements. The investigation will close at the end of 2017.

In July 2015, Animal Pharm took an in-depth look at REDI when Precision Animal Solutions said REDI technology can identify BRD 18 hours earlier than a person working on a beef or dairy feedlot. He also claims the technology can find 55% of sick calves approximately two days before a trained observer.

Boehringer, Merial products set for extensions

BY JOSEPH HARVEY

Products from Boehringer Ingelheim and Merial have received positive opinions for extensions to their existing European authorizations.

The European Medicines Agency’s Committee for Medicinal Products for Veterinary Use (CVMP) recommended the granting of an extension to the terms of the marketing authorization for Boehringer’s Novem (meloxicam) anti-inflammatory treatment.

Novem was first authorized for sale in Europe during 2004. It is currently approved as an injectable solution for cattle and pigs. According to the CVMP, the extension concerns the addition of a new strength (40mg/ml) in cattle for subcutaneous use.

The extension applies to the following indications: acute respiratory infection with appropriate antibiotic therapy to reduce clinical signs; diarrhea in combination with oral re-hydration therapy to reduce clinical signs in calves of over one week of age and young, non-lactating cattle; adjunctive therapy in the treatment of acute mastitis, in combination with antibiotic therapy; and the relief of post-operative pain following dehorning in calves.

Zactran set for extensionAdditionally, Merial’s Zactran antibiotic is also subject to a positive opinion for authorization extension in Europe.

The CVMP has recommended the granting of an extension to the marketing authorization for the addition of sheep as a new food-producing target animal species.

Zactran is currently authorized for use in cattle and pigs. The extension concerns the following indication in sheep: “The treatment of infectious pododermatitis (foot rot) associated with virulent Dichelobacter nodosus and Fusobacterium necrophorum requiring systemic treatment.”

This extension builds on Merial’s range of global indications for Zactran. The product was first given European authorization in 2008. Last year, it was given a global launch as a swine antibiotic.

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UK authorities react to reclassification of Zolvix

BY JOSEPH HARVEY

The British Veterinary Association (BVA) has raised concern following the reclassification of Zolvix, an anthelmintic from Elanco.

The UK’s Veterinary Medicines Directorate (VMD) recently reclassified Zolvix 25mg/ml Oral Solution – for gastrointestinal nematode infections and associated diseases in sheep – from POM-V to POM-VPS.

This regulatory shift means the product can now be prescribed by pharmacists and suitably qualified persons (SQPs), as well as veterinarians, as of July 2017. The BVA is concerned this reclassification brings Zolvix (monepantel) under a less strict regulatory oversight.

The BVA’s president Gudrun Ravetz said: “We know that resistance to anthelmintics is increasing in grazing animals and needs to be addressed if the livestock industry is to avoid a potentially disastrous situation of being unable to tackle parasites.

“The reclassification of Zolvix from POM-V to POM-VPS is in direct opposition to the trend in Europe, where we are seeing increased control over dispensing of anthelmintics in species where resistance is a serious threat to animal welfare and profitable production.

“BVA believes that prescribing of anthelmintics requires a level of control best provided by a veterinary surgeon who has the animals under his/her care, and is based on a sound clinical diagnosis, in order to protect animal welfare and safeguard the efficacy of these products for the future.”

VMD standpointHowever, the VMD stated: “Increasing the availability of this anthelmintic will help it to be incorporated into strategic worm control programs on farms in line with best practice guidance on worm control.

“This could result in long-term health benefits for sheep, for example by reducing the development and spread of anthelmintic resistance, thereby prolonging the effective use of anthelmintics.”

The VMD also noted: “Making sure anthelmintics continue to be effective is essential for the long-term health, welfare and productivity of animals in the UK. The volume and appropriateness of use of all anthelmintics significantly influences the rate of development of anthelmintic resistance in the target parasites.

“In order to ensure the new categories of prescribers are sufficiently familiar with Zolvix, and how to prescribe it effectively and responsibly.”

The VMD said a compulsory training module for Zolvix will be implemented in collaboration with Elanco to augment the skills of all registered SQPs.

Zolvix was originally launched by Novartis Animal Health in the UK during 2010.

Le Vet adds two New Zealand approvalsBY JOSEPH HARVEY

Dutch company Le Vet Pharma has received approval in New Zealand for the generic non-steroidal anti-inflammatory drug (NSAID) meloxicam in dogs and cats.

Meloxoral 1.5mg/ml is an oral suspension for dogs and is used for the alleviation of inflammation and pain in both acute and chronic musculoskeletal disorders. The Meloxoral 0.5 mg/ml oral suspension is approved for the same indication in cats.

“These approvals in New Zealand show Le Vet’s aspiration to make its products available in countries outside of Europe as well,” the Oudewater-based firm told Animal Pharm.

Following the Meloxoral approvals, the company now has seven registered veterinary medicinal products in New Zealand.

In January 2016, the firm received authorization in New Zealand for Meloxidolor – a 5mg/ml solution for injection in dogs and cats, as well as a 20mg/ml version for cattle, pigs and horses. Meloxidolor contains meloxicam, the same ingredient as in Meloxoral.

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Additionally, Le Vet’s Clavubactin broad-spectrum antibiotic tablets for dogs (50mg/12.5mg, 250mg/62.5mg, 500mg/125mg), containing amoxicillin and clavulanic acid as the active ingredients, has been available in New Zealand since mid-2015.

While the firm has been ramping up its international product portfolio, Le Vet has also sealed approvals closer to home this year. In January, the company received approval in 13 European countries for a mucolytic agent in horses.

Anpario buys its Australian distributorBY MALCOLM FLANAGAN

UK feed additive specialist Anpario has acquired its Australian distributor Cobbett.

Cobbett has been Anpario’s distributor for 20 years, supplying products to Australia, New Zealand and Papua New Guinea. Anpario’s key product brands include Salkil, pHorce, Neutox, Mycostat and Mastercube.

Queensland-based distribution business Cobbett will continue to trade under its current name. Jenetta Russell will remain as general manager of the firm. The acquisition of Cobbett cost Anpario just over Aus$1 million ($780,000).

A significant proportion of Cobbett’s business is with the Anpario product range. However, Cobbett also distributes other complementary products, which it will continue to do.

“The acquisition of Cobbett is very much in line with our strategy to strengthen our sales and distribution channels and develop closer relationships with end users of our products. Anpario strives to respond and make decisions quickly to ensure our customers receive the best technical support and service possible.

“Acquiring Cobbett helps us to better deliver a responsive and proactive customer care ethos. The Anpario team is very much looking forward to working with the Cobbett team and its customers and suppliers in the Australasian region,” said Anpario.

Just recently, Anpario also expanded its reach in Southeast Asia with the appointment of three new experts to cover Thailand, Indonesia and the Philippines. The Worksop-headquartered company said it will be expanding sales and distribution of its Meriden, Kiotechagil and Optivite feed additive brands and products in the Southeast Asia region.

In October last year, Anpario said it hoped to expand global sales with the selection of a new global technical director. Dr Wendy Wakeman is based at Anpario’s group headquarters in Nottinghamshire. Anpario said Dr Wakeman will work closely with marketing teams to enhance global feed sales including Australasia, Asia, the US and Latin America.

Skretting to raise spending on aqua research

BY MALCOLM FLANAGAN

Norwegian aquaculture feed specialist Skretting is to increase its research and development capabilities in Europe and Chile.

The Stavanger-headquartered company said it will invest €6 million ($7.4 million) to expand its scientific capacity at the Skretting Aquaculture Research Centre (ARC) in Lerang, south east Norway, and a new facility in Pargua, Chile.

Skretting already has research facilities in Norway, China, Italy, Japan, Australia, Egypt and Ecuador. However, to match the rapid growth of aquaculture and the technological advancements of the industry, the decision has been taken to invest in expanding its research capabilities to continue to support the ever-changing industry’s progress.

Skretting’s R&D expansion will focus on two key areas. Recirculation aquaculture systems (RAS) are becoming increasingly popular, not only for salmon but also other species. Today, companies in all of the world’s main aquaculture production regions are increasingly looking to extend the use of RAS beyond the hatchery and early life stages to cover entire production cycles.

Skretting ARC’s upgrade to its facility at Lerang in Norway will primarily be focused on the process of recirculation – examining and optimising the whole system while taking into consideration inputs and outputs.

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At the same time, another major change taking place across the entire aquaculture industry is the expanding raw material base. Launched in 2016, Skretting’s FLX diets “proved that equal health, growth and performance could be achieved using zero fishmeal in carefully formulated feeds”. This work is now being progressed through investigation into additional alternative raw materials.

The Chilean facility will cover the entire production cycle, and focus on raw materials and challenges that directly affect the local industry. In the interest of sharing knowledge and progressing the sector, both facilities will also explore possible collaborations with specialist research centres, universities and other stakeholders.

Alex Obach, Skretting ARC managing director, said: “Things have changed rapidly, from the early days of aqua diets with only fishmeal and fish oil to now where Skretting has achieved full flexibility with regard to fishmeal with our FLX diets. We expect similar results in the near future from our investigations into fish oil alternatives.

“Chile has the second largest salmon farming industry in the world. It is also able to use a different set of raw materials in its salmon feeds than Europe does, including land animal proteins. So it makes sense for Skretting to invest in research facilities in this region.”

Just recently, Skretting’s managing director Steven Rafferty said he firmly believed innovative solutions to fish and shrimp health will be required if the world is to feed its growing population.

Speaking to delegates at the Animal Health Investment Europe forum in London, Mr Rafferty said he supported the view that sustainable aquaculture growth will be one of the main solutions to feeding a fast growing global population.

Mr Rafferty said there is a critical need for increased innovation that supports aquatic and terrestrial animal health plus biosecurity. He said the FAO has predicted the global population will reach nine billion people by 2050. This population growth requires current global food production to increase by 70%.

“No matter what we do as an industry to alleviate environmental pressures such as raw material exploitation, land and water use, energy, waste and our carbon dioxide footprint, whether on land or in the sea, it cannot be considered sustainable if the animals themselves are suffering from disease challenges or have other welfare issues. A healthy animal is a productive animal, and to feed the nine billion people in 2050 we need healthy fish and a healthy aquaculture industry,” said Mr Rafferty.

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