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Animal health advances bring crossover benefits to humans

Kansas City Business Journal
Special Section: Branding KC
By Rob Roberts
08/25/06

Developing new pharmaceuticals for the human health market is a costly proposition, which is one reason why eight of the world's 10 largest drug-makers have animal health divisions.
"It's a huge investment, and they want to get as much money out of it as they can," said Ernst Heinen, vice president of research and development for Bayer HealthCare LLC's Animal Health Division in Shawnee.

That, and the fact that companion animals are getting older and dearer to their owners, explains the steady flow of human-to-animal crossover drugs for everything from Tabby's arthritis to Rover's separation anxiety.

But those involved in a new initiative to build Kansas City's animal health base said developing that market will have positive implications for human health, too.

"Personally, I know of two compounds already registered for animals that are being evaluated for human application," said Steve Chu, senior vice president of global research for Overland Park-based Fort Dodge Animal Health, a division of Wyeth.

One is moxidectin, a Food and Drug Administration-approved drug that Fort Dodge produces for the prevention of canine heartworm and treatment of internal and external parasites in cattle, sheep and horses.

Wyeth now is collaborating with the World Health Organization to investigate the use of moxidectin as a new-generation treatment for river blindness -- a parasitic disease and the world's second-leading cause of blindness among humans.

More human benefits, Chu said, could spring from Fort Dodge's work in developing genetically engineered vaccines for the prevention of West Nile virus in horses and avian influenza in poultry.
In July 2005, the national Centers for Disease Control and Prevention reported that its scientists, in collaboration with Fort Dodge, had developed the equine West Nile vaccine -- the world's first DNA-based vaccine. Licensed by the U.S. Department of Agriculture, the regulatory authority for all animal biologicals, the vaccine uses selected pieces of the West Nile virus's genetic material to stimulate immune response.

That technology could lead to benefits for human vaccine development, the CDC said in a release, because it offers two important advantages over the traditional use of weakened or killed forms of the whole virus:

  • Once a vaccine model is developed for an organism, it can be adapted easily for similar organisms, offering a quick turnaround time during emerging epidemics.
  • DNA-based vaccines are less vulnerable to temperature changes -- a significant asset to vaccination in the developing world.

"The DNA technology used to develop the vaccine is serving as the foundation for a small human West Nile virus vaccine trial currently being conducted through the National Institutes of Health," the CDC said in 2005.

Just this month, Chu said, Fort Dodge received USDA approval for the avian flu vaccine it developed in collaboration with St. Jude Children's Research Hospital in Memphis and the University of Wisconsin.

The vaccine was developed through a cutting-edge technology called reverse genetics, which Fort Dodge licensed from the Wisconsin Alumni Research Foundation.

Approved by French regulators in March, the vaccine could minimize the risk of a bird flu pandemic by controlling the disease in poultry populations, Chu said.

In addition, he said, Fort Dodge's efforts in developing the reverse genetics vaccine for the animal health market could in some way advance efforts to develop a human vaccine.

Bob Tully, one of five private-industry representatives on the advisory board guiding the regional animal health initiative, said crossover potential is heightened by the fact that the same basic laboratory skills are required for animal health and human health research.

Tully, the manager of large animal biologics for Lenexa-based CEVA/Biomune Vaccines, said a convergence between human and animal health also is being driven by the rise in zoonotic diseases, those that can be transmitted between humans and animals.

"In the 40 years I've been in this business," Tully said, "I've never seen so many zoonotic diseases emerging -- bird flu, SARS, West Nile, mad cow.

"That's why it's important to work together. There has to be some cross-pollination between human and veterinary medicine."

Some attribute the rise in zoonotic diseases to the world's human population explosion -- from 750 million in 1900 to more than 6 billion -- pushing people and animals close together.

The mixing of human and animal populations also has increased concerns that the use of antibiotics in animals will lead to drug-resistant disease strains capable of infecting humans.

"We now have to do risk assessments, which are part of the package to get approval for an antibiotic for food animals," Heinen of Bayer Animal Health said. "The biggest concern is the transfer via the food chain, so there is not so much concern on the companion animal side. But dogs sometimes sleep with children together in a bed. So it's coming up there also."

With governments becoming increasingly concerned about food safety and people increasingly embracing pets as family members, the federal approval process has become at least as strict for new animal drugs as new human drugs, Heinen said.

The good news for animal pharma companies, Heinen said, is that America's growing love affair with its pets now means drug treatment, instead of euthanasia, for animals diagnosed with cancer, heart disease and neurological diseases.

That's also good news for human health research, which often starts with animal models, said Nelson Mann, one of the founders of the new animal health initiative.

In other words, Mann said, don't think that cancer researchers like Dr. Roy Jensen at the University of Kansas Medical Center wouldn't be interested in a canine tumor registry developed as a result of the emergence of pet oncology.

Crossover drugs

Many pharmaceutical compounds developed for human use now are marketed for use in animals, as well. Here are a few examples:

Etodolac -- Wyeth markets this non-steroidal anti-inflammatory compound as Lodine, a treatment for osteoarthritis and rheumatoid arthritis. Wyeth subsidiary Fort Dodge Animal Health markets it as EtoGesic, a treatment for arthritic dogs.

Enalapril -- Merck & Co. markets this compound as Vasotec, a treatment for high blood pressure. Merial, a joint venture of Merck and Sanofi Aventis, markets it as Enacard, a treatment for heart failure in dogs.

Clomipramine -- Novartis Pharmaceuticals markets this compound as Anafranil, an antidepressant. Novartis Animal Health markets it as Clomicalm, a separation anxiety treatment for dogs. Although approved for use in only dogs and humans, clomipramine also is widely used to prevent feline inappropriate urination.

Ciprofloxacin -- Bayer HealthCare markets this synthetic antibiotic as Cipro, a treatment for urinary-tract and other types of infections. A very similar compound, enrofloxacin, is marketed by Bayer Animal Health as Baytril, a treatment for bovine respiratory disease, and skin and urinary-tract infections among dogs and cats, among other uses.

 

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