Collaborating with animal health drug developers isn’t a common developmental strategy for human pharmaceutical development, but it offers benefits worth considering—for both parties.
Working at the intersection of human and animal health can potentially shorten time to commercialization by improving the understanding of the underlying science and by providing early notice of potential issues within a family of therapeutic candidates. Companies also have the possibility of reaching new market segments by repurposing existing drugs for new indications as well as finding uses in other animal species.
Animal health visibility increases
Animal health still flies under the radar for most biotech companies. “Traditionally, animal health pipelines weren’t visible. The animal health businesses were embedded within their larger human health parents and their sales were lumped into the category of “Other Revenue,” said Peter Opdam, PhD, director of business development, Europe, for MSD Animal Health (known as Merck Animal Health in North America).
Peter Opdam, Director of Business Development, Europe, MSD Animal Health
Additionally, he said, “animal health is a relatively small industry. To put the market in perspective, Merck’s human health division generates more revenue than the entire prescription animal health industry in a given year.”
Visibility for the animal health industry began improving several years ago as Pfizer made plans to spin out its animal health division in 2013. At about the same time, people were becoming more aware of the health needs of their pets and the important role filled by veterinary drugs. That increased awareness has helped animal health startup companies attract more investment from both public and private markets, which increases the options for biotechs interested in partnering in this space.
Opportunities with animal health
One of the most obvious opportunities for collaboration is for human and animal health developers to repurpose existing molecules for new indications and new markets. “That may allow companies to build new IP and can significantly extend the profitable lifespan of even well-known molecules,” Opdam said.
At MSD Animal Health, “We offer Merck’s human health division an opportunity to use their IP and invest in a way that’s complementary to their own programs,” Opdam said. “We don’t compete with the human health products or take focus away from their own R&D priorities.”
Often, MSD Animal Health finds new, veterinary applications for human compounds. For example, human chorionic gonadotropin (hCG), a protein used in fertility treatments, has long been used to regulate animals’ reproductive cycles. This enables all animals of breeding age in a herd to be bred at the same time, thus simplifying farm management. MSD Animal Health uses this molecule in products for cattle, swine and even fish.
Medications also may be repurposed for use in companion animals. “Mometosone, a corticosteroid developed in-house for treatment of allergy and inflammation, and posaconazole, a human health antifungal, have been combined with an anti-infective to create an effective treatment for otitis externa in dogs,” he said.
Biotech developers may find particular opportunities in vaccines. “They’ve been a pillar of veterinary medicine because they’re the most cost-effective way to maintain animal health,” Opdam said.
Parasite control is another big concern for animal health. “Merck’s drug ivermectin was the first real blockbuster in animal health. It is used in virtually every major animal species against many types of parasites. Human use of ivermectin (for certain tropical diseases), came only after the molecule had been proven safe and effective in animal health.”
Any revenues garnered through veterinary drug development programs may improve cash flow, but they are likely to be modest, Opdam cautioned. “A blockbuster product in the animal health industry may generate USD 100 million per year in peak revenue.” In contrast, human blockbuster drugs debuting in the next year can expect to earn USD 1 billion each within five years of launch. The difference is attributed both to the cost of the drug and the significantly smaller animal health market.
“There is a misconception that getting an animal health product on the market is fast and easy, but we are highly regulated. In the EU, the EMA is the sole regulator, but in the US, the FDA, USDA and EPA each regulate different types of animal health products. And, like human products, most animal health products are manufactured under GMP guidelines.”
A “nontrivial advantage”
That said, there are certain benefits that may speed development. Although animal products undergo the equivalent of clinical trials for safety and efficacy, “we can test directly in our patients earlier within the development process. That’s a nontrivial advantage.”
For companion animals, a typical developmental timeline is four to six years. For food animals, drug approvals may take as long as 12 years. “The difference is often because we must develop a substantial toxicology package for food animals that evaluates the effects of the medication on the animals, the environment in which they live and the humans who consume products (meat, milk and eggs) derived from that animal.”
For animal health products, Opdam said, “we spend a lot of time in feasibility testing, trying to deliver the molecule effectively. Once it works and we move to the development phase, there is a high likelihood (approaching 50%) that it will be approved because we removed significant risk before the development decision was made.”
Before partnering with an animal-focused drug developer, biotech companies should determine their own motivations for considering such a partnership. “If they intend to generate a quick cash flow, they may be disappointed. Those instances of rapid returns are few and far between.
“If, however, drug developers want to learn more about the science underlying their candidates, partnering with animal health companies can help,” Opdam said. Animal health programs may explore pharmacokinetics and pharmacodynamics (PK/PD), stability and formulation options in ways small biotechs may not easily manage.
For example, human programs prefer oral delivery but, “animals don’t like pills (as anyone who’s given a pill to a cat can attest).” Therefore, other methods must be developed. Those methods may also be effective for humans.
Transdermal delivery is an effective option for dogs and cats. For cattle and pigs, injectables ensure they receive the proper dose. Chickens and fish often receive medications through their water or food. “We have a way to freeze dry and stabilize vaccines for chickens so the dose is measured as a number of pellets, dissolved in water and administered in a very cost-effective way. The underlying technology has been licensed by a developer of human pharmaceuticals,” he pointed out.
Strategy to separate programs
Sometimes, human drug developers harbor concern about pursuing parallel development in animal health. However, human and animal programs are separated, often by the choice of molecule. “In many veterinary therapeutic applications, there’s a strong preference to use a molecule that’s related to the lead molecule in the human therapeutic program, but not the actual lead itself.
“We’re often looking for different PK properties for animal health, so we can work with a backup molecule. The lead and backup molecules are in the same family, so they usually share the same mechanism of action and the same underlying biology. Therefore, in developing assays and performing toxicology studies, researchers can anticipate that certain biological features will be shared.”
For example, a toxicological finding encountered with one molecule may reflect a class effect shared by all molecules in that family. Knowing to look specifically for a particular off target effect and confirming if the effect is limited to a particular compound or subset of compounds helps both programs advance more rapidly.
The natural symbiosis between human and animal drug development presents opportunities for both types of companies to speed development and enlarge their markets. To learn more about biotech opportunities in animal health, join the panel discussion, “Opportunities at the intersection of animal and human health“ at BIO-Europe® 2015, November 2–4 in Munich.
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