Piedmont Animal Health Takes the Bite Out of Pilling Pets

Piedmont Animal Health logo

Ever tried to pill a cat? If your kitty isn’t cooperative, it’s an ordeal for you both. Ditto for your dog.

Piedmont Animal Health, Inc., a Greensboro developer of novel medications that improve ease of use and compliance, has received a patent for the formulation platform of its long-acting sterile injectable macrolide antibiotics for administration to companion animals and humans.

That means pets could receive one-time injections in a veterinary clinic, rather than undergoing the rigors of using oral medications at home for days at a time. It also ensures compliance -- the animals get the full treatment of the prescribed antibiotics.

Compliance studies have shown that pet owners aren’t successfully administering many oral doses of antibiotics to their pets, particularly cats, according to Doug Hepler, Ph.D., chief scientific officer at Piedmont. This can lead to recurrent infections, additional prescriptions of antibiotics and ultimately contributes to the current worldwide crisis of antibiotic resistance.

Roland Johnson and Rocky
Roland Johnson and Rocky. -- Piedmont Animal Health photos

“We’re seeing a trend among veterinarians toward a preference for injectable medications that can be administered in-clinic,” said Roland Johnson, Piedmont CEO. “For example, in several proprietary market research studies with veterinarians, nearly 100 percent indicated a desire to use injectables.”

Macrolide antibiotics are one in a class of commonly prescribed broad-spectrum antibiotics that inhibit the growth of bacteria. They include, for example, Clarithromycin, Azithromycin, Fidoximycin and Erythromycin. Piedmont’s management team declined to reveal exactly which antibiotic is in the sterile injectable product under development, only that it is a commonly used one and that there is no other sterile injectable formulation of it on the market.

“The U.S. antibiotic companion animal market represents approximately $400 million in total annual revenue for the pharmaceutical companies,” said Eric Barnett, M.D., ACA, Piedmont’s executive vice president of business development and marketing. “Our technology will, we believe, take a significant share of the antibiotic market because of the convenience and compliance benefits for both pet owner and veterinarian.”

R&D challenges overcome

Some of the R&D challenges Piedmont has overcome include a way to maintain the active pharmaceutical ingredient in a stable environment within the vial for suitable shelf life at the veterinarian’s office, said Barnett. Another included formulating a single long-acting dose that will sufficiently eradicate all the bacteria, leaving none to cause the infection to come back and require additional treatment.

Cat getting injection
Cats are likely to benefit first from
Piedmont Animal Health breakthrough.

Finally, he said they needed to develop a method for smooth subcutaneous (under the skin) injection that is comfortable for the animal and does not cause redness or swelling at the injection site. Barnett said the company has gone through “many, many iterations” to balance the requirements for achieving all three.

The platform is in late-stage development undergoing pivotal field study, which is analogous to a Phase III trial in human subjects. Piedmont anticipates the first product to market to utilize its innovative technology will be an injectable to treat upper respiratory infections in cats. It is working with a North Carolina company that performs lab and analytical work in-state, but which has manufacturing facilities in South Carolina.

“Our goal is to develop a portfolio of targeted antibiotics for in-clinic administration by veterinarians,” added Johnson. “In addition to this first product in development, we have successfully formulated a second antibiotic into an injectable formulation which will target multiple diseases in dogs and cats, including urinary tract infections.”

Seeking potential partners, buyer

Piedmont is actively seeking partners to commercialize this platform for an array of human, as well as animal uses, said Michael Kelly, CFO and COO. They are eyeing the potential of the pediatric market, again, because of the convenience and certainty of compliance with an injectable antibiotic administered in a clinic. However, Kelly said the company may decide to commercialize it themselves.

He said international firms have visited Piedmont’s Greensboro headquarters and shown interest in purchasing their technology, partnering with them to commercialize their products and even to buy the company. Kelly said they are considering all three different scenarios.

Piedmont already has significant global partnerships. In August, the company announced a license agreement with Hokusan Co. Ltd based in Hokkaido, Japan, to develop, manufacture and commercialize recombinant interferon-alpha in the U.S. to treat gingivitis in dogs and potential other oral indications. Hokusan invented, developed and registered recombinant canine interferon-alpha in Japan. Piedmont already has an ongoing technology partnership with Tokyo-based Sumitomo, a Fortune 500 company that made a strategic equity investment in Piedmont in 2018.

In July, the FDA granted Piedmont approval for the product Baytril (enrofloxacin) Soft Chewable Tablet, a generic of Baytril Tablets and the third soft chew developed and approved in the U.S. for Bayer Animal Health in the soft chew platform invented by Piedmont. This was the fourth Piedmont companion animal product approved for Bayer Animal Health in the last five years.

About Piedmont Animal Health

The company specializes in inventing, developing, and gaining approval by FDA for medications that it then out-licenses to major pharmaceutical companies for commercialization. It is led by a team of experienced veterinary pharmaceutical innovators and has a robust pipeline of primarily companion animal products in development.

Piedmont has project collaborations with academic and company partners throughout the state and has benefited from the programs and services of the North Carolina Biotechnology Center. In 2003, NCBiotech provided a critical $150,000 loan during its startup phase. The company went on to leverage that into $9.5 million in venture funding. It is now privately held and venture capital-backed by Talu Ventures, of Brisbane, Australia. NCBiotech published an extensive profile of Piedmont in 2017.

“This company continues to attract global attention to North Carolina and the Piedmont Triad region,” said Nancy Johnston, executive director of NCBiotech’s Piedmont Triad Office. “There is significant value in its ongoing ability to move ideas forward to commercialization. Piedmont is clearly an important stakeholder, and we’re truly fortunate to have its partnership, contributing not only to our advisory committee, but also to the state’s overall life science community.”

Elizabeth Witherspoon, NCBiotech Writer
Thu, 10/03/2019 - 14:55