Piedmont to capitalize on big pharma’s empty pet product pipelines. By Joseph Harvey, Animal Pharm

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In 1982, Roland Johnson came aboard Ciba-Geigy US and initiated the launch of what would become the country’s largest companion animal health firm by 1995. Animal Pharm editor Joseph Harvey spoke to two of Mr Johnson’s colleagues at Piedmont Animal Health, to find out how this process is happening all over again.

So what happened to Ciba-Geigy? The legacy business now finds itself part of Elanco via way of Novartis Animal Health and now contributes to one of the largest companion animal product portfolios in the world.

However, it is not these big companies that are fuelling all pet product innovation. According to North Carolina-based Piedmont Animal Health, many of the breakthroughs in pharmaceutical pet health innovation lie with smaller firms like itself.

“We are in communication with just about every animal health company in the industry, and they are hungry for new companion animal products,” pointed out Michael Kelly, Piedmont’s chief financial officer and chief operating officer.

In the next five years, he expects Piedmont to be challenging firms such as Merial, Zoetis, Bayer and Elanco in the pet therapy space, thanks to the firm’s proprietary pharmaceutical pipeline currently in development. In fact, Mr Johnson – the company’s chief executive and founder – points to third-party market research that indicates Piedmont’s portfolio of products will reach sales of $175 million at manufacturer level by 2020.

Not only would this make Piedmont one of the top seven companion animal companies in the US, but sales of this magnitude would put it on the cusp of the global top 20. If this sales target is achieved, Piedmont could be the largest standalone companion animal therapy business.

Moreover, according to the company’s executive vice president of business development and marketing, Eric Barnett, the forecasted $175m is just a portion of the company’s potential. “We will still be introducing products in 2020,” he explained, noting the full sales potential of these therapies would not yet have been reached.

Next product approval anticipated later this year

Mr Kelly added: “We should have our second product of 2015 approved later this year –and it has the potential to be a market leader.”

Piedmont has not yet announced the anticipated label indication for the new therapy, but Mr Kelly did say it would be a new animal drug application (NADA). The product will then be marketed by Piedmont’s unnamed licence partner.

This would be Piedmont’s second NADA of the year – February saw the US approval of advantus (imidacloprid), an antiparasitic soft chewable tablet for dogs. At the time of the advantus approval, it was one of only four NADAs granted by FDA during the previous 12 months. Bayer HealthCare Animal Health now owns this product.

Piedmont, which is named after the region of North Carolina it is situated in, currently has 20 products under development. Of these, 13 will be commercialized by the company itself, whereas the remaining seven have been out-licensed and will be sold by multiple Piedmont partners.

The first of its 13 proprietary products is forecast for US authorization in 2017.

Piedmont has not revealed what indications it is seeking for these products, but Mr Kelly said the companion animal candidates are all for “major pharmaceutical indications”. Mr Barnett added: “We don’t generally focus on niche areas.”

Goldmine of approval experience

But can the company really expect all 20 products to come to market?

Mr Kelly pointed to the Piedmont team’s R&D and regulatory achievements in the past: “Our historical success rate is around 85% of projects receiving regulatory approval.”

Collectively, members of the Piedmont team and board lay claim to helping develop, launch, or market 20 products in the veterinary industry for dogs, cats, and horses. Today, the canine and feline products on that list represent approximately 25% of total revenue at manufacturer level in the US small animal veterinary segment – nearly $900m.

The Piedmont team’s past companion animal product successes include top brands such as Heartgard (ivermectin), Frontline, Sentinel (milbemycin oxime/lufenuron), Interceptor (milbemycin oxime), Quellin (carprofen) and Iverhart(ivermectin), to name a few.

The company also claims it knows how to streamline the regulatory process for veterinary medicines and has succeeded in getting products to market in six years – 40% faster than the average time of up to 10 years.

Where next for VC-backed company?

The firm’s last funding round was in 2009 – led by CM Capital Investments (now Talu Ventures) of Australia – and it has been self-funded ever since. According, to Mr Barnett, Piedmont has managed to develop several supportive revenue streams.

Aside from development funds from partners, Piedmont draws revenues from its patented treatment for head lice. This product treats human head lice in five to ten minutes without the use of traditional pesticides and is sold through partners internationally under the brand names Resultz (marketed by Tribute Pharmaceuticals, Lapidot and Takeda) and Full Marks (marketed by Reckitt Benckiser).

Mr Barnett said: “Our deep knowledge of parasitology and drug delivery technologies allowed us to cross-fertilize expertise in animal health and create a product with double-digit growth for humans.

As to the future, it is evident the company has set itself high targets and will soon be gearing up for the challenge of commercialization.

Resultz is a registered trademark of Piedmont Pharmaceuticals; Full Marks is a trademark of Reckitt Benckiser Group; Heartgard and Frontline are registered trademarks of Merial; Sentinel and Iverhart are registered trademarks of Virbac; Interceptor is a registered trademark of Elanco; Quellin is a registered trademark of Bayer Healthcare.