Media Coverage

Can Aratana Entyce the market with its canine appetite stimulant?


Jul 12, 2017 - Animal Pharm

By Joseph Harvey
Animal Pharm
July 12, 2017 

Around four years since Aratana Therapeutics launched its initial public offering, the company is recording its first significant revenues and closing in on its next product launch in the US.

The firm anticipates Entyce will be commercially available by the fall of 2017, if its manufacturing transfer is approved by the FDA. Currently, Entyce is the only therapeutic approved in the US to safely and effectively stimulate appetite in dogs – an area with limited treatment options until now.

The product will follow Galliprant into the US sector and hope to emulate the early-stage success of Aratana's first commercial treatment. Galliprant – for the treatment of pain and inflammation caused by osteoarthritis – is sold throughout the country as part of a co-promotion deal with Elanco.

Aratana's president and chief executive Steven St. Peter told investors about Galliprant's debut: "The first month in the market, we already accessed 5,000 clinics who put in orders for the drug, which is remarkable in terms of uptake. I can assure you that number is much higher now.

"We believe Galliprant has the opportunity to become one of the top pet therapeutics launched in the US over the last decade."

Aratana could still be set to earn up to $83 million in potential milestone payments from its partnership with Elanco.

Dr St. Peter said the agreement sees Elanco in charge of the pricing plan for Galliprant. He said the product is priced at a "modest premium" by Elanco and, as it is the only new treatment in the osteoarthritis pain area in the last 20 years, veterinarians are willing to pay Galliprant's price.

"For customers who want the cheap products, there's half a dozen generic products available that veterinarians can use," he noted.

As well as the company's Nocita long-acting local anesthetic for post-operative pain relief in dogs, Aratana is focused on building a significant sales presence for Entyce. However, even though Entyce is approved in the US, it is not on sale yet.

According to Aratana's research, 68% of veterinarians the company surveyed reported they were unsatisfied with products available to treat inappetance. Additionally, 81% of veterinarians expressed a need for an effective product indicated to treat inappetance.
Dr St. Peter explained: "Today, when our reps call on a clinic, the majority already have Galliprant, which is a great calling card when you begin to talk about your next product. Entyce was approved last year but part of launching the product is you have to scale-up the manufacturing and build up the inventory.

"Our original plan with Entyce was to launch it at the conference at NAVC in February and so, going back multiple years with this product, we had a strategy of scaling up the manufacturing from who we used to make the product for the clinical studies to who made the product for commercial purposes.

"So we had built the inventory for 10mL, 15mL and 30mL products, sitting in the warehouses ready to launch but part of getting that technology transfer approved is going to the FDA and making sure that when you use a new vendor on your API that they approve it. Unfortunately, a few days before we were going to launch this product, we got some questions from the FDA about that transfer, which isn't unheard of but was unfortunate given that we were ready to launch the product.

"We spent a few months, as you would do, going back, requesting meetings, understanding the questions, making sure you know what they want to see, so you can re-submit that. So we had that interaction in April and now we have the confidence to resubmit that package and will be launching the product in the fall."

This delay has caused Aratana to miss two quarters of selling time. However, Dr St. Peter pointed out the company had Galliprant to sell during this period. He added: "We've been using this time to prepare the market for Entyce but we can't technically ship the product to customers until the FDA has approved the new vendor for the product."

Demand in place
Despite the delay, Aratana still believes it has developed a product that will be highly sought after by veterinarians.

There are currently no approved drugs in the US to stimulate canine appetite, leaving clinicians to use human treatments for extra-label medication. According to Aratana's research, 68% of veterinarians the company surveyed reported they were unsatisfied with products available to treat inappetance. Additionally, 81% of veterinarians expressed a need for an effective product indicated to treat inappetance.

The company's market research also indicated around 87% of surveyed veterinarians were extremely likely, or very likely, to use Entyce for chronic conditions and 63% of veterinarians said they would use the therapeutic in acute conditions.

"We do intend to work with distributors to sell Entyce and we already have in place agreements for what we consider a full complement of national and regional distributors," Dr St. Peter noted.

Earlier this year, investment firm William Blair showed additional confidence in Aratana, despite the delayed commercial launch of Entyce.

What next?
Aside from getting Entyce into the marketplace, Aratana is focused on its pivotal studies for capromorelin and Nocita in cats.

The firm is also aiming to take its business to a wider global audience next year. Dr St. Peter told investors: "Our model is to develop these products for global use. From a commercial perspective, Aratana is focused on the US. Entyce and Nocita outside US is a 2018 initiative."

The company is additionally awaiting approval of Galliprant in Europe, which was submitted for authorization in February 2016.

Following precedents
At the investor conferences, Dr St. Peter highlighted the lack of innovation in the companion animal health industry. He also suggested there may be a turning tide in the innovation stakes, particularly in terms of new chemical entities (NCEs).

The table below reflects the rise in US approvals for pet-focused NCEs during 2016, which was partly due to Aratana itself.

According to Aratana's research, 68% of veterinarians the company surveyed reported they were unsatisfied with products available to treat inappetance. Additionally, 81% of veterinarians expressed a need for an effective product indicated to treat inappetance.
Dr St. Peter explained: "Today, when our reps call on a clinic, the majority already have Galliprant, which is a great calling card when you begin to talk about your next product. Entyce was approved last year but part of launching the product is you have to scale-up the manufacturing and build up the inventory.

"Our original plan with Entyce was to launch it at the conference at NAVC in February and so, going back multiple years with this product, we had a strategy of scaling up the manufacturing from who we used to make the product for the clinical studies to who made the product for commercial purposes.

"So we had built the inventory for 10mL, 15mL and 30mL products, sitting in the warehouses ready to launch but part of getting that technology transfer approved is going to the FDA and making sure that when you use a new vendor on your API that they approve it. Unfortunately, a few days before we were going to launch this product, we got some questions from the FDA about that transfer, which isn't unheard of but was unfortunate given that we were ready to launch the product.

"We spent a few months, as you would do, going back, requesting meetings, understanding the questions, making sure you know what they want to see, so you can re-submit that. So we had that interaction in April and now we have the confidence to resubmit that package and will be launching the product in the fall."

This delay has caused Aratana to miss two quarters of selling time. However, Dr St. Peter pointed out the company had Galliprant to sell during this period. He added: "We've been using this time to prepare the market for Entyce but we can't technically ship the product to customers until the FDA has approved the new vendor for the product."

Demand in place
Despite the delay, Aratana still believes it has developed a product that will be highly sought after by veterinarians.

There are currently no approved drugs in the US to stimulate canine appetite, leaving clinicians to use human treatments for extra-label medication. According to Aratana's research, 68% of veterinarians the company surveyed reported they were unsatisfied with products available to treat inappetance. Additionally, 81% of veterinarians expressed a need for an effective product indicated to treat inappetance.

The company's market research also indicated around 87% of surveyed veterinarians were extremely likely, or very likely, to use Entyce for chronic conditions and 63% of veterinarians said they would use the therapeutic in acute conditions.

"We do intend to work with distributors to sell Entyce and we already have in place agreements for what we consider a full complement of national and regional distributors," Dr St. Peter noted.

Earlier this year, investment firm William Blair showed additional confidence in Aratana, despite the delayed commercial launch of Entyce.

What next?
Aside from getting Entyce into the marketplace, Aratana is focused on its pivotal studies for capromorelin and Nocita in cats.

The firm is also aiming to take its business to a wider global audience next year. Dr St. Peter told investors: "Our model is to develop these products for global use. From a commercial perspective, Aratana is focused on the US. Entyce and Nocita outside US is a 2018 initiative."

The company is additionally awaiting approval of Galliprant in Europe, which was submitted for authorization in February 2016.

Following precedents
At the investor conferences, Dr St. Peter highlighted the lack of innovation in the companion animal health industry. He also suggested there may be a turning tide in the innovation stakes, particularly in terms of new chemical entities (NCEs).

The table below reflects the rise in US approvals for pet-focused NCEs during 2016, which was partly due to Aratana itself.

Lack of new chemical entities specific to companion animals
02

He pointed to Zoetis' canine dermatology treatment Apoquel as a precedent for change and an example of the type of revenues that can be generated from an innovative companion animal product. Dr St. Peter suggested Apoquel is expected to soon rake in over $300m in annual sales and could peak at $500m per year.

"Apoquel surprised a lot of folks with how big that product is, how profitable it is, how much it is driving their global business," Dr St. Peter said. "All of us in the industry agree, we need more Apoquels."

Share price on the up?
Recently, Aratana's share price has jumped higher than $7 for the first time since February. The company has also seen a 40% improvement in its share valuation since the beginning of April.

Reprinted with permission of Animal Pharm News

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