By Joseph Harvey
March 14, 2017
Aratana Therapeutics has reported a significantly lower net loss for fiscal 2016.
In a year in which the firm began evolving into a commercial entity, net losses came to $33.6 million. This was less than half of the $84.1m loss it recorded in the previous year, as Aratana reduced it general costs and expenses.
The firm was also boosted this year by revenues of around $38.6m, which largely stemmed from its licensing and collaboration deal with Elanco. Product sales contributed $0.3m in 2016.
Aratana now has about 50 employees in commercial operations. The firm said its commercial team consists of: "A chief operating officer, regional sales leaders, national account managers, therapeutic specialists (sales representatives), a veterinary medical director, veterinary medical liaisons, a sales director, a sales operations director, a senior marketing director and marketing managers, pharmacovigilance, customer service and other operations personnel."
Q4 loss widens
While the Kansas-based firm's loss improved across the year, the fourth-quarter showed an increased loss. In Q4, Aratana reported a net loss of $23.3m. This included $10.7m in inventory adjustments and impairment of an intangible asset.
Aratana's fourth-quarter revenues reached $292,000 after Nocita became commercially available towards the end of the year.
Despite bringing its first three products through to fruition, Aratana ramped up its R&D costs in 2016. R&D expenses totaled $30.5m in 2016. The previous year Aratana spent $25m on R&D.
The firm said: "The increase in research and development expenses in 2016 was due primarily to increased milestone payments related to Galliprant, Entyce, Nocita and AT-016, and costs related to transfer and scale-up of the manufacturing of Entyce, which were partially offset by a decrease in development costs after the completion of several pivotal studies for the company's lead programs."
Aratana is currently conducting a pivotal field effectiveness study and a pivotal target animal safety study to evaluate capromorelin for weight management in cats with chronic kidney disease.
The firm said it is evaluating Nocita in other surgical procedures in dogs to potentially expand the label. Additionally, Aratana is enrolling a pivotal field effectiveness study for post-operative pain management in cats. Results are expected from this study by mid-2017.
The company also recently completed enrollment of a pivotal field safety study investigating AT-014 for the treatment of canine osteosarcoma. Aratana anticipates conditional licensure for this product by the USDA in the second half of 2017.
The firm also pointed out its partner VetStem BioPharma has recently begun enrollment in a pivotal field effectiveness study of AT-016, an adipose-derived allogeneic stem cell therapeutic candidate for osteoarthritis pain in dogs. Results from this study should arrive in 2017.
Aratana said it expects VetStem "to initiate a pivotal target animal safety study in 2017 and is making progress on the required chemistry, manufacturing and controls technical section".
In November 2016, VetStem revealed the results of landmark research into stem cell therapy in canine osteoarthritis.
Update on approved products
Aratana expects European approval of Galliprant (grapiprant tablets) – for the control of pain and inflammation associated with osteoarthritis in dogs – in 2017. The firm said the European Medicines Agency has commenced review of the product.
Recently, Aratana said Entyce (capromorelin oral solution) – approved in the US for appetite stimulation in dogs – will be commercially available by late 2017. The product's launch was delayed after Aratana said it aims to transfer the manufacturing of Entyce to a new vendor. In relation to this, the FDA requested additional information "regarding the proposed transfer in order to complete the supplemental application".
The company said around 200 customers have placed initial orders for Nocita (bupivacaine liposome injectable suspension), which was approved in the US last year for local post-operative analgesia for cranial cruciate ligament surgery in dogs. Aratana said its near-term commercial objectives include "securing additional re-orders from this customer base". Reprinted with permission of Animal Pharm News