Galliprant® (grapiprant tablets) Now Available for Canine Osteoarthritis

GREENFIELD, Ind. and LEAWOOD, Kan., Jan. 24, 2017 /PRNewswire/ -- Elanco Animal Health, a division of Eli Lilly and Company (NYSE: LLY), and Aratana Therapeutics, Inc. (NASDAQ: PETX) have announced veterinarians have a new targeted tool for the management of pain and inflammation associated with canine osteoarthritis (OA). Galliprant^® (grapiprant tablets), a first-in-class piprant, is now available to veterinarians for once-daily use in dogs with OA. Galliprant can be used in patients as young as 9 months, weighing 8 pounds or more, and most dogs can be dosed once a day with a whole or half tablet.

"Osteoarthritis is one of the most common causes of chronic pain in dogs—and there is no cure¹," stated Dr. Tony Rumschlag, Director of Regional Consulting Veterinarians for Elanco Animal Health. "However, early diagnosis and intervention to control pain and inflammation can help give arthritic dogs improved quality of life. With Galliprant, we have a medication that provides targeted pain relief from the earliest diagnosis of canine OA, while reducing the impact on gastrointestinal (GI), kidney and liver homeostasis."²

Mode of action targets OA pain
Galliprant is the first piprant (a non-COX-inhibiting prostaglandin receptor antagonist, or PRA) approved for use in veterinary medicine. It represents an important innovation in the evolution of canine anti-inflammatory drugs because it targets the clinical signs by specifically blocking the prostaglandin EP4 receptor, which is the primary mediator of OA pain and inflammation.² At the same time, Galliprant does not inhibit the production of many housekeeping prostanoids that maintain homeostatic functions.^2,3

Studies demonstrate efficacy, safety of Galliprant
Galliprant was proven effective in a placebo-controlled, 16-site field study evaluating 285 dogs with OA.⁴ Both veterinary and owner assessments reported statistically significant improvement in pain interference and pain severity compared to placebo on days 7, 14, 21 and 28. The most common adverse reactions were vomiting, diarrhea, decreased appetite and lethargy.

Additionally, a 9-month study in which Galliprant was administered to healthy dogs at approximately 15 times the labeled 2 mg/kg dose, demonstrated the product's safety. ^3,5 During the study, no clinically significant changes in liver, kidney or coagulation parameters were noted and there were no noticeable effects on food consumption, body weight, ECG, organ weight or hematology. In most situations, gastrointestinal disturbances were mild or slight. (see Important Safety Information below for more details).

"While all dogs receiving NSAID therapy require diligent monitoring for signs of adverse reactions, studies with Galliprant demonstrated an excellent safety profile," said Dr. Rumschlag.

New strategy for a painful problem
"It is estimated that one in five dogs is affected by osteoarthritis,⁶" said Dr. Rumschlag. He added, "Large breeds, such as the popular retriever breeds, as well as overweight dogs, are especially prone."

"Along with employing such strategies as diet, exercise and disease modifying osteoarthritis drugs (DMOADs), managing the pain and inflammation of osteoarthritis is vital," Dr. Rumschlag explained. "With Galliprant, veterinarians can feel confident about addressing canine OA pain and inflammation, even at the earliest diagnosed stages of OA."

Galliprant tablets are available from Elanco Animal Health, Aratana Therapeutics or authorized distributors. Elanco has exclusive rights to develop, manufacture and market Galliprant globally, and it co-promotes the product with Aratana in the United States.

Indication
Galliprant is indicated for the control of pain and inflammation associated with osteoarthritis in dogs.

Important Safety Information
Not for use in humans. For use in dogs only. Keep this and all medications out of reach of children and pets. Store out of reach of dogs and other pets in a secured location in order to prevent accidental ingestion or overdose. Do not use in dogs that have a hypersensitivity to grapiprant. If Galliprant is used long term, appropriate monitoring is recommended. Concomitant use of Galliprant with other anti-inflammatory drugs, such as COX-inhibiting NSAIDs or corticosteroids, should be avoided. Concurrent use with other anti-inflammatory drugs or protein-bound drugs has not been studied. The safe use of Galliprant has not been evaluated in dogs younger than 9 months of age and less than 8 lbs. (3.6 kg), dogs used for breeding, pregnant or lactating dogs, or dogs with cardiac disease. The most common adverse reactions were vomiting, diarrhea, decreased appetite, and lethargy. For full prescribing information call 1-888-545-5973.

About Elanco Animal Health
Elanco provides comprehensive products and knowledge services to improve animal health and food-animal production in more than 70 countries around the world. We value innovation, both in scientific research and daily operations, and strive to cultivate a collaborative work environment for nearly 7,000 employees worldwide. Together with our customers, we are committed to raising awareness about global food security, and celebrating and supporting the human-animal bond. Founded in 1954, Elanco is a division of Eli Lilly and Company. Our worldwide headquarters and research facilities are located in Greenfield, Indiana. Visit us at www.Elanco.com.

About Aratana Therapeutics
Aratana Therapeutics focuses on licensing, developing and commercializing innovative pharmaceutical products for dogs and cats. Aratana believes that it can leverage the investment in the human pharmaceutical industry to bring therapeutics to pets in a capital and time efficient manner. Aratana has multiple products approved by the Food and Drug Administration's Center for Veterinary Medicine or licensed by the United States Department of Agriculture. Their pipeline includes therapeutic candidates targeting pain, inappetence, cancer, viral diseases, allergy, and other serious, unmet or underserved medical needs. Aratana believes providing innovative options to veterinarians and pet owners will help manage pets' medical needs safely and effectively, resulting in longer and improved quality of life for pets. For more information, please visit www.Aratana.com.

This press release contains forward-looking statements (as that term is defined in the Private Securities Litigation Reform Act of 1995) about the collaboration between Aratana and Elanco, and reflects Lilly, Elanco's and Aratana's current beliefs. However, as with any pharmaceutical product, there are substantial risks and uncertainties in the process of development and commercialization. Among other things, there can be no guarantee that the research collaboration will yield successful results, that either company will achieve the anticipated benefits or that the results will be commercially successful. For further discussion of these and other risks and uncertainties, see Lilly's and Aratana's most recent Form 10-K and Form 10-Q filings with the United States Securities and Exchange Commission, respectively. Except as required by law, Elanco and Aratana undertakes no duty to update forward-looking statements to reflect events after the date of this release.

References

© 2017 Eli Lilly and Company, its subsidiaries or affiliates. Elanco and the diagonal bar are trademarks owned or licensed by Eli Lilly and Company, its subsidiaries or affiliates. Galliprant is a registered trademark of Aratana Therapeutics, Inc. USCACGLP00039

Media Contacts:
Tina Gaines, 317-213-0754
tgaines@elanco.com
Rachel Reiff, 913-353-1050
rreiff@aratana.com

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SOURCE Aratana Therapeutics, Inc.; Elanco Animal Health