Prescription Animal Products

dog licking catOur Prescription Drug Candidates:
The US companion animal market, which is a target market for our prescription drug candidates, generally consists of dogs, cats and horses. There are a limited number of animal drugs currently on the market, and veterinarians sometimes prescribe human drugs in an effort to treat animals but do not have the benefit of clinical support with respect to efficacy or dosing. In addition, administering a potentially unpalatable human formulation is often difficult and may lead to further uncertainty of the amount actually ingested by the animal.

We estimate that in the United States there are approximately six million annual veterinarian cases of acute and chronic watery diarrhea in dogs. This makes diarrhea one of the most common reasons for veterinary office visits and the second most common reason for visits to the veterinary emergency room, yet there are no FDA-approved anti-secretory products for the treatment of diarrhea. Veterinarians typically treat watery diarrhea in dogs with antibiotics, probiotics, dietary restrictions and products approved and formulated for humans, such as Imodium and other anti-motility agents, as well as binding agents that absorb water such as Kaopectate and Pepto-Bismol. None of these treatment options address the water loss associated with watery diarrhea.

We believe that Canalevia is an ideal treatment for acute watery diarrhea in dogs because of its demonstrated novel anti-secretory mechanism of action. If approved for the treatment of acute diarrhea in dogs, Canalevia will be the only FDA-approved anti-secretory agent to treat diarrhea in dogs.

Canalevia for Chemotherapy-induced Diarrhea
Jaguar has received Minor Use in a Major Species (MUMS) designation for Canalevia for Chemotherapy-Induced Diarrhea (CID) in dogs. We also completed submission of all required major technical sections for the conditional approval application for Canalevia for CID in dogs to the FDA for phased review.

Prescription Drug Product Candidates For Equine

Diarrhea Associated with Acute Colitis in Horses
We believe colitis affects thousands of horses in the United States each year and can cause sudden, massive fluid loss and severe electrolyte imbalances that can result in death in a matter of hours. We intend to develop a species-specific formulation of crofelemer for the treatment of diarrhea associated with acute colitis in horses.

Acute colitis often occurs when salmonella and C. difficile, bacteria that are normally present in the gut, are activated by stress, or when the bacteria N. risticii is ingested, causing Potomac horse fever. A 2009 Compendium Equine article reported fatality rates of 32% to 60% for salmonellosis and

15% to 35% for Potomac horse fever. Stress (e.g., shipping, changes in daily routines, illness, hospitalization, racing), recent diet changes, recent antimicrobial administration and non-steroidal anti-inflammatory drug therapy can also put horses at risk for acute colitis. The current standard of care includes hospitalization, intubation and intravenous fluids, with little opportunity to culture stools to determine the exact source of the disease. We believe that treatment of diarrhea associated with acute colitis in high-value race and performance horses with crofelemer represents a premium niche market opportunity.

Other Prescription Drug Product Candidates

We have also licensed intellectual property to develop prescription drug products for insulin resistance, diabetes and metabolic syndrome for dogs, horses, and cats. Similar to our lead prescription drug product candidate, these products were tested in animals for safety and efficacy to support their development for use in humans. Additionally, we will be initiating clinical studies for virend, a topical drug product candidate to treat herpes virus in cats, which has been through Phase 2 human clinical testing by third parties.

MYTESI® is an antidiarrheal indicated for the symptomatic relief of noninfectious diarrhea in adult patients with HIV/AIDS on antiretroviral therapy (ART).

Important Safety Information about MYTESI®
MYTESI® is not indicated for the treatment of infectious diarrhea. Rule out infectious etiologies of diarrhea before starting MYTESI®.

If infectious etiologies are not considered, there is a risk that patients with infectious etiologies will not receive the appropriate therapy and their disease may worsen. In clinical studies, the most common adverse reactions occurring at a rate greater than placebo were upper respiratory tract infection (5.7%), bronchitis (3.9%), cough (3.5%), flatulence (3.1%), and increased bilirubin (3.1%).

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