Due to a drastic reduction in the production of the only drug approved in the United States to treat a sometimes fatal glandular disorder in dogs, there may be a shortage, according to a North American distributor of the drug.
In a lawsuit filed Dec. 22, Novartis Animal Health U.S. states that Baxter Healthcare has abruptly ended a 10-year agreement to produce the drug Percorten-V, used to treat canine Addison’s disease.
Under the contract, which began in 1998 and was due to expire in 2008, Baxter was supposed to provide 31 batches of the drug in 2007. However, Baxter said it intends to provide just four batches of the drug, Novartis claims.
Percorten-V is currently the only veterinary product approved by the U.S. Food and Drug Administration to treat the disease, which causes a hormonal deficiency that mainly afflicts middle-aged dogs, notably Poodles.
Canine Addison’s affects the adrenal glands and can cause vomiting, fatigue and dehydration. Without treatment, it can sometimes lead to death.
The Novartis suit states that if the drug is unavailable, “thousands of dogs in the U.S. and Canada will die,” and alleges that Baxter is overcommitted to serving other clients, and its solution “has been to prioritize the customers it most prefers to serve, rather than adhering to its contract with Novartis.”
In court papers, Novartis said it is considering whether to make Percorten-V itself or find another supplier, but production of the drug would be delayed by the extensive testing and certification processes by the United States and Canada.
Although DogChannel was unable to reach a Baxter representative for comment, Baxter spokesman Tom Kline told the Bloomberg news service that Baxter is “committed to attempting to resolve the issues raised by Novartis in our discussions with them and transitioning their production to a new manufacturer.”