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Oasmia Gets FDA Approval for Paccal Vet in Canine Cancers

Oasmia Pharmaceutical AB got conditional approval for Paccal Vet from the U.S. Food and Drug Administration for the treatment of two canine cancers. The stock rose the most in more than a year.

The FDA approved the drug for dogs with squamous cell skin cancer and mammary carcinomas, providing a treatment option for indications where there are currently no effective systematic treatment choices, the company said in a statement today.

Paccal Vet is one of two dog cancer drug candidates the company is developing under a license and distribution agreement with Abbott Laboratories. Uppsala, Sweden-based Oasmia’s animal program focuses on the two most common indications, mastocytoma and lymphoma, which make up about half of all canine cancers. The leading cause of canine disease-related mortality, cancer accounts for almost half of all deaths in dogs 10 years or older with as many as three million new cases diagnosed annually.

“Ever since we started this project 15 years ago, we have waited for the day when we could have a product on the market,” Oasmia Chief Executive Officer Julian Aleksov said in a text message. “There is a large and rapidly growing market for effective drugs that can treat cancer in dogs, and we believe Paccal Vet, being the first cytostatic drug specifically made for dogs, has a great potential to become the standard treatment.”

Aleksov said the FDA approval improves the possibilities to secure Oasmia’s long-term financing.

Oasmia shares rose as much as 28 percent, the biggest intraday gain since Jan. 17, 2013, and advanced 12 percent to 27.20 kronor as of 9:45 a.m. in the Swedish capital. The stock has climbed 41 percent this year, giving the company a market value of 2.22 billion kronor ($343 million).

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