Oasmia Pharmaceutical AB (OASM) rose the most in more than three months after the Swedish biotechnology company said its ovarian cancer drug paclical met its primary effectiveness and safety objectives in a late-stage study.
The stock rose as much as 22 percent, the steepest intraday advance since Feb. 28, and climbed 9 percent to 21.8 kronor as of 12:44 p.m. in Stockholm. Trading volume was more than nine times the daily average in the past three months.
The study of 789 patients compared paclical to taxol, a chemotherapy drug that is also paclitaxel-based, and showed Oasmia’s drug wasn’t worse in treating the cancers, Oasmia said in a statement today. The company will continue to follow the patients in the study to measure overall survival and expects to have those results in the fourth quarter, Chief Executive Officer Julian Aleksov said in a telephone interview.
“These solid clinical results provide a boost of confidence to our entire platform,” Aleksov said. “Depending on the overall survival data, we will send an application to the Food and Drug Administration” in the U.S., he said.
Oasmia, based in Uppsala, Sweden, said it plans to submit an application to the European Medicines Agency early next year.
The company on Feb. 28 won conditional approval in the U.S. for Paccal Vet for the treatment of two canine cancers, sending its shares to their highest price in a year. Paccal Vet is one of two dog cancer drug candidates Oasmia is developing under a license and distribution agreement with Abbott Laboratories. (ABT) The drug will be widely available for veterinary clinics in the U.S. starting next month, the CEO said.
Oasmia’s animal program focuses on the two most common indications, mastocytoma and lymphoma, which make up about half of all canine cancers. The cost of a treatment for a pet owner will be $4,000 to $5,000, Aleksov said, adding that the interest in the drug from veterinarians has been “intense.”
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