Oasmia Rises in Stockholm After Plant Passes FDA Pre-ApprovalKim McLaughlin
Oasmia Pharmaceutical AB rose the most in more than three months after the biotechnology company said its manufacturing plant in Sweden passed a pre-approval inspection by the U.S. Food and Drug Administration.
Oasmia jumped as much as 11 percent in Stockholm, its steepest intraday advance since Aug. 26. The stock traded 5.8 percent higher at 10:04 a.m. local time, giving Oasmia a market value of 1.64 billion kronor ($250 million). The shares have more than quadrupled in value this year, while the OMX Stockholm All-Share Index has gained 20 percent.
The FDA’s inspection confirms that Oasmia’s plant meets the requirements of a regulatory framework enforced by the FDA with requirements as to how a drug must be made with respect to Paccal Vet, one of two canine cancer drug candidates the company is developing under a license and distribution agreement with Abbott Laboratories.
“It’s an important step for Oasmia and confirmation that our plant is up to the required standards,” Oasmia Chief Executive Officer Julian Aleksov said in a text message. “The process to get the approval has taken several years and we had a large team working to make it happen.”
Shares in the Swedish drugmaker soared 45 percent on Jan. 7 after it said it signed the agreement with Abbott Laboratories for its canine cancer drugs. Oasmia, which doesn’t yet have any products on the market, sold 123 million kronor of shares before costs in November last year to fund drug development. Oasmia’s animal health program focuses on the two most common indications, mastocytoma and lymphoma, which make up about half of all cancers in dogs.