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Oasmia Receives FDA Conditional Approval for Its Lead Product Paccal Vet® CA-1

UPPSALA, Sweden, February 28, 2014 /PRNewswire/ --

The Swedish pharmaceutical company Oasmia Pharmaceutical AB (publ) today announced that the U.S. Food and Drug Administration (FDA) has conditionally approved Paccal Vet® CA-1 (paclitaxel for injection), providing veterinary oncologists with a new treatment option in the battle with canine mammary carcinoma and squamous cell carcinoma.

Paccal Vet CA-1 is the first veterinary drug to utilize paclitaxel, one of the most frequently used chemotherapeutics for the treatment of a wide range of cancers in humans for the past 20 years.  Oasmia has signed an agreement with the global pharmaceutical company Abbott which gives its Animal Health division the exclusive worldwide distribution rights to Paccal Vet CA-1, excluding Russia, Japan and the Commonwealth of Independent States (CIS).

"The conditional approval of Paccal Vet CA-1 is a big step forward for veterinary cancer treatment," commented Julian Aleksov, chief executive officer of Oasmia. "In addition, it confirms the potential of our unique patented drug delivery technology, XR-17 - a novel derivative of vitamin A that we will be using in clinical trials with our other compounds for a number of human and veterinary indications."  

"Pets are living longer and owners increasingly desire a 'human level of care' for serious and chronic conditions," said Andrea Wainer, divisional vice president and general manager, Abbott Animal Health. "With the FDA conditional approval of Paccal Vet CA-1 we are able to offer veterinarians and pet owners a trusted cancer therapy used to treat millions of people each year."

Cancer accounts for nearly 50 percent of all deaths in dogs 10 years of age or older. It is the leading cause of canine disease-related deaths, with up to three million new cases diagnosed annually worldwide.  

Canine squamous cell carcinoma, a type of skin cancer, is a malignant tumor of epidermal cells which is often developed in the oral and nasal cavities and on the paws. Light-skinned and short-haired dogs who spend a long time in the sunshine have a higher risk of squamous cell carcinoma.  

Mammary tumors are the most common tumor in female dogs that have not been spayed, affecting one out of every four.

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