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Oasmia's veterinary drug, Paccal Vet-CA1 receives US FDA conditional approval

Uppsala, SwedenMonday, March 3, 2014, 16:25 Hrs  [IST]

The Swedish pharmaceutical company Oasmia Pharmaceutical AB (publ) has received the US Food and Drug Administration (FDA)'s conditional approval for Paccal Vet-CA1 (paclitaxel for injection), providing veterinary oncologists with a new treatment option in the battle with canine mammary carcinoma and squamous cell carcinoma.

Paccal Vet-CA1 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 health care company Abbott which gives its Animal Health division the exclusive worldwide distribution rights to Paccal Vet-CA1, excluding Russia, Japan and the Commonwealth of Independent States (CIS).

“The conditional approval of Paccal Vet-CA1 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. This also improves the possibilities to secure the company’s long-term financing.”

“Until now, veterinarians in the United States have not been able to safely use one of the most proven and commonly used chemotherapy agents used to treat human cancer. With the conditional approval of Paccal Vet-CA1, there is new hope for our canine patients,” said Dr Chand Khanna, DVM, PhD, DACVIM, at The Oncology Service, LLC in Washington D.C., and past president of the American College of Veterinary Internal Medicine (Oncology). “Paccal Vet-CA1 is specifically formulated for use in dogs, giving us an important new weapon in the fight against canine skin and mammary cancers, which are both significant clinical problems in veterinary oncology. I am enthusiastic about this new option and expect to use it widely for pets with these types of cancer.”

"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, Animal Health, Abbott. "With the FDA conditional approval of Paccal Vet-CA1, 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 per cent 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 tumour of epidermal cells which is often developed in the oral and nasal cavities and on the paws. Light-skinned and short-haired dogs that spend a long time in the sunshine have a higher risk of squamous cell carcinoma.

Mammary carcinoma is the most common tumour in female dogs that have not been spayed, affecting one out of every four. Overweight females and those fed a diet high in fat are at the greatest risk for developing mammary cancer.

Oasmia Pharmaceutical AB develops new generations of drugs within human and veterinary oncology. The company’s product development aims to create and manufacture novel nanoparticle formulations and drug-delivery systems based on well-established cytostatics, which, in comparison with current alternatives, show improved properties, reduced side effects, and expanded applications.

 
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