Stirling Products (ASX:STI) Gets First Approval For Obesity Patent
Highlights:
- R-salbutamol application for treatment of overweight mammals and birds.
- First Approval received from New Zealand Patent Office.
- Stirling exploring prescription and non-prescription applications for dogs.
- Stirling seeking new licensing partners for human application.
The patent relates to the use of Stirling's R-salbutamol compound and its potential application for reducing body weight in companion animals (dogs, cats and horses) and also in humans.
CEO and Managing Director of Stirling Products, Dr Calvin London said, "It is always goo! d to get the initial validation that a patent application has ! been suc cessful. We hope that this will be the start of a series of approvals in other countries where we have filed similar patent applications".
The American Veterinary Medical Association estimates that 48 million of the total population of dogs in the United Sates (35%) are considered to be overweight or obese. Surveys in Europe and Australia reflect similar levels of obesity and a recent survey in the United Kingdom indicated that 8 out of 10 vets are seeing an increased number of obese animals. As in humans, a number of secondary disorders are associated with obesity that lead to diabetes, cardiovascular problems, respiratory disorders and orthopaedic disorders. The market for the treatment of obese dogs is valued in excess of US$500 million per annum and for humans, is at least 3 times that figure.
Stirling has already conducted proof of concept studies on the compound for this application in laboratory models known as obese male Zucker rats (specifi! cally bred to be overweight) and more recently conducted trials in the United States on obese dogs. These studies indicated that not only did R-salbutamol have the ability to reduce body weight, it also had an excellent safety profile which is of great importance in regulatory and consumer approval of obesity treatments.
The initial trials in obese male Zucker rats (ASX January 31, 2006), demonstrated that when obese male Zucker rats received either 1.25 mg or 2.5 mg of R-salbutamol, there was a significant reduction in weight gain; 57% and 79% respectively compared to the controls over a two week period.
In a later study (ASX May 27, 2007) we demonstrated in a number of trials that R-salbutamol, when administered orally to overweight beagle dogs at a dose of 0.08 mg/kg, produced no visible clinically significant side-effects and weight loss in the order of 2-3% over a week was achieved.
"These trials demonstrated the potential of this co! mpound to reduce weight in fat dogs and have also shown, that ! while st ill at an early stage of development, it would appear that the side-effects of using this compound, not only in dogs but also potentially in humans, would be safe and free of side-effects. We will now pursue some novel ways to administer the compound that we believe can further enhance the ability of the compound to safely and effectively remove fat", indicated Dr London.
Putting this into context, the prescribing information for Slentrol(TM) documents a target weight loss of > 0.7% each week. Common side effects listed are vomiting, sometimes lethargy, diarrhoea or anorexia. None of these side effec! ts were apparent with dogs treated with R-salbutamol compared to the controls for any of the treated group.
"Stirling has always thought that there are significant opportunities in the treatment of overweight and obese dogs and cats. We have been actively searching for other compounds that we can introduce into a portfolio to build around R-salbutamol for obesity treatment. We are currently in discussion for products in this area, both as prescription medications and as over-the-counter, natural products. This is in-line with our strategy to find products with lower regulatory hurdles and that are closer to market", indicated Dr London.
The patent approval also provides Stirling with a renewed opportunity to find technical or commercial licensing partners for the application of R-salbutamol in the treatment of human obesity. R-salbutamol is already prescribed to several million patients for the treatment of asthma and while the mechanism of act! ion is different (not all asthmatics are thin); Stirling belie! ves that the clinical experience supports the excellent safety profile of the compound.
"We are keen to develop an on-going relationship with companies that have an interest in human obesity treatments and are seeking licensing opportunities. Stirling is, and remains, a company specialising in animal health, but if we can maximise the use of our compounds in the human arena, then that is beneficial for shareholders", indicated Dr London.
The Company also has a joint venture based in Denmark (Pulmovet ApS) which is developing and commercializing products for the treatment and diagnosis of respiratory disorders in horses.
About Stirling Products Limited
Stirling Products is developing patented animal growth agents that increase meat production, therefore improving the production efficiency of livestock animals, while decreasing fat accumulation for the benefit of consumers. The Stirling growth agents are under development for swine, poultr! y, cattle and sheep for global markets and are being positioned to take a major role in reducing the global use of antibiotics and steroid hormones in livestock. Stirling is also developing veterinary medications for heaves in horses through its joint venture in Europe (Pulmovet ApS, www.pulmovet.com) and an obesity treatment in companion animals.
Stirling Products recently acquired a Canadian company Progressive BioActives Incorporated (PBI) under its North American subsidiary, Stirling Products NA Inc. PBI is part of the Bioscience cluster established on located Prince Edward Island, Canada. PBI's lead product ProVale, is the latest high purity beta glucan extract that has been designed as an alternative tool for sustainable livestock management in face of increasing viral disease challenges where antibiotics have no or limited application. ProVale is available for targeted applications in swine, poultry and farmed aquaculture with a future focus on further dev! eloping applications for companion animals (e.g. horses, dogs,! cats an d reptiles).
Stirling Products Limited
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