Perth, Jan 24, 2008 (ABN Newswire) - Stirling Products (ASX: STI) advises that it has recently received information from its current Distribution partner in South Africa (Afgri Operations Pty Limited) that the MCC has approved the application for R-salbutamol to be included under Section 36 of the Stock Remedy Act. The approval means that Afgri, on behalf of Stirling Products, can now conduct the necessary trials for registration and commercialisation under this Act rather than the more stringent MCC process."
CEO and Managing Director for Stirling Products, Dr Calvin London indicated "This is a major step forward for us in South Africa and takes us much closer to being able to sell product in South Africa. The lengthy delay that has been caused while we have waited for this decision has slowed us down considerably, but we now have a pathway forward."
Total market potential per year for beef cattle, sheep, pigs and chickens is estimated to be in excess of US$4.5 million.
In the letter received from the MCC, exemption from Schedule 4 of the Medicines and Related Substances Act was granted for all applications where R-salbutamol is being used as a growth agent. The approval stipulated only two areas where data was specifically required to support the application; residue levels and dust control.
"While we acknowledge that we will need to do trials in South Africa for residue levels, we are confident that this will not be an issue," indicated Dr London.
Previous studies have demonstrated that the effective residue levels in meat from animals that have been fed with R-salbutamol in the finishing stage, have a very large safety margin. Many kilograms of meat, regardless of whether it is chicken, beef or pork, needs to be consumed each day before getting close to the low residue levels that even humans with asthma are exposed to every day.
"We expect to hear in the near-term the precise requirements the regulators will require for testing and product verification in order to get the product approved for market," commented Dr London.
CEO and Managing Director for Stirling Products, Dr Calvin London indicated "This is a major step forward for us in South Africa and takes us much closer to being able to sell product in South Africa. The lengthy delay that has been caused while we have waited for this decision has slowed us down considerably, but we now have a pathway forward."
Total market potential per year for beef cattle, sheep, pigs and chickens is estimated to be in excess of US$4.5 million.
In the letter received from the MCC, exemption from Schedule 4 of the Medicines and Related Substances Act was granted for all applications where R-salbutamol is being used as a growth agent. The approval stipulated only two areas where data was specifically required to support the application; residue levels and dust control.
"While we acknowledge that we will need to do trials in South Africa for residue levels, we are confident that this will not be an issue," indicated Dr London.
Previous studies have demonstrated that the effective residue levels in meat from animals that have been fed with R-salbutamol in the finishing stage, have a very large safety margin. Many kilograms of meat, regardless of whether it is chicken, beef or pork, needs to be consumed each day before getting close to the low residue levels that even humans with asthma are exposed to every day.
"We expect to hear in the near-term the precise requirements the regulators will require for testing and product verification in order to get the product approved for market," commented Dr London.
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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, poultry, 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 developing applications for companion animals (e.g. horses, dogs, cats and reptiles).
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