Perth, May 28, 2008 (ABN Newswire) - Stirling Products (ASX: STI) advises that its South African partner, Afgri Limited, has submitted the next stage in the regulatory process towards Act 36 approval.
In a previous announcement (ASX: 24 January), the company reported that in an official correspondence from the South African Medical Control Council (SAMCC), exemption from Schedule 4 of the Medicines and Related Substances Act had been granted for all applications where R-salbutamol is being used as a growth agent, subject to two areas; clarifying the degree of any human impact to the feed additive and the control of potential dust generation.
"Using the subject matter experts in South Africa, our distribution partner Afgri has now submitted an expert report that addresses the potential aspect of any impact on humans," indicated CEO and Managing Director, Dr Calvin London. "We are confident that the report presents a logical argument addressing the concerns about the potential impact of R-salbutamol on users. This is a compound that is used all over the world and is dispensed in several different pharmaceutical forms even at significantly higher dosages without any deleterious effects."
While this is being considered by the SAMCC, the company will prepare and submit a second report to address potential concerns with dust generation thereby satisfying all conditions placed on the approval.
"While we cannot predict what length of time for the reviewers to complete their assessment of the reports, we are one step closer to an approval. On a recent trip to South Africa we discussed some innovative steps to address the dust issue and I am very confident that these steps will not only lead to a better product in South Africa but also provide us with a novel formulation for R-salbutamol products in other jurisdictions.
We look forward to sharing the outcomes of this process with our shareholders," indicated Dr London.
In a previous announcement (ASX: 24 January), the company reported that in an official correspondence from the South African Medical Control Council (SAMCC), exemption from Schedule 4 of the Medicines and Related Substances Act had been granted for all applications where R-salbutamol is being used as a growth agent, subject to two areas; clarifying the degree of any human impact to the feed additive and the control of potential dust generation.
"Using the subject matter experts in South Africa, our distribution partner Afgri has now submitted an expert report that addresses the potential aspect of any impact on humans," indicated CEO and Managing Director, Dr Calvin London. "We are confident that the report presents a logical argument addressing the concerns about the potential impact of R-salbutamol on users. This is a compound that is used all over the world and is dispensed in several different pharmaceutical forms even at significantly higher dosages without any deleterious effects."
While this is being considered by the SAMCC, the company will prepare and submit a second report to address potential concerns with dust generation thereby satisfying all conditions placed on the approval.
"While we cannot predict what length of time for the reviewers to complete their assessment of the reports, we are one step closer to an approval. On a recent trip to South Africa we discussed some innovative steps to address the dust issue and I am very confident that these steps will not only lead to a better product in South Africa but also provide us with a novel formulation for R-salbutamol products in other jurisdictions.
We look forward to sharing the outcomes of this process with our shareholders," indicated 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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