Development and Commercialisation

Commercialisation of the intellectual property remains a key challenge for the company. Market approval for each product is derived from a registration dossier that addresses in a systematic presentation the evidence that the product is safe, effective in its use, manufactured by processes that assure its quality and integrity throughout its use, and results in no adverse side effects for consumers of the meat from treated animals.

Three features of R-salbutamol will potentially facilitate its rapid and successful introduction beyond the current levels of acceptance:

1. Human safety - short half life, low absorption by humans, well known and established safety profile;
    
2. Animal efficacy - demonstrated efficacy of the racemic form (salbutamol) in livestock and the superiority of R-salbutamol's beta-2 receptor specificity (compared with current beta agonists that have considerable beta-1 activity) thus reducing adverse effects in livestock;
    
3. Animal and worker safety - published hazards associated with beta-agonists with beta-1 activity will be reduced or absent for R-salbutamol, a selective beta-2 agonist.

The market shift towards the R-salbutamol products, giving them a multi-million dollar opportunity, will be supported and reinforced through four key factors:

• Regulatory and lobby pressure on industry to stop the use of antibiotics as growth promoters - R-salbutamol products offer greater potential as growth agents and can minimize or replace the use of antibiotics and/or steroid growth hormones for this purpose.
• Regulatory changes that may require the use of single enantiomers of new feed additives where benefits are shown (as is the case with drugs for human use).
  
• Increased consumer demand for a healthy diet, including meat with greater protein and less fat content - R-salbutamol products result in far less fat and more meat (see Regulatory Studies for further details).
  
• Increased production efficiencies - In animal studies conducted with R-salbutamol, a more efficient feed conversion (the ratio of feed to meat produced) is observed compared to other growth agents.
  

Development and Commercialisation

The company depends heavily on outsourcing opportunities not only for its animal studies but also for its raw material manufacture and biological testing. These opportunities are maximised through Stirling's internal resources, such that the integrity and quality of product development is maintained. Wherever possible, the company will seek exclusive agreements.
 
The extensive use of consultants is deliberate. The company recognises that it can progress more efficiently with a core team of expertise in the areas of scientific development, commercialisation and business development. More specific expertise can be harnessed for animal studies, chemical testing and regulatory consultation from outside the company.

Raw Material Supply

The company has patented processes of manufacture with established pharmaceutical active ingredient manufacturers and has already established a formal supply arrangement. Stirling has strict requirements for raw material manufacturers in order to secure the most advantageous regulatory position. Sources for the R-salbutamol active ingredient must be from pharmaceutical plants approved by the US FDA for GMP standards. The manufacturer must also hold its own manufacturing patent for producing R-salbutamol.

Manufacturing of Finished Product

The manufacturing of finished product will follow a similar strategy. Efficiencies of scale for supply into international markets are likely to be maximised by utilising localised, country-specific medicated feed mills to manufacture products under contract manufacturing agreements in each country. 
 
The commercial product will be supplied as a medicated feed premix of active compound bound to an inert substance.  The pre-mix concentrate will then be further diluted into a supporting nutrient mix.  Formulation (pelleting, for example) and packaging will be contracted through one of several facilities with the appropriate levels of control required for regulatory approval.

Alternately, product may be supplied as stand-alone pellets whereby the active ingredient is combined with appropriate protein, vitamin and mineral supplements in a ready-to-use product. 
 
This strategy avoids the capital-intensive construction of manufacturing plants that by their nature are expensive to build and maintain due to the regulatory requirements imposed by international regulatory agencies such as the FDA. 

Sales, Marketing and Distribution

Sales, marketing and distribution will be effected by collaborating with multinational companies. These companies have established systems for supply and distribution and the appropriate sales and marketing teams to support them. As Stirling progresses through its regulatory process for each of its products it will attract and seek the attention of large multinational animal health companies keen to address replacements for their current antibiotic products, slowly being phased out as feed supplements. The company will review these opportunities as they arise.

Stirling has recently signed two Agreements as examples of how commercialisation of its R-salbutamol products will be implemented. The first is a distribution agreement with Afgri Limited for distribution rights in South Africa for use of R-salbutamol as a growth agent for livestock animals.  The second agreement is a joint venture with Equine HealthCare in Denmark (Pulmovet ApS).  Pulmovet will specialise in the development and commercialisation of applications of drug/device combinations for heaves and other equine respiratory disorders. 

For growth agents in other territories, Stirling will partner with established companies for customer distribution and will itself play the role of technical support, regulatory guidance and supplier of the initial product. 

Stirling has a material transfer agreement in place with Merial Animal Health to investigate the opportunity to maximise the delivery and hence the effects of R-salbutamol in the commercial production of sheep and cattle.

Similarly, Stirling will seek joint ventures or partnerships with established companies to develop potential products for companion animals and obesity.