Poultry Productivity Enhancer

Introduction

Imugene is developing a cytokine-based productivity enhancer (or immune system booster) delivered by the Adenoviral Delivery Vector. The vaccine enhances poultry growth and weight gain together with improved feed conversion rates.

When administered, a harmless adenovirus infection results in the production of a natural component of the immune system, a cytokine known as gamma interferon. Gamma interferon acts to boost the immune system resulting in increased resistance to a range of bacterial and viral infections (antibiotics in feed can only be used to treat bacterial infections and have no effect on viral infections). Increased protection against these infections improves growth rates, reduces mortality and improves feed conversion ratios, thereby reducing the cost of production.

The Poultry Productivity Enhancer vaccine, sub-licenced for global sales to Merial, has completed all pre-regulatory trials. In excess of 48 billion chickens are produced globally each year with most produced at intensively farmed operations. The Poultry Productivity Enhancer, due to its unique qualities and low cost of production, will be marketed to this global poultry market.

Current Status

Imugene’s most advanced product, the Poultry Productivity Enhancer, has passed through several major milestones in its progress toward global commercialisation:

  1. Intellectual property – granted for the FAV vector in the US, Canada, Japan, Australia, New Zealand and allowed in Europe.
  2. Commercial – finalisation of the Imugene sublicense in October 2005 granting Merial exclusive global rights to sell and distribute the Poultry Productivity Enhancer in return for a series of milestone licensing fees and royalty income on product sales.
  3. Regulatory
    1. Finalisation of regulatory dossier for the initial Australian regulator – the ‘OGTR’. Following their review of this dossier, the OGTR granted Imugene a licence to undertake the intentional release safety trial of the Poultry Productivity Enhancer outside of the laboratory.
    2. An additional regulatory success was achieved with the receipt of a permit from the APVMA (Australian regulator of animal health products) to also conduct these trials. Successful completion of further safety trials.
    3. Documentation is under preparation to begin the regulatory approval process in the US for the platform FAV technology.
  4. Product Optimisation – product development, being dose, timing, best method of manufacture and safety data, is being undertaken by the Merial product development team.

Merial Sub-License Deal for the Poultry Productivity Enhancer Vaccine

In October 2005 Imugene and Merial finalised the arrangements for the exclusive sub-license agreement which granted Merial the global rights to develop and sell Imugene’s PPE.

Merial is a world leading animal health company and is the joint venture between Merck & Co. and sanofi-aventis. Merial is the widely recognised leader in poultry disease management. Merial provides a comprehensive range of products to enhance the health, well-being and performance of a wide range of animals. Merial employs approximately 5,000 people and operates in more than 150 countries worldwide. Its 2007 sales were in excess of $US2.2 billion. Further information is available on the Merial website.

While the details of the license agreement are confidential, Imugene has earned sign up fees and a milestone payments based on the product development process. Royalty payments on product sales will be received by Imugene following successful commercialisation. The agreement includes agreed minimum performance requirements and timelines. The license grants Merial the right to use the Fowl Adenovirus Delivery Vector only for this poultry product and Imugene retains the rights to develop other products from the platform technology.

The Competitive Advantages Over Antibiotics and Other Treatments

In addition to the weight gains and improvement in food conversion ratios, Imugene’s Poultry Productivity Enhancer also delivers significant benefits over antibiotics and antimicrobial chemicals.

As the necessary regulatory approvals are obtained, the Poultry Productivity Enhancer vaccine will be sold across global poultry markets for use both with in-feed antibiotics and following their withdrawal. The product is ideally positioned to move into this expanding market.

Trial Results

Trials have demonstrated significant productivity improvement results:

Summary of results – Double Blinded 900 bird trial

Trial Group FCR FCR improvement Mean Weight
grams
Weight Improvement
(Control)
Weight Improvement
(Ross Index)
Imugene Poultry Productivity Enhancer with antibiotics in feed 1.558 11.73 2,627 13.75 15.6
Imugene Poultry Productivity Enhancer with antibiotic-free feed 1.608 8.90 2,601 12.64 14.5
Control (antibiotics in feed only) 1.716 2.78 2,309 N/A 1.6
Industry best practice(Ross Index) 1.765 N/A 2,272 N/A N/A

Table Index

FCR means Food Conversion Ratio. The ratio is calculated from the amount of food required to produce 1kg weight gain. The less feed required to produce 1kg of chicken meat the more efficient and profitable the production system.

FCR Improvement means the improvement in the FCR compared with the Ross Index, expressed as a percentage.

Mean Weight means the average weight per bird in each group of 50 birds and expressed in grams.

Weight Improvement (Control) means the percentage weight improvement compared with the Control Group (no Poultry Productivity Enhancer, with antibiotics in feed).

Weight Improvement (Ross Index) means the percentage weight improvement compared with the industry best practice Ross Index (with antibiotics in feed).