Two in One BRD Vaccine Commercialisation Plan

Summary

The Bovine Respiratory Disease Complex (BRDC) is the most significant infectious disease within Australian feedlots with an estimated annual cost to the industry of A$50m. Based on this, Meat & Livestock Australia Limited (MLA) funded two projects that were implemented by the Queensland Department of Employment, Economic Development and Innovation (DEEDI) that were focused on developing a live viral vaccine targeted at key components of BRDC.
The four viruses associated with BRDC are bovine herpesvirus 1 (BoHV-1), bovine viral diarrhoea virus (BVDV or bovine pestivirus), bovine parainfluenza 3 virus (PI3) and bovine respiratory syncytial virus (RSV).  BRDC is also associated with three bacterial species, Pasteurella multocida, Mannheimia haemolytica and Haemophilus somnus.
MLA and DEEDI have developed a platform technology that, with further R&D, will enable the creation of a vaccine that covers many of the pathogens associated with BRDC. The proposed patent application for the technology will encompass the development of such vaccines. The application should also provide patent protection for the development of similar vaccines for other countries that are exposed to different strains of BoHV to those found in Australia.
Rudco Pty Ltd was engaged to:Gainan understanding of this technology and its limitations to adoption.
Review the patentability search and work with partners and patent attorney to identify any background IP which needs to be considered in commercialisation.
Consult with partners to understand the technology and draft a short commercialisation plan based around preferential adoption in Australia, including: a review of the technology and related IP space, competitor analysis, SWOT, estimated timelines to adoption and a list of  potential licensees.
Develop basic promotional material for use in promoting technology to potential licensees (eg: one page pamphlet and presentation).

Information included in this report has been obtained from scientific and management personnel from MLA and DEEDI as well as from the patent attorney firm, Davies Collison Cave. As this is an internal report to inform management decisions these information sources have not been referenced.
Based on an assessment of the prior art searches conducted by the patent attorney, the technology appears to be patentable and there are no patents that could impede commercialisation of the IP in Australia (assuming a standard vaccine is commercialised).
The focus of this Commercialisation Plan is on a two-in-one vaccine (TIOV) that was created using the platform technology and for which trials have been conducted. The TIOV targets the major viruses associated with BRDC, being BoHV-1 and BVDV. The proposed strategy, however, takes into account the commercial potential of the platform including:

1)            License the platform technology for a BoHV-1 and BVDV TIOV for the Australian market

2)            License the platform technology for a BoHV-1 and BVDV TIOV for other jurisdictions

3)            Establish a R&D program focused on extension of the platform technology. This could include:

a.            Creation of a BoHV-1 and BVDV two-in-one vaccine for the USA/European market using BoHV-1 strains found in those markets.

b.            The development of 3 in 1, 4 in 1 or 5 in 1 vaccines for Australian and overseas markets.

c.            The development of vaccines that have markers that will enable their use in the broader cattle market, potentially extending beyond feedlot cattle.

d.            Assess the potential to create ovine vaccines using the platform technology.

The TIOV is a genetically modified live vaccine that has a single dose intranasal delivery method that is administered at induction into a feedlot. The vaccine will be distributed as a freeze dried formulation and no issues are envisaged with production scale-up.
Trials conducted in Australia have demonstrated:

•             The vaccine cannot infect humans.

•             The vaccine is effective against BoHV-1.

•             The vaccine does not affect cattle that have pre-existing immunity to BoHV-1.

•             There are no negative effects from the vaccine from repeated passage through multiple animals.

•             The vaccine is safe for the vaccination of cattle even if delivered at ten times the recommended dose rate.

•             The vaccine becomes inactive upon exposure to environment so does not contaminate.

Further information is available on request.  This report contains commercial and confidential information.
Interest for investment and/or licensing the technology is welcomed.
The related research and discussions with potential licensees is ongoing.