media release hda devices

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COMMERCIAL OPPORTUNITY OF HDA DRUG DELIVERY PLATFORM
FOR IMMEDIATE RELEASE
22 October 2009
Australian healthcare company Stirling Products Limited (ASX:STI) following extensive inquiry with regard to its HDA technology and in regard to its bullet-point statement in its release earlier today “Unprecedented multi-billion revenue potential for drug delivery of off-patent blockbuster drugs through potentially improved safety profiles” advises as follows:
There are many types of nebulisation and inhalation devices on the market today. The Company is not aware of any or any other technology that has the capability of delivery for multiple individual drugs in essentially a concentrated atomised liquid form of sub-5 micron particles. Further, as the actual delivery of the HDA technology devices through its piezo generated kinetic energy is regulated to the actual patient breathing, then the administration of any drug becomes far more user friendly and efficient. This would particularly be the case for young children and the elderly – a further market opportunity that will be addressed in the future.
Initial validation and independent testing of drug administration using prototype demonstration devices has shown this High Density Aerosol (“HDA”) technology to be highly efficient and effective in delivering drugs via inhalation. The major benefit of drug administration through the HDA technology is that it promises to provide the same efficacy as drugs taken orally, with far less active drug content which, subject to formal trial validation, should therefore increase drug safety and substantially lessen any side effects.
As advised within the earlier release today - The HDA technology offers a significant opportunity for the Stirling Products joint venture to target a multi-billion revenue market as it leverages its new technology to improve the safety profile of and thereby exclusively use this safer profile of some of the world’s major drugs as they come off patent. This is particularly relevant as in the five year period from 2007 to 2012 over 36 major drugs will come off patent which is expected to lower yearly product sales of the major pharmas in the US by around US$67 billion, and more than double this amount globally.
For further clarification, the Company’s immediate focus and objective is to produce a limited number of pre-production HDA devices within the next 12 months which will then be used in preliminary equivalency, efficacy, safety and performance trials in order to establish the improved safety profile of the use of the HDA inhalation devices. These trials are fully expected to confirm the preliminary but limited trials performed to date using the original proto-type devices.
ABN 32 077 105 429
Level 1, 275 George Street, Sydney, NSW Australia
Tel: +61 2 9299 9270 Fax: +61 2 9299 9276
The Company’s HDA technology has potential application to many of the world’s leading drugs that are either recently off-patent protection or especially in the period to 2012, coming off patent protection. Around 30-40 of these drugs, under patent protection either have or have had global sales of within the US$2 – 15 Billion each per annum. For example the global market for just the respiratory disease products is around US$22 Billion with the majority of products either recently or soon being off patent.
As products go off patent they are then essentially in a free-for-all generic market and generally their respective price to market substantially decreases. It is within this market that the Company has its unique and unprecedented opportunity. As, to date there have been no regulatory trials of product using the HDA technology platform, the Company advises that its opportunity is subject to the establishment of at least equivalency regulatory approvals, but will be seeking to achieve efficacy equivalent with improved safety profiles.
In the example of the US$22 Billion respiratory disease market above, the conservative potential of the HDA technology was assessed at 3% of the market – US$660 Million per annum. This assessment was included in a comprehensive Market Evaluation Report prepared for Sheiman Ultrasonic Research Foundation and formed part of the Company’s due diligence review of the HDA opportunity. Similar market and revenue opportunities exist within other disease sectors of the market.
Overall, the HDA device technology is extensively patent protected with a suite of existing issued patents. The technology is fully proven and market ready. The HDA technology inhalation devices are not intended to be licensed out but rather to be developed as a preferred delivery mechanism aimed for use by the Company’s future pre-packaged generic drugs which in general would be contract manufactured. Importantly, the approval of any use of any prescription drug through the future HDA devices is subject to validation by regulatory trials where in the least equivalency would be required to be established but optimally improved safety. It should be noted however that these trials in many cases are expected to be of relative short duration and cost.
ABN 32 077 105 429
Level 1, 275 George Street, Sydney, NSW Australia
Tel: +61 2 9299 9270 Fax: +61 2 9299 9276
For further information see www.stirlingproducts.net or contact:
Peter Boonen
Managing Director
Stirling Products Limited
Ph: +61 2 9299 9270
E: [email protected]
For all Investor Relations inquiries please contact:
James Moses
Mandate Corporate
Ph: +61 420 991 574
E: [email protected]