IMUGENE LIMITED — Investor Presentation 2012

Sep 19, 2012

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Melbourne, 20 September 2012 : Australian biotechnology company Imugene (ASX: IMU) today detailed the specific drug targets it is pursuing centred on its newly acquired Linguet™ drug delivery technology. Consegna Group Limited (ASX:CGP) is a major shareholder of Imugene Limited, with a 29% holding.

Through the Linguet buccal (inside lining of the cheek) and sublingual (under the tongue) tablet technology, many drugs that are usually poorly absorbed or tolerated by oral administration can be delivered to the bloodstream more effectively. Most importantly, the key to the Linguet platform is that the amount and rate of drug to be delivered through the oral mucosa directly to the bloodstream can be precisely controlled.

“ Each new drug formulation is chosen to provide a solution to a current market opportunity and uses well characterised molecules that have known and proven regulatory routes”, described Dr Nicholas Ede, Imugene. “Our focus is on pushing early revenue generating products, rather than a traditional biotech platform technology that focuses on a single opportunity licensing deal far into the future. We are targeting pharmaceutical products that do not need significant clinical investment to gain regulatory approval. This ensures the most cost effective and most rapid path to market ”, he added.

The initial product development is for the treatment of Vitamin D deficiency, a therapeutic area that has seen rapid growth in sales over the past 5 years, and has become one of the fastest growing nutrients worldwide. According to Euromonitor data, US Vitamin D sales have grown from $141.1m in 2005 to $366.3m in 2009, with CARG growth expected to be 11.2 per cent in the US between 2009 and 2014.

Vitamin D deficiency has been linked to a wide range of conditions including pre-diabetes (metabolic syndrome), osteoporosis, cardiovascular health, Alzheimer’s and as reported recently in the peer-reviewed Journal of Clinical Endocrinology and Metabolism, there is a significant association of Vitamin D deficiency with the rate of progress of low-risk prostate cancer under active surveillance[1.]

The major source of Vitamin D for humans derives from sun exposure however this is not recommended due to the increased risk of skin cancer. Imugene’s UK-based scientist, Mr Steve Martin says, “ Due to changes in lifestyle and demographics, the UK has seen a significant increase in the attention of Vitamin D deficiency. The use of high factor sun creams also plays a significant role in decreasing the natural production of Vitamin D from the sun. With increased awareness, and more accurate assay methods, the level of Vitamin D deficiency and its role in a number of therapeutic areas, it has become more important to formulate effective treatments. In the first seven months of 2012, 100 new international clinical trials[2] on the use and impact of Vitamin D were registered ”.

Mr Martin continued, “ The Imugene Linguet product uses a specific form of Vitamin D which has been shown to be 5 times more effective in raising blood serum levels of Vitamin D than the usual colecalciferol form of the vitamin that has been traditionally used as a supplement .”

A key benefit of the Linguet technology is that it’s an oral delivery form with kinetics almost as fast as an injection (if desired). Hence it is particularly useful for drugs where an immediate effect from dosing such as for migraine, acute pain, allergic reactions, erectile dysfunction, acute seizures are desired.

In addition to Vitamin D, over the next 12 months a further four specific pharmaceutical product programs are scheduled for development. The target areas selected are Parkinson’s Disease (dopamine agonist), pain (a specific NSAID), men’s health (erectile dysfunction) and status epilepticus. The in-house knowledge and patent position on Linguet formulations incorporating NSAID’s is very strong and will be leveraged by the experience of the board and management team to develop and partner these new drug formulations.

The development program will use outsource partners to minimise internal overheads enabling maximum effort in generating products and early revenues. Importantly, an EU approved pharmaceutical manufacturer has been engaged to conduct formulation development and subsequent scale-up. Combined with leading EU-based CRO’s and specialist regulatory and ‘freedom to operate’ experts in the pharmaceutical space, Imugene is now initiating its fasttrack drug development program.

The Linguet pharmaceutical development plan is based on three pillars of time to market, risk and return. Our first specific formulation of Vitamin D has been selected based on our ability to bring it to market quickly (Q1 2014) and at very low cost by industry standards (less than A$500K), and is EU focused where the expertise of the development team resides. Generic pharmaceutical products focusing on Parkinson’s Disease and status epilepticus are planned for release later in 2014, also in the EU initially. The second and third pillars relate to launching products with progressively higher risk and clinical cost in the US and elsewhere, but with greater return on investment. These include pharmaceutical products targeting pain and erectile dysfunction.

Imugene Executive Chairman, Mr Fabio Pannuti concluded “ The Imugene plan is to bring our products to pharmacy shelves for sale as early as 2014. This means we will be negotiating with distributors next year. Speed to market is our main focus. The Linguet technology affords the user the speed to remedy almost instantaneously whatsoever situation they wish the active ingredient to treat, without side effects associated with oral medications. Curiously, when our scientists focused on speeding up the results that erectile dysfunction drugs could deliver on, compared to current offerings, it was clear that we would have no shortage of trial participants. ”

ENDS

For further information, please contact Consegna Group Limited on (03) 9417 5001.

About Consegna Group Limited

Consegna Group Limited’s purpose is to identify, acquire and commercialise late stage therapeutic delivery technologies. The Company targets high value markets and indications using an acquisition strategy driven by strategic value creation, patent protection and realisation criteria. The Company employs a low fixed overhead model with a panel of successful, best in field regulatory, intellectual property and scientific advisors.

About Imugene

Imugene Limited (ASX:IMU) is commercialising drug delivery applications in the licensed pharmaceutical space based on its novel buccal (inside lining of the cheek) and sub-lingual (under the tongue) Linguet™ technology. Linguet™ is a patient friendly and cost effective system used to deliver established pharmaceutical and nutraceutical products. Imugene also currently specialises in the development and commercialisation of novel animal health products for pigs and poultry. The range of products under development includes vaccines to prevent important livestock diseases and productivity enhancers to improve the economics of raising commercial livestock.

1. Vitamin D3 Supplementation at 4000 international units per day for one year results in a decrease of positive cores at repeat biopsy in subjects with low-risk prostate cancer under active surveillance. Marshall DT, et al J Clin Endocrinol Metab. 2012 Jul;97(7):2315-24.

2. Source WHO – International Clinical Registry