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IMUGENE LIMITED — Interim / Quarterly Report 2013
Feb 27, 2013
65124_rns_2013-02-27_8410c462-66cc-4d60-bb1e-fa059a196029.pdf
Interim / Quarterly Report
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Half
Year Financial Results
Highlights
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Solid progress on first drug in development using Linguet technology platform – a specialised Vitamin D target – with initial formulation development completed
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UK regulatory filing targeted for 1H 2014
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Board and management restructured
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Management focus is on creating value and generating early revenues from the Linguet drug delivery platform
Melbourne, 28 February 2013 : Imugene (ASX.IMU) has today released its half year financial results for the six months ended 31 December 2012.
Imugene’s strategy is to focus on the development of a class of drugs known as super generics – which involves taking an off-patent drug and improving its effectiveness by applying a drug delivery technology, thereby achieving product differentiation and premium pricing. Imugene selects drug candidates where its technology can make improvements to the drug’s performance, which also addresses an unmet market need and delivers commercial benefits.
Over the past six months Imugene has completed feasibility testing and initial formulation development of its first target, a novel dosage form of Vitamin D, which is designed to rapidly address Vitamin D deficiency.
The Linguet drug delivery technology, enables the drug to be delivered via the buccal mucosa, that is, the drug is absorbed through the lining of the cheek directly into the bloodstream and avoids passing through the liver or gastro-intestinal tract.
“Vitamin D is an ideal first target to showcase our business model: it addresses a growing market need, there’s limitations to the current treatments, and with few novel dosage forms in development – an innovative product that offers distinct advantages is highly sought after,” said Dr Nicholas Ede, Executive Director of Imugene.
“Vitamin D also has a streamlined path to market, and we are on track to file for regulatory approval in the UK in 2014 and aim to be generating early revenues from licensing.”
Vitamin D deficiency is a major public health concern, and affects 31% of all Australian adults – and more than 1 billion people worldwide - and is associated with a wide range of conditions including pre-diabetes, osteoporosis, cardiovascular health and prostate cancer.
Current oral Vitamin D supplements are absorbed through the gastro-intestinal tract erratically and lead to transient surges of Vitamin D in the blood stream, limiting the effectiveness of the treatment. In contrast, Imugene’s Vitamin D formulation is designed to
be absorbed directly into the blood stream to deliver a controlled dose which can restore circulating Vitamin D levels more rapidly, effectively and safely.
Imugene’s high and low dose formulations of Vitamin D have now advanced through initial formulation development, and long-term stability studies and laboratory testing for the transport of the molecule across the buccal mucosa is now underway. These tests are due for completion by Q4 2013. A bioequivalence clinical study will be conducted in parallel, before projected regulatory filing in the UK 1H 2014.
In February 2013, Imugene announced changes to its Board and management, specifically the appointment of Dr Nicholas Ede as an Executive Director and Mr Steve Harris as NonExecutive Chairman. The Company’s focus is on minimising cash burn, including reducing internal overhead by outsourcing to specialised professionals, and is aiming to generate early revenues from the Linguet drug delivery platform
Imugene finished the half year ended 31 December 2012 with $747,470 in cash reserves. The Company reported revenues of $14,871 and a net loss of $1,235,999 after expensing all research and development costs (see attached report).
For more information please visit www.imugene.com .
Ends
For enquiries please contact:
Dr Nicholas Ede, Imugene, +61 (0)400 642 254 or email [email protected]
Kyahn Williamson, Buchan Consulting +61 3 9866 4722 or email [email protected]
About Imugene
Imugene Limited (ASX:IMU) is commercialising drug delivery applications for the super generics market based on its novel buccal (drugs administered via the cheek) Linguet™ technology. Linguet™ is a patient friendly and cost effective system used to deliver established pharmaceutical and nutraceutical products.