anp enters negotiation on licensing proposal f

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29th June 2012
ANP Enters Negotiation on Licensing Proposal for ATL1103
? Licensing proposal received from international pharmaceutical company
? Follows extensive due diligence conducted on ATL1103
? Application for Phase II clinical trial of ATL1103 in acromegalic patients
on track for submission next month
Antisense Therapeutics Limited (ASX:ANP) wishes to advise that it has received a non-binding
licensing proposal from the international pharmaceutical company that has been conducting licensing
due diligence on ANP’s growth hormone receptor targeting drug ATL1103 and ANP will now enter
into licensing negotiations with this pharmaceutical company.
Any outcome to these discussions will be dependent on the progress of the commercial negotiations
and on what ANP considers to be in the best interests of shareholders and the ongoing development
of ATL1103.
The further development of ATL1103 is on track and ANP expects by next month to have finalised
the clinical trial protocol for the planned Phase II clinical trial of ATL1103 in acromegalic patients and
to be in a position to submit its application for approval to begin the Phase II clinical trial in Europe.
Further material updates in relation to the licensing and the ongoing development of ATL1103 will be
provided in due course.
ATL1103 is a second generation antisense drug designed to block growth hormone receptor (GHr) expression thereby
reducing levels of the hormone insulin-like growth factor-I (IGF-I) in the blood and is a potential treatment for diseases
associated with excessive growth hormone and IGF-I action. These diseases include acromegaly, an abnormal growth
disorder of organs, face, hands and feet, diabetic retinopathy, a common disease of the eye and a major cause of
blindness, diabetic nephropathy, a common disease of the kidney and major cause of kidney failure, and some forms of
cancer. Acromegalic patients are known to have significantly higher blood IGF-I levels than healthy individuals. Reduction of
these levels to normal is accepted by clinical authorities as the primary marker of an effective drug treatment for the
disease. GHr is a clinically validated target in the treatment of acromegaly. In the case of diabetic retinopathy, published
clinical studies have shown that treatments producing a reduction in IGF-I levels retarded the progression of the disease
and improve vision in patients. Scientific papers have been published on the suppression of blood IGF-I levels in mice
(Tachas et al., 2006, J Endocrinol 189, 147-54) and inhibition of retinopathy in a mouse retinopathy model (Wilkinson-
Berka et al., 2007, Molecular Vision 13, 1529- 38;) using an antisense drug to the GHr. ANP have also previously reported
that ATL1103 suppressed circulating levels of IGF-I in primates and that in a Phase I study, ATL1103 was assessed as being
safe and well tolerated, with a preliminary indication of activity including suppression of IGF-I. ATL1103 commercialisation
is covered by patents to at least 2024, with the potential for extensions up to 2029 in some countries and 2030 in the US.
Antisense Therapeutics Limited (ASX: ANP) is an Australian publicly listed biopharmaceutical drug discovery and
development company. Its mission is to create, develop and commercialise second generation antisense pharmaceuticals
for large unmet markets. ANP has 4 products in its development pipeline. ATL1102 (injection) has successfully completed a
Phase II efficacy and safety trial, significantly reducing the number of brain lesions in patients with multiple sclerosis.
ATL1103 is a second-generation antisense drug designed to block GHr production and thereby lower blood IGF-I levels and
is in clinical development as a potential treatment for growth and other GH-IGF-I disorders. ATL1102 (inhaled) is at the
pre-clinical research stage as a potential treatment for asthma. ATL1101 is a second-generation antisense drug at the preclinical
stage being investigated as a potential treatment for prostate cancer.