Immuron Ltd — Regulatory Filings 2011

Nov 6, 2011

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IMMURON SUBMITS INVESTIGATIONAL NEW DRUG APPLICATION FOR FATTY LIVER DISEASE AND NASH WITH US FDA

 Promising ea r ly results le a d to Phase 2 b trial

 Unmet medical need for life-t h reatening d i sease with n o approved treatment  Significant market pote n tial related t o metabolic diseases, in c luding diab e tes and ob e sity  Early di s cussions underway with potential global licensee s

Melbourne, Australia, 7 November 2011 : Immuron Limited (AS X : IMC) has s ubmitted a n app l ication for a n Investigati o nal New Dr u g (IND) for its proprietar y IMM-124E fatty liver dis e ase product candidate with the US F o od and Dru g Administra t ion (FDA). T his follows a n enc o uraging pre-IND meetin g with the F D A earlier thi s year.

IM M -124E is a p otential new treatment o f fatty liver di s ease, in pa r ticular Non- A lcoholic Ste a tohepatitis (NASH). It c o uld enter a m arket that h as no existi n g approved competitors wor t h an estima t ed US$4.4 b illion per an n um in the US alone. Based on the d ata generat e d to dat e the unique n ess of IMM-124E is bot h in its high s a fety profile a nd its abilit y to elicit a re s ponse in m a ny fatty liver/NASH par a meters incl u ding insulin resistance a n d elevated ser u m cholester o l.

Im m uron intend s to proceed with a Phas e 2b clinical t rial to furthe r test the saf e ty and effic a cy of I M M-124E. The Phase 2 b trial has be e n designed by Immuron in conjuncti o n with Principal Inv e stigator Pro f essor Arun S anyal, imm e diate past P resident of t h e American Association for the S tudy of Liv e r Diseases ( AASLD). Th e trial will be a dose ranging placebo controlled, dou b le blind multi-centre stu d y in NASH p atients rec e iving 6 months of active t reatment inv o lving sites in Australia, t h e US and Is r ael.

Im m uron Chief E xecutive Mr Joe Baini s a id, “This is a key milesto n e for Immu r on but is ev e n mor e important f or the millio n s of patient s suffering fr o m NASH as it remains o ne of few lif e thre a tening dise a ses without any approv e d treatment.”

“Along with the s trong sales g rowth of Tr a velan[®] , this further reinf o rces our str a tegy of acc e lerating to m arket more of our oral i m munothera p ies. IMM-124E represen t s a highly pro s pective commercial opp o rtunity and t he IND is c e ntral to our p rogress wit h licensing partners.”

Contact Joe Baini – Chief Executive O fficer Rudi Mi c helson +61 3 8637 110 7 Monsoon Communi c ations +61 3 9 6 20 3333 0411 4 0 2 737

About Immuron Limited

Imm u ron is a bioph a rmaceutical c o mpany focuse d on oral immunotherapy trea t ments using d a iry-derived an t ibody prod u cts for human s . Immuron is u niquely positioned with a ver s atile technology platform cap a ble of generating a wide range of prod u cts with a high safety profile. This high safe t y profile make s it possible to c omplete pre-clinical studies relatively q u ickly and incre a ses the prosp e ct that the clinical developm e nt of Immuron’ s products will be expedited. Immuro n ’s current pro d ucts and prod u ct candidates t arget infectiou s diseases of t h e gastrointestinal tract , chronic disea s es such as fat t y liver (NASH) , and the prevention of influen z a. Immuron h as one produc t in the m arket, Travela n , for preventing travellers’ di a rrhoea. Imm u ron’s main sci e ntific alliance s are with Had a ssah Medical C enter (Israel), the University o f Melbourne and Mon a sh University ( Australia).

About Fatty Liver & NASH

Non-alcoholic Steatohepatitis (NASH) is a chronic disorder of the liver, also known as fatty liver disease. It is associated with type 2 diabetes, excessive amounts o fat in liver cells and abnormal liver function. NASH is more prevalent in the obese population and is an independent risk factor for the development of metabolic syndrome and cardiovascular complications. The increase in obesity worldwide is likely to raise the incidence of NASH with the associated outcomes of liver failure and cardiovascular disease. The United States National Centre for Infection Control has predicted that by 2025, 25 million Americans will suffer from NASH, with very few current treatment options. At present approximately 5% of Americans are affected, with similar rates in Australia. Health authorities around the world are already overburdened with the results of metabolic syndrome such as obesity, liver disease, type 2 diabetes and hyperlipidemia (excess lipids such as cholesterol in the blood stream). It is estimated that between 10 and 20% of population have fatty liver, with an estimated 75% of obese individuals being at risk of developing fatty liver. Non-alcoholic fatty liver disease is the most prevalent liver disease in the Unites States, with more than 24 million people currently diagnosed and the prevalence expected to grow. The market size for a drug indicated for fatty liver has been estimated to be around US$4.4 billion in the USA alone, with the NASH market comprising more than one third of these anticipated sales.