Melbourne, 21 November 2012: Australian infectious disease therapy development company BioDiem Ltd (ASX: BDM) announced
today the successful application for the grant of a key Japanese patent for the Company’s antimicrobial compound, BDM-I. This
signals the achievement of patent coverage for BDM-I in the world’s three largest patent jurisdictions.
BDM-I is active against a range of pathogenic micro-organisms including bacteria, fungi and protozoa. The new Japanese patent
provides protection around BDM-I as a treatment for vulvovaginitis, a general term for inflammation of the vulva or vagina.
Vulvovaginitis is commonly caused by infection from a range of different micro-organisms. It is one of the most common female
health complaints across all demographics.
Specifically, the patent covers BDM-I as an antimicrobial compound for vulvovaginitis caused by a number of bacterial, fungal and
parasitic agents such as Neisseria gonorrhoea, Candida albicans or Trichomonas vaginalis, respectively. C.albicans is one of the
most common causes of yeast infections and is commonly referred to as thrush. N.gonorrhoeae causes gonorrhoea, and T.vaginalis
is the most common sexually transmitted protozoan infection in industrialised countries. Infection with T.vaginalis has been
correlated with reproductive issues and increased susceptibility to a range of other health issues including infection with HIV.
BioDiem CEO Julie Phillips said: “We are pleased to secure yet another key patent for BDM-I. Japan is a major regulatory market
and successful granting of a Japanese patent is a milestone for BDM-I’s protection for this major indication across the world’s largest
patent jurisdictions. Along with our recently initiated research project with Griffith University exploring new variants of BDM-I with
enhanced commercial characteristics, this is a good progression of the BDM-I package.”
The rise in resistant infections has energised investment in novel antimicrobials. The market for anti-infectives was valued at US$53
billion in 2011 and is forecast to exceed $100 billion by 2015. The antifungals market was valued at US$9.4 billion in 2010 and
estimated to reach US$11.3 billion in 2014.
BioDiem has been actively accelerating its development of BDM-I through reputable partnerships such as with the United States
Army Medical Research Institute of Infectious Diseases (USAMRIID), the National Institutes of Health and the Queensland Institute
of Medical Research (QIMR), while retaining full commercial and intellectual property rights for the work conducted.
Currently BioDiem is progressing further validation of BDM-I’s antimicrobial activity through in vivo proof of concept testing in models
of target diseases including fungal, bacterial and parasitic models (schistosomiasis); conducting further studies to explore the scope
of BDM-I’s indications with expanded screening studies, and embarking on a new project in collaboration with Griffith University.
BioDiem continues to utilise NIAID1’s In Vitro Assessment and Antimicrobial Activity Service2. Depending on the results and NIAID
approval, BioDiem in the future may use NIAID’s Animal Models of Infectious Disease Service3
Patents for BDM-I have been granted in the US, Europe, China, Russia, Singapore, South Africa and Australia whereas National
Phase prosecution continues in other major markets. BioDiem has also filed additional divisional patents in Europe and the US for
to further evaluate BDM-I’s activity.
About BioDiem Ltd
BioDiem is an ASX-listed company based in Melbourne with an international focus on discovering, developing and commercialising
world-class research and technology targeting infectious diseases and related cancers. BioDiem’s core technologies include the Live
Attenuated Influenza Virus (LAIV), the SAVINE platform and the BDM-I antimicrobial compound.
The LAIV influenza vaccine is an intranasal vaccine to prevent infection from seasonal and pandemic influenza. The LAIV influenza
vaccine can be produced using both egg-based and cell-based manufacturing methods. The cell-based LAIV vaccine has completed
a Phase II clinical trial in Europe. The egg-based LAIV vaccine technology is licensed to the World Health Organization as part of the
Global Pandemic Influenza Action Plan to Increase Vaccine Supply.
The LAIV influenza vaccine is marketed as Nasovac™ in India by the Serum Institute of India, and has been licensed to China-based
Changchun BCHT Biotechnology Co. The LAIV vaccine was in-licensed from the Institute of Experimental Medicine in St Petersburg,
Russia where it has been used for over a decade in many millions of people - children, adults and the elderly. The LAIV is
administered by nasal spray and induces a rapid immune response in the mucosal lining of the nose and pharynx.
The LAIV is also being developed as a viral vector for making novel non-influenza vaccines for different diseases including cancers.
Viruses have the ability to generate proteins prolifically and can be programmed to produce disease-specific proteins. As part of a
vaccine, disease-specific proteins can help generate a beneficial immune response.
SAVINE (patented Scrambled Antigen Vaccine) is a platform technology for the design of antigens for incorporation into vaccines
targeting an immune response to a range of different diseases. SAVINE antigens are encoded as synthetic genes which, together
with a delivery technology such as BioDiem's LAIV-based vaccine vector technology, can be used to develop novel vaccines.
BioDiem is also developing BDM-E, a tetra peptide synthetic compound, as a treatment for ophthalmic disorders. The US Food &
Drug Administration (USFDA) has granted Orphan Drug designation to BDM-E for the treatment of retinitis pigmentosa, a serious
degenerative disease of the retina.
BioDiem’s research is ongoing in partnerships with internationally recognised laboratories and commercial groups.
BDM-I is a synthetic compound targeted at the treatment of serious human infections. BDM-I is in the preclinical stage with
outlicensing as the intended outcome. BDM-I is active against a range of pathogenic micro-organisms including gram-positive and
gram-negative bacteria, fungi and protozoa. Key patents have been granted in major markets around BDM-I’s antimicrobial activity.
BioDiem has benefited from work conducted by major research institutions in the United States that have undertaken R&D studies of
BDM-I at reduced cost to BioDiem. Other US patents cover BDM-I’s activity against Plasmodium falciparum, the protozoan (a type of
microorganism) responsible for causing the most commonly severe form of malaria, and Trichomonas vaginalis, the protozoan
responsible for causing a common sexually transmitted disease named trichomoniasis.
For additional information, please visit www.biodiem.com
Julie Phillips, Chief Executive Officer
Phone +61 3 9613 4100
Phone +61 3 8866 1224 / +61 422 557 107