BioDiem Ltd.
BioDiem is an Australian biopharmaceutical company that is focused on developing and commercialising vaccines and infectious disease therapies. Our business model is to generate income from partnerships including with other vaccine and infectious disease treatment companies through existing and new licences to its LAIV vaccine and other technologies. We have an established influenza vaccine licensing business. Our revenue comes from licence fees and royalties on sales. Our lead asset, the LAIV (Live Attenuated Influenza Virus) vaccine technology, is used for production of seasonal and pandemic influenza vaccines and is given intranasally. This technology is licensed currently to two commercial partners, in India and China, and is licenced to the World Health Organisation as part of the Global Pandemic Influenza Action Plan to Increase Vaccine Supply.
Company details
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- Business Type:
- Manufacturer
- Industry Type:
- Pharmaceuticals
- Market Focus:
- Globally (various continents)
About Us
Nasovac-S™ is based on BioDiem’s technology and is already marketed in India; our licencee in China received marketing approval for their LAIV vaccine in February 2020.
Our antimicrobial in development, BDM-I, is a synthetic compound targeting the treatment of infections, including antibiotic-resistant infections. BDM-I is active against a range of disease-causing microbes. Key patents have been granted worldwide. BioDiem has benefited from work conducted by major research institutions in the United States that have undertaken studies of BDM-I. BDM-I is in the preclinical stage of development and is being commercialised through our subsidiary, Opal Biosciences Ltd (www.opalbiosciences.com). Opal Biosciences seeks investment to develop its antimicrobial products.
Vaccine licensing
Our lead product is the Live Attenuated Influenza Virus (LAIV) technology, which has been used to develop a novel intranasal vaccine for the prevention of seasonal and pandemic influenza. The technology is licensed to BioDiem by the Institute of Experimental Medicine (IEM) in St Petersburg, Russia.
Egg-based production: The version of the LAIV vaccine that uses chicken eggs for production is licensed to the World Health Organization for use in developing countries as part of the Global Pandemic Influenza Action Plan to Increase Vaccine Supply. This allows governmental and non-governmental organisations or private companies in those territories to produce seasonal and pandemic vaccines using eggs. In 2014 the egg-manufactured LAIV vaccine was launched in India as Nasovac-S™ for protection against seasonal influenza. Marketing approval was granted in China in February 2020. The LAIV technology is currently available for licence from BioDiem for additional markets.
Cell-based production: A version of the vaccine which can be grown in tissue culture has completed first-in-human and proof-of-concept clinical trials in Europe as part of development for European registration. This technology is currently available for licence from BioDiem.
To request further information on the LAIV technology, please contact info@biodiem.com.
Development of the antimicrobial BDM-I
The continued rise in antibiotic-resistant strains of bacteria such as MRSA, tuberculosis and gonorrhoea, and the increasing problem of clinical fungal infections, has led to significant interest in compounds which may address the lack of treatment options.
BDM-I is a novel compound which has shown impressive activity in screening studies against a range of pathogenic micro-organisms including vancomycin-resistant Staph aureus and Neisseria gonorrhoea, as well as a selection of pathogenic fungi including Scedosporium spp. BDM-I is being developed in BioDiem’s subsidiary, Opal Biosciences. For more information see http://www.opalbiosciences.com
Technology and Products
BioDiem is an Australian-based biotechnology company with a focus on developing and commercialising vaccine and infectious disease therapies.
The strength of our global partnering network is a key advantage of the Company. Our partners (the World Health Organisation and the US National Institutes of Health among others) are world-leading institutions that have in some cases facilitated our access to major markets (e.g. China and India).
Our strategy is to grow a diverse infectious disease treatment and prevention portfolio.
We currently earn revenue through licensing of LAIV influenza vaccine technology to Indian and Chinese partners.
In parallel to our LAIV technology commercialisation, our subsidiary, Opal Biosciences Ltd, is developing BDM-I, our novel antimicrobial compound which has shown impressive activity in screening studies against a range of pathogenic microbes. Opal-T, in development for the treatment of infections of the skin, has shown activity in vitro against methicillin-resistant Staph aureus (MRSA) and Neisseria gonorrhoea. The continued rise in antibiotic-resistant strains of bacteria such as the deadly MRSA, and the increasing problem of clinical fungal infections, have led to significant interest in compounds which may address the lack of treatment options. Patents for BDM-I have been granted worldwide.
About Our Disease Targets
We use our in-house expertise in development of therapeutics and in infectious disease plus our extensive partnership network to identify the best cost-effective commercial opportunities for portfolio value growth.
The focus on infectious diseases is timely. The worldwide anti-infectives market is projected to reach an astounding US$111 billion by 2024. Anti-infectives include antivirals, antifungals and antibacterials .
BioDiem’s development work currently focuses on the following key disease targets:
- Influenza
- Antibiotic-resistant infections
- Sexually transmitted infections (STIs)
- Serious bacterial infections
- Invasive fungal infections
Partner Network
- Institute of Experimental Medicine (IEM), St. Petersburg, Russia
- World Health Organization
- Program for Appropriate Technology in Health (PATH) Program
- Centers for Disease Control and Prevention (CDC)
- Commercial partners and contract research organisations
- Australian and US research institutions
The Institute of Experimental Medicine achieved international prominence early in the 20th century, when Nobel Prize winner Pavlov worked with dogs to establish the central nervous system basis of conditioned reflexes. The IEM has developed a broad-based research capacity in many areas of biology and medicine.
In 1956 the IEM’s Department of Virology, under Academician Anatoly Smorodintsev, developed live vaccines against polio and in 1959 against measles. These vaccines and derivatives of them were used throughout Russia. After years of research in these and other areas of viral infection the Department turned its attention to influenza. They were able to develop an attenuated i.e. weakened form of the influenza virus which would serve as the basis for a safe, live influenza vaccine.
In 2001 the IEM entered into a Commercialisation Agreement with BioDiem Ltd, whereby worldwide rights (outside of Russia and the CIS) to the proprietary LAIV technology were granted to BioDiem in exchange for a royalty payment.
Prof Larisa Rudenko, the Head of the Dept of Virology at the IEM is a director of BioDiem. Prof Rudenko is a world expert in live attenuated influenza vaccine technology working closely with the CDC and WHO and other world-recognised influenza groups.
World Health OrganizationBioDiem contributes to the WHO’s Global Pandemic Influenza Action Plan by licensing the WHO to transfer an egg-based live attenuated influenza virus (LAIV) vaccine production technology to developing country manufacturers.
The agreement is a non-exclusive licence designed to support wider distribution of the LAIV influenza vaccine in developing countries. Whereas public sector usage is royalty-free, royalties flow to BioDiem from private sector sales. BioDiem has authorised the Institute of Experimental Medicine (IEM) and the Centers for Disease Control and prevention (CDC) to supply LAIV reassortants to the WHO for use by its sublicencees. The vaccines developed through the WHO program are manufactured using eggs. WHO has issued sublicences to the LAIV technology to three entities: the Serum Institute of India (SII), the Government Pharmaceutical Organization in Thailand (GPO), and Changchun BCHT Biotechnology Co. in China (BCHT).
In 2014 the Serum Institute of India launched its seasonal influenza vaccine, called Nasovac-S™, in India. This vaccine is a result of the WHO collaboration using BioDiem’s technology and follows on from the SII launch of Nasovac for swine flu prevention in 2010. BioDiem receives royalty payments on sales of vaccines in the private market.
Facilitated by a grant from the WHO, work has been completed on a new laboratory fit-out at the Institute of Experimental Medicine to allow the Institute to handle highly pathogenic influenza (HPAI) strains e.g. H5N1 (avian or bird flu). Any material generated will be made available for use in developing countries under the World Health Organization’s Global Pandemic Influenza Action Plan to Increase Vaccine Supply.
Program for Appropriate Technology in Health (PATH) ProgramIn August 2009 the Institute of Experimental Medicine (IEM), the originator of BioDiem’s Live Attenuated Influenza Virus (LAIV) technology, entered into a development and collaboration agreement with the PATH, an international non-profit organization to develop prototype pandemic LAIVs for use in developing countries. The aim of this collaboration is to speed the development of live attenuated influenza vaccines that can be a safe, low-cost, and highly effective method for enabling real-time response against an influenza pandemic which is likely to hit developing countries hardest.
This agreement has seen preclinical and clinical study use of BioDiem’s cold-adapted master donor LAIV virus bearing avian or human influenza virus genes from viruses with pandemic potential. PATH has provided financial and technical support to the Institute of Experimental Medicine and third party contractors to complete this important public health work.
PATH has also sponsored large clinical trials of LAIV in young children to assess safety and efficacy.
Centers for Disease Control and Prevention (CDC)The aim of the Cooperative Research and Development Agreement (CRADA) between BioDiem and the US Center for Disease Control and Prevention (CDC) was to develop a vaccine candidate against the H5N1 avian influenza based on BioDiem’s technology. Preclinical studies to assess the infectivity, immunogenicity and protective efficacy of the H5N1 LAIV versus the standard inactivated influenza vaccine have been successfully completed. The results support the value of the LAIV vaccine technology in protection against the H5N1 virus. In particular it was demonstrated that the cell-based manufacturing method, which allows rapid scale up in the case of a pandemic, produced successful results and that the LAIV vaccine provided greater cross-protection against variants of the H5N1 virus than the inactivated vaccine. This feature could be extremely advantageous in the event of an avian flu outbreak. Also in such a situation, access to chicken eggs could be compromised and so the ability to manufacture flu vaccine rapidly in mammalian cells would give an advantage. Previous published work has demonstrated the efficacy of cell-produced LAIV vaccine vs. egg-produced vaccine in ferret studies.
Commercial partnersMore information about BioDiem’s commercial flu vaccine partners, the Serum Institute of India (India), and Changchun BCHT Biotechnology Co. (China) can be found on our LAIV webpage.
Australian research institutionsBioDiem has strong ties to the world-class research institutions of Australia, which have assisted in the research and development of BioDiem’s portfolio. These partners include:
Licensing Strategy and Available Licenses
BioDiem welcomes inquiries from potential partners on the licensing and collaboration opportunities available. BioDiem has world-class in-house expertise in the areas of vaccines and infectious disease therapy development. The Company also has an existing partnering network that spans the globe, which has provided access to top research facilities in the development of its asset portfolio.