Regulatory Filings • May 9, 2012
Regulatory Filings
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Press release
BIODIEM LTD ABN 20 096 845 993
Level 10, South Tower, 459 Collins Street, Melbourne, Victoria, 3000 Australia
Phone +61 3 9613 4100 Fax +61 3 9613 4111 Email: [email protected] Web: www.biodiem.com
Reuters: VLS.PA – 6, Rue Alain Bombard 44800 Saint-Herblain Bloomberg: VLS FP Herblain
France
Phone +33 2 28 07 37 10 Fax +33 2 28 07 37 11 Email: [email protected] Web: www.vivalis.com
Melbourne (Australia), Nantes, Lyon BioDiem Ltd (ASX: BDM) today announced that it has begun a research collaboration with France VIVALIS (Euronext code: VLS), a biopharmaceutical company with expertise in vaccine production technologies. The collaboration involves investigation of the synerg and VIVALIS' proprietary cell line, EB66 for a new agreement between the companies in order to test the feasibility of development of BioDiem's LA as a vector in VIVALIS' proprietary cell line. Viral vector technology is used in vaccines to deliver immune stimulating proteins into the body. VIVALIS is undertaking this initial research to further the high potential value of this technology in BioDiem's non , Lyon (France) 9 May 2012: Australian vaccine development company Euronext synergy of BioDiem's proprietary virus, LAIV, ® . Successful results from this investigation could be used as a basis em's non-influenza vaccine applications. France-based y LAIV immune-
BioDiem has considerable in-house expertise around the Live Attenuated Influenza Virus (LAIV), having an existing LAIV-based technology for the production of influenza vaccines, currently generating licensing revenues in India and China. BioDiem has proposed developing the LAIV as a versatile 'vector' (carrier) technology, which could be used to create a variety of new vaccines (both therapeutic and preventative). This proposed vector would be developed to have the toxicity (as the virus backbone is already weakened), excellent virus characterisation from extensive prior work, and the ability to be customised to target particular diseases. house based ues additional advantages of a good safety profile and low
This initial collaboration involves VIVALIS confirming that BioDiem's LAIV strains grow satisfactorily in VIVALIS' proprietary cell line EB66® BioDiem's long-term collaborator, and LAIV developer, the In Petersburg, will send an LAIV expert to work on tion and examining any effects on the virus' characteristics. During this stage term Institute of Experimental Medicine in St on-site with VIVALIS in France.
This initial program is estimated to take up to ten weeks. Following successful demonstrations of growth and productivity, BioDiem will look to negotiate another agreement with VIVALIS regarding a longer research project aimed at developing a stable LAIV vector technology incorporating EB66 platform for growth. ok stitute longer-term ® as a base VIVALIS is an ideal vaccine development partner, with a strong commercial mindset, a history of successful partnerships and great technology in the internationally established EB66® cell line. We are excited to be beginning this collaboration and moving forward on the LAIV vector project" said BioDiem Chief Executive Officer, Julie Phillips.
Franck Grimaud, CEO, and Majid Mehtali, CSO, co-managers of VIVALIS jointly stated, "Advancing the EB66® platform into novel areas is an objective we have maintained from the initial launch of the platform. This agreement with BioDiem, the second EB66® agreement since January 1st, continues these objectives by moving our EB66® technology into applications like those being developed by BioDiem in the therapeutic and preventative vaccine fields. We look forward to working with BioDiem in this program and the possibility of expanding our relationship into a process development, a future commercial license and biomanufacturing agreement as we both advance the field of vaccine design and development."
Terms of the agreement were not disclosed.
BioDiem is an ASX-listed company based in Melbourne with an international focus on discovering, developing and commercialising world-class research and technology for vaccines. BioDiem's lead technology is the Live Attenuated Influenza Virus (LAIV) technology, which has been developed as an intranasal vaccine to prevent infection from seasonal and pandemic influenza.
The LAIV influenza vaccine can be produced using egg-based and cell-based manufacturing methods.
The cell-based LAIV vaccine has completed a Proof of Concept (Phase II) clinical trial. 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. This allows governmental and non-governmental organizations or private companies in developing countries to produce seasonal and pandemic vaccines in eggs. The LAIV influenza vaccine is marketed as Nasovac™ in India by the Serum Institute of India. The LAIV is also being explored as a viral vector for use in the development of novel non-influenza vaccines.
In December 2011 BioDiem acquired Savine Therapeutics Pty Ltd. Savine is a platform technology for the design of antigens for incorporation into vaccines targeting a range of different diseases.
The Live Attenuated Influenza Virus (LAIV) vaccine was in-licensed from the Institute of Experimental Medicine in St Petersburg, Russia, where it has been approved and used in its present form 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 vaccines are based on 'Master Donor Strains' that have been rendered 'cold adapted' and temperature sensitive, such that they will not replicate readily at temperatures above 33°C, as found in the lungs. The administration of the live vaccine stimulates mucosal, cellular and humoral immune responses (which are required to optimise the effective prevention of influenza), without causing the disease. For additional information, please visit www.biodiem.com
Investors
Julie Phillips, Chief Executive Officer BioDiem Ltd Phone +61 3 9613 4100 Email [email protected]
Tom Donovan Buchan Consulting Phone +61 3 8866 1224 / +61 422 557 107 Email [email protected]
VIVALIS (NYSE Euronext: VLS) is a biopharmaceutical company that provides innovative cell pharmaceutical industry for the manufacture of vaccines and proteins, and develops drugs for the prevention and treatment of unmet medical needs. VIVALIS' expertise and intellectual property are leveraged in three main areas: cell-based solutions to the areas:
VIVALIS offers research and commercial licenses for its EB66 pharmaceutical and biotechnology companies for the production of therapeutic and prophylactic viral vaccines, virosomes, VLP's, and recombinant proteins (with a focus EB66® cell line based vaccines are currently in clinical trials in the USA and Japan. receives upfront, clinical stage milestone payments along with royalties on d ® cell line, derived from duck embryonic stem cells, to on monoclonal antibodies having enhanced cytotoxic activity). Through these programs VIVALIS licensees net sales.
Customized solutions for the discovery, development, and production of fully human monoclonal antibodies are now offered by VIVALIS. Through these programs VIVALIS receives upfront, cli royalties on licensees net sales. clinical stage milestone payments along with
VIVALIS performs discovery and development, up to pre identified with its proprietary platform, 3D molecules that alter the three-dimensional structure of a target protein, thus modulating its biological function through an innovative mode of action. VIVALIS is bui hepatitis-C virus infection. VIVALIS also offers on a service basis to develop ready assays directed against target proteins of interest. pre-clinical evaluation, of original small chemical molecules ry 3D-ScreenTM . This unique screening platform is designed to identify original dimensional building a portfolio of proprietary new chemical entities for the treatment of ready-to-use customized 3D nical clinical lding use 3D-ScreenTM HTS
Based in Nantes & Lyon (France) and in Toyama (Japan) VIVALIS was founded in 1999 by the Grimaud Group (ca. 1,600 employees), a worldwide leader in animal genetic selection. VIVALIS has established more than 30 partnerships and licenses with world leaders in this sector, including Sanofi Pasteur, GlaxoSmithKline, Transgene, Pfizer Animal Health, Kaketsuken, Kitasato Daiichi Sankyo Vaccine, Merial, a member of the French ATLANTIC BIOTHERAPIES and LYON BIOPOLE bioclusters and a member of the Japanese HOKURIKU INNOVATION CLUSTER FOR HEALTH SCIENCE in Toyama. n 00 o Merck Animal Health, and SAFC Biosciences. VIVALIS is OKURIKU ,
VIVALIS Listed on Euronext Paris – Compartment C of NYSE Euronext Reuters: VLS.PA – Bloomberg: VLS FP Included in NYSE Euronext's SBF 250, CAC Small 90 and Next Biotech indexes
This document contains forward-looking statements and comments on the company's objectives and strategies. No guarantee can be given as to any of the events anticipated by the forward inherent risks, including the risk factors described in the company's conditions, the financial markets or the markets in which the company operates. looking forward-looking statements, which are subject to isk document de référence looking , changes in economic
VIVALIS Franck Grimaud, CEO Email: [email protected]
Financial communications agency Axelle Vuillermet / Pierre Laurent Tel.: +33 (0) 1 44 71 94 91 Email: [email protected]
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