Melbourne, Wednesday 31 March 2010: Australian biopharmaceutical development company BioDiem Ltd (ASX: BDM) announces an update on the Pandemic Influenza Vaccine Program with the World Health Organization (WHO).
In September 2009 the World Health Organization entered into two sublicences, under its Global Pandemic Influenza Action Plan for developing countries, with the Government Pharmaceutical Organization of Thailand (“GPO”) and the Serum Institute of India, Ltd. (“SII”). In October the WHO signed a further sublicence with Zhejiang Tianyuan Bio-Pharmaceutical Co. Ltd. of Hangzhou, China. These agreements authorize egg-based manufacturing and distribution of influenza vaccines, made using BioDiem’s LAIV technology, in the public sector of these countries.
The Institute of Experimental Medicine (IEM) in St. Petersburg, Russia produced influenza reassortants using the wild-type H1N1 California vaccine strain for the development of a pandemic influenza vaccine. In accordance with the WHO agreement, the IEM supplied these reassortants to the GPO in Thailand and the SII in India and these companies prepared experimental batches for preclinical and clinical studies in December 2009. Batches of these vaccines were sent to Viroclinic in The Netherlands and were tested in ferrets for quality and efficacy. The results confirmed that they were similar to the Russian product, which has been extensively used in that market for many years.
The Government Pharmaceutical Organization in Thailand has completed a Phase I clinical trial in healthy adults of its candidate vaccine and it was shown to be safe. The GPO is expected to commence a Phase II clinical trial in April 2010.
The Serum Institute of India has also successfully completed a Phase I trial and safety was shown. A Phase II/III clinical trial is now in progress. Subject to results, the vaccine is expected to be ready for public use in April-May this year.
BioDiem understands there is significant potential for use of the vaccine in these private markets. This will require the establishment of new royalty agreements.
BioDiem’s director and Head of the Virology Department in the Institute of Experimental Medicine, St Petersburg, Prof. Larisa Rudenko, said “In the event of an influenza pandemic we need to protect not only the developed countries but also those in developing countries with their vast and often crowded populations, which can only lead to higher infection rates. The majority of highly virulent influenza viruses emanate from these countries. Our LAIV technology will accelerate production and increase yield of pandemic vaccine supplies.”
About BioDiem Ltd
BioDiem is an ASX-listed company, based in Melbourne, with an international focus on finding, adding value to and commercializing world-class research for vaccines, infectious diseases and other therapeutic areas. The company uses a cost-efficient approach to drug development through collaborations with academic centres of excellence, contract research organizations and partnerships with international pharmaceutical companies.
BioDiem’s leading product is the Live Attenuated Influenza Vaccine (LAIV) technology, a novel intranasal vaccine being developed to prevent infection from endemic and pandemic influenza. The technology was licensed to BioDiem by the Institute of Experimental Medicine in St Petersburg. In 2004, BioDiem licensed the LAIV technology to Nobilon International B.V. (now part of Merck & Co, Inc.). It is currently in Proof of Concept (Phase II) stage clinical trials as part of its development for European registration.
About LAIV Technology
The Live Attenuated Influenza Vaccine (LAIV) is delivered by nasal spray which is easier to administer than traditional influenza injections which require intramuscular delivery. The vaccine contains live viruses but because they are attenuated (weakened) they cannot cause illness. The viruses are cold-adapted and temperature sensitive so that they cause infection only at the cooler temperatures found within the nose, and not in the lungs or other areas where warmer temperatures exist. Both egg- and cell-based production methods can be used for product manufacture.
For additional information, please visit www.biodiem.com
Chief Executive Officer
Ph: +61 3 9613 4100
Ph: +61 (0)422 20603