Melbourne, 24 December 2009: Australian biopharmaceutical development company BioDiem Ltd (ASX: BDM) announced that it has commenced discussions regarding the manufacturing and marketing rights of its LAIV technology for the Japanese market. Japan is the second largest pharmaceutical market in the world. BioDiem, which previously held the co-marketing rights in conjunction with Nobilon, whose parent company Schering-Plough has recently merged with Merck, has now claimed full rights to that market. The reversion of the rights means that Merck is relieved of the requirement to pay the final milestone payment of US$1m to the Company in accordance with the arrangement in the licence agreement signed in 2004.
Attaining the full Japanese rights to the technology, including manufacturing, allows BioDiem to out-license the complete Japanese rights package and the Company anticipates that this presents an attractive package given the market interest in influenza and the strong benefits of the LAIV technology.
The Japanese license package will allow the licensee the opportunity for development of both egg and cell-based manufacturing options. In particular, the licensee could achieve a pipeline through the faster introduction of an egg-based vaccine product and then subsequently a cell-based vaccine. In addition, BioDiem is now able to provide pandemic avian ‘flu strains to a licensee as a result of its partnership with the US Center of Disease Control and Prevention under the CRADA agreement.
Chief Executive Officer of BioDiem, Julie Phillips, commented, “The recovery of 100 percent rights to the Japanese market is an exciting development for the Company and opens up a number of commercial avenues. Japan represents a lucrative potential market for BioDiem’s technology and we have achieved these rights very cost-effectively for the equivalent of US$1m. We are already in discussions with Japanese companies. At this time we cannot make any disclosures about specific details but we are confident that there is interest in our LAIV technology in Japan. We will be holding further meetings early next year.”
BioDiem continues to hold the marketing rights in the North American market for the LAIV technology.
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 licenced to BioDiem by the Institute of Experimental Medicine in St Petersburg. In 2004, BioDiem licenced the LAIV technology to Nobilon International B.V., Schering-Plough’s human vaccine business unit. It is currently in Proof of Concept (Phase II) stage clinical trials as part of its development program for European registration.
BioDiem’s second product is BDM-E, a small synthetic peptide being developed for the treatment of retinal eye diseases. It is currently in pre-clinical testing.
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.
For additional information, please visit www.biodiem.com
About the Co-operative Research and Development Agreement (CRADA)
The US Centers for Disease Control and Prevention (CDC) and Nobilon International B.V. (Schering-Plough’s human vaccine business unit), signed an agreement in August 2006 to develop BioDiem’s Live Attenuated Influenza Vaccine (LAIV) against H5N1 (avian ‘flu). Under the agreement the LAIV will be advanced through pre-clinical development at the CDC in its high-security laboratories. The CDC in Atlanta is the US government’s leading site for research into the prevention and monitoring of high-risk bio-terrorist and pandemic diseases.
The co-operative research will generate, characterize and evaluate live attenuated cold-adapted influenza vaccine (LAIV) candidates against influenza A H5N1 viruses in pre-clinical models.
