Melbourne, Monday 12 July 2010: (ASX: BDM) BioDiem Ltd’s lead product, the Live Attenuated Influenza Vaccine (LAIV) has been granted regulatory approval for marketing in India. “NasoVac” was launched this week by the Indian vaccine company, the Serum Institute of India (“SII”).
This is the first approval for marketing of BioDiem’s LAIV outside of Russia and the CIS.
This comes as a result of SII’s licence for the development of an intranasal egg-based vaccine against the H1N1 influenza strain (swine flu) under WHO’s Pandemic Flu program. BioDiem is eligible to receive royalty payments on sales of this product in the private market.
BioDiem Ltd’s lead product, the Live Attenuated Influenza Vaccine (LAIV) was licensed to Nobilon (subsequently part of Schering-Plough) in 2004 for certain rights to manufacture, market and sell the intranasal influenza vaccine. In 2009 Schering-Plough and Merck merged.
BioDiem is aware that Merck has announced the proposed phase out of operations at a number of its R&D sites and that one of these sites is the Nobilon facility at Boxmeer in the Netherlands, which is one of the areas where work on BioDiem’s LAIV has been taking place. BioDiem has no further information at this stage about any potential impact on the LAIV program. BioDiem will keep investors informed of developments as they arise.
About BioDiem Ltd
BioDiem is an ASX-listed company, based in Melbourne, with an international focus on finding, adding value to and commercialising 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. It has also been launched in India as NasoVac for protection against H1N1 influenza.
For additional information, please visit www.biodiem.com
Contact information
COMPANY MEDIA & INVESTOR RELATIONS Julie Phillips - Chief Executive Officer Fay Weston - Director BioDiem Ltd Talk Biotech Ph: +61 3 9613 4100 Ph: +61 2 4885 2662 or 0422 206036 Email: jphillips@biodiem.com Email: fayweston@talkbiotech.com.au
