CORPORATE PARTNERS

Institute of Experimental Medicine (IEM), St. Petersburg, Russia

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 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 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 the BioDiem Board. 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 Organization

BioDiem 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 will flow to Biodiem directly from private sector sales. BioDiem has authorised the Institute of Experimental Medicine (IEM) to supply LAIV reassortants to the WHO for use by its sublicencees. The vaccines developed through the WHO program are manufactured using eggs.  In September 2009, the WHO issued sublicences to the LAIV technology to two companies: the Serum Institute of India, Pune, India and the Government Pharmaceutical Office, Bangkok, Thailand.

In July 2010 the Serum Institute of India launched its H1N1 (swine flu) pandemic vaccine, called Nasovac™, in India. This vaccine is a result of the WHO collaboration using BioDiem’s technology. BioDiem receives royalty payments on sales of this product in the private market.

It is anticipated that the Government Pharmaceutical Office of Thailand will launch its pandemic vaccine into the Thai market in 2011.

Facilitated by a grant from the WHO, work has commenced on a new laboratory fit-out at the Institute of Experimental Medicine to allow the Institute to handle highly pathogenic influenza strains e.g. H5N1 (avian or bird flu). Any material generated will be also 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) Program

In 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 organizationto develop a prototype pandemic LAIV 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.

The first stage of this agreement has seen use of BioDiem’s cold–adapted master donor LAIV virus bearing avian or human influenza virus genes from viruses with pandemic potential. Preclinical studies of the vaccine candidates have been completed and clinical trials are planned shortly. PATH will provide financial and technical support to the Institute of Experimental Medicine and third party contractors to a maximum of US$3.6 million.

Co-operative Research and Development Agreement (CRADA)

The Cooperative Research and Development Agreement (CRADA) between BioDiem and the US Center for Disease Control and Prevention (CDC) aims 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. Previous published work demonstrated the efficacy of cell-produced LAIV vaccine vs. egg-produced vaccine in ferret studies.