Updated on 12 December 2012
Will Serum Institute of India get WHO and DCGI's consent for exporting flu vaccines?
Singapore: Serum Institute of India (SII) has applied for permits to export flu vaccines produced using Australia's BioDiem's proprietary technology. The permit is applied with the World Health Organization (WHO) and the Drugs Controller General of India (DCGI).
Once approved, this permit will open doors to increased sales for SII, leading to increased royalty payments for BioDiem. In the FY 2012, SII contributed the bulk of the $1.3 million received by BioDiem in form of royalty payments, based solely on swine flu vaccines sold in India, indicating the scope for very large expansion of this revenue stream through international sales of seasonal flu vaccines (guaranteed annual revenues, not ‘patchy' sales as per swine flu pandemics).
The application is supported by data from the successful completion of a phase II clinical trial for a BioDiem/SII seasonal flu vaccine in 300 children in Bangladesh. This trial was run by an international consortium of health agencies.
SII has also acquired a Netherland-based vaccine business, which marks its first step in accessing developed markets such as Europe, Australia and the US. Until date, SII has in-licensed BioDiem's technology for the manufacture of flu vaccines for developing nations only. BioDiem retains the option to outlicense its LAIV technology for sales in developed nations and this expanded partnership with SII would again significantly expand revenue streams.