Amarillo Biosciences Inc announced that BioVet Inc, a Tokyo-based animal health company with whom Amarillo Biosciences has been collaborating, has confirmed that the Ministry of Agriculture, Forestry and Fisheries of Japan has granted regulatory approval for production and marketing the product for oral interferon treatment of rotavirus in cattle.
The animal health approval is for low dose oral administration of human interferon alpha supplied by Hayashibara Biochemical Laboratories (HBL). The approved oral dosage is 0.5 IU (international units) of human interferon alpha (less than a nanogram) per kilogram of body weight, once daily for 5 days to treat rotavirus diarrhea in calves not more than 30 days old. The product will be launched in Japan in September 2004, company said in a release.
Amarillo Biosciences, which owns the distribution rights to HBL interferon for animal health outside Japan, will receive a royalty on all Japanese HBL interferon sales and, will cooperate with BioVet in the international marketing of oral interferon for animal health.
As a result of animal health approval for treatment of the rotavirus in cattle, BioVet can start production and distribution of the product. BioVet intends to submit their animal health data and regulatory approval to regulatory agencies outside Japan.
BioVet and ABI expect to join forces with strategic partners in order to distribute oral interferon. Multi-national animal health companies can use the Japanese data to generate sales in many countries. To date, the company has received indications of serious interest from a number of multinational pharmaceutical companies and is in active discussions with these companies.
"Japanese regulatory approval will enable our Japanese partner BioVet to begin marketing HBL interferon immediately, which translates into royalty payments to Amarillo Biosciences," said Dr. Cummins. "Equally, if not more important, the Japanese approval will assist both Amarillo Biosciences and BioVet to reach a distribution agreement with a major pharmaceutical partner or partners, in order to market HBL interferon in other countries. This is particularly important to Amarillo Biosciences since we own the distribution rights to HBL interferon outside Japan."
Rotavirus diarrhoea is a major cause of disease and death in animals and humans.
Amarillo Biosciences Inc is a US biotechnology firm operating in global partnership with the Hayashibara Group, which also holds 32 per cent of Amarillo Biosciences shares.