US nod boosts biotech firm

By YOKE HAR LEE

New Zealand biotechnology company Genesis Research and Development has received United States regulatory approval to begin the second stage of clinical trials for a vaccine it is developing to treat psoriasis.

Psoriasis, a skin disorder, affects up to 100 million people worldwide, but US approval is vital for any pharmaceutical product since it has the most lucrative market.

Genesis is developing the psoriasis vaccine in conjunction with its partner, Nasdaq-listed Corixa Corporation.

Dr Jim Watson, chief executive of Genesis, said the approval from the US Food and Drug Administration is a result of five years of laboratory and clinical work, and six months of regulatory process.

"We anticipate that it may take up to two more years to complete this stage and be ready for phase three. Only after the successful completion of phase three trials can the vaccine be launched as a product."

The partnership approach developed between Genesis and Corixa is unusual, said Dr Watson, in that companies often buy an original intellectual property which they then they take through the testing cycle.

In August last year, Japanese pharmaceutical company Zenyaku Kogyo said it would buy limited rights to the vaccine for research and development in Japan. Genesis and Corixa retain rights for the rest of the world.

Dr Watson said: "What's exciting for Genesis is we have now taken PVAC [the vaccine], a discovery we made ourselves, and developed in collaboration with Corixa, over a considerable hurdle in the world's most stringent regulatory process."