ENACT Pharma, the biopharmaceutical company with a base at Porton Down, has announced that the European Union has adopted the European Medicine Evaluation Agency recommendation of Voraxaze for orphan drug status in the European Union.

Orphan drug status gives Voraxaze market exclusivity for ten years.

Voraxaze is a life saving new drug for the treatment of methotrexate toxicity during cancer therapy.

Completed clinical trials in the USA and Europe, have shown that it can reduce dangerously raised methotrexate levels by about 98 per cent within 15 minutes of administration.

Without Voraxaze, high levels of methotrexate are trapped in the patient's bloodstream leading to severe, or even lethal, methotrexate toxicity.

Enact believes it already has enough clinical data to file for marketing approval in Europe and the USA this year this process normally takes 12 to 18 months.

Projected revenues from Voraxaze are more than £1 million in the first year, rising to more than £6 million per annum within three years and to more than £15 million within five years.

Dr Tony Atkinson, chief executive officer of Enact, said: "We are delighted that the European Union has upheld the EMEA's decision to grant Voraxaze orphan drug status.

"This is a significant milestone for Enact and its early revenue strategy.

"We expect to receive notification of our application for orphan drug in the USA by the end of March.

"If granted this will give Enact market exclusivity for seven years."

Dr Roger Melton, project manager for Voraxaze, said: "This represents an important first step forward in the drug registration process for Voraxaze and opens the way for Enact to prepare its marketing application for Europe."

Enact has appointed Harry Dutson to the operating board as a non-executive director.

The board now consists of five executive directors and three non-executive directors.

Mr Dutson has had a long involvement with Enact.

He has a masters degree from the London Business School and more than 20 years' experience in the development of business plans, obtaining of finance and investing in a wide range of businesses, particularly biotechnology.

He is a director at Acorn Capital, where he is responsible for fundraising and the flotation of companies.

Mr Dutson said: "Having advised Enact for many years now, I am pleased to be invited to join the board and work with them."