FDA warns Medeva on problems at US plant

BY NIGEL COPE

Drugs group Medeva has received a further warning from the US Federal Drugs Administration following an inspection at one of its US plants. But the company also announced progress yesterday on its Hepatitis B vaccine, which suffered patent setbacks last year.

The FDA warning letter is the company's second in less than two years. A similar warning in July 1993 , accompanied by a profits warning, forced one of Medeva's US plants to quit production for two weeks. Medeva played down the importance of the letter, saying such warnings were common and that the problems had since been addressed.

Medeva said yesterday that its Hepatitis B vaccine has taken a significant step towards the market .The company said preliminary results from clinical trials show Hepagene vaccine can immunise sufferers who have not responded to other Hepatitis B vaccines.

Further details will be announced at Medeva's full-year results next month and the full trial results will be available in the summer. The vaccine would be priced at a three-figure sum per dose, making it significantly cheaper than existing treatments, which can cost as much as $3,000 (£1,900).

Medeva's chief executive, Dr Bill Bogie, said the trial findings had enormous implications as an estimated 10-15 million people per year receive Hepatitis B vaccines. "Clearly we are at the beginning of a very exciting adventure," he said.

Medeva bought the rights to the vaccine from a Swiss group, aware that a rival American group, Biogen, was challenging its rights to the patents in the US courts. Medeva lost the case and must wait until 2004 in the US before its vaccine can be marketed.

However, Dr Bogie said he felt the medical need for an add-on vaccine would drive the product onto the market sooner. He added that the product's patent was already cleared in the UK and would be in Europe by the end of 1999.

Analysts welcomed the announcement. Some said there was evidence that the vaccine could be used for treatment as well as for immunisation.

The shares shrugged off the FDA warning to close up 2p at 178p.