Gilead and Roche's flu drug approved in first market, Switzerland

Roche of Switzerland's orally-active neuraminidase inhibitor Tamiflu(oseltamivir), originally developed by Gilead Sciences of the USA, has been approved for marketing by the regulatory authority in Switzerland. This is the first approval of the influenza treatment, which was scheduled for launch on October 1, as this issue of the Marketletter went to press. Approvals of Tamiflu in the USA and Canada are still pending, though both countries have agreed to a fast-track review of the drug and a decision in the USA is expected this month, well in advance of the 1999/2000 flu season.

Tamiflu is the second drug in the neuraminidase inhibitor class to reach the market, after Glaxo Wellcome's inhaled product Relenza (zanamivir), which is already available in the UK, Denmark and Australia and is rolling out in other markets. Introductions in France and Germany are expected this month.

For Roche, the approval is a welcome success for its drug development program, which has just this year seen three other products - Neuleze (recombinant nerve growth factor) for diabetic retinopathy, the antiplatelet drug Xubix (sibrafiban) and the Alzheimer's disease drug Tempium (lazabemide) - fail to show positive effects in late-stage trials. Added to this, in 1998 the company was forced to withdraw two newly-launched products - the antihypertensive Posicor (mibefradil) on a worldwide basis and Tasmar (tolcapone) for Parkinson's disease in Europe - on safety concerns (Marketletters passim). The availability of Tamiflu, following on from the launch of potential blockbuster Xenical (orlistat) for obesity, represents a turning point for Roche which will be reinforced by a wave of new products nearing the end of development, a spokesman for the company told the Marketletter.