BioWorld International Correspondent

LONDON - Shares in Vernalis Group plc rose by 19 pence to 48.5 pence Friday when the company said it was on track to break even in 2004 without the need to raise further funding. That follows better than expected U.S. sales of its migraine treatment Frovatriptan, coupled with £3 million (US$4.7 million) per annum in cost-cutting measures.

The drug, trade-named Frova, was launched in June and now accounts for 2.6 percent of new prescriptions for triptans. CEO Robert Mansfield told BioWorld International, "We are very pleased with the response. The comment from physicians to our company has been positive. This is a very competitive market, but the feedback is good."

Frova also is getting its first launch in Europe this quarter. The drug is approved in 15 European countries, but Mansfield said Vernalis' marketing partner, Menarini Group, Florence, Italy's leading pharmaceutical company, "is not saying what country it will launch in first, because this is competitively sensitive."

In the U.S., Frova is being jointly marketed by Elan Corp. plc and UCB Pharma. Mansfield said there have been no complications to date arising from Elan's financial struggles and restructuring. "It is not affecting our product because UCB is playing a lead role. Obviously, Elan's position is an issue for all its partners. Under our contracts, if anyone slides into liquidation the rights will come back to Vernalis."

If the current growth rate is maintained in the U.S. market, Frova could account for more than 5 percent of new prescriptions by the end of 2002. The number of repeat prescriptions also is growing and in total there were 2,700 prescriptions per week in early September.

Mansfield said Vernalis is just getting the data through on a positive Phase IV study on the use of Frova for the prevention of menstrually associated migraine. No triptans are currently approved for this indication and the company is preparing to talk to regulatory agencies. "We may have to do one more, but smaller, efficacy trial, and we may have to do a safety study," Mansfield said. "We expect to get clarification on this by the end of 2002 and do any studies in 2003."

Expenditure by Vernalis, based in Wokingham, is coming down by £3 million per annum, mainly because of reduced spending on frovatriptan. The company had £20 million in cash on June 30.