LONDON ¿ Vernalis Group plc joined the elite band of UK biotech companies with a U.S.-approved product when the FDA gave its seal to frovatriptan for acute treatment of migraine.
CEO Robert Mansfield told a teleconference, ¿This is not only a major corporate milestone, it is also an important event for the whole of the UK biotech sector. We are among the very small group of biotechnology companies that have developed a drug through to market in the U.S. and Europe.¿
Shares in Vernalis, based in Wokingham, Berkshire, rose by 63.5 pence to #2.43 when the news was announced Friday.
The FDA approval was secured by Elan Corp. plc, of Dublin, Ireland, Vernalis¿ U.S. marketing partner. The approval triggered an immediate milestone payment to Vernalis of US$15 million. However, as part of the October 1998 deal, Elan made a $10 million loan to Vernalis, which was payable on the earlier of approval or Dec. 31, 2002. Elan also has the option to buy out a proportion of Vernalis¿ royalty, and Mansfield said there had been no discussion of that as yet.
Vernalis also is entitled to three further milestones, totaling $30 million, upon reaching agreed sales levels for frovatriptan in North America, expected to be within the next three years.
Donal Geaney, CEO of Elan, said the company was in discussion with co-promotion partners and expected to ¿conclude the launch plan this quarter.¿ Elan will market the drug under the trademark Frova. Mansfield said there would be no impact on Vernalis¿ royalty rate if Elan does a co-promotion deal. ¿We would be delighted if there was a co-promotion partner in the U.S.¿
Frovatriptan has received approval in France, acting as the reference member state in the European Union mutual recognition process. Vernalis¿ European marketing partner, Menarini, expects to launch the drug in the first half of 2002.
Studies at the approved dose of 2.5 mg showed frovatriptan has a prolonged presence in the bloodstream and that few patients suffered a recurrence of headache within 24 hours of taking the drug. Frovatriptan has a half-life of 26 hours, whereas no other triptan has a half-life of more than six hours, Mansfield said. ¿The profile means there is scope for our marketing partners to differentiate the product in the marketplace.¿
Elan said that more than 50 percent of the 27 million migraine sufferers in the U.S. are underdiagnosed or undertreated, and that the market for oral triptans would be $1.2 billion in 2001.
Vernalis, then Vanguard Medica Group plc, in-licensed frovatriptan from SmithKline Beecham plc in October 1994. In May 1998, SB said it would not be taking up its option to market the drug, and Vernalis bought out the worldwide royalty rights for $25 million when SB merged with GlaxoWellcome plc in 2000. The money is payable in installments over four years after registration, subject to frovatriptan making certain sales targets.