LONDON - Drug development company Vanguard Medica Group plc has begun preparations for the launch of its lead product, frovatriptan for the treatment of migraine, in the U.S. and Europe.
The program, which Vanguard is running in collaboration with London-based SmithKline Beecham, is one year ahead of its original schedule.
CEO Robert Mansfield said efficacy results from the Phase III studies will be available by the end of the second quarter this year. “We plan to file for marketing approval with the FDA at the end of this year, and in Europe shortly afterwards,“ he said. “We are increasingly optimistic that frovatriptan will be launched as a product before 2000.“
One consequence of acceleration of the program was that results for the year ended December 1997 showed a near doubling of development expenditures - to £22.4 million from £12.37 million for 1996.
Losses for the year doubled, from £10.95 million in 1996 to £21.16 million. Turnover rose to £1.55 million from £600,000, reflecting initial payment received from development partner Sankyo Co. Ltd., of Tokyo, for VML 252 for treatment of elevated blood phosphate.
There was cash of £59.35 million at the end of 1997. This included net proceeds of £25.7 million from a placing and open offer in December. Eighty percent of the shares were taken up by existing stockholders and the remaining 20 percent were placed with a single new institutional shareholder, International Biotechnology Trust, of London.
Vanguard, of Guildford, U.K., was founded in 1991 and currently has four compounds in clinical trials. Mansfield said he expects to announce a further expansion of the portfolio later this year.
The company has no discovery program, but relies on its core expertise to identify and license commercially attractive early-stage compounds. It also outsources the majority of its clinical development work.
The other compounds in the clinic are VML 252, currently in Phase II in hemodialysis patients, with results expected in the third quarter of 1998; VML 262, a topical treatment for psoriasis, in Phase II; and VML 295, an oral treatment for psoriasis, in Phase IIa.
Another compound, VML 530, is an oral treatment for asthma and is under development in collaboration with Abbott Laboratories, of Abbott Park, Ill. It is expected to enter Phase I at the end of 1998. *