Vanguard Medica, a pharmaceutical development company inthe United Kingdom founded a year ago by the former heads ofresearch at Glaxo, SmithKline Beecham, ICI, Squibb, Bristol-Myers and Wellcome, has raised $9.2 million (6 million pounds)in its first round of venture financing.

Burr, Egan Deleage & Co. took the largest position in thefinancing -- $1.92 million (1.25 million pounds) -- and AdventLtd. led the deal from London. Also joining in wereBiotechnology Investments Ltd., Medical Science Partners,Advent International Corp., Alta-Berkeley III C.V., Finovelecand TVM.

Vanguard's strategy is to adopt abandoned drug candidates --those compounds that research-based pharmaceuticalcompanies and academic institutions have decided not topursue -- and nurture them through advanced preclinical andearly clinical trials to assess their actual worth as therapeutics.

"The overall process is to predict which drugs are likely to beworthwhile and target them," explained Peter Bick, a partner atBurr, Egan, Deleage & Co.

Vanguard's intent is to complete this process rapidly, a timeframe to which the regulatory environment in the UnitedKingdom lends itself nicely, according to John Fromson,Vanguard's director of research and development. Bydemonstrating the compounds' safety in humans, this approachshould enhance their value and increase their commercialpotential, to the mutual benefit of Vanguard and theiroriginators.

Thus, Vanguard's first step was to round up the portfolios onlikely drug candidates. Since "the founding directors know anextremely large number of people in the pharmaceuticalindustry," it wasn't long until they had about 160 candidates toscreen, explained Robert Mansfield, Vanguard's president andchief executive officer.

The company has whittled those down to four or five, but inthe meantime is "now getting spontaneous applications frompharmaceutical companies, both large and small (includingbiotech companies), from U.S., European and Japaneseorganizations," Mansfield told BioWorld.

Once it pinpoints the drug leads, Vanguard will either acquireall rights to the compound from its owner or form apartnership with the parent company for co-development.

From there, the strategy is to "concentrate on taking the druginto the clinic as quickly as possible," said Mansfield. Thisincludes Phase I trials in volunteers and Phase IIa trials, whichare deemed early patient studies in the United Kingdom. Thiscan be done relatively quickly in the United Kingdom becauseit's sufficient for regulatory purposes to go into humanvolunteers with "one-month rat or dog toxicology data and invitro mutagenicity testing," Fromson told BioWorld. "All youhave to satisfy is the ethics review committees."

If the drug then proves successful enough to warrant putting itinto a patient population, the company must apply to theMedicines Control Agency for a CTX (clinical trials exemptioncertificate) and wait 30 days for permission to go into patients,a process similar in some respects to an IND (investigationalnew drug application), Fromson explained.

But Vanguard isn't planning on conducting the trials or runningthe preclinical tests itself. For that, it's depending on contractresearch organizations, a large number of which it has alreadyidentified in the U.S. and France, as well as the United Kingdom,Mansfield said.

All-in-all, "by initiating a program such as this, it's possible toget a (pure) compound into patients within 18 months to twoyears," according to Fromson. And given a positive outcome forthe Phase IIa trials, Vanguard will either license out thecompound or retain it and take it through the regulatoryapproval process, Mansfield added.

But the Hertfordshire, England, company isn't wedded tobringing all its products through the United Kingdom approvalnetwork. "We have a certain degree of flexibility," Fromson toldBioWorld. "If we're developing a compound from the States andthe company has already thought about doing clinical work inthe States, we would go with an IND.

"All we're trying to do is shorten the development time, andmake certain that the compound works," he said.

-- Jennifer Van Brunt Senior Editor

(c) 1997 American Health Consultants. All rights reserved.