By Kim Coghill

Washington

WASHINGTON ¿ Funding granted by Congress for research on drugs or other products to combat biological warfare has sort of yo-yoed over the past few years, but some biotechnology industry insiders expect that to change fairly soon.

And although the Department of Defense (DOD) this fiscal year applied for $140.1 million for the research, the terrorist attacks here and in New York likely showed that more money is warranted.

The threat of bio-terrorism is so real that within hours of the deadly terrorist attacks on the Pentagon and World Trade Center, top ranking military officials reportedly telephoned family and friends to warn them against drinking the water.

Jan Walker, spokeswoman for the Defense Advanced Research Projects Agency (DARPA), the arm of the DOD charged with administering funding for biological warfare research, said she can¿t speak to whether Congress will appropriate more money in the upcoming budget, but she did say the door remains open since the fiscal year 2002 budget has not been approved.

Last year DARPA received $166.8 million. The entire DARPA budget is awarded to businesses or universities for research purposes.

Carl Feldbaum, president of the Washington-based Biotechnology Industry Organization, met with the DOD last week to discuss the industry¿s role in combating bio-warfare, and he told BioWorld Today that the $140.1 million ¿is just the beginning.¿

Feldbaum and Walker alluded to the fact that some portion of the $40 billion approved by Congress for victim relief and recovery efforts could become available for research.

As Walker put it, ¿It¿s not clear what the $40 billion is for.¿

Over the last several years a number of biotechnology companies have taken an active approach in trying to develop to product to fight a biological war that could come in the form of smallpox, anthrax, the plague or other agents.

Take for example the work of Genelabs Technologies Inc., of Redwood City, Calif.

Under the Unconventional Pathogens Countermeasures programs, in 1998 Genelabs received a three-year, $13.6 million DARPA grant to develop novel anti-infective compounds. ¿Their vision, which we share, was compounds that could be usable against commonly encountered pathogens, but also would be effective against exotic pathogens that might be used in bio-terrorism or bio-warfare,¿ Jim Smith, Genelabs¿ president, told BioWorld Today.

Genelabs¿ three-year grant resulted in a broad array of leads and a number of active compounds. ¿We¿ve shown good, broad spectrum and potent activity. We have some good data from pharmacokinetics, as well as some in vivo efficacy. We are looking forward to promoting an initial compound or compounds to preclinical status by the end of the year.¿

Smith said public funding for the research is critically important because ¿you are not going to find a commercial entity to fund programs that are targeted toward agents that might be employed in bio-warfare. Commercially, it is not viable; you can¿t draw a business model that shows you can make money off it.¿

A company might not be able to break even on such research unless it is awarded a contract similar to the $343 million, 20-year deal snagged by Acambis Inc., of Cambridge, UK, and Cambridge, Mass.

The year-old contract signed by National Institutes of Health calls for Acambis to develop and stockpile 40 million doses of a smallpox vaccine.

According to the Center for Civilian BioDefense Studies at Johns Hopkins University in Baltimore, smallpox, because of its high case-fatality rates and transmissibility, represents one of the most serious bio-terrorist threats. Smallpox has a case-fatality rate of 30 percent or more and has the ability to spread in any climate or during any season. Once the disease was eradicated in the 1980s, countries stopped vaccinating for it.

Despite the heavy media coverage of recent events and the continuing fear of biological warfare, Lyndsay Wright, Acambis¿ communication manager in the UK, said the company remains on its original schedule.

¿We are right on track to enter clinical trials next year and we are looking forward to submitting a [biologics license application] in 2004,¿ Wright told BioWorld Today. ¿In terms of all the speculation about increasing the contract, or acceleration of the contract, or anything like that ¿ there¿s no comment to make.¿

Commonwealth Biotechnologies Inc., a life sciences contract research organization based in Richmond, Va., released a statement last week saying it works under government contracts to develop and implement novel methods for detection and analysis of human pathogen organisms and toxins that could be used in a bio-terrorist attack.

Annually, the company brings in more than $2 million on research contracts.

For more information on possible grants through DARPA, visit the web site at www.darpa.mil.

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