Biosecurity Gets Needed Attention

In the wake of terrorist attacks, funding is increasing for life science companies engaged in virtually any area of biosecurity. Organizations that produce vaccines and antibiotics, as well as those developing therapeutics, detection systems, and diagnostics, are receiving much-needed attention from government and private sectors. Individual companies and labs, from big pharma to small start-ups, are likely to benefit from this focus on bioterrorism countermeasures, at least into the foreseeable future. But, like anything else in these unsettled times, uncertainties abound in the biotech world. It is not at all clear that this increased attention on biosecurity will benefit the biotech industry as a whole. And no one can say whether the government's planned countermeasures for producing vaccine and stockpiling antibiotics will be sufficient to respond to any future bioterrorist attacks. "We are likely to see a lot of financial activity related to vaccines, monoclonal antibodies, antibiotics, and antivirals," says Brent Erickson, director of industrial and environmental biotechnology at the Biotechnology Industry Organization (BIO), an industry group in Washington, D.C. "And on the military side, we will see a lot more work on detection systems and diagnostics," he says. "Biotech companies already are responding very quickly to the needs of the government," adds Calvin Chue, an adviser to the Center for Civilian Biodefense Studies at Johns Hopkins University. "Some of them have had previous relationships with the military, but there are lots of small companies that are trying to adapt their technology from clinical labs to environmental [applications]." In Senate testimony last month, Health and Human Services (HHS) Secretary Tommy G. Thompson said government agencies, including the Centers for Disease Control and Prevention (CDC), the National Institutes of Health (NIH), and the Defense Department, are collaborating to address scientific issues related to bioterrorism. "In some cases, new vaccines, antitoxins, or innovative drug treatments need to be developed or stocked," he said. "Our continuing research agenda is vital to overall preparedness." Appropriating the Money The Bush administration has asked Congress to appropriate $2.8 billion from an approved $20 billion emergency spending package to deal with bioterrorism. Of these new funds, $1.5 billion would be allocated to HHS for bioterrorism preparedness. These funds would increase stockpiles of antibiotics, vaccines, and other drugs and also improve the public health network at the state and local levels. This appropriation would be combined with $345 million that HHS already has requested for FY 2002, bringing the bioterrorism war chest to nearly $1.9 billion. Of these funds, $643 million would dramatically expand the National Pharmaceutical Stockpile by purchasing additional supplies of antibiotics, antitoxins, and antidotes for chemical weapons. These drugs and supplies are stored near major cities, such as New York and Washington, that have been or are likely to be targets of bioterrorism. One objective is to increase the supply of antibiotics to treat Bacillus anthracis, the organism that causes anthrax, to treat 12 million people for 60 days, up from 2 million people at present. Until recently, only ciprofloxacin, manufactured as Cipro by patent-holder Bayer AG of Germany, had been approved by the Food and Drug Administration to treat pulmonary anthrax. Generic drug manufacturers are eager to get a piece of the Cipro business, but Bayer has been fighting them off. Because of the demand, the FDA has also approved use of the generic antibiotics doxycycline and penicillin, which have proven effective on the B. anthracis bacterium strain sent in letters to New York, Washington, and elsewhere. The FDA has been meeting with other manufacturers in addition to Bayer, including Bristol-Myers Squibb (which makes Tequin, an antibiotic similar to Cipro), on ways to increase anthrax antibiotics production at reduced cost. An additional $509 million of HHS's war chest would speed development and acquisition of smallpox vaccine. The smallpox virus "represents one of the most serious bioterrorist threats to the civilian population," according to the Hopkins' Center for Civilian Biodefense Studies, due to its transmissibility, high fatality rates, and shortage of vaccine. The government has only 15.4 million doses of old smallpox vaccine left in cold storage. Because of the virulence of the disease, federal officials are negotiating with various companies to purchase 300 million doses of vaccine, more than enough to immunize everyone in the Unite States. Companies in the discussions include Acambis PLC, Merck & Co., and Baxter International. The CDC has contracted with London-based Acambis to produce 54 million doses of a new, safer smallpox vaccine, Dryvax, with delivery pushed up from 2004 to next year. Acambis, in turn, has subcontracted with BioReliance Corp. in Rockville, Md., to manufacture the vaccine once FDA gives approval. In addition, BioReliance and a number of other contract vaccine manufacturers have been tasked to produce some of the 18 vaccines needed for the U.S. military stockpile under a subcontract from DynPort Vaccine LLC. "The vaccine industry in this country has been less than robust because of the legal constraints linked to liability and the lack of good long-term contracts with the government," Erickson says. That seems certain to change. Like a number of biotech companies involved in the bioterrorism effort, BioReliance's stock has more than doubled in price since late September. Making Ends Meet Meanwhile, researchers at the University of Maryland School of Medicine in Baltimore and three other institutions are exploring how far they can stretch the existing supply of smallpox vaccine. Research sponsored by the National Institute of Allergy and Infectious Diseases (NIAID) is testing the effectiveness on 650 healthy volunteers of smallpox vaccine diluted to one-fifth and one-tenth the standard dose. Elsewhere, efforts are under way to develop new treatments for pulmonary anthrax. Researchers at the University of Texas at Austin are investigating certain antibodies that seem to block the bacterium's destructive properties. Researchers at Harvard Medical School are experimenting with altered forms of protective antigen that appear to block the ability of anthrax to enter blood cells. As of the end of October, the nation's only licensed supplier of anthrax vaccine, BioPort Corp. of Lansing, Mich., was still struggling to gain FDA approval to resume packaging the vaccine for military use. Over the past few years, BioPort had repeatedly failed FDA inspections. Recently the company announced it had solved the deficiencies and had reapplied for FDA approval. Agency officials said they would expedite their review. Separately, researchers funded by NIAID and the Defense Department are said to have developed safer and more potent anthrax vaccines using genetic engineering. Although details are scarce, early-stage human clinical trials are said to be near. Vaxin Inc. a Birmingham, Ala.-based company specializing in topical vaccine delivery systems, has received an NIH Small Business Innovation Research (SBIR) grant to develop a recombinant- vectored anthrax vaccine that can be applied with a skin patch. A vaccine is not expected for three to five years, however. Other research efforts are focusing on even more-deadly biotoxins, including Francisella tularensis, the organism that causes tularemia; Yersinia pestis, the bacterium that causes plague; and Botulinum toxin, made by the Clostridium botulinum bacterium, one of the most poisonous substances known. NIH-funded research includes genome sequencing of the organisms that cause anthrax and tularemia in hopes of speeding development of more-rapid diagnostic methods. Researchers at the Sanger Centre in Cambridge, England, last month reported decoding the genome for Yersinia pestis,1 a development that could aid in creating a new vaccine for inhaled plague, something vitally needed since the existing vaccine only protects against the bubonic form of the pestilence. Integrating Biotechnology Until now, much of the federal bioterrorism research has been funded by the Defense Advanced Research Projects Agency (DARPA), which last fiscal year spent $166.8 million on biodefense projects, according to the General Accounting Office. This compares to $49.7 million at NIH, $46.6 million at CDC, and $39.6 million at the Energy Department. DARPA's biodefense projects include developing advanced biosensors, advanced diagnostics, therapeutics countermeasures, and sequencing codes for potential biological agents, said DARPA director Tony Tether in testimony before a House armed services subcommittee in June. The Pentagon has been "way behind the curve in integrating biotechnology into every area of defense," Erickson claims. "They need to integrate biotechnology into all their operational capabilities, and that includes therapeutics, enzymes, detection systems, drugs to help troop performance in combat fatigue, biological computers, biopower, and bioenergy generation systems." One of DARPA's more intriguing efforts involves developing monoclonal antibodies that might afford immediate protection against a range of blood-borne pathogens. EluSys Therapies Inc., a privately held company in Pine Brook, NJ, has received funding from DARPA and the US Army Medical Research Institute of Infectious Diseases to develop heteropolymers that can be tailored to destroy principal anthrax toxins and other pathogens. Other DARPA-sponsored research seeks to develop enzyme systems that can be sprayed over anthrax-laced battlefields, deactivating the microbes before they infect troops. "That kind of stuff probably will be accelerated and better funded" in the current war on terrorism, Erickson says. But no one can say whether these activities will be sufficient to protect against future bioterrorism attacks. "We can't really predict it, unless you have some sort of knowledge of what's coming down the pike," says Chue. "We can proceed only as fast as the situation currently allows." Acambis may be producing smallpox vaccine as fast as it can, he says, "but we don't need necessarily to have 40 million doses up front. A few million doses every few months would be probably adequate to contain any potential releases." And while biotech companies, large and small, clearly will benefit financially from the current situation, long-term growth of the industry depends on many factors. In this case, with the government as the purchaser of vaccine and antibiotics, margins will tend to be narrower and profits less than if the products were sold in the retail market. Plus, there will be pressures to hold down costs and perhaps even force licensing or generic production of high-demand patented drugs. All this makes the industry outlook seem less certain. Bioterrorism "does not affect where we put our money," says Brenda Gavin, an analyst with S R One Ltd., a venture capital firm in Wayne, Pa. "We invest in companies that have multiple markets, and if it so happens that we also have something that could benefit to combat terrorism, that's great. But I don't think we would pick that as a target [for investment] in and of itself." Ted Agres (tagresa@usa.net) is a freelance writer in Washington, D.C. 1. R. Lewis, "Plague genome: The evolution of a pathogen," The Scientist, 15[21]:1, Oct. 29, 2001.

Biosecurity Gets Needed Attention

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