WASHINGTON - With bipartisan support from the likes of Sens. Bill Frist and Ted Kennedy, Project BioShield on Wednesday passed the Senate in a 99-0 vote.
If signed into law by President Bush in the next few weeks, BioShield would flood the industry with $5.6 billion over the next decade for the procurement of vaccines against chemical, biological, nuclear or radiological attacks. The federal budget for 2004 allocates $890 million to the project.
Products under consideration for BioShield are a recombinant protective antigen (rPA) anthrax vaccine, anthrax therapeutics, a next-generation smallpox vaccine, antitoxins to botulinum neurotoxins, a plague vaccine and a botulism vaccine. Potential future products include an Ebola-Marburg vaccine, a Rift Valley fever vaccine, novel antibiotics and anti-infectives, polyclonal human anthrax and botulism antibodies, and a third-generation anthrax vaccine.
Bush introduced the nation to Project BioShield in his State of the Union address January 2003. The idea behind the plan was to speed development and availability of countermeasures by streamlining government research, creating incentives for companies to take on the research and providing the FDA with the authority to make investigational products widely available in a public emergency.
Prior to the vote Wednesday, Senate Majority Leader Bill Frist (R-Tenn.), a world-renowned heart surgeon, said the U.S. is less than adequately prepared for bioterrorism threats.
Indeed, vaccines for such threats as anthrax or smallpox have not topped the industry's priority list because there's no market for the products.
But if BioShield becomes law, Sen. Ted Kennedy (D-Mass.) said the industry can rest assured that the government will buy products that work.
The Senate legislation is similar to the House version that passed in a 421-2 vote last July. (See BioWorld Today, July 23, 2003.)
As passed, BioShield would not provide companies with research and development money, said Frank Rapoport, a partner with McKenna, Long & Aldridge LP, of Philadelphia. He also is an attorney for Aventis Pasteur Inc., the vaccine business of Aventis SA, of Strasbourg, France.
Under BioShield, "the government will enter into a contract promising to buy a product that [a company] promises to develop with its own money in the next eight years," Rapoport told BioWorld Today.
However, Rapoport said research and development funding is available through the National Institutes of Health, and companies working under such contracts are not exempt from winning procurement contracts via BioShield.
Rapoport said the bill is a wonderful start.
"I wish it had happened a year ago," he said. "I think it will jerk the heads of some of the venture capitalists who weren't sure the government was serious about this."
As for biotechnology companies, many working in the countermeasures arena already have tapped into government funds.
For example, Brisbane, Calif.-based VaxGen Inc. has received two NIH grants totaling $100 million (one worth $80.3 million, the other $20 million) for an anthrax vaccine called rPA102. The vaccine, originally researched at the U.S. Army Medical Research Institute of Infectious Diseases in Fort Detrick, Md., cannot cause anthrax infection, as it is made of an alum adjuvant and a purified protein designed to induce antibodies that neutralize anthrax toxins. (See BioWorld Today, Oct. 2, 2003.)
In recent weeks, VaxGen submitted a proposal to the U.S. Department of Health and Human Services describing its plan to provide up to 75 million doses of its anthrax vaccine to the U.S. national stockpile of biodefense products. HHS plans to award purchase contracts for such a vaccine in August.
Meanwhile, Hollis-Eden Pharmaceuticals Inc., of San Diego, is working under a Cooperative Research and Development Agreement in conjunction with the Army to develop the immune-regulating hormone HE2100 (Neumune) as a candidate for radiation protection. Preliminary results in non-human primates have shown that administration of HE2100 two, four or 24 hours after radiation exposure resulted in a statistically significant reduction in the occurrence of severe neutropenia, compared to control animals.
Still another company, Acambis plc, headquartered in Cambridge, UK, is developing a smallpox vaccine under a $500 million contract with the Centers for Disease Control and Prevention in Atlanta. The firm is contracted to develop 209 million doses of the vaccine ACAM2000, a vaccina virus believed to have a safety profile similar to Dryvax, the vaccine used to eradicate smallpox in the U.S. during the 1970s.
In mid-April the firm suspended recruitment of additional volunteers in a Phase III program after three out of 2,800 participants showed signs of heart inflammation. (See BioWorld Today, April 16, 2004.)
Meanwhile, it is widely viewed around Washington and within the industry that BioShield does not settle all the issues that the government and companies might face in the countermeasures business.
As such, Sens. Orrin Hatch (R-Utah) and Joseph Lieberman (D-Conn.) are expected to submit BioShield II in the next few weeks. The legislation likely will correct and add certain provisions, including tax incentives and indemnity protection, left out of the first BioShield.