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New Vaccine-Making Facility Opens

Boca Raton, (UPI) Fla., June 3, 2005
Nabi Biopharmaceuticals has opened its $20 million state-of-the art vaccine-production facility, from where the company expects to begin supplying StaphVAX -- the first agent aimed at preventing deadly infections from the highly antibiotic-resistant Staphylococcus aureus bacteria.

Long-considered an unattainable goal, a vaccine for S. aureus could radically change the healthcare picture -- saving lives and saving money. A major consideration with S. aureus is it is ubiquitous, highly infectious, viciously toxic and almost invulnerable to the human arsenal of anti-bacterial agents.

"Staph today is largely resistant to all antibiotics," said Thomas McLain, chairman of Nabi, at the ceremony, which was dedicated to the late scientist Walter Karakawa, a driving force in the development of the still-investigational vaccine.

A Phase 3 trial is underway testing StaphVAX. If successful, the vaccine could be available in 2006. The company already has applied for approval in Europe, where it may be in use by this year. The vaccine there will be produced by a plant in Belgium.

The market for Staph VAX will depend largely on the indication the vaccine receives from the Food and Drug Administration, said Raafat Fahim, senior vice president for research, technical and production operations at Nabi. He said Nabi is testing its vaccine in patients on kidney dialysis, but noted the vaccine also might be offered to other hospitalized patients, particularly those undergoing orthopedic surgeries, such as hip and knee replacements or heart procedures.

"About 6 percent of people on dialysis a year contract S. aureus infection," said Dr. Henrik Rasmussen, senior vice president for clinical, medical and regulatory affairs. "Mortality is about 25 percent."

About 300,000 people in the United States have end-stage kidney disease and require dialysis.

Rasmussen said the current clinical trial, which rapidly enrolled almost 4,000 people in 10 months, would try to show StaphVAX cuts mortality rates by at least 50 percent compared with a placebo. He said if the vaccine can do a little better than that and cuts infections by 60 percent, the estimated yearly savings in healthcare dollars would approach $350 million. The preliminary results of the pivotal clinical trial may be reported at infectious disease meetings later this year.

About 18,000 people a year who are on dialysis develop a staph infection, Rasmussen said. The average cost for treating one of those infections -- often requiring long-term hospitalization for those who survive -- amounts to about $32,000, he said.

The main impact that Nabi's vaccine may have against staph, however, will be in preventing so-called community-acquired infection. Once a rarity, now strains of methicillin-resistant S. aureus or MRSA have become increasingly common.

"We are in the midst of an epidemic of community-acquired S. aureus," said Dr. Robert Daum, professor of medicine at the University of Chicago, who discussed cases of the disease during a scientific forum preceding the dedication ceremonies.

Daum said otherwise-healthy children are showing up at emergency rooms of facilities such as the University of Chicago's Children's Hospital with advanced disease. Despite heroic efforts and use of available antibiotics, several of these children die due to S. aureus. "We may have to give this vaccine to everyone," Daum said.

Fahim said the company is working on developing vaccines that also attack other strains of S. aureus, including strains that cause serious skin infections, as well as community-acquired strains that often have different virulence factors than hospital-acquired infections. The vaccine being tested now is aimed at common hospital-acquired infections from the organism.

"We think that about 12 million Americans are at risk of S. aureus infections," said Steven Fuller, Nabi's vice president for product and process development. He told United Press International that along with dialysis patients and those undergoing surgical procedures, people in nursing homes or long-term care facilities and diabetics also would be considered at-risk individuals. Several of those groups overlap, he noted.

Fahim said the company's plant in Boca Raton, designed to be expandable if necessary, contains the latest developments in fermentation devices, centrifuges and containment facilities. One of the dangers in creating a vaccine is the need to grow the bacteria.

"We grow the bacteria and then strip it of the capsule and use that capsule in making the vaccine," he explained. "Then we destroy the rest of the bacterium."

Karakawa, who died in 1993 at age 62, discovered that a polysaccharide capsule surrounds the S. aureus bacterium that can be targeted by a vaccine.

Fahim said to his knowledge there has not been a new vaccine facility built in the United States in at least 10 years. He noted the plant was completed despite international supply shortages and four hurricanes that disrupted most of Florida in late summer of 2004.

The commitment to build the facility underscores the growth of the state as a biotechnology hot spot, said Judy Goodman, a public-policy attorney with Edwards & Angell in West Palm Beach.

"This facility will help build the critical mass that will push Florida into the forefront of biotechnological research," Goodman told UPI. "The vaccine is poised to have a major health impact. It is part of the rising tide in research that will prime the pump for other biotech research companies to locate in Florida."

That enthusiasm was shared in a business forum following the dedication ceremony in which government, education and industry leaders discussed the impact of Nabi's expansion, as well as the development of the Scripps' East Coast campus, also in Palm Beach County.

Bo Taff, deputy director of Florida's Office of Tourism, Trade and Economic Development, said that 30 biotechnology companies are already looking at Florida for relocation. Already 71 life sciences companies are located in the state, from Pensacola to Key West.

"A rising tide in biotechnology will raise all our boats," said Harry Orf, professor of chemistry and vice president of Scripps Florida.

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Gold Nanoparticles May Simplify Cancer Detection
Atlanta GA (SPX) May 10, 2005
Binding gold nanoparticles to a specific antibody for cancer cells could make cancer detection much easier, suggests research at the Georgia Institute of Technology and the University of California at San Francisco (UCSF).

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