The Long Road
Nabi Biopharmaceuticals is in the homestretch as it works on two drugs designed to fight infections.
The website of the state's independent bioscience organization explains the various types of biotechnology applications and has a list of biotech companies in the state, monthly calendars of events and details of the group's annual fall conference.
Nabi's story illustrates the nature of the path a biotech company takes as it makes its way through research, development, clinical trials, the regulatory approval process and finally marketing. Launched in 1969, Nabi started out as a plasma-collection company. In the early 1990s, it shifted its focus to drugs for the immune system. One high-profile project was an immune therapy product designed to stop transmission of the HIV virus from mother to infant. After extensive clinical trials, the product was discontinued when studies showed that AZT drug therapy alone reduced the rate of mother-to-infant HIV transmissions to almost zero.
Today, Nabi focuses on bacterial infections that patients pick up in hospitals. McLain says that after a long period in which the mortality rate from these infections was only 5%, it is increasing because some infections are becoming resistant to antibiotics. The issue is attracting media attention in developed countries. In the recent British parliamentary elections, the opposition Conservative Party charged that the number of deaths from hospital infections was greater than the number of traffic deaths each year. In the U.S., the Centers for Disease Control reports that studies show between five and 10 infections for every 1,000 patient days in the hospital.
Nabi has two products in its pipeline designed to prevent infections and treat them in conjunction with antibiotics. StaphVAX, which the company has been working on for a decade, is in the final stages of phase III clinical trials -- the final research and development before gaining regulatory approval. Patients would be given StaphVAX seven to 10 days before entering the hospital for surgery, an IV line or other invasive procedure to protect them from infection. Earlier this year, Nabi applied to the European Medicines Agency for a license, and McLain says Nabi plans to submit its license application to the U.S. Food and Drug Administration by the end of 2005.
The second product, Altastaph, would be given to patients after they enter the hospital for immediate protection. It also would be used with antibiotics to treat patients who did pick up a bacterial infection. Altastaph is going through phase I and II clinical trials.
An unrelated product in Nabi's pipeline is NicVAX, a vaccine to treat nicotine addiction.
"Florida has a lot going for it," says Nabi CEO Thomas McLain.
Funding much of this research is the cash from three products currently on the market: Nabi-HB, a plasma-based product that contains antibodies to the hepatitis B antigen; Aloprim, a drug for oncology patients who have elevated blood uric acid levels; and PhosLo, a drug to control high serum phosphorus levels in patients with end-stage renal failure. The company projects revenue between $137 million and $142 million for 2005, with $88 million to $91 million coming from biopharmaceutical products and the remainder from plasma and related products.
McLain is upbeat about Nabi and the future of biotech in Florida. "Florida has a lot going for it," he says, noting the state's universities and pool of entrepreneurs. But as a reminder that biotech research and development successes don't happen overnight, he notes, "To bring a drug forward, it's a 12- or 15-year process."