Chief of Staph - Pharmaceutical Executive


Chief of Staph
Many said it couldn't be done, but one small company is about to get a step ahead of one giant killer bug.

Pharmaceutical Executive

Dialysis Risk Continuum
In fact, in the ongoing Phase III study, patients are being followed for eight months after their first dose of vaccine to ensure efficacy. At the eight-month point, they will get a booster shot to see, within the following four months, how it restores protective levels. But while that research continues, Nabi has already figured out another way to protect patients who, even if they are re-infected, can get immediate treatment. Currently in Phase II trials and designated as an orphan drug by FDA, its passive immunity-conferring Altastaph antibody product, is designed to serve the needs of renal failure patients throughout the typical progression of their disease and treatment. (See "Dialysis Risk Continuum")

Progress and Potential Like any well-conceived lifecycle management plan, Nabi's R&D program is filled with studies examining new indications for currently marketed and experimental products. The company launched a UK-based trial studying StaphVax in orthopedic and cardiothoracic surgical patients and a head-to-head study that pits PhosLo against Genzyme's Renagel, its main competitior, in pre-dialysis patients. This year, McLain says Nabi will take on new research on Staph epidermidis infections, another bacteria prevalent on the skin of hospitalized patients including neonates and diabetics, and then, enterococcal infections.

Henrik S. Rasmussen, MD, PhD After earning a medical degree and doctorate in cardiology at the University of Copenhagen in Denmark, Rasmussen went on to work for 15 years (and counting) in clinical research and regulatory leadership positions at companies including GenVec, British Biotech, and Pfizer. Words of wisdom: "It may be more important do develop a rapport with site coordinators than physicians to be competitive in patient recruitment."
As positive as the analysts and physicians are about the potential of Nabi's nephrology franchise, they are relatively skeptical about Nabi's nicotine vaccine, NicVax. NicVax, a conjugate nicotine vaccine, blocks nicotine from crossing the blood-brain barrier, which removes the pleasurable sensation that smokers experience. Nabi's theory is that by eliminating that feeling, people who want to quit get vaccinated and are "immune" to the effects of nicotine for about a year. At that point, a broader smoking cessation program would help them kick their habit for good.

The product potentially serves an enormous market, but that, critics say, is the problem. "Given the financial resources and capabilities of Nabi," says Bear Sterns' Schoenbaum, "we do not see this program moving forward until the company signs a partnership with a large pharmaceutical company which could sponsor additional clinical trials and which has the infrastructure to market to a large number of primary care physicians."

That opinion isn't surprising to McLain, who admits that the search for viable partnerships is still in an active phase. He says, "We are in a fortunate position with NicVax in that with the expectation that we'll have continued funding from the National Institute on Drug Abuse (NIDA), it allows us to wait for the right business relationship rather than having to accept any business relationship. That's a nice part of what we've built by working with NIDA."


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