Chief of Staph - Pharmaceutical Executive

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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


McLain went on to lead a team responsible for divesting Nabi of most of its 56 plasma collection centers in 2001. "Because the biopharmaceutical business supported itself, we could take that strategic action," he explains. The transaction, which brought in $153 million, allowed Nabi to pay its debt obligations and make a fresh beginning. "We really began to redefine clearly what we were about and what our future was," says McLain. "We built the business model, and we have adhered to it ever since."

The remaining nine centers collect plasma and use it to produce purified antibody products—the foundation of the Nabi-HB hepatitis B virus antibody business, which brought in about $40 million in 2004. While not a core business, antibody production generates revenue from sales to companies including Bayer, AmerisourceBergen, and Cardinal Health. It also produces the antibodies for Nabi's investigational Civacir (Hepatitis C immune globulin), which the company hopes will help keep liver transplant patients virus-free after surgery.

In 2003, Nabi acquired Braintree Labs' PhosLo, a treatment for elevated blood phosphate levels in patients with end-stage renal disease (ESRD)—which is approved for Medicaid reimbursement. The acquisition launched the nephrology franchise on which the company's entire future hinges.

The franchise, although niche, promises to be lucrative. Not only do an aging population and increase in the prevalence of diabetes portend growth in the population of kidney disease patients, but since 1973 all patients with chronic kidney failure requiring dialysis, no matter what their age, have automatically been covered by Medicare. In addition, PhosLo's key role in treating a common condition among kidney failure patients boosted the visibility of Nabi's sales force with nephrologists worldwide—and will almost certainly get them through the door when the company brings to market its first-of-its-kind pipeline star, StaphVax, and its Phase II, orphan-designate adjuvant staph antibody treatment Altastaph.

"StaphVax will remake us as a company," says McLain. "And because that is the transforming event and has not happened yet, we are in a unique position to define ourselves and how we will do business. There are best practices in other pharmaceutical and biotech companies that we hope to draw on, but what is unique about us is we can create a business model that is not burdened by history, that is not burdened by old treatment patterns, old reimbursement schemes, old regulatory approaches.

"We are building a company that is focused on where the pharmaceutical industry is headed. So with an understanding of that, what we are doing is building a new business model, what we hope will become a new model for the biopharmaceutical investor and something that will make us unique in our space. But I also think it would put us in a position for unparalleled success, because we will be the company designed with the future in mind."


Lure of the Emerald Isle
The combination of exceptional strategic planning and cash in hand not only sets Nabi apart in the eyes of the financial community, but also instills the company's leaders with a sense of security and momentum that will enable them to grow even more as a fully integrated R&D, manufacturing, and commercial operation. And they're already well on their way—with the opening of a brand new European headquarters in Bray, Ireland announced in May, Nabi will be able to hit the ground running with StaphVax. (See "Lure of the Emerald Isle.) The company has already filed for EMEA approval for StaphVax use in ESRD patients, and analysts expect that to come through later this year. In the United States, Phase III clinical trials have been capturing the attention of not only the financial community, but the medical community as well; a BLA filing is expected by the end of 2005.

Resistance Assistance Fred E. Husserl, MD, FACP, director of clinical services, nephrology, at the Ochsner Clinic Foundation in New Orleans can testify to the particular importance of a staph vaccine for the approximately 180,000 patients on dialysis nationwide today. And while that seems like a relatively small market, the need is so overwhelming it seems incredible that a vaccine hasn't been developed already.


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