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FDA committee favors Nabi hepatitis B drug for Post-Transplant
  Washington Business Journal - 12:04 PM EDT Friday
by Neil Adler
Staff Reporter
A Nabi Biopharmaceuticals drug frequently prescribed off-label by doctors may soon get an official approval from federal health regulators.
In a dose of good news for Nabi, which has taken its share of hits lately, a committee of the Food and Drug Administration has voted 9- 2 to recommend approval of the company's intravenous treatment to prevent the recurrence of hepatitis B in patients who have received liver transplants.
Nabi currently sells a non-intravenous product to provide protection from infection after accidental exposure to hepatitis B.
This drug, called Nabi-HB, is also used off-label in liver transplant patients at risk for re-infection. Off-label refers to the legal use of a prescription drug to treat a disease for which the drug has not been approved by the FDA.
Executives with Nabi (NASDAQ: NABI) -- which is based in Boca Raton, Fla., and has research and development operations in Rockville -- say the positive opinion from the blood products advisory committee bodes well for the drug's future in an intravenous form. The FDA in many instances follows the recommendations of its committees, though it is not obligated to do so.
The Centers for Disease Control and Prevention estimates that there are 8,500 new hepatitis B infections a year in the United States and 5,000 individuals who die annually from the virus or its complications. About 6,000 liver transplants are conducted a year, of which 200 to 250 are due to hepatitis B.
Nabi took a hit late last year when its promising vaccine for staph infections, which many expected to become a blockbuster product, failed in a second round of late-stage testing. Nabi is attempting once more to get this vaccine approved, in addition to other preclinical and clinical products in its pipeline.
Nabi Biopharmaceuticals Receives Positive Opinion from FDA Blood Products Advisory Committee for Nabi-HB(TM) Intravenous
Press announcement from company. Thursday July 13, 3:17 pm ET
- Positive Opinion Represents Critical Step Forward Toward Product Approval; Committee Finds Nabi-HB Intravenous Safe and Efficacious -
- The Committee Voted 9 to 2 in Favor of Recommending Approval of Nabi-HB Intravenous for the Prevention of Recurrence of Hepatitis B Following a Liver Transplant -

ROCKVILLE, Md., July 13 /PRNewswire-FirstCall/ -- Nabi Biopharmaceuticals (Nasdaq: NABI - News) today announced that the Blood Products Advisory Committee (BPAC) of the U.S. Food and Drug Administration (FDA) rendered a positive opinion of the company's Biologic License Application (BLA) for Nabi-HB(TM) Intravenous [Hepatitis B Immune Globulin (Human) Intravenous] during its meeting today. The Committee voted to recommend approval of the use of Nabi- HB Intravenous for the prevention of recurrence of hepatitis B after liver transplant. The FDA generally follows the recommendations of its Advisory Committees, although it is not obligated to do so. Nabi Biopharmaceuticals submitted its BLA for Nabi-HB Intravenous in November 2002. Nabi-HB Intravenous has received Orphan Drug status in the United States.
The Committee voted 9 to 2 in favor of recommending approval of Nabi Biopharmaceuticals' BLA for Nabi-HB Intravenous, with 3 abstentions. Specifically, the Committee concluded that the data from Nabi Biopharmaceuticals' BLA supported the product candidate's safety and efficacy. This is an important step forward in validating the use of Nabi-HB in preventing recurrence of hepatitis B in liver transplant recipients. If Nabi- HB Intravenous is ultimately approved by the FDA, it would be the only product available in the U.S. indicated for the protection of the transplanted liver from HBV infection in HBV-positive liver transplant patients.
The U.S. Centers for Disease Control (CDC) currently estimates that in the U.S. there are approximately 1.2 million chronic hepatitis B carriers, 8,500 new hepatitis B infections per year, and 5,000 individuals who die annually from hepatitis B or its complications. A total of approximately 6,000 liver transplant procedures are conducted each year in the United States, of which 200 to 250 are due to hepatitis B.
Thomas H. McLain, chairman, chief executive officer and president, Nabi Biopharmaceuticals, stated, "We are thrilled with the recommendation from BPAC. This decision is a positive one both for our company and for HBV- infected patients, who are in dire need of protection from re-infection. We also view this as an affirmation of the importance and significant potential of our hepatitis B program and further validation of our underlying strategy to invest in our transplant franchise. We expect Nabi-HB Intravenous to be ultimately approved by the FDA. That approval will provide Nabi Biopharmaceuticals with an increased cash return that could positively contribute to strengthening our financial position as early as this year. This is fully aligned with our strategic goal to improve the cash return from operating assets."
Nabi-HB [Hepatitis B Immune Globulin (Human)], a non-intravenous form of the product, is currently licensed in the U.S. to provide protection from infection after accidental exposure to the hepatitis B virus. It is also used off-label in liver transplant patients at risk for re-infection and is acknowledged as the standard-of-care.
Dr. David K. Imagawa, MD, Ph.D., FACS, professor of clinical surgery, hepatobiliary and pancreas surgery, University of California, Irvine Medical Center, remarked, "While Nabi-HB is used extensively off-label to protect liver transplant patients from HBV re-infection, patients would benefit greatly from a standardization for the product's use. FDA approval for Nabi- HB Intravenous, if granted, would provide physicians with the information they need to provide their patients with the most beneficial treatment and dosing regimens both at the time of transplant and for long-term maintenance."
Henrik S. Rasmussen, MD, Ph.D., senior vice president clinical, medical and regulatory affairs, Nabi Biopharmaceuticals, stated, "When left untreated, HBV-infected patients face an almost universal rate of recurrence of HBV infection following liver transplant. Moreover, the re-infection is often more aggressive in these patients than the original infection, likely due to the immune suppressive treatment these patients receive to avoid rejection of the transplanted liver. The clinical data we have compiled demonstrate the benefits of using Nabi-HB at the time of transplant and on a maintenance basis for long-term prevention of recurrence. We look forward to continuing to work with the FDA as we move forward in the approval process for this product candidate, as well with the American Liver Foundation, the Hepatitis B Foundation and other key third parties, which have provided us with important input and guidance during this process."
About Nabi-HB Intravenous
Nabi-HB Intravenous is a purified human polyclonal antibody product manufactured using plasma collected from donors who have been previously vaccinated with a hepatitis B vaccine. This plasma is sourced at Nabi Biopharmaceuticals' antibody collection centers and is manufactured at the company's state-of-the-art fractionation facility in Florida. When administered, the anti-hepatitis B antibodies contained in Nabi-HB Intravenous, bind to the hepatitis B virus and trigger its clearance by the body's immune system.
About Nabi Biopharmaceuticals
Nabi Biopharmaceuticals leverages its experience and knowledge in powering the immune system to develop and market products that fight serious medical conditions. The company has three products on the market today: PhosLo (calcium acetate), Nabi-HB [Hepatitis B Immune Globulin (Human)], and Aloprim(TM) (allopurinol sodium) for Injection. Nabi Biopharmaceuticals is focused on developing products that address unmet medical needs and offer commercial opportunities in our core business areas: Gram-positive bacterial infections, hepatitis and transplant, kidney disease (nephrology) and nicotine addiction. For a complete list of pipeline products, please go to: http://www.nabi.com/pipeline/index.php . The company is headquartered in Boca Raton, Florida. For additional information about Nabi Biopharmaceuticals, please visit our Web site: http://www.nabi.com .
Forward-Looking Statement
Statements in this press release about the company that are not strictly historical are forward-looking statements and include statements about our products in development, the market for such products, and regulatory approval of our product candidates. You can identify these forward-looking statements because they involve our expectations, beliefs, intentions, plans, projections, or other characterizations of future events or circumstances. These forward-looking statements are not guarantees of future performance and are subject to risks and uncertainties that may cause actual results to differ materially from those in the forward-looking statements as a result of any number of factors. These factors include, but are not limited to, risks relating to the company's ability to advance the development of products currently in the pipeline or in clinical trials; maintain the human and financial resources to commercialize current products and bring to market products in development; obtain regulatory approval for its products in the U.S., Europe or other markets; successfully develop, manufacture and market its products; successfully partner with other companies; realize future sales growth for its biopharmaceutical products; maintain sufficient intellectual property protection or positions; raise additional capital on acceptable terms; re-pay its outstanding convertible senior notes when due. Many of these factors are more fully discussed, as are other factors, in the company's Annual Report on Form 10-K for the fiscal year ended December 31, 2005 and Quarterly Report on Form 10-Q for the Quarter ended April 1, 2006 filed with the Securities and Exchange Commission.
Source: Nabi Biopharmaceuticals
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