- 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) 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(R) [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(R) (calcium acetate), Nabi-HB(R) [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
 back to top
Related links:
http://www.nabi.com
http://www.nabi.com/pipeline/index.php
CONTACT:
Thomas E. Rathjen, Vice President, Investor
Relations, Nabi Biopharmaceuticals, +1-561-989-5800
|
