- Next Steps are Advisory Panel Meeting in U.S. and Compiling Stability
Data for Reformulated Product in Europe -
ROCKVILLE, Md., May 30 /PRNewswire-FirstCall/ -- Nabi
Biopharmaceuticals (Nasdaq: NABI) provided updates today on its progress
with regulators toward the licensure of its antibody product to prevent
re-infection with hepatitis B in liver transplant patients in the U.S. and
Europe.
U.S. Update: Nabi-HB(TM) Intravenous [Hepatitis B Immune Globulin
(Human) Intravenous]
The company announced that its Biologic License Application (BLA) for
Nabi-HB Intravenous will be reviewed and discussed by the Food and Drug
Administration's (FDA) Blood Products Advisory Committee (BPAC) at a
meeting scheduled for July 13, 2006 in Gaithersburg, Maryland. The BPAC
meeting represents the culmination of lengthy discussions between the FDA
and Nabi Biopharmaceuticals concerning the data that might be accepted to
support the BLA. BPAC is expected to render its view as to whether the BLA
for Nabi-HB Intravenous for the prevention of recurrence of hepatitis B
after liver transplant should be approved based on a combination of
prospective and retrospective clinical data. Nabi Biopharmaceuticals
believes that such data should be sufficient for approval given Nabi-HB's
widely accepted off-label use in liver transplant patients.
Currently, Nabi-HB(R) [Hepatitis B Immune Globulin (Human)] is licensed
in the U.S. to provide protection from infection after accidental exposure
to the hepatitis B virus. However, it is acknowledged as a standard-of-care
in liver transplant patients at risk for re-infection. Because this use of
the product is off-label, there are no FDA-approved guidelines for how such
a product should be dosed to optimize patient outcomes. If approved, the
intravenous formulation of Nabi-HB would be the only product in the U.S.
indicated for preventing re-infection of the transplanted liver in
HBV-positive patients. Previously, the FDA granted orphan drug designation
to Nabi-HB Intravenous. Nabi Biopharmaceuticals believes the BPAC meeting
will not only advance a thorough consideration of the relevant clinical
data, it will also provide the opportunity to establish clear standards for
how the product should be used in liver transplant patients. The company is
particularly encouraged about the outcome for this meeting because the same
clinical data set was acceptable for licensure in Europe.
Henrik S. Rasmussen, M.D., Ph.D., senior vice president clinical,
medical and regulatory affairs, Nabi Biopharmaceuticals, stated, "We
believe the benefits from using Nabi-HB in liver transplant patients have
been amply demonstrated in thousands of liver transplant patients. The
clinical data we have compiled supports using Nabi-HB at the time of
transplant, a time when no other drugs can be used effectively. The data
also demonstrate the importance of using Nabi-HB in combination with
anti-virals on a long-term maintenance basis to prevent re-infection. If
they approve the product's use in these patients, the FDA would be
providing physicians with the information they need to make the best
treatment and dosing decisions for their patients. In addition, we believe
this indication will build physician awareness and understanding about the
positive long-term prognosis for liver transplants in hepatitis B-positive
patients. That in turn may help to increase the numbers of patients helped
each year."
EU Update: HEBIG(TM) [Hepatitis B Immune Globulin (Human) Intravenous]
The company also announced that as a result of discussions about its
Marketing Authorization Application (MAA) for HEBIG with regulators of the
Reference Member State (RMS), it has made certain improvements in the
formulation of the product to comply with EU standards. As a result of this
agreement with regulators of the RMS, the company has voluntarily withdrawn
its MAA in Europe while it compiles 12 months of stability data for the
reformulated product. Nabi Biopharmaceuticals expects to resubmit its MAA
with this data during the first half of 2007. It is important to emphasize
that all other pieces of the MAA have already been reviewed and accepted by
the RMS and that the RMS has committed to an accelerated turn-around upon
re- submission of the MAA. The company believes that this new formulation
will yield several benefits for the intravenous product in Europe and the
U.S. These improvements will increase the product's shelf-life, benefiting
hospital pharmacies and product distributors. In addition, the formulation
changes are designed to enhance the product's safety profile by providing
additional viral inactivation benefits and further differentiating HEBIG
from other hepatitis B immune globulin products. Finally, these changes are
a first step in the company's 2006 program to capture yield improvements in
the production of polyclonal antibody products and product candidates like
Nabi-HB, Civacir(R) [Hepatitis C Immune Globulin (Human)], Altastaph(R)
[Staphylococcus aureus Immune Globulin Intravenous (Human)] and IVIG in its
biological manufacturing facility in Florida. When fully implemented, these
improvements are intended to leverage the value of the full supply chain
within Nabi Biopharmaceuticals, from sourcing plasma at its antibody
collection centers, through production in its plant, and finally to the
distribution of final products to hospitals and distributors in the U.S.
using its sales force.
Dr. Rasmussen continued, "The intravenous formulation of HEBIG will
provide competitive differentiation from other licensed products approved
in the European market today. Its launch in Europe will increase the
opportunity to leverage our integrated manufacturing platform. We are
encouraged that European regulators have offered that, upon this
resubmission, the MAA will be granted an immediate and accelerated review,
as the other components of the application, that is the preclinical,
toxicological and clinical pieces, as well as other parts of the quality
dossier, have been reviewed and accepted by the regulators. We are
particularly pleased that the RMS agrees that the clinical data are
acceptable for licensure."
A Significant Medical Need
Nabi-HB Intravenous (U.S.) and HEBIG (Europe) are being developed to
prevent hepatitis B disease in HBV-positive liver transplant patients.
According to the World Health Organization (WHO), of the two billion people
who have been infected with HBV, more than 350 million have chronic
infections and are at high risk of death from cirrhosis of the liver and
liver cancer; and as a result, many of these patients are in need of a
liver transplant. Recurrence of HBV infection following liver transplant is
almost universal if left untreated, and most often leads to rapid
deterioration of liver function, often resulting in death or the need for
re-transplantation. The U.S. Centers for Disease Control (CDC) currently
estimates that in the U.S. alone 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.
Thomas H. McLain, chairman, chief executive officer and president, Nabi
Biopharmaceuticals, stated, "Hepatitis B remains a serious, global
healthcare threat. The commitments from regulators that we have announced
today significantly advance our efforts to make this safe and efficacious
product available to patients in the U.S. and Europe. We believe that the
steps we will undertake for HEBIG will also build added value in this
important and highly needed product, and may even contribute to an
increased number of transplants that take place because of the benefits it
can provide to patients. In addition, the formulation enhancements will
advance our efforts to build the value of our integrated supply chain for
the manufacture and distribution of not only Nabi-HB and HEBIG, but also
our portfolio of high- value products including Civacir and Altastaph, as
well as IVIG."
Nabi-HB Intravenous and HEBIG are purified human polyclonal antibody
products 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 the product 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 and HEBIG bind to the hepatitis B virus and trigger its
clearance by the body's immune system.
Nabi-HB, currently marketed in the U.S., provides passive immunization,
or short-term protection, following exposure to the hepatitis B virus.
Nabi-HB is indicated for the treatment of:
* acute exposure to blood containing hepatitis B surface antigen (HBsAg)
* perinatal exposure of infants born to HBsAg-positive mothers
* sexual exposure to HBsAg-positive persons
* household exposure to persons with acute HBV infection
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 Website at:
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; 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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Related links:
http://www.nabi.com
http://www.nabi.com/pipeline/index.php
CONTACT:
Thomas E. Rathjen, Vice President, Investor
Relations, Nabi Biopharmaceutical, +1-561-989-5800
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