- First Therapy Being Developed Specifically for the Prevention of the
Recurrence of Hepatitis C-Related Liver Disease in Liver Transplant
Recipients-
BOCA RATON, Fla., Jan. 16 /PRNewswire-FirstCall/ -- Nabi
Biopharmaceuticals (Nasdaq: NABI) announced today that it has initiated its
Phase II "proof-of-concept" clinical trial for Civacir(R) [Hepatitis C
Immune Globulin (Human)]. Civacir, the company's plasma-derived, polyclonal
antibody product candidate, when approved, would be the first therapy for
the prevention of the recurrence of hepatitis C-related liver disease in
hepatitis C virus (HCV) positive liver transplant recipients, or in
patients who received an HCV-positive liver. Currently, there are no
marketed therapies specifically indicated for prevention of re-infection
post-liver transplant in HCV-positive patients. The trial marked another
critical milestone being met by the company.
Nabi Biopharmaceuticals is co-developing Civacir with Kedrion S.p.A., a
global biopharmaceutical company, located in Lucca, Italy. Kedrion is fully
funding the costs of the clinical trials and is also funding some of the
costs of manufacturing Civacir for use in the trial. The two companies will
pursue a common strategy to develop and commercialize Civacir in Europe and
the U.S., with Kedrion being Nabi Biopharmaceuticals' exclusive licensee to
commercialize Civacir in Europe. In addition to assuming the majority of
the funding for the clinical trials and clinical materials in Europe and
the U.S., Kedrion will pay milestone and royalty payments to Nabi
Biopharmaceuticals.
Thomas H. McLain, chairman, chief executive officer and president, Nabi
Biopharmaceuticals, stated, "Civacir is uniquely positioned to fill a
critical gap in the care of liver transplant patients by preventing
re-infection with hepatitis C during a period after surgery when other
therapies cannot be used. If we are successful, this product will become a
very important part of our global transplant franchise and product
portfolio. Certainly, initiating this Phase II 'proof-of-concept' trial is
an important milestone for us and our partner, Kedrion. But this trial also
represents an important milestone for advancing clinical knowledge in an
area of significant, unmet medical need. We are pleased to be partnering
with Kedrion, who is contributing important knowledge and resources to this
program. Through our strategic partnership, we expect to conduct this and
future clinical trials for Civacir in a way that is faster and at the same
time much less costly for Nabi Biopharmaceuticals."
About Hepatitis C
Each year there are approximately 5,000 liver transplant procedures
performed in the U.S. and of those approximately 2,000 are due to HCV(1).
Considering the prevalence of hepatitis C in the U.S. and Europe, and the
size of the medical need, Civacir could develop into a significant product
in a global market estimated at $400 million(2). Available therapies have a
poor efficacy and safety profile and re-infection of the transplanted liver
is almost universal. These infections often result in complications, the
most serious of which is the re-development of end-stage liver disease,
which in turn can lead to the need for a re-transplant or death. Currently,
none of these therapies are specifically indicated for prevention of
re-infection post-liver transplant in HCV-positive patients.
Henrik S. Rasmussen, M.D., Ph.D., senior vice president, clinical,
medical and regulatory affairs, Nabi Biopharmaceuticals, stated, "There is
a significant medical need to prevent the recurrence of hepatitis C-related
liver disease in HCV-positive liver transplant recipients. The polyclonal
antibody approach of Civacir, either alone or in combination with new
antiviral agents that may be developed in the future, has the potential to
neutralize the numerous strains of hepatitis C virus that exist and the
dire health consequences that they cause. Hence, we are very excited about
the initiation of this 'proof-of-concept' study."
About the Phase II "proof-of-concept" Trial
The Civacir Phase II "proof-of-concept" trial is a randomized,
controlled study involving 30 patients in a 2:1 randomization, with 20
patients allocated to Civacir at a dosage of 400mg/kg vs. 10 patients
receiving standard-of-care. The primary endpoints are progression of liver
fibrosis on biopsies as well as HCV levels in liver and serum. The
secondary endpoints include liver enzymes as well as safety and tolerance.
The company expects to complete enrollment in the second half of 2007, with
the results being announced in the second half of 2008.
The protocol for the current trial was developed through consultation
with regulators in the U.S. and Europe and work with an outside advisory
panel. The trial design is based upon an understanding of what would be
evaluated in a Phase III study. The current Phase II "proof-of-concept"
trial was sized to allow the results to demonstrate the therapeutic benefit
of the drug candidate prior to initiating a Phase III studies. Product used
in the trial was manufactured in Nabi Biopharmaceutical's Boca Raton,
Florida facility at commercial scale.
Next Steps: Civacir Development Program
Based on positive results from the Phase II trial, Nabi
Biopharmaceuticals and Kedrion would then collaborate on the development of
a pivotal Phase III trial for Civacir. The pivotal study is expected to be
conducted in the U.S. and Europe. It is also expected that the results of a
single Phase III trial, if positive, would be sufficient to obtain the
regulatory approvals needed for Kedrion to market Civacir in Europe and for
Nabi Biopharmaceuticals to obtain regulatory approval to market the product
in the U.S.
About Civacir
Civacir is an investigational human polyclonal antibody product that
contains antibodies to the hepatitis C virus (HCV). In February 2006, Nabi
Biopharmaceuticals announced that Civacir had been granted Fast Track
Designation by the U.S. Food and Drug Administration (FDA). This
designation facilitates the development of products that treat serious
diseases where an unmet medical need exists. Civacir also has Orphan Drug
Status in the U.S. which for provides a seven-year period of market
exclusivity in the U.S. when the product is approved. Civacir has also
gained Orphan Medicinal Product (OMP) designation in Europe. If a product
with OMP designation is the first to receive marketing authorization in
Europe for its designated indication, the product will be entitled to
10-year market exclusivity, thereby preventing a similar drug from
receiving authorization for the same indication during this period.
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 two products on the market
today: 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: Hepatitis and transplant,
Gram-positive bacterial infections 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.
About Kedrion S.p.A.
Kedrion is a biotechnology company specializing in the development,
production and distribution of plasmaderivatives. In Italy, Kedrion is the
main reference point for the National Health Service as regards the
production of plasma-derived drugs. Moreover, its skills are also put to
use in strategic partnerships with overseas health services. The quality of
its products, its continuous commitment to research and development, its
consistent industrial capacity and its consolidated presence on the
national and international market are the company's main areas of
competitiveness. Kedrion SpA is the parent company of a group comprising:
Hardis SpA, Haemopharm, Advanced Bioservices LLC. It is located in
Castelvecchio Pascoli, in the province of Lucca, Tuscany, and has two
production plants, Kedrion Bolognana, in the vicinity of Lucca and Hardis
S. Antimo, in the vicinity of Naples. Kedrion is characterized by its focus
on the international scene and its commitment to improving its local
plants. The specific assets of the various companies allow Kedrion to offer
partner companies and health institutes a complete and integrated approach
within the field of plasmaderivatives. Thanks to these assets, Kedrion is
able to manage the entire plasma processing cycle, from its acquisition to
the distribution of plasma-derived products, including logistical support
services. Kedrion's operations cover three different areas of business:
production and distribution of plasma-derived products (it produces
plasma-derived drugs and virus deactivated plasma and it also distributes
flu vaccines), Contract Manufacturing (working with the National Health
Service, Kedrion receives the plasma from the regions and transforms it
into drugs that are redistributed to the regions in order to respond to the
population's therapeutic requirements), transfer of technological know how
(by means of international partnerships, it offers its technological know
how concerning two main activities, the construction of plasma-derived
product production plants and the transfer of technological production
processes). Its Website is http://www.kedrion.com.
Forward-Looking Statements
Statements in this press release about the company that are not
strictly historical are forward-looking statements and include statements
related to our plans to explore strategic alternatives and prospects. 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; and
identify and complete transactions that represent strategic alternatives
and opportunities. 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 September 30, 2006 filed with the Securities and Exchange
Commission.
(1) Schiano TD, Martin P. Management of HCV Infection and Liver
Transplantation. Int J Med Sci 2006; 3:79-83.
http://www.medsci.org/v03p0079.htm.
Brown RS. Hepatitis C and liver transplantation. Nature. 2005
436:973-8.
Davis GL, Albright JE, Cook SF, Rosenberg DM. Projecting future
complications of chronic hepatitis C in the United States. Liver
Transpl. 2003 9:331-8, El-Serag HB. Hepatocellular carcinoma: recent
trends in the United States. Gastroenterology. 2004 127:S27-34.
(2) LEK Market Analysis 2005, commissioned by Nabi Biopharmaceuticals
SOURCE Nabi Biopharmaceuticals
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Related links:
http://www.nabi.com
http://www.nabi.com/pipeline/index.php
http://www.kedrion.com
http://www.medsci.org/v03p0079.htm/
CONTACT:
Thomas E. Rathjen, Vice President, Investor
Relations of Nabi Biopharmaceuticals, +1-561-989-5800
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