-- Kedrion to Assume Product Development Costs; Nabi Biopharmaceuticals
Garners Milestone and Royalty Payments; Agreement Aligned with Nabi
Biopharmaceuticals' Strategic Direction and Goals --
BOCA RATON, Fla., June 29 /PRNewswire-FirstCall/ -- Nabi
Biopharmaceuticals (Nasdaq: NABI) today announced that it has secured an
agreement with Kedrion S.p.A., a global biopharmaceutical company, located
in Lucca, Italy. Under the terms of the agreement, Nabi Biopharmaceuticals
and Kedrion will pursue a common strategy to develop and commercialize
Civacir(R) [Hepatitis C Immune Globulin (Human)] in Europe and the U.S.,
with Kedrion being Nabi Biopharmaceuticals' exclusive licensee to
commercialize Civacir in Europe. Civacir is Nabi Biopharmaceuticals'
plasma-derived, polyclonal antibody product candidate, which, when
approved, would be the first therapy for the prevention of the recurrence
of hepatitis C-related liver disease in HCV-positive liver transplant
recipients, or in patients who receive an HCV- positive liver. In addition
to milestone and royalty payments to be paid to Nabi Biopharmaceuticals,
Kedrion will assume development costs for the product candidate in both
Europe and the U.S. through at least Phase II clinical trials.
"This agreement represents a major funding event for Nabi
Biopharmaceuticals. It is also a validation of the clinical and commercial
potential of the Civacir program. This agreement marks a successful
achievement of a stated company objective to form strategic partnerships to
advance our pipeline programs," stated Thomas H. McLain, chairman, chief
executive officer and president, Nabi Biopharmaceuticals. "Kedrion is the
recognized leader in plasma-derived products in Italy and is helping to
drive the evolution of the broader marketplace within Europe for these
products. Kedrion's leadership role in this transformation provides us with
a rare and exciting opportunity to speed the clinical and commercial
advancement of Civacir across Europe and does so in a way that is
financially advantageous to Nabi Biopharmaceuticals. We are thrilled to
begin this partnership with Kedrion and believe that it may afford us the
chance to explore other, mutually beneficial collaborations between our two
companies."
Mr. McLain continued, "This agreement is aligned with our 2006 to 2008
growth strategy, focused on optimizing the value of current operations,
building incremental value through strategic partnerships and commercial
alliances, and demonstrating proof-of-concept through clinical studies for
key programs in our pipeline. We look forward to readily advancing this
program in collaboration with Kedrion."
Paolo Marcucci, President and Managing Director, Kedrion S.p.A.,
stated, "While the number of vulnerable patients continues to rise, there
remains no commercially available products that can be dosed safely at the
time of transplant or immediately after transplant in hepatitis C-positive
liver transplant recipients. We believe that Civacir, if approved, would
fill a critical and growing void in viable treatment options for
HCV-positive liver transplant recipients and patients who receive an
HCV-positive liver. We are
looking forward to developing this clinically and commercially
important product with Nabi Biopharmaceuticals."
Gary L. Davis, M.D., Director, Division of Hepatology, Medical
Director, Liver Transplantation, Baylor Regional Transplant Institute,
Baylor University Medical Center, stated, "There is an unmistakable need
for a new approach to preventing the recurrence of hepatitis C-related
liver disease in HCV-positive liver transplant recipients. It is well
established that currently approved therapies have minimal efficacy in
treating this population and that the inevitable re-infection of the liver
leads to an increase in a number of serious health risks, most concerning
of which is loss of the transplanted organ. The polyclonal antibody
approach of Civacir, either alone or in combination with new antiviral
agents that may be developed in the future, is a potential way to
neutralize the numerous strains of hepatitis C virus that exist and the
dire health consequences that they cause."
Next Steps: Civacir Development Program
Under the terms of the agreement announced today, Nabi
Biopharmaceuticals and Kedrion will jointly oversee the development and
registration of Civacir in Europe and will work collaboratively on the
design and implementation of the Phase II clinical trial for Civacir, which
will be conducted in Europe and the U.S. The trial is planned to be
initiated in the second half of 2006.
With positive results from the Phase II trial, the two companies would
then collaborate on the development of a pivotal Phase III trial for
Civacir. The pivotal study would also be conducted in the U.S. and Europe.
It is expected that the results of this 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 United States.
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 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. Civacir also has Orphan Drug
Status in the United States. This provides a seven-year period of market
exclusivity in the United States when the product is approved.
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.
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 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
http://www.kedrion.com
CONTACT:
Thomas E. Rathjen, Vice President, Investor
Relations, of Nabi Biopharmaceuticals, +1-561-989-5800
|
