- Agreement With Fresenius Biotech for Development and Marketing of
ATG-Fresenius S will Significantly Bolster Nabi Biopharmaceuticals'
Transplant Franchise -
BOCA RATON, Fla., April 3 /PRNewswire-FirstCall/ -- Nabi
Biopharmaceuticals (Nasdaq: NABI) today announced that it has signed an
agreement with Fresenius Biotech to advance the development of ATG-Fresenius S
in the U.S. and Canada. ATG-Fresenius S is an immunosuppressive polyclonal
antibody product used for the prevention and treatment of acute rejection
following organ transplantation. The product, which Fresenius currently
markets in more than 60 countries worldwide, has been shown to significantly
reduce transplant failure and substantially improve survival rates.
Under the terms of the agreement, Fresenius Biotech has granted Nabi
Biopharmaceuticals exclusive sales and distribution rights to ATG-Fresenius S
in the U.S. and Canada for up to 15 years following the first commercial sale
of the product after licensure in the U.S. Nabi Biopharmaceuticals is
required to make aggregate milestone payments of $1 million to Fresenius
Biotech during development and a $4 million payment upon approval by the U.S.
Food and Drug Administration (FDA). Fresenius Biotech will manufacture and
supply the product from its European facility in exchange for a royalty. Nabi
Biopharmaceuticals will be responsible for the clinical development,
regulatory approval process, marketing and sales of ATG-Fresenius S in the
U.S. and Canada.
In January 2005, the FDA granted Fast Track Status for ATG-Fresenius S in
lung transplantation. As a result of its agreement with Fresenius Biotech,
Nabi Biopharmaceuticals will assume oversight of an ongoing randomized,
double-blind, placebo-controlled Phase III clinical study that is being
conducted in lung transplant patients in the U.S. and Europe. The company may
also undertake additional studies to expand the indications into other areas,
such as bone marrow transplantation. Based on the outcome of its upcoming
meeting with the FDA, and assuming all regulatory and clinical milestones are
met, Nabi Biopharmaceuticals expects to file its Biologics License Application
(BLA) for ATG-Fresenius S in early 2009.
Thomas H. McLain, chairman, chief executive officer and president, Nabi
Biopharmaceuticals, stated, "This agreement represents an exciting opportunity
for Nabi Biopharmaceuticals to leverage our proven strengths in marketing
specialized antibody products to commercialize a drug that has been used in
the treatment of more than 150,000 transplant patients around the world. It
is also an important step forward in our strategy to become a leading provider
of products that improve both the longevity and the quality of life of
transplant patients."
Dr. Thomas Gottwald, chief executive officer, Fresenius Biotech, stated,
"We are very pleased to have found an experienced partner in transplantation
medicine that can continue and expand the current clinical development program
of ATG-Fresenius S. Nabi Biopharmaceuticals created what today is a very
favorable commercial product in Nabi-HB, the current gold standard in the U.S.
for prevention of re-infection with hepatitis B in liver transplant patients."
Strategic Importance
Clinical Need
In 2004, over 26,000 solid organ transplants were conducted in the U.S.,
and solid organ transplants in the U.S. have been increasing at an annual rate
of four percent per year. More than 60 percent of these procedures involve
the replacement of a kidney and 23 percent are for liver transplants. Nabi
Biopharmaceuticals' transplant franchise is focused on addressing the
critical, unmet medical needs of this sizeable and growing population, and
ATG-Fresenius S is a highly complementary addition to the company's existing
product offering.
Competitive Product
A number of European-based studies conducted to date have shown that ATG-
Fresenius S targets the cells responsible for organ rejection better than
competing products. Nabi Biopharmaceuticals believes that the limited side
effects, better patient tolerance and convenient dosing regimen associated
with ATG-Fresenius S, will make it a highly attractive alternative to other
products that are currently on the market.
Professor Emeritus Dr. Walter Land, University Hospital Munich Grosshadern
in Germany, one of Europe's most highly-regarded transplant surgeons and a
leading international authority in the field of transplant medicine, said,
"ATG-Fresenius S is a safe and highly efficacious product that, in combination
with standard immunosuppressive drugs, significantly improves the long-term
survival prognosis of organ graft and transplant patients."
Low Risk/High Reward Potential
By drawing on its core competencies in the development, manufacture and
commercialization of polyclonal antibodies, as well as its strong
relationships with key opinion leaders, physicians, payers and patients across
the transplant community, Nabi Biopharmaceuticals is uniquely positioned to
maximize the considerable value-creation potential of ATG-Fresenius S in North
America. In addition, ATG-Fresenius S complements the company's existing
development infrastructure and leverages the value of existing internal
development resources.
The foundation of Nabi Biopharmaceuticals' transplant franchise is Nabi-
HB(R) [Hepatitis B Immune Globulin (Human)], a polyclonal antibody product
that is indicated to prevent hepatitis B infection following accidental
exposure to the hepatitis B virus, but is primarily used to prevent re-
infection with hepatitis B virus in HBV-positive liver transplant patients.
Nabi Biopharmaceuticals' complementary product, Civacir(R) [Hepatitis C Immune
Globulin (Human)], is being developed to prevent re-infection with the
hepatitis C virus in hepatitis C liver transplant patients. A Phase II proof-
of-concept clinical trial for Civacir is planned for the second half of 2006.
Mechanism of Action
In contrast to other immunosuppressive agents, ATG-Fresenius S works by
selective suppression of activated cells, which are responsible for the
rejection of transplanted organs. Transplant rejection occurs when the immune
system of the patient attacks the newly transplanted organ or tissue from
another donor. Rejection occurs because a normal healthy human immune system
can distinguish foreign tissues and attempts to destroy them.
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, 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 Fresenius Biotech GmbH
Fresenius Biotech GmbH is a company of the Fresenius Health Care Group,
focused on the development and marketing of biopharmaceuticals in the fields
of oncology, immunology and regenerative medicine.
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, clinical trials and
studies, intellectual property position, and alliances and partnerships. You
can identify these forward-looking statements because they involve our
expectations, beliefs, 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; realize future sales growth for
its biopharmaceutical products; secure patent positions and prevail in patent
litigation; raise additional capital on acceptable terms; and 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 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 Biopharmaceuticals, +1-561-989-5800
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