-- Technology Expected to Give Company's Hyperimmune Product Candidates Key
Competitive Advantages: Increased Yield and Better Product Margins --
BOCA RATON, Fla., Aug. 29 /PRNewswire-FirstCall/ -- Nabi
Biopharmaceuticals (Nasdaq: NABI) today announced that it has obtained the
exclusive rights to use a novel hyperimmune immunoglobulin extraction
technology from ProMetic Life Sciences Inc., a global biopharmaceutical
company based in Montreal, Canada, in the manufacture of certain of Nabi
Biopharmaceuticals' pipeline hyperimmune products. Access to this
technology is expected to provide higher yields of Nabi Biopharmaceuticals'
Civacir(R) [Hepatitis C Immune Globulin (Human)] and Altastaph(R)
[Staphylococcus aureus Immune Globulin Intravenous (Human)]. Nabi
Biopharmaceuticals also has an option to use the technology with its
marketed product, Nabi-HB(R) [Hepatitis B Immune Globulin (Human)] and
Nabi-HB(TM) Intravenous [Hepatitis B Immune Globulin (Human) Intravenous],
as well as additional product candidates.
The agreement combines ProMetic's patented plasma proteins purification
technology with Nabi Biopharmaceuticals' expertise in the large-scale
development and manufacture of hyperimmune products. Nabi
Biopharmaceuticals expects to achieve a number of benefits through the
utilization of ProMetic's technology, including a more efficient
manufacturing process and higher product margins.
"The advantage of the ProMetic technology is that it affords Nabi
Biopharmaceuticals the ability to maximize the yield of specific
immunoglobulins from a liter of hyperimmune plasma, and, as a result,
reduces the cost of manufacturing and increases the capacity for production
of some its most promising product candidates," stated Raafat Fahim, Ph.D.,
senior vice president research, technical and production operations, Nabi
Biopharmaceuticals.
Thomas H. McLain, chairman, chief executive officer and president, Nabi
Biopharmaceuticals, stated, "This agreement exemplifies our commitment to
maximizing Nabi Biopharmaceuticals' core competencies and assets, including
our plasma collection centers and manufacturing facility. We look forward
to continuing to advance our hyperimmune product candidates, which we
believe hold strong commercial promise and for which there is a clear
clinical need."
About the Agreement
Under the terms of the agreement, Nabi Biopharmaceuticals obtains the
exclusive worldwide rights to use ProMetic's plasma fractionation
technology in the development of several of Nabi Biopharmaceuticals'
hyperimmune product candidates, including Civacir and Altastaph. In
addition, Nabi Biopharmaceuticals obtains an option for the exclusive North
American rights to this technology for use with Nabi-HB and in the
development of Nabi-HB Intravenous and certain possible product candidates.
Pierre Laurin, ProMetic's chief executive officer and president,
stated, "We are pleased to partner with one of the world's leaders in the
field of blood-derived products. Nabi HB has over 85 percent of the
anti-hepatitis B immunoglobulin U.S. market for the prevention of hepatitis
B re-infection in hepatitis B-positive liver transplant patients. We are
looking forward to helping, through our technology, in the treatment of
diseases for which there are few options available. We expect our Mimetic
Ligand(TM) technology will allow Nabi Biopharmaceuticals to obtain higher
recovery yields of specific hyperimmunes from plasma."
Nabi Biopharmaceuticals has previously assessed ProMetic's
fractionation technology on a pilot scale, which supports its belief that
the licensed technology can be used with larger-scale manufacturing
operations. These activities are aligned with the company's clinical
development strategy, which includes conducting "proof-of-concept" studies
to best inform and establish optimal Phase III programs.
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 Altastaph
Altastaph is an investigational human antibody-based product containing
antigens to S. aureus types 5, 8 and 336 and may provide protection against
S. epidermidis. Altastaph is being developed as a treatment for patients
with persistent S. aureus and S. epidermidis infections and those who do
not optimally respond to an antibiotic; a prophylaxis for patients (e.g.
ICU patients; emergency surgery patients; and neonates) who are at risk for
S. epidermidis and S. aureus infections; and a combination antibody and
vaccine regimen designed to prevent recurrence of these infections in
hospital patients.
About Nabi-HB Intravenous
Nabi-HB Intravenous is designed to prevent the re-infection of
hepatitis B disease in HBV-positive liver transplant patients. Nabi
Biopharmaceuticals filed a BLA with the U.S. Food and Drug Administration
(FDA) for this intravenous formulation of their marketed product, Nabi-HB.
If approved, this formulation 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 drug has received
Orphan Drug Status in the United States and the BLA has been granted
expedited review by the FDA.
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 its core business
areas: hepatitis and transplant, kidney disease (nephrology), 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 Nabi's website:
http://www.nabi.com.
About ProMetic Life Sciences
ProMetic Life Sciences Inc. is a biopharmaceutical company specialized
in the research, development, manufacture and marketing of a variety of
commercial applications derived from its proprietary Mimetic Ligand(TM)
enabling technology. This technology is used in large-scale purification of
biologics and the elimination of pathogens. ProMetic is also active in
therapeutic drug development with the mission to bring to market effective,
innovative, lower cost, less toxic products for the treatment of
inflammation and cancer. Its drug discovery platform is focused on
replacing complex, expensive proteins with synthetic "drug-like" protein
mimetics. Headquartered in Montreal (Canada), ProMetic has R&D and
manufacturing facilities in the UK and business development activities in
the U.S., Europe, Asia and MENA countries (Middle East and North Africa).
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 July 1, 2006 filed with
the Securities and Exchange Commission.
SOURCE Nabi Biopharmaceuticals
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Related links:
http://www.nabi.com/
CONTACT:
Thomas E. Rathjen, Vice President, Investor
Relations of Nabi Biopharmaceuticals, +1-561-989-5800
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