Hepatitis C Clinical Landscape and Need Aligned with Product Approach;
- Outside Scientific and Clinical Advisory Panel is being Formed -
ROCKVILLE, Md., Feb. 1 /PRNewswire-FirstCall/ -- Nabi Biopharmaceuticals
(Nasdaq: NABI) today announced important regulatory and clinical advancements
for its product candidate Civacir(TM) [Hepatitis C Immune Globulin (Human)],
an antibody for preventing Hepatitis C virus re-infection in liver
transplants. Civacir has been granted Fast Track Designation by the U.S. Food
and Drug Administration (FDA). Under the FDA Modernization Act of 1997, Fast
Track regulations facilitate the development of products that treat serious
diseases where an unmet medical need exists. Fast Track regulations are also
designed to expedite the review process for designated products, including the
potential for companies to ask for priority review.
The company also announced today that recent discussions with regulators
in the U.S. and EU have been very productive with respect to advancing the
development program for Civacir. Based on this important input, Nabi
Biopharmaceuticals believes that a proof-of-concept Phase II trial, followed
by a single pivotal Phase III study, would be adequate for licensure in the
U.S. and Europe, assuming that prospectively defined endpoints are met. The
Phase II proof-of-concept study will be designed to add to the knowledge of
how Civacir works and the levels of antibodies needed to protect the
transplanted liver from re-infection with the Hepatitis C virus.
In addition, Nabi Biopharmaceuticals announced today that consistent with
its overall approach to product development, it is establishing an outside
scientific and clinical advisory panel to work with the company on the Civacir
development program. The company believes that the input and guidance it
receives from the panel, combined with input from regulatory bodies in the
U.S. and Europe, will be valuable in advancing the regulatory, clinical and
commercial development path for Civacir and lead to the design of an optimal
Phase III pivotal trial for this first-of-its-kind product.
The Fast Track Designation is the latest in a number of regulatory
milestones achieved with Civacir by Nabi Biopharmaceuticals. In June 2005,
the company announced that it had gained Orphan Medicinal Product (OMP)
designation for Civacir 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. OMP designation in the EU was an important
milestone for Nabi Biopharmaceuticals, as it represents further validation for
the need for new treatment approaches in the care of HCV-positive liver
transplant patients. Civacir received orphan drug status in the U.S. in 2002.
Among other benefits of orphan drug designation, Civacir will be entitled to
seven years of market exclusivity in the U.S., post-launch, thereby preventing
a similar drug from receiving authorization for the same indication during
this period.
About Civacir
Designed to be the first therapy approved specifically for the prevention
of recurrence of Hepatitis C-related liver disease in HCV-positive liver
transplant recipients, or in patients who receive a HCV-positive liver,
Civacir has the potential to fill a critical void in treatment options for
this vulnerable patient population. Most notably, market research completed
by the company in 2005 supports growing physician awareness and support for
this potential new treatment alternative for HCV. This increased awareness is
due, in part, to the following factors:
* Currently, there are no products that can be dosed safely at the time of
transplant or immediately after transplant in hepatitis C-positive liver
transplant recipients; and as a result, transplanted livers universally
become re-infected;
* Current products and products under development for maintenance tend to
convey a poor risk-benefit ratio in liver transplant recipients; and
* Due to the variations in strains of the Hepatitis C virus, it is well
recognized that a polyclonal antibody approach is needed; a monoclonal
antibody is unlikely to be effective.
HCV is the most common chronic blood-borne infection in the U.S. and a
leading cause of end-stage liver disease resulting in liver transplantation.
Interferon and ribavirin, currently available treatments, have demonstrated
limited efficacy in chronically infected HCV patients. Furthermore, these
therapies cannot be used to protect liver transplant patients from HCV re-
infection after surgery and are considered too toxic for immune-suppressed
liver transplant patients. As a result, among chronic HCV patients who
undergo liver transplantation, HCV recurrence in the transplanted liver is
nearly universal(1). In addition, associated severe side effects often lead
to dose reductions and discontinuation of treatment.
Henrik S. Rasmussen, M.D., Ph.D., senior vice president clinical, medical
and regulatory affairs, Nabi Biopharmaceuticals, stated, "The Fast Track
Designation provided by the FDA not only acknowledges Civacir as a viable
potential treatment option for HCV patients, but it also recognizes that
current therapies are inadequate. Nabi Biopharmaceuticals has engaged in
extensive and productive discussions with the FDA and the European Medicines
Agency regarding the optimal development path for Civacir. The guidance we
have received from these organizations and other third parties will be
critical factors in the future development of Civacir. Based on input
received so far, we plan to initiate a larger dose-ranging proof-of-concept
Phase II study later this year."
Next Steps: Civacir Development Program (Phase II Proof-of-Concept Study)
Nabi Biopharmaceuticals plans to initiate a Phase II proof-of-concept
study for Civacir in the second half of 2006. This timing is aligned with our
goal to have the clinical lot of Civacir manufactured by October 2006, a
critical and required step before trial initiation. It is also important to
note that Nabi Biopharmaceuticals has developed important technical know-how
through a unique and safe production process for Civacir that allows for the
separation of high-quality antibodies from patients infected with Hepatitis C.
We believe this timing and product development approach will support our
goals of completing enrollment within twelve months, and, subsequently, having
data available in the second half of 2008.
The trial will be designed as a double-blinded, placebo-controlled study
in approximately 100 HCV-positive patients, post-liver transplant (3 active
dose levels, 100, 200 and 400mg/kg, 25 patients per group). The endpoints of
the trial are: progression of liver fibrosis; liver enzyme levels; and safety
and tolerance. Nabi Biopharmaceuticals plans to conduct the trial in the U.S.
and EU.
Thomas H. McLain, chairman, chief executive officer and president, Nabi
Biopharmaceuticals, stated, "Civacir is an important and strategic part of
Nabi Biopharmaceuticals' product portfolio and our global hepatitis franchise.
Civacir leverages assets and competencies within Nabi Biopharmaceuticals
today, including our expertise in plasma collection, manufacturing, clinical
and regulatory, and sales and marketing, and it builds upon our commercial
success with Nabi-HB(R) [Hepatitis B Immune Globulin (Human)] the current gold
standard for Hepatitis B. Combined, Civacir and our Nabi-HB product,
currently marketed for the prevention of HBV infections following acute
exposure, could represent better medical care for patients and a reduction in
healthcare dollars spent on additional transplants. Nabi Biopharmaceuticals
remains committed to advancing this clinically and commercially important
global franchise."
About Liver Transplants and Hepatitis C
There are approximately 6,000 liver transplants conducted yearly in U.S.
and 4,000 in the EU, the majority of which are due to Hepatitis C.
Furthermore, the proportion of transplants due to Hepatitis C is expected to
increase as other causes of end-stage liver disease decrease (i.e., Hepatitis
B).
Hepatitis C is the most common cause of end-stage liver disease in the
developed world. Most transplant patients, because of their immunocompromised
status, suffer immediate re-infection of the liver, which in many cases will
progress to liver cirrhosis and can eventually result in death or the need for
a re-transplantation. The U.S. Centers for Disease Control and Prevention
(CDC) estimates that approximately three million individuals in the U.S. are
chronically infected with HCV, and the World Health Organization (WHO)
estimates that 170 million individuals worldwide are infected with HCV. The
virus can be transmitted through blood transfusion, organ transplants,
intravenous drug use, kidney dialysis and sexual contact.
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. We are focusing on developing products addressing commercial
opportunities in our core business areas: Gram-positive bacterial infections,
hepatitis, kidney disease (nephrology), and nicotine addiction. We have 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)] and a number of products in various stages of clinical and
pre-clinical development. The company also filed Marketing Authorization
Applications (MAA) in Europe to market Nabi-HB(R) Intravenous [Hepatitis B
Immune Globulin (Human) Intravenous] under the trade name HEBIG(TM) for the
prevention of hepatitis B disease in HBV-positive liver transplant patients;
and for PhosLo, which is already marketed in the United States. The company's
products in development include NicVAX(TM) (Nicotine Conjugate Vaccine), a
vaccine to treat nicotine addiction, and Civacir(TM) [Hepatitis C Immune
Globulin (Human)], an antibody for preventing hepatitis C virus re-infection
in liver transplant patients. For additional information on Nabi
Biopharmaceuticals, please visit our website: http://www.nabi.com.
This press release contains forward-looking statements that reflect the
company's current expectations regarding future events. Any such forward-
looking statements are not guarantees of future performance and involve
significant risks and uncertainties. Actual results may differ significantly
from those in the forward-looking statements as a result of any number of
factors, including, but not limited to risks relating to the company's ability
to: advance the development of products currently in the pipeline or in
clinical trials; complete the assessment of the StaphVAX Phase III clinical
trials during the first half of 2006; 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. or other
markets; successfully develop manufacture and market its products; utilize the
full capacity of its manufacturing facility; realize the value of its
acquisition of PhosLo; realize sales from Nabi-HB due to patient treatment
protocols and the number of liver transplants performed in HBV-positive
patients; realize the value from its vaccine manufacturing facility; realize
future sales growth for its biopharmaceutical products; prevail in patent
litigation; raise additional capital on acceptable terms; re-pay its
outstanding convertible senior notes when due; and the company's dependence
upon: third parties to manufacture its products and a small number of
customers. 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 25, 2004 filed with the Securities and Exchange Commission.
(1) U.S. Department of Health and Human Services. Management of Hepatitis
C: 2002. NIH Consensus State Sci Statements. National Institutes of
Health, 2002 Jun 10-12; 19 (3) 1-46
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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