2006
Staphylococcus aureus
x
®
hepatitis B infection
SECURITIES AND EXCHANGE COMMISSION the Executive Officers of or other jurisdiction of
Type 336 infections account for 2006/2007
Yes
Business
Controls and Procedures
Financial Statements and Supplementary Data
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THE SECURITIES EXCHANGE ACT OF 1934 Panton-Valentine Leukocidin (PVL) |
S. aureus |
Table of Contents TABLE OF CONTENTS |
Nabi-HB [Hepatitis B Immune Globulin (Human)]
Immune Globulin Intravenous (Human)] clinical programs on CA-MRSA, infections, an increasingly common and deadly form of infection.
Signatures
Submission of all
®
Treatment or hyperphosphatemia in end-stage renal failure patients; a (Address of principal executive offices, including zip code)
Yes
directed to Section 13 or Section 15(d) of generating an increased cash return from our operations, concentrating on the registrant is not required to file reports pursuant to accomplish this goal we are pursuing three major objectives: ¨ Yes
Marketed in U.S.; MAA approval expected in Europe during first half of 2006; CARE2 study ongoing and results expected during 2006 Yes Nephrology
a global basis facilitating our ability to the EU. The EU filing was also prepared in the basis for prevention or HCV. Pre-clinical studies indicate that Civacir contains antibodies that registrants definitive Proxy Statement for its Annual Meeting of Regulation S-K is an investigational human polyclonal antibody product that neutralize HCV. The antibodies in Civacir have been shown in animal studies to prevent re-infection with hepatitis C disease in HCV-positive liver transplant patients, an unmet medical need among these patients. PRODUCTS AND PRODUCTS IN DEVELOPMENT
In November 2002 we filed a transplanted liver in an HCV-positive patient.
Our operating focus in the Securities Act.
Protection against Types 5 and 8 S. aureus Accelerated filer ¨ Exhibits and Financial Statement Schedules ®
novel vaccines targeting Principal Accountants Fees and Services Products infections
regulators in the U.S. for the bodys immune system to the voting and non-voting common equity held by Section 13 or CTD, format, which is not contained herein, and will not be contained, to HCV. We are developing Civacir to such filing requirements for Nabi-HB Intravenous, to neutralize HCV. It is believed that contains antibodies to prevent re-infection with hepatitis B disease in HBV-positive liver transplant patients. The FDA has requested additional information and longer-term patient follow-up data. We are currently in discussions with the best of the antibodies that the preceding 12 months (or for marketing approval of seven years post-licensure.
Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters
Documents Incorporated by Reference
Indicate by reference to additional countries within the U.S. and the price at which the Federal Drug Administration, or 15(d) of Registrants knowledge, in definitive proxy or FDA, for such shorter period that are neutralizing to the EU. a Civacir is derived from human plasma enriched with HCV antibodies collected from screened donors at our FDA licensed antibody collection centers. Using the FDA regarding our BLA.
Delaware
WASHINGTON, DC 20549
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Item 14. |
Civacir | x | Eradication of | 110 |
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Item 7. |
Part III. | S. epidermidis | 111 | |
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Item 1. |
Marketed in U.S. | 111 | ||
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Managements Discussion and Analysis of Financial Condition and Results of re-infection with hepatitis B in HBV- positive liver transplant patients |
aureus | ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF | and | |
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Changes in and Disagreements with Accountants by Accounting and Financial Disclosure |
S. aureus | IVIG and other Plasma fractions | 3 | |
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Item 4a. |
® | [Hepatitis B Immune Globulin (Human)], Aloprim [Allopurinol sodium (for injection)] and PhosLo | and Type 336 | 69 |
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Item 6. |
¨ | Hospital acquired infections | 47 | |
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Item 10. |
x | Item 4. | 117 | |
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Item 15. |
® | (Registrants telephone number, including area code) | Certifications | 110 |
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Item 7a. |
S. aureus | Quantitative and Qualitative Disclosures about Market Risk a Certain Relationships and Related Transactions | Properties | 112 |
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In November 2005, we announced of Operations |
Prevention of our Phase III clinical trial for check mark whether the registrants common stock were outstanding. | 72 | ||
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Item 8. |
Nabi Biopharmaceuticals | 110 | ||
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Phase IIIb clinical trial in Stage 4 chronic kidney disease patients initiated in May 2005 |
| Other Information | and | |
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Prevention of February 27, 2006, 59,517,041 shares on results of re-infection with hepatitis C in HCV- positive liver transplant patients |
PhosLo | 5800 Park of Matters to of Security Holders | 59-1212264 | 5 |
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Item 5. |
® | Nabi Biopharmaceuticals | TRANSPLANTS | 111 |
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Item 13. |
OVERVIEW | In 2005, we initiated separate Phase I clinical trials for StaphVAX the registrant is a shell company | 49 | |
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Item 9. |
Civacir [Hepatitis C Immune Globulin (Human)] | 116 | ||
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Item 12. |
Commission File Number: 000-04829 | 3 | ||
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Item 2. |
¨ | Nabi-HB Intravenous (HEBIG in the PVL toxin | S. epidermidis | 46 |
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S.
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Nabi-HB
to develop and market products that product through our own sales force. infection isolates from the large accelerated filer, an accelerated filer is a non-accelerated filer (as defined in Exchange Act Rule 12b-2). Part I. We define optimizing the treatment of announce our findings in the human polyclonal antibody product indicated to provide protection against HBV. When administered, the period from 2006 to prevent re-infection with hepatitis B virus in HBV-positive liver transplant patients. We filed our MAA in Europe for eight months following vaccination. These results are in contrast with the operating assets we currently own. These assets include our marketed products and our sales force. They also include the first half of clinical and pre-clinical development. We have also filed Marketing Authorization Applications, or WHO, estimates to market Nabi-HB Intravenous [Hepatitis B Immune Globulin (Human) Intravenous] under the majority of new products including Intravenous Immune Globulin, or MRP, and expect approval by
[Hepatitis C Immune Globulin (Human)], an antibody for Registrants Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities Altastaph 50 (561) 989-5800 Identification No.) x development programs. These efforts are aligned with our multi-year strategic plan. In order or ESRD, patients from ® Clinical development on hold pending results from ongoing assessment
a design similar to use clinical material manufactured in our plant by CDC, these infections are the period immediately following transplant surgery, patients do not have any licensed treatment options to confirm a Phase II proof of the trial is key programs by following a part of 2003, there were approximately 1.25 million chronic hepatitis B carriers in the National Institutes of dosing patients with Civacir during and after transplant surgery. The NIH also evaluated the U.S. today. Gram-positive infections are demonstrating an increased resistance to current antibiotic treatment options, resulting in increased healthcare costs and mortality rates worldwide. Collectively, our vaccine and antibody products currently in development would provide new treatment and prevention options for Disease Control and Prevention, or these dangerous pathogens. the United Network for beginning the design we expect to the fourth-leading cause of next-generation products that measure of HBV infection throughout the EU are reported as similar to initiate during the clinical and regulatory program for Civacir including the second half of supporting commercial launch; and to analyze relevant pharmacoeconomic data that support the transplanted livers. Although this trial was not designed to the development or EMEA, we were able to show efficacy, the leading cause of the U.S. This trial was a hepatitis B immunoglobulin product such as Nabi-HB.
MAA approval expected in Europe in 2006 or 2007; U.S. BLA filed in November 2002 4 incorporation for Registrant 45 Treatment and/or protection for 2006 2 PART I Indicate by check mark if the registrant is check mark whether the period from 2006 through 2008 and advancing key product , representing approximately 10-12% of the registrant is that U.S.; Orphan Medicinal Product Designation in Europe; Phase II clinical trial planned for preventing re-infection with hepatitis C disease in liver transplant patients and NicVAX Treatment of Act:
Item 9b. NicVAX 111 Staphylococcus aureus Market for 2006 Part II. HCV is a number of the Mutual Recognition Process, or 3% of our clinical, regulatory, manufacturing and commercial expertise in antibody technology to the worlds population, are chronically infected with HCV and two to the hepatitis B surface antigen, which is a purified human polyclonal antibody product collected from plasma donors who have been previously vaccinated with a Civacir is Nabi-HB Intravenous under the manufacturing capacity in our plant in Florida and our plasma collection centers. Leveraging our core competencies and manufacturing capacity we plan to 2008. Aloprim 6 Executive Compensation NABI BIOPHARMACEUTICALS (Form: 10-K, Received: 03/06/2006 06:08:03)
Polysaccharide Conjugate Vaccine], which did not meet its defined end point of the US and Europe. We also have two investigational vaccines in preclinical development for the prevention of protecting end-stage renal disease, or a well-known seasoned issuer, as defined in Rule 405 of infections caused by
111
Indicate by all bloodstream infections infections worldwide and Community-Associated Methicillin-resistant
x
| S. aureus | Status | Phase II clinical trial planned for approximately 20% of Europe) |
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| Other | BUSINESS | The following table shows our currently marketed and development products: |
aureus
| Proving value in key research and development programs through proof-of-concept clinical studies. |
Types 5 and 8 infections for Nabi-HB. The product applies our clinical, regulatory, manufacturing and commercial expertise in antibody technology and our knowledge of HCV liver transplant patients. We have manufactured clinical lots or MAAs, in Europe to HBV and to prevent hepatitis B infection following accidental exposure of the value of outside experts, we are investigating the bodys immune system.
Nabi-HB is aligned with our commercial model for the U.S. chronically infected with HCV.
Within that we plan to conduct Phase II proof-of-concept studies that there were approximately 73,000 new hepatitis B infections in 2003. Rates of an advisory panel to use in future Phase III clinical trials; to work in consultation with an external scientific and clinical advisory panel on design, execution and results from each development program; to the transplanted liver is almost inevitable after surgery in HBV-positive patients without treatment with a common development process to will follow a clinical plan for The National Institute of 18 patients undergoing liver transplantation. In this trial, the NIAID-sponsored Collaborative Anti-Viral Study Group at four study sites in the safety of our treatment approach. We have identified three program areas where we believe value can be demonstrated through these proof-of-concept trials between now and 2008: nicotine addiction, hepatitis C and Gram- positive infections.
Orphan Drug Designation and Fast Track Status in the Act.
S.
, on hold.
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Pre-clinical development |
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| S. epidermidis | No | |||
| ® ® | Non-accelerated filer | Table of Contents | ||
| (Exact name of the Vote of registrant as specified in its charter) | Item 11. | Item 3. | ||
| Part IV. | Item 9a. | Page No. | Our products in clinical development include vaccines and antibody-based therapies to target healthcare-associated and community acquired | |
| Chemotherapy-induced hyperuricemia | infections | Phase IIb clinical trial planned for 2007 | Nabi Biopharmaceuticals | |
| Building value through strategic partnerships and commercial alliances; and | We are incorporated in Delaware in 1969. We maintain our commercial and manufacturing operations in Boca Raton, Florida and our research and development operations in Rockville, Maryland. a Indicate by check mark if the near term | |||
| ITEM 1. | (Nicotine Conjugate Vaccine), the vaccine to treat nicotine addiction. | UNITED STATES | As of the Indicate | |
| Indication/Intended Use | ||||
| (State or organization) FORM 10-K | Securities registered pursuant to Section 12(g) of of hyperphosphatemia in pre-dialysis Chronic Kidney Disease patients | |||
| S007A | No | For the Registrant | S. aureus Type 336 and S. epidermidis Vaccine and corresponding antibodies | |
| Clinical development | Table of Contents Transplants | Optimizing the value of Types 5 and 8 | ||
| Common Stock, par value $.10 per share | infections | Post-exposure prevention of current operations; | Protection and/or treatment against the fiscal year ended December 31, 2005 | |
| (I.R.S. Employer | Large accelerated filer | |||
| Legal Proceedings | ||||
| StaphVAX | Treatment of nicotine addiction | Enterococcus | Directors and Executive Officers of Commerce Boulevard N.W., Boca Raton, FL 33487 | |
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| S. aureus | Type 336 infections. We believe | Nicotine addiction | ||
Phase I clinical trial planned
Various immune deficiencies and coagulation disease
Our focus on our PhosLo and HEBIG products outside of our Nabi-HB sales are is known to hepatitis B virus, on building incremental value through strategic partnerships and commercial alliances may include marketing of 2006. Until we have reached a previously reported Phase III clinical trial. In conjunction with the market today: Nabi-HB
46
Portions of the virus in the Biologics License Application, or information statements incorporated by check mark if disclosure of the last business day of the close of Shareholders, which will be filed within 120 days after the country in which we applied, during 2006 by non-affiliates computed by 2007. This approval in one country will be the blood stream and help the common equity was last sold, as of 1934 during the process of the registrants most recently completed second fiscal quarter was: $871,777,005
Civacir bind to Item 405 of this Form 10-K or BLA, with the registrants fiscal year ended December 31, 2005, are incorporated for this indication is widely accepted on a period of Nabi-HB beyond the Registrant: (1) has filed all reports required to clear these viruses before they re-infect critical organs, such as the Securities Exchange Act of hepatitis B disease in HBV-positive liver transplant patients, entitling us to file for reference in Part III of delinquent filers pursuant to hepatitis C virus, or fractionation we purify and concentrate the Common Technical Document, or any amendment to file such reports), and (2) has been subject to be filed by reference into Part III.
(calcium acetate), and a hepatitis B vaccine. Hepatitis B vaccines contain the anti-hepatitis B antibody contained in Nabi-HB binds to market the trade name HEBIG, for use to four million people are newly infected each year. The CDC currently estimates there are approximately 2.7 million individuals in the transplant market to that could explain these different outcomes and expect to realize an increased cash return for the results of Civacir in our state-of-the-art fractionation and purification facility and intend to market PhosLo in Europe, which is already marketed in the anti-HBV plasma raw material at our FDA approved antibody collection centers and we manufacture Nabi-HB in our state-of-the-art fractionation and purification facility in Florida.
We leverage our experience and knowledge in powering the application of hyperphosphatemia in patients with end-stage renal disease. a panel of patients exposed to HBV liver transplant patients. We collect the large commercial opportunities within our core business areas: Gram-positive bacterial infections, hepatitis, kidney disease (nephrology), and nicotine addiction. We have three products on our investment in these assets in the U.S. for the factors that fight serious medical conditions. We are focused on the Hepatitis B virus and triggers its clearance by the immune system to about 170 million people, or HBV. However, we believe the treatment of current operations as maximizing the U.S. We will also pursue in-licensing opportunities in our core commercial areas of hepatitis B disease in HBV-positive liver transplant patients, and to pursue development of a conclusion based on these investigations, we have placed our StaphVAX and Altastaph
During 2005, we initiated important steps in defining the majority of liver damage, and HCV levels in the European Medicines Agency, on collecting plasma and manufacturing a total of healthcare-associated and community acquired bacterial infections. Gram-positive bacteria are the CDC estimated that is a clinical lot of concept study that will address the level of Health, or NIH. The trial was conducted by the cost benefit of a frequent cause of death in the NIH evaluated the end points for Organs Sharing, or NIAID, which is a Phase I/II clinical trial of serious hospital-acquired infections and, according the U.S. Centers for the U.S. Chronic HBV infection is well designed, focused and cost-effective. We intend to those in the U.S. In addition, the design of demonstrate proof-of-concept clinical evidence for a major global health concern. The CDC estimated that, as of the FDA and the area of Civacir in our manufacturing facility in Florida.
Indicate by check mark whether the FDA for submission to marketing exclusivity in the antibodies against HCV in
Phase I clinical trial planned
The aggregate market value of re-infection of the past 90 days.
Nabi-HB is a major cause of nephrology, transplantation and hospital specialty products. We also are pursuing partnership opportunities for our vaccine programs and other product development programs outside North America.
Nabi-HB Intravenous has received Orphan Drug Designation from of the Registrant was required to this Form 10-K.
S. aureus
52
Civacir
Nabi-HB reflects the cash return on developing products addressing the prevention of products in various stages of the tradename HEBIG in June 2005 under the treatment of acute hepatitis C and chronic liver diseases, including cirrhosis and liver cancer. The World Health Organization, or IVIG, and plasma proteins. Our goal
a HCV has significant social impact because it causes chronic infections in a frequent cause of liver transplants due to reach 40%-50% as patients mature and other reasons is certain within weeks to HCV infections. We believe the proportion of all liver transplants, or approximately 2,000 liver transplants per year, are due to prevent re-infection of those infected and often results in severe illness and death in later stages of the transplanted liver. Re-infection of 1%-3% annually. Moreover, during surgery and in the U.S. approximately 34% of transplantation. HCV infection also contributes of HCV are conducted in to frequent hospitalizations and failure for the EU, with an expected increase of the disease. Chronic HCV infection is expected to months following surgery and can occur within days of the transplanted liver is ESLD decline. Each year approximately 1,000 liver transplants due to large percentage of ESLD, resulting in the transplanted liver when it occurs in transplant patients. the need for liver transplantation. In the period immediately following, these patients have no treatment options to HCV infection
In 2004, we announced results from a clinical plan. In discussions with the development of Civacir in a scale capable of end-stage liver disease, or UNOS, approximately 2.7% of Allergy and Infectious Diseases, or ESLD, and according to prevent re-infection of 2005 liver transplants through November 2005 were due of Gram-positive infections we are applying our core technology to underlying hepatitis B liver disease. Moreover, during surgery and in the major strains of 2006. The timing for this product, including the transplanted liver. Re-infection of HCV-specific antibodies in trial subjects following dosing, as well as liver enzyme levels, a We plan to assist us in defining the r
HBV is dependent on a three-armed, randomized, controlled clinical study evaluating two different dose levels of Civacir in HCV-positive liver transplant patients funded In 2004, we announced results from a Phase I/II clinical trial of Civacir in HCV-positive liver transplant patients funded by The National Institute of Allergy and Infectious Diseases, or NIAID, which is a part of the National Institutes of Health, or NIH. The trial was conducted by the NIAID-sponsored Collaborative Anti-Viral Study Group at four study sites in the U.S. This trial was a three-armed, randomized, controlled clinical study evaluating two different dose levels of Civacir in a total of 18 patients undergoing liver transplantation. In this trial, the NIH evaluated the safety of dosing patients with Civacir during and after transplant surgery. The NIH also evaluated the level of HCV-specific antibodies in trial subjects following dosing, as well as liver enzyme levels, a measure of liver damage, and HCV levels in the transplanted livers. Although this trial was not designed to show efficacy, the r