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