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Nabi Biopharmaceuticals Provides Regulatory Update on Hepatitis B Liver Transplant Programs

[In the U.S., Nabi goes before the BPAC advisory panel on July 13. In Europe, Nabi has withdrawn the MAA due to formulation problems.]

http://biz.yahoo.com/prnews/060530/fltu019.html?.v=49

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Tuesday May 30, 4:51 pm ET

- Next Steps are Advisory Panel Meeting in U.S. and Compiling Stability Data for Reformulated Product in Europe -

ROCKVILLE, Md., May 30 /PRNewswire-FirstCall/ -- Nabi Biopharmaceuticals (Nasdaq: NABI ) provided updates today on its progress with regulators toward the licensure of its antibody product to prevent re-infection with hepatitis B in liver transplant patients in the U.S. and Europe.

U.S. Update

The company announced that its Biologic License Application (BLA) for Nabi-HB Intravenous will be reviewed and discussed by the Food and Drug Administration's (FDA) Blood Products Advisory Committee (BPAC) at a meeting scheduled for July 13, 2006 in Gaithersburg, Maryland. The BPAC meeting represents the culmination of lengthy discussions between the FDA and Nabi Biopharmaceuticals concerning the data that might be accepted to support the BLA. BPAC is expected to render its view as to whether the BLA for Nabi-HB Intravenous for the prevention of recurrence of hepatitis B after liver transplant should be approved based on a combination of prospective and retrospective clinical data. Nabi Biopharmaceuticals believes that such data should be sufficient for approval given Nabi-HB's widely accepted off-label use in liver transplant patients.

Currently, Nabi-HB® [Hepatitis B Immune Globulin (Human)] is licensed in the U.S. to provide protection from infection after accidental exposure to the hepatitis B virus. However, it is acknowledged as a standard-of-care in liver transplant patients at risk for re-infection. Because this use of the product is off-label, there are no FDA-approved guidelines for how such a product should be dosed to optimize patient outcomes. If approved, the intravenous formulation of Nabi-HB would be the only product in the U.S. indicated for preventing re-infection of the transplanted liver in HBV-positive patients. Previously, the FDA granted orphan drug designation to Nabi-HB Intravenous. Nabi Biopharmaceuticals believes the BPAC meeting will not only advance a thorough consideration of the relevant clinical data, it will also provide the opportunity to establish clear standards for how the product should be used in liver transplant patients. The company is particularly encouraged about the outcome for this meeting because the same clinical data set was acceptable for licensure in Europe.

Henrik S. Rasmussen, M.D., Ph.D., senior vice president clinical, medical and regulatory affairs, Nabi Biopharmaceuticals, stated, "We believe the benefits from using Nabi-HB in liver transplant patients have been amply demonstrated in thousands of liver transplant patients. The clinical data we have compiled supports using Nabi-HB at the time of transplant, a time when no other drugs can be used effectively. The data also demonstrate the importance of using Nabi-HB in combination with anti-virals on a long-term maintenance basis to prevent re-infection. If they approve the product's use in these patients, the FDA would be providing physicians with the information they need to make the best treatment and dosing decisions for their patients. In addition, we believe this indication will build physician awareness and understanding about the positive long-term prognosis for liver transplants in hepatitis B-positive patients. That in turn may help to increase the numbers of patients helped each year."

EU Update

The company also announced that as a result of discussions about its Marketing Authorization Application (MAA) for HEBIG with regulators of the Reference Member State (RMS), it has made certain improvements in the formulation of the product to comply with EU standards. As a result of this agreement with regulators of the RMS, the company has voluntarily withdrawn its MAA in Europe while it compiles 12 months of stability data for the reformulated product. Nabi Biopharmaceuticals expects to resubmit its MAA with this data during the first half of 2007. It is important to emphasize that all other pieces of the MAA have already been reviewed and accepted by the RMS and that the RMS has committed to an accelerated turn-around upon re- submission of the MAA. The company believes that this new formulation will yield several benefits for the intravenous product in Europe and the U.S. These improvements will increase the product's shelf-life, benefiting hospital pharmacies and product distributors. In addition, the formulation changes are designed to enhance the product's safety profile by providing additional viral inactivation benefits and further differentiating HEBIG from other hepatitis B immune globulin products. Finally, these changes are a first step in the company's 2006 program to capture yield improvements in the production of polyclonal antibody products and product candidates like Nabi-HB, Civacir® [Hepatitis C Immune Globulin (Human)], Altastaph® [Staphylococcus aureus Immune Globulin Intravenous (Human)] and IVIG in its biological manufacturing facility in Florida. When fully implemented, these improvements are intended to leverage the value of the full supply chain within Nabi Biopharmaceuticals, from sourcing plasma at its antibody collection centers, through production in its plant, and finally to the distribution of final products to hospitals and distributors in the U.S. using its sales force.

Dr. Rasmussen continued, "The intravenous formulation of HEBIG will provide competitive differentiation from other licensed products approved in the European market today. Its launch in Europe will increase the opportunity to leverage our integrated manufacturing platform. We are encouraged that European regulators have offered that, upon this resubmission, the MAA will be granted an immediate and accelerated review, as the other components of the application, that is the preclinical, toxicological and clinical pieces, as well as other parts of the quality dossier, have been reviewed and accepted by the regulators. We are particularly pleased that the RMS agrees that the clinical data are acceptable for licensure."

A Significant Medical Need

Nabi-HB Intravenous (U.S.) and HEBIG (Europe) are being developed to prevent hepatitis B disease in HBV-positive liver transplant patients. According to the World Health Organization (WHO), of the two billion people who have been infected with HBV, more than 350 million have chronic infections and are at high risk of death from cirrhosis of the liver and liver cancer; and as a result, many of these patients are in need of a liver transplant. Recurrence of HBV infection following liver transplant is almost universal if left untreated, and most often leads to rapid deterioration of liver function, often resulting in death or the need for re-transplantation. The U.S. Centers for Disease Control (CDC) currently estimates that in the U.S. alone there are approximately 1.2 million chronic hepatitis B carriers, 8,500 new hepatitis B infections per year, and 5,000 individuals who die annually from hepatitis B or its complications. [Please see #msg-11099728 and #msg-11058133 for related background info on this.]

Thomas H. McLain, chairman, chief executive officer and president, Nabi Biopharmaceuticals, stated, "Hepatitis B remains a serious, global healthcare threat. The commitments from regulators that we have announced today significantly advance our efforts to make this safe and efficacious product available to patients in the U.S. and Europe. We believe that the steps we will undertake for HEBIG will also build added value in this important and highly needed product, and may even contribute to an increased number of transplants that take place because of the benefits it can provide to patients. In addition, the formulation enhancements will advance our efforts to build the value of our integrated supply chain for the manufacture and distribution of not only Nabi-HB and HEBIG, but also our portfolio of high- value products including Civacir and Altastaph, as well as IVIG."

Nabi-HB Intravenous and HEBIG are purified human polyclonal antibody products manufactured using plasma collected from donors who have been previously vaccinated with a hepatitis B vaccine. This plasma is sourced at Nabi Biopharmaceuticals' antibody collection centers and the product is manufactured at the company's state-of-the-art fractionation facility in Florida. When administered, the anti-hepatitis B antibodies contained in Nabi-HB Intravenous and HEBIG bind to the hepatitis B virus and trigger its clearance by the body's immune system.

Nabi-HB, currently marketed in the U.S., provides passive immunization, or short-term protection, following exposure to the hepatitis B virus. Nabi-HB is indicated for the treatment of:

* acute exposure to blood containing hepatitis B surface antigen (HBsAg)

* perinatal exposure of infants born to HBsAg-positive mothers

* sexual exposure to HBsAg-positive persons

* household exposure to persons with acute HBV infection

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® (calcium acetate), Nabi-HB® [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 and transplant, 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 .
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