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Nabi Biopharmaceuticals Gains Orphan Medicinal Product Designation For Civacir(TM) in Europe

Posted on: Wednesday, 22 June 2005, 18:00 CDT

BRAY, Ireland, June 22 /PRNewswire-FirstCall/ -- Nabi Biopharmaceuticals today announced that, following the favorable opinion of the European Medicines Agency or EMEA (adopted by the Committee of Orphan Medicinal Products), the European Commission has granted Orphan Medicinal Product (OMP) designation to Civacir(TM) [Hepatitis C Immune Globulin (Human)], Nabi Biopharmaceuticals' product candidate for the prevention of recurrent hepatitis C virus-induced liver disease in liver transplant recipients.

The OMP designation will result in reduced Marketing Authorization Application (MAA) fees, free access to scientific advice from the EMEA and other potential research and development incentives. Furthermore, 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, which means that a similar drug is prevented from receiving authorization for the same indication during this period. Civacir has already been granted Orphan Drug designation from the U.S. Food and Drug Administration (FDA).

"The Orphan Drug designation and today's OMP status promises to accelerate Civacir's development and reduce our development costs. We are particularly pleased by getting this designation in Europe because of the pioneering role European investigators have played in demonstrating the utility of hepatitis B immune globulins in liver transplant patients," said Henrik S. Rasmussen, M.D., Ph.D., senior vice president, clinical, medical and regulatory affairs, Nabi Biopharmaceuticals.

Dr. Rasmussen continued, "Nabi Biopharmaceuticals is building a growing commercial hepatitis franchise in Europe. HEBIG(TM), our hepatitis B immune globulin that was recently submitted for registration in Europe, along with Civacir, represents a comprehensive approach to addressing post-liver transplant consequences of viral hepatitis. We look forward to advancing both of these products to the marketplace, in line with our strategy to provide the best solutions for patients, while reducing the financial burden on healthcare systems."

About Civacir

Civacir is an investigational human polyclonal antibody product that contains antibodies to the hepatitis C virus (HCV). Civacir is being developed for the prevention of recurrent hepatitis C virus-induced liver disease in liver transplant recipients. Civacir is also being evaluated for the treatment of chronic hepatitis C virus infections.

The National Institutes of Health (NIH) has funded and conducted a Phase I/II clinical trial of Civacir in HCV-positive liver transplant patients at four study sites in the U.S. This randomized, controlled study evaluated the safety of dosing patients with Civacir during and after transplant surgery, the level of HCV-specific antibodies in trial subjects following dosing, liver enzyme levels (a measure of liver damage) and HCV levels in the transplanted livers. Data from the trial were reported in February 2004 and revealed that Civacir was well tolerated in liver transplant patients and produced a trend towards a reduction in ALT (serum alanine aminotransferase, an important liver enzyme that measures liver function) levels. Based on the results from this trial, the company expects to now be able to define the continued development strategy for this agent following discussions with the FDA and the EMEA.

About Hepatitis C in Europe

HCV can be transmitted through blood transfusions, organ transplants, intravenous drug use, kidney dialysis and sexual contact. Chronic HCV infection is a frequent cause of end-stage liver disease in North America and Europe and is present in approximately one-third of patients undergoing liver transplants. HCV re-infection of a transplanted liver can occur within days of transplantation and is almost inevitable within weeks to months after surgery. HCV infections in transplant patients can contribute to failure of the transplanted liver and frequent hospitalizations.

HCV is the most common cause of end-stage liver failure in Europe, responsible for approximately 30-40 percent of all liver failure transplants within the European Union (EU). The World Health Organization (WHO) estimates 170 million individuals worldwide are infected with HCV. HCV is the most common blood-borne infection in the U.S. and is a leading cause of liver failure and liver cancer. 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.

In June 2004, Nabi Biopharmaceuticals announced that it had filed its first MAA in Europe for its intravenous formula of Nabi-HB(R) Intravenous [Hepatitis B Immune Globulin (Human) Intravenous], under the trade name HEBIG(TM). A Biologics License Application (BLA) has been filed in the U.S. for Nabi-HB Intravenous and is currently under review by the FDA. Together, Civacir and HEBIG represent a comprehensive approach in helping to address post-liver transplant consequences of the hepatitis B and C virus.

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 poised to capture large, commercial opportunities in our four 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 preclinical development. The company filed its Marketing Authorization Application in Europe for its product candidate, StaphVAX(R) [Staphylococcus aureus Polysaccharide Conjugate Vaccine], in December 2004. The application was accepted for review in January 2005. StaphVAX is currently in a confirmatory Phase III clinical trial in the U.S. StaphVAX is designed to prevent the most dangerous and prevalent strains of Staphylococcus aureus bacterial infections. S. aureus bacteria are a major cause of hospital-acquired infections and are becoming increasingly resistant to antibiotics. The company's other products in development include Altastaph(TM) [Staphylococcus aureus Immune Globulin Intravenous (Human)], an antibody for prevention and treatment of S. aureus infections, 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 at: 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 possibility that our confirmatory Phase III clinical trial for StaphVAX or our plans to commercialize StaphVAX in the European Union and United States may not be successful; the possibility that we may not realize the value of our acquisition of PhosLo; the company's ability to raise additional capital on acceptable terms; the company's dependence upon third parties to manufacture its products; the company's ability to utilize the full capacity of its manufacturing facility; the impact on sales of Nabi-HB from patient treatment protocols and the number of liver transplants performed in HBV-positive patients; reliance on a small number of customers; the future sales growth prospects for the company's biopharmaceutical products; and the company's ability to obtain regulatory approval for its products in the United States or abroad or to successfully develop, manufacture and market its products. These factors are more fully discussed 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.

Nabi Biopharmaceuticals

CONTACT: Mark Soufleris, Vice President, Marketing, NabiBiopharmaceuticals, +1-561-989-5800

Web site: http://www.nabi.com/

Source: PRNewswire-FirstCall

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