Nabi Biopharmaceuticals announced that it has filed its first Marketing Authorization Application (MAA) in Europe. The company is seeking approval to market Nabi-HB Intravenous [Hepatitis B Immune Globulin (Human) Intravenous] under the trade name HEBIG. This is an important first step toward establishing a commercial presence for Nabi Biopharmaceuticals' marketed and pipeline products in Europe, a release from the company said.
The company plans to expand the commercial opportunity in Europe by submitting license applications for PhosLo [Calcium Acetate] and StaphVAX [Staphylococcus aureus Polysaccharide Conjugate Vaccine] later in 2004.
Nabi-HB Intravenous is designed to prevent hepatitis B disease in HBV-positive liver transplant patients. This first MAA is being filed through the Mutual Recognition Procedure, which targets initial approval in one country. Once approved in the initial country, the dossier can then be used to seek approval in additional countries selected by the company within the European Union (EU) on a shortened timeline. In addition, the filing was constructed in the 'Common Technical Document' format, which is an international format that can be used in submissions to many countries worldwide without major modifications.
Nabi-HB Intravenous will be marketed to transplant surgeons in Europe as it has been specifically formulated for the prevention of hepatitis B disease in HBV-positive liver transplant patients. Nabi Biopharmaceuticals previously announced that it has initiated activities to establish commercial operations within the EU in conjunction with the expected MAA filings later this year. Upon the approval of Nabi-HB Intravenous, the company can begin to apply the specialty biopharmaceutical marketing expertise and success in the United States to develop a commercial presence within Europe to support Nabi-HB Intravenous, StaphVAX and PhosLo, the release said.
"The filing of our MAA for Nabi-HB Intravenous is the first important step in establishing our presence and advancing our commercialization strategy in Europe. The approval of Nabi-HB Intravenous will increase the number of treatment options for this desperately ill patient population and, we believe, offer a more convenient dosage form for the liver transplant teams and their patients," stated Thomas H McLain, chairman, chief executive officer and president of Nabi Biopharmaceuticals. "In addition to this important initial filing, we have had very extensive and fruitful discussions with European regulators that will help set the stage for commercialization of our StaphVAX and PhosLo products that we intend to file for marketing approvals in Europe this year," he added.
The company's MAA, based upon clinical data Nabi Biopharmaceuticals has generated, supports that Nabi-HB Intravenous administered either alone or in combination with anti-virals, is effective in reducing the risk of hepatitis B re-infection in HBV-positive liver transplant patients. Prior to the availability of immune globulins, liver transplants were not recommended in hepatitis B positive patients. The recurrence of hepatitis B infections, post-liver transplant, occurred almost universally, and most often resulted in rapid deterioration of patients' liver function with death or the need for re-transplantation as a result. That totally changed with the emergence of immune globulins and more recently with the use of hepatitis immune globulin in combination therapy with anti-virals. As a result, the prognosis for liver transplants in hepatitis B positive patients is now comparable to liver transplants due to other causes.
Nabi Biopharmaceuticals has a licensed, FDA-compliant manufacturing facility in Boca Raton, Florida designed to accommodate the global demand for Nabi-HB. Recent upgrades to the facility were undertaken to ensure compliance with European regulations, the release says.