Nabi Biopharmaceuticals has secured an agreement with Kedrion S.p.A., a global biopharmaceutical company, located in Lucca, Italy. Under the terms of the agreement, Nabi Biopharmaceuticals and Kedrion will pursue a common strategy to develop and commercialize Civacir [Hepatitis C Immune Globulin (Human)] in Europe and the US, with Kedrion being Nabi Biopharmaceuticals' exclusive licensee to commercialize Civacir in Europe.
Civacir is Nabi Biopharmaceuticals' plasma-derived, polyclonal antibody product candidate, which, when approved, would be the first therapy for the prevention of the recurrence of hepatitis C-related liver disease in HCV-positive liver transplant recipients, or in patients who receive an HCV- positive liver. In addition to milestone and royalty payments to be paid to Nabi Biopharmaceuticals, Kedrion will assume development costs for the product candidate in both Europe and the US through at least phase II clinical trials.
"This agreement represents a major funding event for Nabi Biopharmaceuticals. It is also a validation of the clinical and commercial potential of the Civacir programme. This agreement marks a successful achievement of a stated company objective to form strategic partnerships to advance our pipeline programmes," stated Thomas H. McLain, chairman, chief executive officer and president, Nabi Biopharmaceuticals. "Kedrion is the recognized leader in plasma-derived products in Italy and is helping to drive the evolution of the broader marketplace within Europe for these products. Kedrion's leadership role in this transformation provides us with a rare and exciting opportunity to speed the clinical and commercial advancement of Civacir across Europe and does so in a way that is financially advantageous to Nabi Biopharmaceuticals. We are thrilled to begin this partnership with Kedrion and believe that it may afford us the chance to explore other, mutually beneficial collaborations between our two companies."
McLain continued, "This agreement is aligned with our 2006 to 2008 growth strategy, focused on optimizing the value of current operations, building incremental value through strategic partnerships and commercial alliances, and demonstrating proof-of-concept through clinical studies for key programs in our pipeline. We look forward to readily advancing this program in collaboration with Kedrion."
Paolo Marcucci, president and managing director, Kedrion S.p.A., stated, "While the number of vulnerable patients continues to rise, there remains no commercially available products that can be dosed safely at the time of transplant or immediately after transplant in hepatitis C-positive liver transplant recipients. We believe that Civacir, if approved, would fill a critical and growing void in viable treatment options for HCV-positive liver transplant recipients and patients who receive an HCV-positive liver. We are looking forward to developing this clinically and commercially important product with Nabi Biopharmaceuticals."
Gary L. Davis, M.D., Director, Division of Hepatology, Medical Director, Liver Transplantation, Baylor Regional Transplant Institute, Baylor University Medical Center, stated, "There is an unmistakable need for a new approach to preventing the recurrence of hepatitis C-related liver disease in HCV-positive liver transplant recipients. It is well established that currently approved therapies have minimal efficacy in treating this population and that the inevitable re-infection of the liver leads to an increase in a number of serious health risks, most concerning of which is loss of the transplanted organ. The polyclonal antibody approach of Civacir, either alone or in combination with new antiviral agents that may be developed in the future, is a potential way to neutralize the numerous strains of hepatitis C virus that exist and the dire health consequences that they cause."
Under the terms of the agreement announced today, Nabi Biopharmaceuticals and Kedrion will jointly oversee the development and registration of Civacir in Europe and will work collaboratively on the design and implementation of the phase II clinical trial for Civacir, which will be conducted in Europe and the US The trial is planned to be initiated in the second half of 2006.
With positive results from the phase II trial, the two companies would then collaborate on the development of a pivotal Phase III trial for Civacir. The pivotal study would also be conducted in the US and Europe. It is expected that the results of this trial, if positive, would be sufficient to obtain the regulatory approvals needed for Kedrion to market Civacir in Europe and for Nabi Biopharmaceuticals to obtain regulatory approval to market the product in the United States.
Civacir is an investigational human polyclonal antibody product that contains antibodies to the hepatitis C virus (HCV). In February 2006, Nabi Biopharmaceuticals announced that Civacir had been granted Fast Track Designation by the US Food and Drug Administration (FDA). This designation facilitates the development of products that treat serious diseases where an unmet medical need exists. Civacir has also gained Orphan Medicinal Product (OMP) designation in Europe. If a product with OMP designation is the first to receive marketing authorization in Europe for its.