Nabi (a biopharmaceutical company based in Florida) announced today that it has initiated in the USA, further to the agreement signed with Kedrion, its Phase II “proof-of-concept” clinical trial for Civacir® [epatitis C human immune globulin]. Civacir®, when approved, would be the first therapy for the prevention of the recurrence of hepatitis C-related liver disease in hepatitis C virus (HCV) positive liver transplant recipients. Currently, there are no marketed therapies specifically indicated for prevention of re-infection post-liver transplant in HCV-positive patients.
Nabi Biopharmaceuticals and Kedrion pursue a common strategy to develop and commercialize Civacir®: in case of positive results, Kedrion, which is fully funding the costs of the clinical trials of Civacir®, will be the exclusive licensee to commercialize the product in Europe. Thomas H. McLain, President and Chief Executive Officer of Nabi, stated, "Civacir® is uniquely positioned to fill a critical gap in the care of liver transplant patients by preventing re-infection with hepatitis C during a period after surgery when other therapies cannot be used. Certainly, initiating this Phase II “proof of concept” trial is an important milestone for us and our partner, Kedrion, but this trial also represents an important milestone for advancing clinical knowledge in this area. We are pleased to be partnering with Kedrion, who is contributing important knowledge and resources to this program Through our strategic partnership, we expect to conduct this and future clinical trials for Civacir in a way that is fast and effective".
About hepatitis C
Each year there are approximately 5,000 liver transplant procedures performed in U.S. and of those approximately 2,000 are due to HCV. Considering the prevalence of hepatitis C in the US and Europe, and the size of the medical need, Civacir® could develop into a significant product in a global market estimated at $400 million. Available therapies have a poor efficacy and safety profile and re-infection of the transplanted liver is almost universal.
About the Phase II “proof-of-concept” Trial
The Civacir Phase II “proof-of-concept” trial is a randomized, controlled study involving 30 patients in a 2:1 randomization, with 20 patients allocated to Civacir at a dosage of 400mg/kg vs. 10 patients receiving standard-of-care. The primary endpoints are progression of liver fibrosis on biopsies as well as HCV levels in liver and serum. The secondary endpoints include liver enzymes as well as safety and tolerance. The Company expects to complete enrollment in the second half of 2007, with the results being announced in the second half of 2008.
The protocol for the current trial was developed through consultation with regulators in the US and Europe and work with an outside advisory panel.
Next steps: Civacir® development program
Based on positive results from the Phase II trial, Kedrion e Nabi Biopharmaceuticals would then collaborate on the development of a pivotal Phase III trial for Civacir®. The pivotal study is expected to be conducted in the U.S. and Europe. It is also expected that the results of a single Phase III trial, if positive, would be sufficient to obtain the regulatory approvals needed for Kedrion to market Civacir® in Europe and for Nabi 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 U.S. Food and Drug Administration (FDA). This designation facilitates the development of products that treat serious diseases where an unmet medical need exists. Civacir® also has Orphan Drug Status in the United States which for provides a seven-year period of market exclusivity in the United States when the product is approved. 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 designated indication, the product will be entitled to 10-year market exclusivity, thereby preventing a similar drug from receiving authorization for the same indication during this period.
For further information about Nabi: www.nabi.com.