BOCA RATON, Fla., June 29 /PRNewswire-FirstCall/ -- Nabi Biopharmaceuticals today announced that it 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(R) [Hepatitis C Immune Globulin (Human)] in Europe and the U.S., 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 U.S. 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 program. This agreement marks a successful achievement of a stated company objective to form strategic partnerships to advance our pipeline programs," 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."
Mr. 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."
Next Steps: Civacir Development Program
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 U.S. 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 U.S. 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 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 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. Civacir also has Orphan Drug Status in the United States. This provides a seven-year period of market exclusivity in the United States when the product is approved.
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(R) (calcium acetate), Nabi-HB(R) [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.
About Kedrion S.p.A.
Kedrion is a biotechnology company specializing in the development, production and distribution of plasmaderivatives. In Italy, Kedrion is the main reference point for the National Health Service as regards the production of plasma-derived drugs. Moreover, its skills are also put to use in strategic partnerships with overseas health services. The quality of its products, its continuous commitment to research and development, its consistent industrial capacity and its consolidated presence on the national and international market are the company's main areas of competitiveness. Kedrion SpA is the parent company of a group comprising: Hardis SpA, Haemopharm, Advanced Bioservices LLC. It is located in Castelvecchio Pascoli, in the province of Lucca, Tuscany, and has two production plants, Kedrion Bolognana, in the vicinity of Lucca and Hardis S. Antimo, in the vicinity of Naples. Kedrion is characterized by its focus on the international scene and its commitment to improving its local plants. The specific assets of the various companies allow Kedrion to offer partner companies and health institutes a complete and integrated approach within the field of plasmaderivatives. Thanks to these assets, Kedrion is able to manage the entire plasma processing cycle, from its acquisition to the distribution of plasma-derived products, including logistical support services. Kedrion's operations cover three different areas of business: production and distribution of plasma-derived products (it produces plasma-derived drugs and virus deactivated plasma and it also distributes flu vaccines), Contract Manufacturing (working with the National Health Service, Kedrion receives the plasma from the regions and transforms it into drugs that are redistributed to the regions in order to respond to the population's therapeutic requirements), transfer of technological know how (by means of international partnerships, it offers its technological know how concerning two main activities, the construction of plasma-derived product production plants and the transfer of technological production processes). Its Website is www.kedrion.com.
Statements in this press release about the company that are not strictly historical are forward-looking statements and include statements about our products in development, the market for such products, and regulatory approval of our product candidates. You can identify these forward-looking statements because they involve our expectations, beliefs, intentions, plans, projections, or other characterizations of future events or circumstances. These forward-looking statements are not guarantees of future performance and are subject to risks and uncertainties that may cause actual results to differ materially from those in the forward-looking statements as a result of any number of factors. These factors include, but are not limited to, risks relating to the company's ability to advance the development of products currently in the pipeline or in clinical trials; maintain the human and financial resources to commercialize current products and bring to market products in development; obtain regulatory approval for its products in the U.S., Europe or other markets; successfully develop, manufacture and market its products; successfully partner with other companies; realize future sales growth for its biopharmaceutical products; maintain sufficient intellectual property protection or positions; raise additional capital on acceptable terms; re-pay its outstanding convertible senior notes when due. Many of these factors are more fully discussed, as are other factors, in the company's Annual Report on Form 10-K for the fiscal year ended December 31, 2005 and Quarterly Report on Form 10-Q for the Quarter ended April 1, 2006 filed with the Securities and Exchange Commission.