Nabi Biopharmaceuticals Announces Initiation of Civacir(R) Phase II 'Proof-of- Concept' Clinical Trial
- Category: Antibodies
- Published on Wednesday, 17 January 2007 02:00
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BOCA RATON, FL, USA | Jan 16, 2007 | Nabi Biopharmaceuticals (Nasdaq: NABI) announced today that it has initiated its Phase II "proof-of-concept" clinical trial for Civacir® [Hepatitis C Immune Globulin (Human)]. Civacir, the company's plasma-derived, polyclonal antibody product candidate, 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, or in patients who received an HCV-positive liver. Currently, there are no marketed therapies specifically indicated for prevention of re-infection post-liver transplant in HCV-positive patients. The trial marked another critical milestone being met by the company.
Nabi Biopharmaceuticals is co-developing Civacir with Kedrion S.p.A., a global biopharmaceutical company, located in Lucca, Italy. Kedrion is fully funding the costs of the clinical trials and is also funding some of the costs of manufacturing Civacir for use in the trial. The two companies will pursue a common strategy to develop and commercialize Civacir in Europe and the U.S., with Kedrion being Nabi Biopharmaceuticals' exclusive licensee to commercialize Civacir in Europe. In addition to assuming the majority of the funding for the clinical trials and clinical materials in Europe and the U.S., Kedrion will pay milestone and royalty payments to Nabi Biopharmaceuticals.
Thomas H. McLain, chairman, chief executive officer and president, Nabi Biopharmaceuticals, 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. If we are successful, this product will become a very important part of our global transplant franchise and product portfolio. 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 an area of significant, unmet medical need. 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 faster and at the same time much less costly for Nabi Biopharmaceuticals."
About Hepatitis C
Each year there are approximately 5,000 liver transplant procedures performed in the U.S. and of those approximately 2,000 are due to HCV(1). Considering the prevalence of hepatitis C in the U.S. and Europe, and the size of the medical need, Civacir could develop into a significant product in a global market estimated at $400 million(2). Available therapies have a poor efficacy and safety profile and re-infection of the transplanted liver is almost universal. These infections often result in complications, the most serious of which is the re-development of end-stage liver disease, which in turn can lead to the need for a re-transplant or death. Currently, none of these therapies are specifically indicated for prevention of re-infection post-liver transplant in HCV-positive patients.
Henrik S. Rasmussen, M.D., Ph.D., senior vice president, clinical, medical and regulatory affairs, Nabi Biopharmaceuticals, stated, "There is a significant medical need to prevent the recurrence of hepatitis C-related liver disease in HCV-positive liver transplant recipients. The polyclonal antibody approach of Civacir, either alone or in combination with new antiviral agents that may be developed in the future, has the potential to neutralize the numerous strains of hepatitis C virus that exist and the dire health consequences that they cause. Hence, we are very excited about the initiation of this 'proof-of-concept' study."
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 U.S. and Europe and work with an outside advisory panel. The trial design is based upon an understanding of what would be evaluated in a Phase III study. The current Phase II "proof-of-concept" trial was sized to allow the results to demonstrate the therapeutic benefit of the drug candidate prior to initiating a Phase III studies. Product used in the trial was manufactured in Nabi Biopharmaceutical's Boca Raton, Florida facility at commercial scale.
Next Steps: Civacir Development Program
Based on positive results from the Phase II trial, Nabi Biopharmaceuticals and Kedrion 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 Biopharmaceuticals to obtain regulatory approval to market the product in the U.S.
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 U.S. which for provides a seven-year period of market exclusivity in the U.S. 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.
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 two products on the market today: Nabi-HB® [Hepatitis B Immune Globulin (Human)], and Aloprim™ (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: Hepatitis and transplant, Gram-positive bacterial infections 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 Web site: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 related to our plans to explore strategic alternatives and prospects. 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; and identify and complete transactions that represent strategic alternatives and opportunities. 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 September 30, 2006 filed with the Securities and Exchange Commission.
(1) Schiano TD, Martin P. Management of HCV Infection and Liver
Transplantation. Int J Med Sci 2006; 3:79-83.
Brown RS. Hepatitis C and liver transplantation. Nature. 2005
Davis GL, Albright JE, Cook SF, Rosenberg DM. Projecting future
complications of chronic hepatitis C in the United States. Liver
Transpl. 2003 9:331-8, El-Serag HB. Hepatocellular carcinoma: recent
trends in the United States. Gastroenterology. 2004 127:S27-34.
(2) LEK Market Analysis 2005, commissioned by Nabi Biopharmaceuticals
SOURCE Nabi Biopharmaceuticals