Nabi Biopharmaceuticals Announces U.S. Fast Track Designation For Civacir To Prevent Hepatitis C Re-infection In Liver Transplants
ROCKVILLE, Md., Feb. 1 /PRNewswire-FirstCall/ -- Nabi Biopharmaceuticals today announced important regulatory and clinical advancements for its product candidate Civacir(TM) [Hepatitis C Immune Globulin (Human)], an antibody for preventing Hepatitis C virus re-infection in liver transplants. Civacir has been granted Fast Track Designation by the U.S. Food and Drug Administration (FDA). Under the FDA Modernization Act of 1997, Fast Track regulations facilitate the development of products that treat serious diseases where an unmet medical need exists. Fast Track regulations are also designed to expedite the review process for designated products, including the potential for companies to ask for priority review.
The company also announced today that recent discussions with regulators in the U.S. and EU have been very productive with respect to advancing the development program for Civacir. Based on this important input, Nabi Biopharmaceuticals believes that a proof-of-concept Phase II trial, followed by a single pivotal Phase III study, would be adequate for licensure in the U.S. and Europe, assuming that prospectively defined endpoints are met. The Phase II proof-of-concept study will be designed to add to the knowledge of how Civacir works and the levels of antibodies needed to protect the transplanted liver from re-infection with the Hepatitis C virus.
In addition, Nabi Biopharmaceuticals announced today that consistent with its overall approach to product development, it is establishing an outside scientific and clinical advisory panel to work with the company on the Civacir development program. The company believes that the input and guidance it receives from the panel, combined with input from regulatory bodies in the U.S. and Europe, will be valuable in advancing the regulatory, clinical and commercial development path for Civacir and lead to the design of an optimal Phase III pivotal trial for this first-of-its-kind product.
The Fast Track Designation is the latest in a number of regulatory milestones achieved with Civacir by Nabi Biopharmaceuticals. In June 2005, the company announced that it had gained Orphan Medicinal Product (OMP) designation for Civacir 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. OMP designation in the EU was an important milestone for Nabi Biopharmaceuticals, as it represents further validation for the need for new treatment approaches in the care of HCV-positive liver transplant patients. Civacir received orphan drug status in the U.S. in 2002. Among other benefits of orphan drug designation, Civacir will be entitled to seven years of market exclusivity in the U.S., post-launch, thereby preventing a similar drug from receiving authorization for the same indication during this period.
About Civacir
Designed to be the first therapy approved specifically for the prevention of recurrence of Hepatitis C-related liver disease in HCV-positive liver transplant recipients, or in patients who receive a HCV-positive liver, Civacir has the potential to fill a critical void in treatment options for this vulnerable patient population. Most notably, market research completed by the company in 2005 supports growing physician awareness and support for this potential new treatment alternative for HCV. This increased awareness is due, in part, to the following factors:
* Currently, there are no products that can be dosed safely at the time of transplant or immediately after transplant in hepatitis C-positive liver transplant recipients; and as a result, transplanted livers universally become re-infected; * Current products and products under development for maintenance tend to convey a poor risk-benefit ratio in liver transplant recipients; and * Due to the variations in strains of the Hepatitis C virus, it is well recognized that a polyclonal antibody approach is needed; a monoclonal antibody is unlikely to be effective.
HCV is the most common chronic blood-borne infection in the U.S. and a leading cause of end-stage liver disease resulting in liver transplantation. Interferon and ribavirin, currently available treatments, have demonstrated limited efficacy in chronically infected HCV patients. Furthermore, these therapies cannot be used to protect liver transplant patients from HCV re- infection after surgery and are considered too toxic for immune-suppressed liver transplant patients. As a result, among chronic HCV patients who undergo liver transplantation, HCV recurrence in the transplanted liver is nearly universal(1). In addition, associated severe side effects often lead to dose reductions and discontinuation of treatment.
Henrik S. Rasmussen, M.D., Ph.D., senior vice president clinical, medical and regulatory affairs, Nabi Biopharmaceuticals, stated, "The Fast Track Designation provided by the FDA not only acknowledges Civacir as a viable potential treatment option for HCV patients, but it also recognizes that current therapies are inadequate. Nabi Biopharmaceuticals has engaged in extensive and productive discussions with the FDA and the European Medicines Agency regarding the optimal development path for Civacir. The guidance we have received from these organizations and other third parties will be critical factors in the future development of Civacir. Based on input received so far, we plan to initiate a larger dose-ranging proof-of-concept Phase II study later this year."
Next Steps: Civacir Development Program (Phase II Proof-of-Concept Study)
Nabi Biopharmaceuticals plans to initiate a Phase II proof-of-concept study for Civacir in the second half of 2006. This timing is aligned with our goal to have the clinical lot of Civacir manufactured by October 2006, a critical and required step before trial initiation. It is also important to note that Nabi Biopharmaceuticals has developed important technical know-how through a unique and safe production process for Civacir that allows for the separation of high-quality antibodies from patients infected with Hepatitis C.
We believe this timing and product development approach will support our goals of completing enrollment within twelve months, and, subsequently, having data available in the second half of 2008.
The trial will be designed as a double-blinded, placebo-controlled study in approximately 100 HCV-positive patients, post-liver transplant (3 active dose levels, 100, 200 and 400mg/kg, 25 patients per group). The endpoints of the trial are: progression of liver fibrosis; liver enzyme levels; and safety and tolerance. Nabi Biopharmaceuticals plans to conduct the trial in the U.S. and EU.
Thomas H. McLain, chairman, chief executive officer and president, Nabi Biopharmaceuticals, stated, "Civacir is an important and strategic part of Nabi Biopharmaceuticals' product portfolio and our global hepatitis franchise. Civacir leverages assets and competencies within Nabi Biopharmaceuticals today, including our expertise in plasma collection, manufacturing, clinical and regulatory, and sales and marketing, and it builds upon our commercial success with Nabi-HB(R) [Hepatitis B Immune Globulin (Human)] the current gold standard for Hepatitis B. Combined, Civacir and our Nabi-HB product, currently marketed for the prevention of HBV infections following acute exposure, could represent better medical care for patients and a reduction in healthcare dollars spent on additional transplants. Nabi Biopharmaceuticals remains committed to advancing this clinically and commercially important global franchise."
About Liver Transplants and Hepatitis C
There are approximately 6,000 liver transplants conducted yearly in U.S. and 4,000 in the EU, the majority of which are due to Hepatitis C. Furthermore, the proportion of transplants due to Hepatitis C is expected to increase as other causes of end-stage liver disease decrease (i.e., Hepatitis B).
Hepatitis C is the most common cause of end-stage liver disease in the developed world. Most transplant patients, because of their immunocompromised status, suffer immediate re-infection of the liver, which in many cases will progress to liver cirrhosis and can eventually result in death or the need for a re-transplantation. The U.S. Centers for Disease Control and Prevention (CDC) estimates that approximately three million individuals in the U.S. are chronically infected with HCV, and the World Health Organization (WHO) estimates that 170 million individuals worldwide are infected with HCV. The virus can be transmitted through blood transfusion, organ transplants, intravenous drug use, kidney dialysis and sexual contact.
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. We are focusing on developing products addressing commercial opportunities in our core business areas: Gram-positive bacterial infections, hepatitis, kidney disease (nephrology), and nicotine addiction. We have 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)] and a number of products in various stages of clinical and pre-clinical development. The company also filed Marketing Authorization Applications (MAA) in Europe to market Nabi-HB(R) Intravenous [Hepatitis B Immune Globulin (Human) Intravenous] under the trade name HEBIG(TM) for the prevention of hepatitis B disease in HBV-positive liver transplant patients; and for PhosLo, which is already marketed in the United States. The company's products in development include NicVAX(TM) (Nicotine Conjugate Vaccine), a vaccine to treat nicotine addiction, and Civacir(TM) [Hepatitis C Immune Globulin (Human)], an antibody for preventing hepatitis C virus re-infection in liver transplant patients. For additional information on Nabi Biopharmaceuticals, please visit our website: http://www.nabi.com.
This press release contains forward-looking statements that reflect the company's current expectations regarding future events. Any such forward- looking statements are not guarantees of future performance and involve significant risks and uncertainties. Actual results may differ significantly from those in the forward-looking statements as a result of any number of factors, including, but not limited to risks relating to the company's ability to: advance the development of products currently in the pipeline or in clinical trials; complete the assessment of the StaphVAX Phase III clinical trials during the first half of 2006; 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. or other markets; successfully develop manufacture and market its products; utilize the full capacity of its manufacturing facility; realize the value of its acquisition of PhosLo; realize sales from Nabi-HB due to patient treatment protocols and the number of liver transplants performed in HBV-positive patients; realize the value from its vaccine manufacturing facility; realize future sales growth for its biopharmaceutical products; prevail in patent litigation; raise additional capital on acceptable terms; re-pay its outstanding convertible senior notes when due; and the company's dependence upon: third parties to manufacture its products and a small number of customers. 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 25, 2004 filed with the Securities and Exchange Commission.
(1) U.S. Department of Health and Human Services. Management of Hepatitis
C: 2002. NIH Consensus State Sci Statements. National Institutes of
Health, 2002 Jun 10-12; 19 (3) 1-46
Nabi BiopharmaceuticalsCONTACT: Thomas E. Rathjen, Vice President, Investor Relations of NabiBiopharmaceuticals, +1-561-989-5800
Web site: http://www.nabi.com/