Healthcare Industry News: Nabi-HB
News Release - January 25, 2006
Nabi Biopharmaceuticals Provides Update on Strategic Direction of NicVAX(TM) ProgramROCKVILLE, Md., Jan. 25 (HSMN NewsFeed) -- Nabi Biopharmaceuticals (Nasdaq: NABI ) today provided an update on the strategic direction of NicVAX(TM) (Nicotine Conjugate Vaccine), the company's novel, innovative and proprietary investigational vaccine being developed to treat nicotine addiction and prevent smoking relapse.
The company completed its Phase II dose-ranging study for NicVAX, which was designed to assess tolerability and antibody response of the vaccine at higher doses than those used in previous studies; the results showed that NicVAX was well tolerated. The vaccine used in the study was manufactured with a lower level of adjuvant in an attempt to further optimize the formulation. An adjuvant is an additive that is often used in vaccines to enhance the immune response.
Based on this Phase II dose-ranging study and in line with the company's product development strategy to best prepare for its Phase III study, Nabi Biopharmaceuticals will next conduct a full Phase II proof-of-concept study. Importantly, the vaccine manufactured for this Phase II study has been manufactured at commercial scale in an optimized formulation at the company's vaccine manufacturing facility in Boca Raton, Florida. This further demonstrates the significant advancements that have already been achieved in the development of Nabi Biopharmaceuticals' nicotine addiction program. The study design will incorporate recommendations from a newly formed scientific advisory panel. The panel is comprised of scientific and clinical experts in smoking cessation. The panel will also provide input to the company on other aspects of the NicVAX development program.
Nabi Biopharmaceuticals has also met with the U.S. Food and Drug Administration (FDA), as well as the European Medicines Agency (EMEA), to ensure all key regulatory requirements are built into the NicVAX Phase II trial design and overall development program. Enrollment in the proof-of- concept Phase II study will commence during the second quarter of 2006 and will be comprised of approximately 210 patients, a large enough sample size to establish both proof-of-concept and optimal dose identification for its Phase III program. The study results are anticipated in the second half of 2007.
Thomas H. McLain, chairman, chief executive officer and president, Nabi Biopharmaceuticals, stated, "Nabi Biopharmaceuticals is the only company able to produce commercial-scale manufacturing quantities of the vaccine, making NicVAX the most clinically advanced product candidate in development for smoking cessation. Furthermore, we have generated positive results to date for NicVAX, garnered important scientific evidence to support NicVAX's mechanism of action, hold strategically important patents in major global markets, and will have in place a good body of clinical data that will be aligned with our Phase III protocol."
Henrik S. Rasmussen, M.D., Ph.D., senior vice president clinical, medical and regulatory affairs, Nabi Biopharmaceuticals, stated, "Findings from the Phase II proof-of-concept study will be key determinants in the advancement of NicVAX and will also allow us to design an optimal Phase III program. So far, the development program established for the vaccine is based on extensive input and comprehensive discussions with the FDA, the EMEA, the National Institute on Drug Abuse, as well as leading external consultants. We have a clear sense of the focus shared by regulators on an optimal smoking cessation product; and we believe NicVAX will be strongly differentiated from currently marketed, as well as development-stage, products."
NicVAX is designed to cause the immune system to produce antibodies that bind to nicotine and prevent it from entering the brain. It is believed that these nicotine antibodies will act like a "sponge" soaking up nicotine as it circulates in the bloodstream and preventing it from reaching the brain. The positive stimulus in the brain that is normally caused by nicotine is no longer present, thereby eliminating the addictive properties of nicotine and, consequently, helping people to quit. Because these antibodies are expected to be long lasting, it is believed NicVAX will also be effective in preventing smoking relapse, a significant challenge with existing smoking cessation therapies. By preventing the pleasurable response that occurs when nicotine reaches the brain, NicVAX takes away what is believed to be the main physical reason that most people cannot stop smoking.
Early clinical data indicates that NicVAX, if approved, could potentially be one of the most efficacious smoking cessation products available. In a Phase II clinical trial, NicVAX achieved a 33 percent quit rate in smokers who received the highest dose level versus 9 percent in the placebo group. These results represented a vaccine-only effect, as patients were not given any supplemental treatments, behavioral support or counseling. It is expected that the response rate would be further improved as behavioral support and counseling are built into the program.
In September 2005, Nabi Biopharmaceuticals announced that it had received a $4.1 million grant by the U.S. National Institute on Drug Abuse (NIDA), part of the National Institutes of Health, for partial funding of the development program for NicVAX. Partnering remains Nabi Biopharmaceuticals' strategic goal for NicVAX.
About the Phase II Dose-Ranging Study
The Phase II dose-ranging study was comprised of 50 healthy smokers, who were randomized to receive one of four dose levels (100, 200, 300 and 400 mcg), administered as five injections and given on days 0, 21, 42, 56 and 182. A total of 20 patients received the 200 mcg dose, with ten patients receiving each of the other dose levels. The study was undertaken to assess the tolerability and antibody response at higher doses (300 and 400 mcg), recognizing that the top dose used in previous studies (200 mcg) was well tolerated.
Cigarette Smoking: A Growing Global Health Challenge
Smoking is a global healthcare problem, and The World Health Organization estimates that there are 1.3 billion smokers worldwide and nearly 5 million tobacco-related deaths each year. According to the U.S. Centers for Disease Control and Prevention (CDC), tobacco use is the single leading preventable cause of death in the United States and is responsible for more than 440,000 deaths each year. They estimate that approximately 70 - 80 percent of smokers in the U.S. want to quit, but less than 5 percent of those who try to quit remain smoke-free at 12 months. In addition, they estimate that tobacco use causes $75.5 billion in excess medical costs and $81.9 billion in illness- related productivity losses each year in the U.S.
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® (calcium acetate), Nabi-HB® [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® 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.
Source: Nabi Biopharmaceuticals
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