Antiviral Therapies Promise Significant Rewards in

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Wednesday January 9, 1:37 pm Eastern Time Press Release SOURCE: Decision Resources, Inc. Antiviral Therapies Promise Significant Rewards in the Treatment of Hepatitis B Virus, According to a Decision Resources Study WALTHAM, Mass., Jan. 9 /PRNewswire/ -- Decision Resources, Inc., announces the publication of Hepatitis B Virus, a new study that explains why, despite considerable progress in the prevention and treatment of this disease, the hepatitis B virus (HBV) market remains open to innovation, particularly for therapies to treat chronically infected patients. This study evaluates the therapeutic and commercial potential of promising agents and vaccines expected to fill this gap during the next decade. Antiviral Agents Generate Excitement In the Medical Community Antiviral agents are the most promising drugs in development for the treatment of chronic HBV infection. They suppress HBV DNA replication and reduce the risk of liver damage over the course of chronic infection. The 1998 launch of GlaxoSmithKline's lamivudine, the first antiviral agent approved for chronic HBV infection, sparked a revolutionary change in the treatment of this disease. Lamivudine is administered orally, is relatively inexpensive, and has no apparent serious side effects, resulting in the widespread use of lamivudine for chronic HBV infection. Consequently, lamivudine has taken considerable market share from interferon-alpha, previously the only drug approved for HBV. However, the recent discovery that long-term treatment with lamivudine can lead to antiviral resistant HBV has ignited the search for new antiviral agents. Research on the human immunodeficiency virus, which has a similar mechanism of replication to that of HBV, has identified a plethora of antiviral agents that may be useful in the treatment of chronic HBV infection. Based on the published results of clinical trials and interviews with leading clinicians and researchers, we predict that emerging antiviral agents, such as Gilead Sciences' adefovir dipivoxil, which is effective against lamivudine- resistant HBV strains, and Triangle Pharmaceuticals/Abbott Laboratories' emtricitabine-both in Phase III trials-will be widely used in treating chronic hepatitis B. Improved Prophylactic Vaccines Offer Reduced Dosage Bio-Technology General's Bio-Hep-B and Powderject Pharmaceuticals' Hepagene, in an attempt to improve upon the efficacy of existing HBV prophylactic vaccines, are incorporating the S antigen and other surface proteins of the virus to enable successful immunization with significantly lower doses of vaccine than is possible with other recombinant hepatitis B vaccines. Hepatitis B Virus is part of Infectious Disease, one of six Pharmacor services that evaluate the commercial potential of drugs in research and development. Decision Resources, Inc., is a world leader in pharmaceutical research publications, advisory services, and consulting designed to help clients shape strategy, allocate resources, and master their chosen markets. Founded as a subsidiary of Arthur D. Little, Inc., the company has provided strategic information services for 30 years. Visit the Decision Resources Web site at www.dresources.com. Yahoo News

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Hepatitis B Virus Franka des Vignes Ph.D.; Jean Dies M.P.H.; Andrea Kasowitz; Annie Kruger Study # 56, 12/1/2001, 87 pages Table of Contents Executive Summary The Lamivudine Revolution in Hepatitis B Therapy Hepatitis B Prophylaxes Build on Prior Success New Antiviral Agents to Drive Growth 1. Introduction 2. Etiology and Pathophysiology The Hepatitis B Virus The HBV DNA Genome The HBV Replication Cycle HBV and the Immune Response Clinical Outcome of HBV Infection Acute Hepatitis B Infection Chronic Hepatitis B Infection Precore Mutant Chronic HBV Infection Hepatitis B Virus Resistance Cirrhosis Hepatocellular Carcinoma Extrahepatic Conditions HBV Transmission and Risk Factors 3. Epidemiology General Methodology Total Prevalence of Chronic HBV Infection HBeAg-Positive and -Negative Segmentation of Chronic HBV Prevalent Population Total Incidence of HBV Infection Incidence of Acute Symptomatic HBV Infection Incidence of Chronic HBV Infection Hepatitis B Trends United States Total Prevalence Total Incidence France Total Prevalence Total Incidence Germany Total Prevalence Total Incidence Italy Total Prevalence Total Incidence Spain Total Prevalence Total Incidence United Kingdom Total Prevalence Total Incidence Japan Total Prevalence Total Incidence 4. Current Therapies Hepatitis B Vaccines Single-Antigen Vaccines Multiple-Antigen Vaccines Twinrix Comvax Hepatitis B Immune Globulin Interferon-Alpha Lamivudine Clinical Trial Results Potential Side Effects Liver Transplantation 5. Medical Practice Overview Prevention Diagnosis Treatment United States Prevention Diagnosis and Treatment France Prevention Diagnosis and Treatment Germany Prevention Diagnosis and Treatment Italy Prevention Diagnosis and Treatment Spain Prevention Diagnosis and Treatment United Kingdom Prevention Diagnosis and Treatment Japan Prevention Diagnosis and Treatment 6. Unmet Needs 7. Emerging Therapies Pegylated Interferons Antiviral Agents Adefovir Dipivoxil Emtricitabine Entecavir L-FMAU L-Fd4C L-dT Immunomodulators (Thymosin-Alpha 1) Prophylactic Vaccines Bio-Hep-B SBAS4/MPL Hepagene Therapeutic Vaccines Chiron’s Hepatitis B Vaccine EHT-899 SB-M000026 Theradigm-HBV 8. Market Outlook Interferon-Alpha Antiviral Agents Immunomodulators Hepatitis B Vaccines and Immune Globulin Regional Analysis United States Europe Japan Appendix A. Bibliography—Hepatitis B Virus Appendix B. Physicians and Researchers Interviewed for This Report Tables and Figures Table 1. Viral Markers in HBV Infection Table 2. Interpretation of the Hepatitis B Panel Table 3. Clinical Manifestations of HBV Infection by Age-Group Table 4. Groups at Highest Risk of HBV Infection in the Major Pharmaceutical Markets Table 5. Number of Total Prevalent Cases of Chronic Hepatitis B Infection in the Major Pharmaceutical Markets, 2000-2010 Table 6. Number of Total Incident Cases of Hepatitis B Infection in the Major Pharmaceutical Markets, 2000-2010 Table 7. Number of Total Incident Cases of Symptomatic Acute Hepatitis B Infection in the Major Pharmaceutical Markets, 2000-2010 Table 8. Number of Total Incident Cases of Chronic Hepatitis B Infection in the Major Pharmaceutical Markets, 2000-2010 Table 9. Sources for Epidemiology Estimates—Hepatitis B Virus Table 10. Current Therapies Used for the Prevention of Hepatitis B, 2001 Table 11. Current Therapies Used for the Treatment of Chronic Hepatitis B, 2001 Table 12. Design and Results of Clinical Trials for the Evaluation of Lamivudine for the Treatment of Chronic Hepatitis B Table 13. Emerging Therapies in Development for Hepatitis B, 2001 Table 14. Sales of Drugs for Hepatitis B Virus in the Major Pharmaceutical Markets, 2000-2010 Figure 1. The Dane Particle Figure 2. Hepatitis B Virus Replication Figure 3. Response to HBV Infection: Acute Hepatitis Figure 4. Diagnosis of Hepatitis B Figure 5. Unmet Needs in the Treatment of Hepatitis B Figure 6. Market Shares of Hepatitis B Virus Therapeutic and Prophylactic Agents by Class in the Major Pharmaceutical Markets, 2000-2010 Keywords: Antiviral drugs, Cirrhosis, Drug development, France, Germany, HBV, HCC, Hepatitis B core antigen, Hepatitis B e antigen, Hepatitis B immune globulin, Hepatitis B surface antigen, Hepatitis B virus, Hepatocellular cancer, Hepatocellular carcinoma, Immunomodulators, Infectious diseases, Infectious disease drugs, Infectious disease R&D, Italy, Japan, Multiple-antigen vaccines, Pharmaceutical markets, Prophylactic vaccines, Single-antigen vaccines, Spain, Therapeutic vaccines, United Kingdom, United States ****** Abstract Worldwide, more than 2 billion people have been infected with the hepatitis B virus (HBV); more than 350 million of those infected have progressed to chronic HBV infection. In addition to serving as a pool from which infection can spread, many people with chronic HBV infection eventually develop cirrhosis and primary liver cancer. An estimated 25-33% of all individuals with chronic HBV infection will develop progressive liver disease. Key findings of this Pharmacor study include the following: Epidemiology: In 2000, the number of prevalent cases of chronic HBV infection exceeded 5.0 million in the major pharmaceutical markets (the United States, France, Germany, Italy, Spain, the United Kingdom, and Japan). The implementation of national vaccination programs has reduced the rate of HBV transmission among infants and adolescents but is currently offset by the existence of a sizable pool of persons with chronic infection, which will persist for several generations. As a result, the total number of prevalent cases of chronic HBV infection will increase slightly, to 5.2 million, in 2010. Key unmet needs: Unmet needs in the management of chronic HBV infection include the following: therapies that yield a higher rate of hepatitis B e antigen (HBeAg) seroconversion, eradication of HBV DNA in infected individuals’ serum, and agents that do not lead to HBV resistance. Therapies in development promise to bring such advances to the marketplace in the near future. Current therapies: Current therapies for HBV infection include both prophylactic and therapeutic agents. Among prophylactic vaccines, several multiple-antigen vaccines such as GlaxoSmithKline’s Twinrix and Merck’s Comvax offer improvements relative to the traditional single-antigen vaccines (Merck’s Recombivax HB and GlaxoSmithKline’s Engerix B), allowing for better compliance with childhood immunization schedules. Hepatitis B immune globulin (HBIG) is another currently available prophylactic therapy; because of its high cost, however, it rarely competes with HBV vaccines in the prophylaxis market. More commonly, HBIG is used in infants born to mothers who test positive for HBV surface antigen (HBsAg), in health care workers exposed to the virus, and in liver transplant recipients. Two treatments are currently available for the chronically infected population: a recombinant cytokine, interferon-alpha (IFN-?, and a