Executive Summary
There is still a strong interest in developing novel therapies for HCV despite the promise of the pegylated interferons. The enthusiasm for specifically targeted HCV drugs such as protease inhibitors is increasing. The understanding of hepatitis C at a molecular level has also opened the door for more targeted development of a prophylactic or therapeutic HCV vaccine.
According to the CDC, nearly four million people are or have been infected with HCV in the U.S. alone. 2.7 million have an ongoing chronic infection, the majority being between 40 to 60 years old. Because most persons with chronic HCV infection have yet to be diagnosed, but are likely to come to medical attention in the next decade, a fourfold increase in the number of adults diagnosed with chronic HCV infection is projected from 1990 to 2015. However, the number of new infections per year has declined from an average of 240,000 in the 1980s to about 25,000 in 2001. By 2020, almost all of the infected will have had the disease for more than 25 years. Between the years 2010 and 2020, most patients will have reached an age of 55 to 75 years. Many of the infected will die of other reasons before being diagnosed and starting an anti-HCV therapy.
Schering-Plough is the clear leader in the field. But, from now on Roche will be sharing the market and they will slowly increase their market shares. Also Boehringer Ingelheim, InterCell, Innogenetics and Human Genome Sciences are players to be counting on in the near-term future.
The main hindrance to drug development for hepatitis C has been the lack of a small animal model or productive tissue culture system for assessing drug action. This problem has been addressed both by academic groups and private companies, which has resulted in a drastic improvement of the possibilities for in vivo research. The main obstacle has clearly been difficulty of achieving viral replication in the laboratory both in cell culture and animal models. A general opinion among the scientific community is that it is obvious that substantial hurdles still remain. Getting a reliable system to evaluate products before they go into clinical trials is very problematic.
Several groups are now generating models that have the possibility to revolutionize HCV drug discovery. Merck is one company with high activity in this field, working with bioinformatic tools, cellular assays and animal models. Merck's groups at Instituto di Ricerche di Biologia (IRBM) in Italy are using several approaches to solving the HCV problem. In one project, Merck is utilizing the contribution of computational techniques and the use of structural information for the design and discovery of novel therapeutic agents for HCV. The company's interests lie drug discovery as well as vaccine design.
In the section "HCV Drug Discovery Technologies", we describe and assess the ongoing struggle for improved and novel HCV drug discovery technologies. Technological breakthroughs have been made and BioSeeker Group has identified improvements for new drug discovery platforms that have the potential to substantially improve HTS.
In other sections of the report, the whole range of molecular approaches towards new HCV therapy is presented. These strategies include immuno-modulating substances, protease inhibitors, vaccines, polymerase inhibitors, nucleoside analogues, ribozymes, iminoglucosidase inhibitors, caspase inhibitors, antibodies, and many more. Also other therapeutic or prophylactic approaches such as hyperthermia or plasma inactivation are discussed. For your convenience BioSeeker Group has included extensive appendices with recent patents, detailed information regarding clinical trials and collaborations, and the current collaboration clusters.
Several large pharmaceutical companies, as well as smaller biotech companies, are involved in HCV R&D, but with different focuses. The various approaches are analyzed according to the opportunities in the short, mid-range and long-term market development; and how the return on investment can be maximized bearing this view in mind. Due to the tough competition and a shrinking market, some therapies will have difficulties to reach sufficient revenues within their lifecycle.
The report "Molecular Approaches Towards HCV Therapy - The complete guide" is a comprehensive document providing the reader with an extensive amount of information. To help the reader in grasping the material, several graphs, figures and boxes have been produced as well as a careful indexing of the document.

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