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The hepatitis C market is worth approximately $1.5bn, and is set to rise to $3.4bn by 2010. In the medium-to-long term, the development of products for the treatment of hepatitis C is likely to become a growing area for pharmaceutical companies in the infectious diseases area, providing companies without experience in this sector with the opportunity to establish a new franchise. Recent findings presented at the Annual Meeting of the American Association for the Study of Liver Diseases in Boston, USA suggests that the understanding and treating hepatitis C is high on the agenda for healthcare policy makers and the pharmaceutical industry. Pipeline Perspectives: Hepatitis B and C provides an insight into the late-stage development pipeline for both markets. The report provides a detailed assessment of current patient potential in the seven major markets and analysis of Phase III clinical trial design focusing on key endpoints for both indications. In depth product profiles for key late-stage pipeline products are provided, along with Datamonitor HBV product forecasts to 2011. Hepatitis dangers underestimatedAlthough hepatitis C (HCV) is estimated to be four times as common in the United States as human immunodeficiency virus (HIV), generally only people in infectious disease research or the healthcare community realize its long-term seriousness. Indeed, recent studies suggest that, whilst yearly HIV-related mortality is projected to rise to 4,200-6,700 by 2030, annual deaths due to HCV (liver failure or hepatocellular carcinoma) are predicted to rise to 14,000-19,000. Unless advances in HCV therapy reach those currently experienced in HIV (HAART-therapy), these differences in mortality may become even more pronounced. At the moment, treating physicians have few options for the treatment of HCV. The ‘gold-standard’ normally involves co-administration of an antiviral, ribavirin and an immunomodulatory agent; pegylated interferon. Not all patients respond, and those that do, experience side effects severely affecting their compliance levels. As a result of the lack of competition and treatment substitutes, pegylated-interferons manufacturers, Roche and Schering-Plough have been able to carve-out a global market of approximately $1.5bn (2002), which is expected to rise to $3.4bn by 2010. New treatments optionsOver the past year there have been reports suggesting the search for better HCV treatment options is active and ongoing. One notable case is Boehringer Ingleheim’s developmental candidate, antiviral BILN2061, an oral active inhibitor. Although at high doses the compound has been shown as cardio toxic in animal models, within the therapeutic range in humans, it effectively suppressed HCV viral load in a limited amount of volunteers. It is unknown whether BILN2061 will continue, but importantly it demonstrates ‘proof of concept’ that NS3 is a valid target for drug discovery and design. In addition, Boston based Vertex Pharmaceuticals, recently involved in GSK’s launch of Lexiva, a new HIV antiviral, also have a HCV treatment candidate known as Merimepodib. At an interim stage of six-months, this compound demonstrated a statistically significant antiviral response in combination with pegylated interferon and ribavirin. It is also being assessed as a monotherapy. Smaller companies such as Isis, Maxim, SciClone and Vertex dominate the late-stage HCV pipeline with a number of new treatment candidates on the horizon. However, due to increasing development costs and the increased difficulty to compete, smaller companies, via a number of alliances and partnerships (mainly with Schering-Plough and Roche), are currently targeting a number of niche populations that are currently underserved. Addressing these smaller segments not only makes costs more manageable, but also gives an eventual leverage point into the broader HCV market through further product promotion. Unmet need From a commercial perspective, the huge unmet medical need in HCV treatment promises enormous market potential for newer specific antiviral therapies. Depending on their profile, these agents can not only be targeted to the mass treatment population, but also to niche groups such as non-responders and those co-infected with HIV. Newer therapies could compliment interferons or act as part of new standalone antiviral cocktails similar to those seen in the management of HIV. Possession of new ‘complimentary’ antivirals might give maximum portfolio leverage, an example followed by Gilead for HIV and HBV. Either way, in the medium-to-long term, the development of products aimed at treating hepatitis is one of the more attractive options in the infectious diseases area. This should result in companies who generally operate outside this sector using this opportunity to reestablish a new franchise. If you found
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