InterMune's hepatitis strategy gets the right response

Infection with the hepatitis C virus (HCV) is four times more common than HIV infection, and chronic HCV infection (CHC) is associated with considerable morbidity and mortality due to CHC-associated liver cirrhosis and cancer. Between 170-200 million individuals are estimated to be infected worldwide, with a prevalence of approximately 7.5 million in the seven major markets and 2.7 million in the alone, according to Datamonitor research.

InterMune is a small biopharmaceutical company, primarily focused on pulmonology and hepatology. Although the bulk of InterMune's revenues are derived from Actimmune sales (80% in 2004), the company is shifting its focus to CHC infection. In the past, InterMune's second core product, Infergen, has not gained significant market share for first-line HCV therapy, being prescribed to less than 5% of all CHC patients as first line across the seven major markets according to recent Datamonitor research.

Alternative therapies

However, given the limited chance of success through retreatment with the current standard of care, pegylated-IFN (peg-IFN) alfa plus ribavirin (RBV) following treatment failure, physicians are now turning to alternative therapies in the hope that these might benefit their non-responder patients. Datamonitor research revealed that IFNs other than unmodified or peg-IFN alfa, are used as monotherapy for second-line therapy in 2.5% of patients and as combination therapy with RBV in up to 17%.

In the absence of an approved second-line therapy and with the limited efficacy of retreatment with peg-IFN and RBV combination therapy, the CHC non-responder pool is becoming an increasingly important target population. Indeed, in the for example, this sub-group of patients is estimated at 150,000, increasing by up to 50,000 patients per year.

In addition, the asymptomatic nature of CHC and the long period of viral persistence required for health-threatening disease symptoms to become apparent means there is an anticipated patients requiring antiviral treatment between 2010 and 2020. Consequently, while the CDC reports a sharp decrease of new HCV infections in the past two decades, both big pharma and small biotechs have actively been developing new drugs and strategies to compete for their share in this highly competitive market.

Infergen well-placed

InterMune has been quick to seize on this opportunity, investing in a new Infergen sales force of 31 representatives together with expanded marketing and medical information support. These positive steps are likely to continue in the short term, concomitant with clinical support for the efficacy of Infergen in the key non-responder patient group emerging from InterMune's DIRECT trial. This is a Phase III clinical trial evaluating the use of Infergen in combination with RBV in non-responders to previous peg-IFN-based therapy.

InterMune's strategy is not that unusual, with industry interest in this indication expanding rapidly, as highlighted by the relatively strong HCV pipeline across the pharma sector. Yet InterMune's established HCV market presence should work to its advantage in expanding its indication to a steadily growing patient sub-group that represents a major medical unmet need.

Whether this strategy will work out in the long term depends on how successful new HCV drugs will be in treating non-responders. Heavy investment in a strong sales force might prove critical to secure market share before other drugs in the immunomodulator class reach the market.

Related research:

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