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Pharmasset, Inc. is a pharmaceutical company focused on discovering, developing, and commercializing novel drugs to treat viral infections. The company is currently working on oral therapeutics for the treatment of chronic hepatitis C virus (HCV) infection and the Human Immunodeficiency Virus (HIV). The company focues on a class of compounds known as nucleoside/tide analogs, which inhibit viral replication by disrupting viral polymerases.
Pharmasset is developing its lead compound for the treatment of HCV with Roche Pharmaceuticals (RHHBY). In May 2010, the company reported topline results of its lead candiate RG7128. The study showed that the compound was well tolerated and efficacy data demonstrated that >80% of patients had undetectable HCV RNA in all cohorts receiving the 12 week triple regimen compared to <50% for the placebo/SOC cohort.
The promise of Pharmasset's treatments, combined with an overwhelimg global need drove the company's stock price from its IPO of $9.00 per share in 2006 to over $100 per share in 2011.
The World Health Organization (WHO) estimates that almost 180 million people globally are infected with HCV, representing almost 3% of the world's population. HCV is a leading cause of chronic liver disease and liver transplants.
There has not been much progress in the treatment of HCV drug since the introduction of alpha-interferon and ribavirin, and since the combo cause serious side effects, patients and physicians are calling for new and better treatments.
Beginning in 2009, the FDA implemented a series of reforms that include stricter monitoring of drug adverse events, more funding for the agency, stronger ability to force product recalls, more scientific expertise within the agency, more transparency. Even before 2009 the result has been a much more conservative FDA, demanding more product information.
The various aspects of patent protection and the extremely high costs of researching and developing drugs marks the pharmaceutical industry with high risk and high competitiveness. It is important to keep in mind when considering a comparison of industry players that competition does not arise between each company as a whole, but rather between specific drug areas and their relative advantages in therapeutic treatment.