Low-Cost, Commercial Scale Production of Sofosbuvir

Recent advances in antiviral therapeutics have produced highly effective small molecule drugs to treat Hepatitis C, a deadly infection of the liver. Sofosbuvir, a hepatitis C drug developed by Gilead Sciences, is a breakthrough treatment due to its low side effects and high cure rate. However, the cost of treatment is extraordinarily high, priced at $84,000 per treatment in the US. In response to backlash regarding the cost barriers in developing countries, Gilead has reached licensing agreements with generic pharmaceutical companies to produce the drug for markets in low-income countries such as India, Kenya, and Cuba among others. The report describes a cost-effective, commercial scale process design for the production of sofosbuvir. The proposed production facility is designed to deliver 350,000 kg/year of the active pharmaceutical ingredient, enough to treat 10 million patients per year. The production will be completed over one hundred batches, requiring operation of 120 days/year. Assuming an 11-year period of operation, detailed economic analysis suggests that this is a profitable venture with an IRR of 67.7% and a NPV of $1.2 billion USD.