Memorandum
Gilead provided its 3Q15 update in a call led by CEO Dr. John Martin this afternoon. Gilead did not mention its diabetes-related product pipeline during the call. However, the presentation slides noted that Gilead has completed enrollment for its phase 2 study of ASK-1 inhibitor GS-4997 in diabetic nephropathy. We’ve been waiting for some time for an update on whether Gilead will pursue a type 2 diabetes indication for its sodium current inhibitor Ranexa (ranolazine; approved for angina). Dr. Robert Eckel presented promising phase 3 results on ranolazine’s A1c-lowering efficacy at ADA this past June. Unfortunately, there were no updates on this front from the call or from Gilead’s website. A phase 4 study for ranolazine in diabetic peripheral neuropathic pain is ongoing. According to ClinicalTrials.gov, the expected completion date for the study has been pushed back to June 2016 (from June 2015). We’re glad to see such a powerhouse company addressing areas of unmet need in diabetes complications, though it was clear from the call that Gilead is heavily focused on its hepatitis C cure and HIV treatments. The company’s controversial hepatitis C cure Harvoni (ledipasvir/sofosbuvir) brought in revenue of $3.3 billion in 3Q15, its fourth quarter on the market. This drug has been one of the focal points of the recent public outcry over pharmaceutical prices, as its sky-high cost has forced payers and healthcare systems to limit access to only the sickest of the 130-150 million people with hepatitis C worldwide. For comparison, sales of Sanofi’s top-selling basal insulin Lantus (insulin glargine) reached only $2.2 billion at its peak. While the ability to cure a debilitating condition is incredible, extraordinarily high drug costs are a major shock to the healthcare system and can draw payer resources away from reimbursement for other conditions.