Shares of Gilead Sciences (GILD) declined approximately 0.9% to close the trading session on Sep 17 at $103.84 following a couple of setbacks — the failure of an oncology candidate to meet the primary endpoint in a phase II study and highly concerning data on the company’s blockbuster hepatitis C drug Sovaldi.
Gilead’s pipeline candidate simtuzumab in combination with Eli Lilly and Company’s (LLY) Gemzar (gemcitabine) performed disappointingly in a phase II study (n=236) in treatment naïve advanced pancreatic cancer patients.
Results from the randomized, double-blind, placebo-controlled study did not reveal a statistically significant improvement in progression-free survival (PFS) in patients treated with the combination of simtuzumab (200mg or 700 mg) and Gemzar as compared to those in the placebo arm.
The median PFS across simtuzumab 200mg, 700 mg and the placebo arms was observed to be 3.5 months, 3.7 months and 3.7 months, respectively. Gilead intends to present detailed data from the study at the European Society for Medical Oncology Congress later in the month.
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Gilead however is evaluating simtuzumab in other indications such as advanced colorectal cancer, myelofibrosis, idiopathic pulmonary fibrosis and liver fibrosis caused by non-alcoholic steatohepatitis and primary sclerosing cholangitis. Similar setbacks in these indications would push the biopharmaceutical major further into trouble.
Gilead suffered yet another setback when analysis conducted by the researchers of CVS Health (CVS) Research Institute revealed that the discontinuation rate associated with Sovaldi in the real world was four times more than the 2% (approximately) observed in clinical trials.
Data also revealed that patients new to hepatitis C therapy were less likely to complete the full course of Sovaldi treatment. The high price of Sovaldi in the U.S. ($84,000 for a 12-week course) may have contributed to the high discontinuation rate despite the supreme efficacy of the drug.
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The analysis further revealed that the overall usage of Sovaldi plateaued with a decline between May and August this year. Gilead is looking to introduce its next HCV treatment – a combination of ledipasvir and Sovaldi – later in the year.
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