January 6, 2016
By Alex Keown, BioSpace.com Breaking News Staff
FOSTER CITY, Calif. – Gilead Sciences, Inc. will cease a Phase II clinical study of its investigational monoclonal antibody simtuzumab among patients with idiopathic pulmonary fibrosis due to lack of efficacy, the company announced this morning.
Gilead said it is stopping the trial after an analysis “of unblinded efficacy and safety data by the study’s Data Monitoring Committee.”
In 2014, the U.S. Food and Drug Administration approved Boehringer’s Ofev for the treatment of IPF. Ofev is a kinase inhibitor that blocks multiple pathways that may be involved in the scarring of lung tissue.
Although the company is stopping its study of simtuzumab for use in IPF, Gilead said it will continue to study the drug’s use for patients with non-alcoholic steatohepatitis (NASH) and primary sclerosing cholangitis (PSC). The study has a 96-week endpoint.
This is not the first time simtuzumab has failed to meet expectations. In 2014, Gilead stopped a Phase II study of simtuzumab in combination with gemcitabine for the treatment of pancreatic cancer failed to significantly increase progression-free survival. The addition of simtuzumab to gemcitabine did not cause any more adverse reactions in patients compared to the addition of placebo to gemcitabine.
Gilead acquired simtuzumab from Arresto Biosciences in 2011.
Although Gilead has ceased the mid-stage trial, company stock has not taken a hit as it still seems to be benefitting from a report Tuesday that two Phase III trials of its hepatitis B drug tenofovir alafenamide achieved their primary endpoints. On Tuesday, Gilead announced that tenofovir alafenamide (TAF) was non-inferior to Gilead’s Viread. In addition, TAF demonstrated improved renal and bone laboratory safety parameters compared to Viread, the company said.
Gilead plans to submit regulatory applications for TAF for chronic HBV in the United States and the European Union in the first quarter of 2016.
Additionally, Gilead announced that the U.S. Food and Drug Administration granted priority review to the company’s New Drug Application for an investigational, once-daily fixed-dose combination of the nucleotide analog polymerase inhibitor sofosbuvir, better known as Sovaldi, and velpatasvir , an investigational pan-genotypic NS5A inhibitor, for the treatment of chronic genotype 1-6 hepatitis C virus infection. Gilead filed the NDA for SOF/VEL on Oct. 28 and FDA has set a target action date under the Prescription Drug User Fee Act of June 28, 2016. The FDA has assigned SOF/VEL a Breakthrough Therapy designation, which is granted to investigational medicines that may offer major advances in treatment over existing options, Gilead said.
Based on the news, a Barrons analysis said “Gilead can generate significant free cash flow through the end of this decade.” The report indicated the could reach as high as $137 per share. Gilead hit a high of $122.21 per share in June. Gilead is currently trading at $100.30 per share, up from its opening sign of $97.57 per share.
Gilead has been criticized for the price of its hepatitis treatments, which can reach $95,000 for a 12-week regimen. A U.S. Senate report said the high cost of the drugs has also been damaging to Medicaid programs. According to the investigation, Medicaid programs spent $1.3 billion before rebates for the hepatitis C drugs to treat fewer than 2.4 percent of enrollees diagnosed with the liver disease. More than 700,000 hepatitis C patients on state Medicaid programs are still waiting to receive their medications.
Despite the price, Gilead’s hepatitis C treatments have proven to be highly effective since they were launched. Sovaldi has had a 90 percent efficacy in curing, not treating, but curing, the liver disease when used with other treatments —surpassing older treatments. It was because of that high rate of efficacy that Gilead was able to command such a high price for Sovaldi.
