Uprifosbuvir

February 4, 2015 By Alex Keown , BioSpace.com Breaking News Staff WASHINGTON – On Wednesday Merck & Co. announced the U.S. Food and Drug Administration (FDA) has rescinded its “breakthrough therapy” designation for its experimental combination treatment for hepatitis C because of other recently approved treatments. Merck announced the FDA ’s decision in its fourth quarter earnings report, but said the company plans to “discuss this matter” with the FDA . A “breakthrough designation,” lets drugmakers work closely with the FDA to get experimental treatments submitted faster. Additionally Merck said they do not expect the FDA ’s decision to impact its ability to new drug application (NDA) for the combination regimen. Merck expects to NDA in the first half of 2015 for grazoprevir/elbasvir, the company’s investigational oral, once-daily combination regimen for the treatment of chronic HCV infection. It consists of a protease inhibitor called MK-5172 and a so-called NS5A inhibitor called MK-8742 that together had received the “breakthrough therapy” designation from the FDA . The company accelerated its hepatitis C virus (HCV) clinical development program in 2014. To bolster its foothold in the hepatitis C market, Merck acquired Idenix Pharmaceuticals Inc. for $3.85 billion in June. The acquisition was intended to combine the companies’ most promising drugs to produce a more effective cure for hepatitis C. Merck ’s MK-3682 is the renamed HCV vaccine IDX21437, a pill in the early-stage trials manufactured by Idenix, which also has two other HCV drugs in development. HCV is the most common chronic blood infection in the country, with approximately 3.2 million cases. According to the U.S Center for Disease Control HCV, which causes damage to the liver, is most efficiently transmitted through large or repeated percutaneous exposure to infected blood. If approved, Merck ’s treatment will compete against therapies from Gilead Sciences, Inc. and AbbVie Oral treatments from Gilead Sciences Inc and AbbVie have wiped out all signs of the virus in more than 90 percent of patients after eight or 12 weeks, according to a Yahoo News report. Gilead sold $10.3 billion of its new hepatitis C drug Sovaldi in 2014.Sovaldi sells for approximately $1,000 per pill, the Times reported. Harvoni, another HCV medication produced by Gilead sold about $2.1 billion in 2014. AbbVie’s HCV medication Humira recorded $12.5 billion in sales. In December AbbVie introduced a new hepatitis C treatment called Viekira Pak. Coming on the heels of Merck ’s announcement about its HCV medication were reported that company revenue fell 7 percent to $10.48 billion for the final quarter of 2014 when compared to the same quarter in 2013. Worldwide sales for all of 2014 were $42.2 billion, a decrease of 4 percent compared with the full year of 2013, the company reported in its year end statement. BioSpace Temperature Poll Will Hiring Heat Up in 2015? With companies as large as Biogen Idec and as small as ICON upping their hiring across the board, where do you think the biotech job market will go in 2015? BioSpace wants your opinion! var _polldaddy = [] || _polldaddy; _polldaddy.push( { type: "iframe", auto: "1", domain: "biospace.polldaddy.com/s/", id: "will-hiring-heat-up-in-2015", placeholder: "pd_1422976075" } ); (function(d,c,j){if(!document.getElementById(j)){var pd=d.createElement(c),s;pd.id=j;pd.src=(' '==document.location.protocol)?' ':' ';s=document.getElementsByTagName(c)[0];s.parentNode.insertBefore(pd,s);}}(document,'script','pd-embed')); Read at BioSpace.com

November 10, 2014 By Jessica Wilson , BioSpace.com Breaking News Staff Merck & Co. today announced interim results of its clinical trial of a triple-therapy regimen consisting of the fixed-dose combination of grazoprevir/elbasvir (MK-5172/MK-8742, MK-5172A) and Gilead Sciences, Inc. ’s Sovaldi for the treatment of chronic hepatitis C virus (HCV) infection which showed that the drug combination failed to meet its efficacy endpoint for a four-week treatment. The results of the study, known as C-SWIFT, which were presented at the 65th Annual Meeting of the American Association for the Study of Liver Diseases ( AASLD ). The drug cocktail did show success in a six-week and an eight-week treatment. In the C-SWIFT study, the 102 participants received Merck’s experimental drugs grazoprevir and elbasvir, along with Gilead ’s Sovaldi for as little as four weeks. According to an article in Businessweek , “In patients whose livers weren’t already badly damaged by the virus, 38.7 percent were cured in four weeks and 86.7 percent were cured in six weeks….That’s well below the 90 percent-plus cure rates seen with longer treatments.” Based on these results, Merck will not move forward in clinical testing with the four-week treatment. “These interim data provide a compelling proof-of-concept for the potential of an eight- or six-week triple therapy course in treatment-naive patients with genotype 1 disease, including cirrhotic patients,” Eric Lawitz , vice president of scientific and research development at The Texas Liver Institute and C-SWIFT lead investigator, said in a statement. “These findings will inform the design of larger studies aimed at understanding the potential of short-duration triple therapy across multiple patient types.” Merck ’s Vice President of Infectious Diseases Eliav Barr , told Businessweek , “The key thing for me was having a clear road map. I was afraid it’d be a pastiche of results difficult to interpret, whereas this clearly shows the Achilles’ heel in terms of duration.” Now that Merck has decided not to pursue the four-week treatment in clinical trials, the company has decided to begin testing a new combination therapy that will involve both grazoprevir and elbasvir as well the investigational drug MK-3682. Merck acquired MK-3682 with its $3.85 billion purchase of Idenix Pharmaceuticals Inc. The new study, called C-CREST, is scheduled to begin in in the first quarter of 2015 and will begin at the Phase II stage. According to an article in Business Insider , the Hepatitis C research field is “moving at lightning pace.” A few years ago, patients had to go through an approximately one-year long treatment that had severe side effects and efficacy as low as 40 percent. The most effective treatment today is Gilead ’s Harvoni, a combination of Sovaldi and a second drug, which has shown cure rates as high as 99 percent after 12 weeks of treatment. var switchTo5x=true; stLight.options({publisher: "0341611e-38a4-415d-9e18-75e093ff27e0", doNotHash: false, doNotCopy: false, hashAddressBar: false});