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WASHINGTON – On Wednesday Merck & Co. announced the U.S. Food and Drug Administration (FDA) has rescinded its “breakthrough therapy” designation for its experimental combination treatment for hepatitis C because of other recently approved treatments.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 file a new drug application (NDA) for the combination regimen.
Merck expects to file a 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.
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