Achillion Pharmaceuticals, Inc. announced that it has received a $15 million milestone payment from Janssen Research & Development, LLC., part of the Janssen Pharmaceutical Companies of Johnson & Johnson (Janssen), related to enrollment in the OMEGA-1 phase 2b global, clinical trial of JNJ-4178, a 3DAA combination of odalasvir, simeprevir, and AL-335 in patients with treatment-naive chronic hepatitis C virus infection (HCV) without cirrhosis.
The shares of the four drugmakers were up between 0.1 percent and 0.7 percent on Friday afternoon, roughly in line with the broader health index's 0.5 percent increase.
Driven by several novel regimens recently receiving approval in the US and in Europe, high cure rates exceeding 90% are now achievable for most patients suffering from chronic hepatitis C. As a result of this unprecedented success, the industry is reaching a new phase in the fight against this deadly infectious disease. The pressure is now shifting to the healthcare providers to determine if the future of hepatitis C treatment will include a (near) eradication in the developed world, or if hepatitis C will remain a debilitating and life-threatening factor in our society.
Japan's Pharmaceuticals and Medical Devices Agency (PMDA) is reviewing approved hepatitis C drugs in the country for links to a possible reactivation of the hepatitis B virus, which could result in label changes.nnIn a notice last week, PMDA said that the review covers Gilead Sciences' ($GILD) Sovaldi (sofosbuvir) and Harvoni (ledipasvir and sofosbuvir) as well as AbbVie's ($ABBV) Viekirax (ombitasvir and paritaprevir and ritonavir), Bristol-Myers Squibb's ($BMY) Daklinza (daclatasvir) and Sunvepra (asunaprevir), Mitsubishi Tanabe's Telavic (telaprevir), Janssen Pharmaceutical K.K.'s Sovriad (simeprevir), and Merck's ($MRK) Vanihep (vaniprevir).
The European health regulator said it extended a safety review of chronic hepatitis C treatments after new data showed patients taking the drugs were at risk of their liver cancer returning.
Celltrion is working hard to snatch market share from Merck's ($MRK) Remicade with its biosimilar, Remsima. And now, it's armed with real-world data that could help further that aim.
Last year, currency effects dragged down Johnson & Johnson's ($JNJ) sales and profits, and hefty hep C competition hurt sales of former standout Olysio. But those weren't the only numbers on the decline at the drugmaker.
Regulus Therapeutics Inc said interim mid-stage data for its hepatitis C combination drug showed it had the potential to sharply reduce the duration of the treatment to four weeks from 12 weeks.
Johnson & Johnson's ($JNJ) hep C sales have been nosediving, and the fourth quarter provided more of the same on that front. But in the quarter, a strong dollar took a toll on the company's top line, too, dragging sales below analyst estimates.
PBM giants Express Scripts ($ESRX) and CVS Health ($CVS) have so far found formulary exclusions an effective way to manage drug costs. And unfortunately for pharma companies, that tactic is catching on.