Business briefs: Gilead, Xarelto
Two-and-a-half weeks after Gilead released data showing its experimental hepatitis C therapy sofosbuvir showed “superiority” over predefined viral levels, the company, along with Medivir and Johnson & Johnson, said a combination of sofosbuvir and the J&J/Medivir drug simeprevir cleared the virus among patients who took the combination drug for between 12 and 24 weeks, reported Bloomberg. The companies announced the results Monday at a conference in Atlanta. The hepatitis C category has been a fraught one, with drug makers being forced to idle or halt development of several therapies in 2012. The CDC elevated the profile of the liver disease last year when it recommended all Baby Boomers get tested for the virus, regardless of perceived risk profile. The agency noted at the time that Boomers account for about 75% of HCV infections. HCV infects about 17,000 new patients a year.
Roche chairman Franz Humer is leaving his position next year after 13 years in that role, the Associated Press reported. Meanwhile, the EU has greenlighted Roche's breast cancer drug Perjeta, when paired with Herceptin. A PM Live report said the Perjeta-Herceptin combo costs about $188,000 for an 18-month treatment, or $10,444 per month. The high-priced treatment is in good company following the FDA's recent approval of Kadcyla, which is expected to cost about $9,800 per month. Add $6,000 per month Perjeta, and the the combo comes to $15,800 a month.
FDA has refused approval of an expanded indication for Xarelto that would have greenlighted the drug for use in reducing the risk of stroke and heart attack in patients with acute coronary syndrome. The J&J/Bayer blood thinner was denied approval in June for the same indication, as regulators were concerned about bleeding risks and incomplete trial data. J&J said on Monday it was still evaluating the rejection letter received from FDA. Xarelto was the most widely advertised brand online this past year, according to Kantar Health. The brand was advertised on 37 websites.