Five things for pharma marketers to know: Monday, August 17
Endo International's best-selling painkiller, Opana ER, secured patent protection against generics until 2023 as a result of a court ruling. The US District Court blocked Actavis, Teva and Sun from selling generic versions of the extended-release oxymorphone pain reliever. Endo's version of Opana ER is crush-resistant, making it harder to abuse—while Actavis's generic version isn't crush-resistant, according to Bloomberg Business.
Rep. Elijah Cumming (D-MD) and Sen. Bernie Sanders (I-VT) requested that Valeant explain the price hikes for its heart drug Nitropress and blood pressure medicine Isuprel. Valeant purchased the rights to Isuprel and Nitropress in February and subsequently raised the price for each drug six-fold and three-fold, respectively. The lawmakers also sent a letter to Hospira, which manufactures the drugs for Valeant, seeking information about the cost of producing both medicines, according to The Wall Street Journal.
Roche said a Phase-II trial for immuno-oncology treatment atezolizumab met its primary endpoint—shrinking tumors in lung-cancer patients with high expressions of PD-L1. The drug received the FDA's Breakthrough Therapy designation for non-small cell lung-cancer patients in the second-line setting in February. These are patients whose disease progressed after they were treated with chemotherapy.
Sprout Pharmaceuticals' flibanserin, a drug used to treat low libido in women, is expected to receive its approval decision on Tuesday from the FDA. The drug has been criticized for its safety and efficacy profile, with some saying that the FDA advisory committee's vote 18-6 in favor of the drug was borne out of a “politically charged atmosphere.”
A start-up is looking to treat attention-deficit-hyperactive-disorder with video games rather than prescription drugs. The company, Akili, is developing Project Evo, a game aimed at improving cognitive skills in children with certain mental health conditions with the hope of bolstering their ability to focus. The company plans to eventually receive FDA approval for the game as a medical device, which would open the door for doctors to prescribe it to their patients, according to NPR.