Business Briefs: Amgen, Allergan, Eli Lilly, DePuy
Amgen reached a $25 million settlement with the U.S government today for marketing practices around its anemia drug Aranesp. Allegations include kickbacks to long-term care pharmacies to favor Aranesp over other treatments as well for off-label indications. The Department of Justice alleged that Amgen offered rebates for pharmacies which helped to improve Aranesp's market share and for those who hit volume targets.
FDA denied approval of Allergan's inhalable migraine drug, Levadex, due to concerns about how it will be manufactured. Levadex is an inhaled version of 60-year-old drug dihydroergotamine. Regulators citing manufacturing concerns echo similar claims last March when FDA said it would not approve Levadex for manufacturing and other issues. Allergan purchased Exemplar Pharma to help ease manufacturing concerns, but it has not assuaged FDA's take on the migraine inhaler. Analysts believe regulators' concerns for Levadex are resolvable.
Eli Lilly has released promising late-stage findings of its long-acting GLP-1 dulaglutide pitted against Sanofi's Lantus. A 1.5mg dose of Lilly's experimental drug showed a better efficacy profile than Sanofi Lantus in its AWARD-2 trial. Dulaglutide also showed better efficacy in a combination drug square-off when both it and Lantus were combined with insulin lispro. Lilly expects to submit dulaglutide for marketing authorization to FDA in 2013. That timing is dependent on “satisfactory completion of U.S. FDA requirements for assessment of cardiovascular risk,” Lilly said in a statement last October.
J&J won its second product liability trial over its DePuy ASR Hip, which was recalled in 2010 after the company found that patients were getting replacements faster than anticipated. The case involved an Illinois nurse who got the hip in 2008 and had it removed in 2011. J&J lost a Los Angeles trial over the metal hip in March and was ordered to pay $8.3 million to a retired Montana prison guard, but is appealing the case. Almost 11,000 ASR patients are suing the firm for defective design, reported Reuters.