Business briefs: Sanofi, Gilead, Eli Lilly, Boehringer, Girl Scouts
Sanofi slowed its pipeline progress Thursday, saying that it was keeping its experimental diabetes treatment lixisenatide off the FDA's to-review list until additional data from its cardiovascular outcomes study, dubbed ELIXA, roll in. The company said in a statement that pre-filing talks with the regulator are behind the change. The drug maker said it expects the trial to wrap over the next 15 months or so, which would mean an NDA could be filed around the 2015 mark. The type-2 diabetes GLP-1 medication is already on the market in Europe, Mexico, Japan and Australia.
Gilead has filed its agent idelalisib, designed to treat indolent non-Hodgkin's lymphoma, with the FDA for review. Approval would make it the first PI3K delta targeted therapy, and the first treatment approved for the condition in more than 10 years. The condition is a subset of NHL and means a slow-growing cancer as opposed to a fast, “aggressive” one. Memorial-Sloan Kettering's webpage about the disease indicates that the slower-growing cancer is harder to treat because it can take around seven to 10 years before symptoms begin to surface, and tend to recur after treatment.
Boehringer Ingelheim is taking an animated approach to heartburn, rolling out a character named Captain Zantac to promote its OTC drug Zantac, reports PMLive. The new character and TV spots feature work from the independent agency Jomo LLC and Aardman Animations, which is known for the stop-motion Wallace and Gromit characters.
An industry-backed study comparing Merck DPP-IV diabetes med Januvia (sitagliptin) and Boehringer Ingelheim/Eli Lilly's experimental SGLT-2 agent empagliflozin showed that the BI/Lilly drug lowers HBA1c levels as well as Januvia, but may work better in patients whose diabetes is poorly controlled, reports MedPage Today. The study was published in the Lancet Diabetes & Endocrinology.
The Girl Scouts are taking on mental health. The Congressionally chartered youth organization launched a program with the International Bipolar Foundation to educate girls about mental illness, with the goal of reducing the stigma attached to the condition. The scouts earn the Mental Health Awareness patch by learning about topics including how the media portrays the mentally ill, how discrimination makes it challenging for patients to seek help and creating anti-stigma activities. The IBF says over 500 Girl Scouts have earned the patch.