Eli Lilly and Company (NYSE:LLY) Q4 2017 Earnings Conference Call - Final Transcript
Jan 31, 2018 • 09:00 am ET
[Operator instructions] We will go to Steve Scala with Cowen. Please go ahead.
Thank you so much. Two questions. Do you anticipate an FDA ad comm for baricitinib by, say midyear? And you can you give us reassurance that there is not any safety issue beyond DVT that will be a subject of discussion? So that's the first question. Second one is over the last, say, two to three decades, Lilly always had one to two big potential products in the pipeline that investors could focus on. This would appear less a dimension of Lilly today. You probably disagree, so please tell us what billion dollar-plus opportunities you have in the mid-stage pipeline, so not including lanabecestat, galcanezumab, tanezumab, or lasmiditan. Thanks so much.
Great Steve, thank you for the questions. So Christi, if you'll take the question on whether or not we would expect an FDA ad comm. for baricitinib and if there are any additional safety issues beyond DVT that we think might be addressed should such an ad comm be held. And then maybe Dave and Jan, if you'd like to comment on mid-stage pipeline assets that you are excited about. Christi?
Sure. Hi, Steve. As we said before, we do expect the FDA to have an advisory committee, but the timing of that is up to the FDA and they'll make that publicly known, we won't be commenting on a date before they do. And in terms of other safety, we really don't anticipate other major safety questions and issues in regard to the ad comm and the resubmission.
Great, thank you, Christi. Dave, Jan?
Jan, you want to start?
Dr. Jan Lundberg
Okay, I can start. Let us first look at the two new Phase II programs that we see. Clearly, we are dependent on more clinical data, but we already have some clinical data from Phase Ib in both the D1 potentiator for dementia, which is an interesting molecule that could enhance cognition but potentially also somnolence, and in Parkinson's disease also motor function.
The N3pG program is, as you probably remember, a plaque-removing antibody, and we have optimized the dosing regimen since it has some immunogenicity, and we are putting that now into larger Phase II trials. We are combining it also with an oral BACE inhibitor which we know then will shut off the production of amyloid beta. In fact, now in Alzheimer's, we are trying to get positive data, if at all doable, in Phase II in hundreds of patients, not in thousands of patients in Phase III, and we are addressing early disease, we really want to have a more homogenous patient population, which has been one of the problems, and we are using our imaging tools both for amyloid to make that happen, and we are also trying then to hit the target in a maximal way by not only removing amyloid but stopping the production.
The other agent I want to emphasize is a potential agent with more powerful body weight lowering