JL: We need to pass (the Prescription Drug User Fee Act 5). So far, the proposals for PDUFA 5, which are supported by our industry, not just PhRMA, but also BIO, the association that represents smaller companies, are good. We want to see that supported by Congress, with hopefully a clean bill, before the end of the 2012 fiscal year. Because the FDA depends mightily on the resources that provides. There are other initiatives being talked about. Commissioner [Margaret] Hamburg and others are interested in what they can do to foster innovation.
What I tend to say is, ‘Look, we have an explosion of knowledge going on, and all these tools, and research networks. All of it augers for greater research output.’ So why have fewer medicines been approved in the last five years than in any five year period since 1979, when I joined Lilly?
X: Not to mention, this whole drought of new medicines has been occurring while a lot more money is being spent.
JL: Yes, a lot more money is being spent. But also, let’s not forget the unmeasured toll of human suffering. Nobody can ever argue for the medicine they were unable to use. Alzheimer’s really stands out. All of us are frustrated that there are very few effective strategies for slowing down Alzheimer’s. It’s a huge area of research, and a huge area of risk.
X: Is FDA the problem in your view? You’re talking about all the new tools, and new knowledge…
JL: I don’t like to lay a problem on anybody else. We have to own Lilly. And the biopharma industry has to own the challenge of improving research productivity. There are a number of areas, we’re suggesting, in which we can work with the FDA on the regulatory process. PDUFA covers some of that.
X: You guys recently got divorced from San Diego-based Amylin Pharmaceuticals on your diabetes partnership. Any comment on that, or any lessons learned from that collaboration that might apply to future collaborations?
JL: We’ve had a very successful 10-year collaboration with Amylin. We both brought the first GLP-1 product to the market, Byetta. We both brought the first once-weekly diabetes medicine forward, in the form of Bydureon, which is now approved and launched in Europe. As I said in the announcement a couple weeks ago, we both determined this is the best outcome for both companies. It enables Amylin to have full rights and full ownership to both of these assets, Byetta and Bydureon. It enables Lilly to continue to pursue our own entry in the market, potential entry, GLP1-fc (dulaglutide), which is in Phase 3 studies now—and to focus on other aspects of our diabetes business, including our insulins, and our partnership with Boehringer Ingelheim.
X: OK, I want to fire off a few questions from Twitter, which I asked readers to send me in advance of this interview. First, we have one from France in which a scientist is asking, “What are your views of CETP inhibitors and the competitive landscape?” He’s referring to drugs like Pfizer’s failed torcetrapib, and I know Lilly has a new contender now, that seeks to raise the “good” HDL cholesterol.
JL: Three have now reported out mature data, from Roche, Merck, and now Lilly. I think this approach to lowering LDL and raising HDL is potentially very interesting but remains to be proven in large scale trials.
X: Matt Herper from Forbes asks, “What is Lilly doing about the sad state of psychiatric trials? Inflated placebo effects, bad data from Russia…”
JL: We’ve studied these for over 25 years, since we had the early Prozac trials. These trials can be very difficult because of the thing Matt points to, which is a pronounced placebo response. It can be more or less pronounced based on trial design. We’ve done
