Rachele Berria 2018 Transcript

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Freed: This is Steve Freed and we’re here at the American Diabetes Association, 78th Scientific Sessions. And we have a special guest with us, Rachele Berria. Is that correct?

Berria: Correct. Yes.

Freed: And maybe you can tell us a little bit about your background. We know that you’re Vice President and Head of Diabetes Medical Unit at Sanofi, Bridgewater in New Jersey, which is kind of a unique position for a woman. We’re seeing women getting higher in the food chain and it’s interesting. And being involved with diabetes is very interesting, which is kind of unique. I only saw one other CEO today that was a woman, but that’s two more than last year. So, maybe we could start out with telling us a little bit about yourself and what you do.

Berria:  Absolutely. I earned by MD degree in Italy. As part as my residency program, I moved to the US. And I’ve been passionate about diabetes for the past 25 years. And I believe this is my 21st ADA and Orlando has a special meaning to me because 14 years ago the ADA was in Orlando and my son was turning one month here. I was still working at the University of Texas and I had an oral presentation, and I wouldn’t miss that for my life, and so I came with my mother. And my mother was sitting in the back of the room with my not-even-one-month old, that it made me proud as a professional and as a woman. And since then I continued working in diabetes and joined Sanofi eight years ago. And it matches my realness of doing things differently and this is what we want to do in diabetes from funding early research and partnering with the ADA. In fact, for very, very fascinating new projects and fostering young scientists to working with technology with continuous glucose monitoring up until the real world evidence and its applications to compliment the randomized clinical trials.

Freed: Now, you’re having — I was just told 70 papers, abstracts, posters, presentations, 70 — and that’s all within four days. Obviously, you have a lot to say, so maybe you can kind of highlight the data that you’re the most excited about.

Berria: Absolutely. I’m really proud about our massive presence here at the Scientific Sessions. Clearly it’s a result of teamwork and a lot of passion. The highlights of this ADA are our Toujeo, our long-acting basal insulin analogue, the first head-to-head randomized clinical trial versus another long-acting basal insulin called degludec. And in this study, we show that both insulins at the end of the treatment reached comparable hemoglobin A1C lowering, about 1.6%, and overall equal incidence and event rate in terms of symptomatic and severe hypoglycemia. However, in the triation period Toujeo seemed to have lower incidents and even rate of both symptomatic and severe hypoglycemia. And some clinicians think that for patients that are starting an injectable, specially basal insulin, this period of adjustment is specially important for them. And having less hypoglycemic events may mean that they will stay on therapy and they will reach A1C target. So, that’s only one of the studies that we have but it’s complemented by a whole housed of real world evidence both from electronic medical records up until machine learning with a very comprehensive database that covers more than 5 million lives. It’s the Optum-Humedica database that we’re mining with artificial intelligence and natural language processing. So, this is for Toujeo. I’m also really, really proud about Zynquista, this is the proposed brand name for our SGLT2 and 1 inhibitor, sotagliflozin. I’m very passionate about type 1 diabetes as well. I come from an island, Sardinia, which has the second highest incidence in the world of type 1 diabetes, only after Finland. And I think that with so many options that we have for type 2 diabetic patients, for type 1 for the last 100 years we’ve had insulin and only insulin. So, there’s an opportunity that this could become an additional option for the patients and their clinicians to treat type 1 diabetes. And of course, every medication comes with benefits and risks that will be evaluated, but this has been sent to the FDA for their review and accepted, and we look forward to the dialogue with them. And there’s three studies. In fact, very important studies with Zynquista presented here at the ADA in Tandem 1, in Tandem 2, and an interesting analysis with continuous glucose monitoring. You will also see data on Praluent [which] is our PCSK9 inhibitor. And this data shows that Praluent in patients with either normal glycemia or pre-diabetes or diabetes still is highly effective in preventing cardiovascular events. I could continue on and on but this is really the highlight of the meeting for us.

Freed: How is Sanofi utilizing real world evidence to study the safety, efficacy, and the value of its diabetes products?

Berria: We believe it complements the randomized clinical trials. It’s not either/or. The clinical trials, the classic ones, are helpful for the review with the health authorities and answer the question of, “Can this product work for our patients?” And then, the second also equally important question is, “Will this product — will these results be generalizable to the whole population that the clinicians treat?” And we think that this question is better answered by the real world data and the different ways that we can analyze that in a way that we’ll be able to test the efficacy, the effectiveness, and the safety of our drugs, and potentially even subgroups of patients that can benefit the most out of these drugs.

Freed: Sanofi has come out with some unique products from very few to all of a sudden over a short of period of time an SGLT2, SGLT1s, new insulins, so you’ve been very active in the field. What’s in your pipeline? You must have something.

Berria: Absolutely. So, we talked about Zynquista. We also have a weekly GLP-1 receptor agonist. We’re working and very committed to a dual co-agonist both GLP-1 and glucagon agonist. We have a partnership that is called Onduo, that brings the best of two worlds, the scientific expertise of Sanofi and the technological expertise of Google Verily. And we let them run and play, but they will have a fundamental role because we believe that medicines are important but as you’ve said before Steve, medicines are not the only thing that patients need and the behavioral component is equally important for them to be really taking their meds and be persistent in taking these medications. And Onduo is doing a lot of that with already some pilot projects that are ongoing with the virtual diabetes clinics.

Freed: So, one of the combinations that’s been very successful is the SGLT2 and GLP-1. Do you have something — and one is an injectable and one is not, but as far as combining them is there something in the pipeline that’s combining those two?

Berria: We’re doing even better than that. We have a fixed-ratio combination called Soliqua 100/33, a basal insulin and a GLP-1. There’s not that much data here at the ADA. There’s a few abstracts. One, that I’m really proud about showing that it is equally effective in Hispanic and Non-Hispanic patients that were also starting Solique 100/33 on a background of SGLT2 inhibitors and its oral medications which are becoming widespread, so that will be presented probably at the next Scientific Sessions. And also, since we’re so committed to patients that are of various races and ethnicities, we started recruiting for a study that is solely dedicated to them and that will in fact include Asians, African-Americans, and Hispanics where we are testing Soliqua 100/33 versus glargine 100 which is Lantus.

Freed: Now, one of the things that I’ve noticed is that last year we saw studies that directed to different classes of people, African-American, [for example], does this work better for an African-American or White Anglo-Saxon or Asian? Are you doing kind of looking at how particular medicines affect particular nationality?

Berria: Well, that’s the idea. It’s usually done whole stock in the various clinical trials. We are doing two things. We’re looking at it in these large databases that I was describing to you using predictive analytics. And also, in this new randomized clinical trial, we’re looking at it prospectively and pre-specifying this hypothesis, which is fairly novel. There’s not many examples of that.

Freed: Because now, when you look at the drug literature you don’t see different nationalities, percentage dropping A1C for African-Americans is one point or point A.

Berria: You’re correct, yeah.

Freed: So, I’m thinking that in the future more information we have that would be important information where you don’t have to waste time, effort, and money prescribing something that may not be as effective.

Berria: Absolutely. It’s part of personalized medicine in a way.

Freed: So, what has Sanofi done to help address the unmet needs of diabetes patients through its portfolio over the last year?

Berria: Over the last year, well, we’ve been really busy working on our Zynquista filing. We submitted that to the FDA and the file was accepted for review. This is the SGLT2 and one inhibitor that could potentially be the first oral medication as an additional option to be added to insulin therapy for patients with type 1 diabetes. We also have ongoing all the clinical trials in patients with type 2 diabetes. We have Soliqua 100/33 that we’re still actively studying. It is in the market. And clinicians and patients are starting to appreciate the benefits of both classes of drug. And I don’t know if you’re familiar with the “ominous octect” that type 2 diabetes is a constellation of pathophysiological defects. And this is actually my mentor, Dr. Ralph DeFronzo, that talked about many, many years ago that Soliqua 100/33 really works on seven out of the eight pathophysiological defects of type 2 diabetes. And of course last but not least, is the partnership with Onduo with the Virtual Diabetes Clinics that will help our patients.