It has, to understate things, been a busy month for biopharma. There have been at least four major industry and life sciences meetings held in June, including ASCO, this year's American Diabetes Association conference, DIA, and BIO.
But before the conference mania went into overdrive, BioPharma Dive took some time to have a wide-ranging conversation with Jez Moulding, President of North American pharmaceuticals for drug giant Sanofi, on the company's pipeline, its marketing strategy for the new blockbuster potential therapeutic class of PCSK9 cholesterol-lowering drugs, challenges in an increasingly crowded diabetes field, and much more.
Moulding's been in the industry for 24 years. He started as a medical rep in the U.K. with AstraZeneca, where he worked for seven years in a number of field marketing and commercial positions, before moving to Sanofi, where he's been for 16 years. After a nine-year stint across the globe, he arrived in the U.S. to head up Sanofi's North American pharma division in October 2014.
Here's what he had to say.
PCSK9s: Is lowering cholesterol enough?
BIOPHARMA DIVE: Right now, especially with what happened earlier this month, PCSK9s are sort of the talk of the town. Sanofi was able to get the recommendation for its PCSK9 candidate it was looking for. But a lot of the FDA panelists, during the panel meetings for both alirocumab, as well as Amgen's competing product, brought up concerns about which population these drugs should be targeted towards. Do you have any thoughts on exactly who should be the market for these drugs? And more broadly speaking, is simply achieving the pretty impressive lowering of LDL cholesterol—is that in and of itself going to be effective for patients, or are we going to need to see more tangibles on cardiovascular outcomes?
MOULDING: We are pleased that earlier this month, the FDA advisory committee recommended the approval of Praluent, and that allows us to keep moving forward with the FDA to get Praluent made available for those patients at high risk. And we've studied alirocumab in these high-risk patients—that includes patients with genetic forms of high cholesterol, those who have a high cardiovascular risk, who have suffered a heart attack, and those patients who need statins but cannot take them.
Coming to your point about LDL-C, this is a major risk factor for cardiovascular disease. And it's also a huge economic burden—about $193 billion in direct health expenditure, and about $123 billion in indirect cost of mortality. So statins have been the standard of care. They've been a tremendous influence on public health. But there's still many high-risk patients who fail to reach their LDL-C goals, and in these patients there's a sense of urgency to lower LDL-C to lower high cardiovascular risk in these groups. And let's remember, these PCSK9 inhibitors will be treating the number one cause of death in men and women in the U.S.: heart disease. The costs of a heart attack or stroke are extraordinary, it's a devastating disease which is preventable.
As you know, we do have an outcomes study, the ODYSSEY outcomes, this is an ongoing trial that we'll enroll approximately 18,000 patients and evaluate the effect of alirocumab on the incidence of cardiovascular events in patients treated with Praluent.
BD: When is the expected timeline for that study to wrap up?
MOULDING: It should report no later than 2017.
BD: Earlier this year, when I spoke with Sanofi exectuve vice president Pascale Witz about this same issue during the JP Morgan Healthcare Conference, she brought up the point that marketing this class of drugs is going to take a massive communication effort, both for doctors and for patients. Can you talk to me a little bit about what that effort looks like?
MOULDING: As I've said, LDL-C is a major risk factor for cardiovascular disease, and we are equipping ourselves to ensure that, at a specialty level, cardiologists and lipidologists—we're putting in the required support both at a provider-physician level, and also at a patient level, to make sure there is a patient service and patient support to ensure that Praluent is used for these high-risk patients.
A big pipeline, but a tough competitive landscape, for diabetes
BD: Shifting therapeutic categories a little bit here, let's get into diabetes. This is something Sanofi has long been known for, and it's an issue that's sort of dogged the company a little bit in recent years. In light of Lantus' patent expiration, there's more competition coming from other companies including Eli Lilly, including Novo Nordisk. Just the other day, Merck released information about its own investigational biosimilar of Lantus, and Lilly plans to launch a biosimilar of Lantus later this year.
Now, Sanofi has also been working its own pipeline with products like Toujeo and Afrezza. But from a broad perspective, what are Sanofi's goals for its diabetes franchise, and what in your eyes are the most promising candidates in the pipeline right now?
MOULDING: It's a very exciting time for the diabetes portfolio here in the U.S. for Sanofi. Our portfolio has a number of personalized offerings, including our recently launched products Afrezza and Toujeo, and we're gearing up for two more launches in the coming years, lixisenatide and LixiLan. So that's potentially four launches in two years.
If I come to Toujeo, our new basal insulin, we launched at the end of March, and acknowledging we only have eight weeks' data, the early trends demonstrate we got off to a positive start. We didn't want price to be a barrier, and we set the without-a-prescription price to be the same as Lantus, and we've reached an unprecedented level of market access for this stage of launch.—currently, 73% of all commercialized with unrestricted access, and with Medicare Part D, we have more than 50% of lives contracted.
And I think this demonstrates the value of Toujeo that the payers have seen. Our overall glargine share has been stable at 69% now, for the first five months of 2015, and with these new prescriptions and Rx's increasing, this should give us an opportunity to increase our glargine share later in the year.
I think though, what's really important for Toujeo, is we provide the patient with education and tailored service, which helps them to meet their goals. And we've put significant investment into a coach-patient program. This is an enhanced program, that provides a dedicated coach tailored to their disease, providing proactive calls, nurse support, and a really dedicated education for their diabetic disease.
Afrezza, which we launched in February—the strategy here is targeted and focused, and that's important because we need to educate the specialists and high-prescribing physicians for appropriate usage of their medicine. We believe that this inhaled insulin in this specially-designed inhaler offers an important new option. In terms of access, we've secured third-tier benefit in a number of plans. We'll be launching print and direct-to-consumer promotion in the next few weeks, and we'll be launching a 12-unit cartridge later in Q3. It's been, again, with Afrezza, a solid start.
With lixisenatide, at the ADA, we announced the results of the ELIXA study, which is a significant milestone for lixisenatide, establishing the GLP-1 receptor agonist, which is the first in its class to establish long-term cardiovascular safety results. And then LixiLan, which will potentially provide the first combination of basal insulin with proven CV safety, Lantus, with a GLP-1 receptor agonist with proven CV safety, lixisenetide. And these phase III results should read out in Q3, and we're planning to submit LixiLan's NDA to the FDA as early as the end of 2015. And with lixisenatide, the NDA is on track to be re-submitted to the FDA in Q3 2015.
BD: I also wanted to touch a little bit more on Afrezza. Because there was some recent news where the CFO over at MannKind (Sanofi's partner on Afrezza), he was speaking over a Goldman Sachs conference, and he essentially said that, they haven't really reached the break-even point for that product. And that it's been difficult because the margin on that medicine is not extremely large, and so the low volumes are really hurting there. So what are the challeneges of getting Afrezza out into the market, and what do you think are the reasons the volume might be held back right now?
MOULDING: I think clearly with this inhaled insulin, we've had to take the time to really educate the specialists on the patient groups—that are new to insulin, naive to insulin, require insulin intensification—we've had to put the appropriate education, continuing medical education, and peer-to-peer meetings in place. And we've been doing that in order to ensure we educate our customers in the appropriate way.
We've gone through that phase. We're now seeing that customers are getting some excellent patient testimonials with Afrezza. Patients who were not in control, and are now in control—and again, this is an enlightening point that we see with Afrezza—which is that as our target audience begins to use the product, we are really seeing some excellent results in the patient testimonials.
BD: So you're saying Sanofi has some pretty strong faith that the volume is going to grow for this product?
MOULDING: Yes. We've had a solid start on Afrezza. We'll be putting investment into DTC and print media in the next couple of weeks. And we're seeing more patients get under control with some excellent patient testimonials. It's a solid start with some more to come.
BD: I also wanted to touch on biosimilars. These are becoming much more interesting in the U.S., since they're relatively new to the market here. What are Sanofi's hopes about getting into that market, and are you concerned about the eventual emergence of biosimilars for products such as Lantus?
MOULDING: I think it's a little too early to speculate on that segment. We currently have an IP case in that area, so we have no further comment in that particular area.
When you look at diabetes—and you mentioned competition—the way we look at it, is that diabetes is our competitor. Why do I say that? The U.S. population is absolutely exploding with diabetes. One in ten adults are currently diagnosed with the disease. It's projected to be 1 in 7 by 2020 and 1 in 3 by 2050. And you just look at the annual cost of diabetes—it's currently about $245 billion for diagnosed patients. That's expected to increase to more than $500 billion by 2025. So, I think rather than speculating on these competitor strategies, we have to focus on supporting the diabetes community with our launch products of Toujeo and Afrezza and make sure we're gearing up as well for these two separate launches with lixisenatide and LixiLan. We've just got so much to do for the diabetes community.
A flexible monoclobal antibody and unmet medical needs
BD: Shifting therapeutic categories here a bit, Pascale Witz said during JPM that she was particularly excited about dupilumab. Since that conversation, there's been some relatively recent news about a phase IIb asthma trial for dupilumab with some promising data. This drug is pretty unique, because it has some pretty versatile applications. What's the progress on this, and how many different therapeutic areas might this candidate be applied to?
MOULDING: This is a very exciting monoclonal antibody which is being developed, as you said, for several indications. We've received FDA breakthrough status for atopic dermatitis for treatment of adults with moderate-to-severe atopic dermatitis but who aren't adequately controlled with topical prescription therapy. A phase III clinical program for dupilumab for adults with moderate-to-severe atopic dermatitis is ongoing. And it's important because, this moderate-to-severe atopic dermatitis represents an area of high unmet medical need, as many patients today remain uncontrolled with traditional therapy.
You mentioned the phase IIb data readout. This met its primary endpoint of improving lung function in asthma patients more likely to have atopic or allergic asthma. And in this study, dupilumab added to standard of care therapy, demonstrated fewer exacerbations and improved lung function.
And finally, dupilumab is being studied in a phase IIa proof of concept study in chronic sinusitis with nasal polyps. It is such an exciting prospect across those three indications I've mentioned.
BD: Beyond the therapeutic categories we've touched on, what are some of the most exciting investigational candidates in the Sanofi pipeline right now?
MOULDING: I think in terms of our overall pipeline, the one that really reaches out, I think, has to be the dengue vaccine. The number of patients today that suffer from dengue, and there is no solution there for them today, this again has the potential to be a game-changer.
A new CEO and Moulding's outlook for biopharma
BD: On a non-therapeutic note: Sanofi has a new CEO, Olivier Brandicourt (the former chair of Bayer HealthCare). For a while you were flying without a captain. The board was very busy because there were a lot of launches in place. How has that transition been, and how is it finally having a CEO again?
MOULDING: Well, Olivier brings strong leadership and vast operational experience. He's a medical doctor. He brings a deep understanding of healthcare and public health issues. And I was really pleased that within the first eight days, he visited the U.S., he took the time to understand our business opportunities and challenges, and gave us both his support and great insights.
And globally, Sanofi has the potential to make 18 new medicines and vaccines available to patients in the next five years, and Olivier's leadership and vision will be crucial to our success.
BD: I'm going to wrap up with a slightly more open-ended question. It's a time of major change for biopharma. There's a huge amount of exciting therapeutic innovation, there's legislation in the U.S. right now aimed at helping the industry get drugs to market faster. If you had any piece of advice to give to a professional in pharmaceuticals, whether from a development, marketing, or regulatory standpoint, what would that be?
MOULDING: I think the pace of change in the healthcare environment in the U.S. is increasing so rapidly that what will set us apart is our ability to be agile and responsive as an organization and as an industry. And I think the challenges we face today and into the future will only be solved if we can partner with others in the ecosystem. And if we do that, together we'll commit to improving health through disease awareness, through education and compliance, to treatment and providing well-rounded solutions for patients.
We've talked about our Toujeo coach program. But if we get these well-rounded solutions for patients with our new innovative medicines, this will provide an opportunty for dialog, for overall patient support and enhancement, and I think provide a better healthcare experience for the patient as well as for the healthcare system.