On Wednesday, BioPharma Dive sat down for an interview with Pascale Witz (pictured above), EVP of Global Divisions and Strategic Development at Sanofi, during the JP Morgan Healthcare Conference in San Francisco.
Witz, who holds an MBA and a life sciences Master's, spoke to us about the most important upcoming drug launches for Sanofi, expectations for the game-changing PCSK9 therapeutic class, next-gen insulin products like Toujeo and Afrezza, and what life is like at one of the largest pharma companies in the world without a CEO.
An impending onslaught of drug launches
Sanofi has an extraordinarily busy year ahead when it comes to new drug launches. "We are at a turning point for the company here," said Witz. "We are in a very important moment, because we are about launch six major new products in 2015."
Those products include the insulin candidates Afrezza and Toujeo (the latter expected to launch in Q1 in the U.S. and Q2 elsewhere, and the former also expected to launch in Q1), the PCSK9 cholesterol med alirocumab (in partnership with Regeneron), MS drug Lemtrada, Cerdelga (for Gaucher disease), and Dengue (a mild-to-severe dengue fever vaccine).
That's a whole lot of major new medications across a wide swath of therapeutic categories. And Sanofi knows it. "I don't think any other company has managed that many new product launches in a single year," said Witz. "So this is going to transform our portfolio."
But there's even more potential transformation on the way, Witz explains. "If you think about the year after, we have a new alternative for anti-IL-6 for rheumotoid arthritis, and we are very pleased with the clinical trial results for [atopic dermatitis candidate] dupilumab."
PCSK9s, statins, and the power of the payer
One of the hottest therapeutic categories around right now is the LDL-lowering PCSK9 class. Like many others, Witz believes that these drugs, including Sanofi/Regeneron’s alirocumab, herald a “new paradigm” in cardiovascular disease management.
She also doesn’t think that U.S. and EU advisory groups’ decisions to greatly expand the pool of patients who receive statins will have much interplay with PCSK9s since the latter class is specifically meant for those who are having particular trouble managing their CVD risk.
"We're really focusing on... all these people today who are high risk of CVD and are still not at goal, despite the treatment,” Witz explained. “So the goal is absolutely not to try to replace the statins. The statins have done a tremendous job to bring the LDL level down. The challenge is when you look at the data you still have 24 million people who are at very high cardiovascular risk and are not at [their] goal."
In short? “[PCSK9s are] going to be a large market, but it's not going to be for everybody."
That means that the marketing path ahead will involve an education campaign tailored towards doctors and patients who are at particularly high risk of an adverse CVD event.
“What we're working on is making sure that physicians and patients understand that there is an alternative once you are at the end of your statin journey,” said Witz. “Because if you are at your maximum dose of statin, and you're still not at the right goal, we have now enough a demonstration…that it was not the statin but really the LDL-level cholesterol that was having an impact on cardiovascular risk.”
Of course, price is going to be a major factor. These drugs aren’t expected to be cheap, and payers such as U.S. pharmacy benefits manager Express Scripts have already made it clear that they’re willing to engage in strong-arm tactics to ensure a lower price point.
In fact, as BioPharma Dive reported earlier this week from JPM, Express Scripts CEO George Paz told attendees on Tuesday that PCSK9s and even cancer meds are his next big targets for cost-cutting after the company’s stunning decision to snub Gilead and strike an exclusive deal with AbbVie for its hep C med Viekira Pak in exchange for a discount.
Witz says it’s far too early to comment on PCSK9 price, but that Sanofi is “very conscious about the fact that all the healthcare systems are carrying a lot of costs and a lot of pressure."
“[W]e’ve been working with payers and making sure they understood and we were thinking about the approach. So we are working on ensuring that we have the right access for the patient” and that the company is targeting the right patients.
The insulin wars: Lantus, Toujeo, and Afrezza
There’s been plenty of ballyhoo surrounding Afrezza, the inhaled insulin product that Sanofi is planning to launch later this year in conjunction with MannKind. The fact that Afrezza still doesn’t have an official launch date, in particular, has stoked whispers that Sanofi isn’t all that excited for the product.
But that’s all a bunch of nonsense, according to Witz. "We are focusing on the two [insulin] products, but they're different,” she said. “Toujeo is the new golden standard insulin glargine, and that's a market in which we have more of a ground today. This is really our field, if you like."
Toujeo is the highly-anticipated next-gen insulin that’s expected to bolster Sanofi’s sales just as its flagship Lantus falls off the patent cliff. But it’s not just about bigger sales with a fresh product, Witz says—there’s a real potential to help diabetes patients avoid the disastrous downstream consequences of the condition.
"[D]espite Lantus, despite insulin glargine, half of diabetic patients still aren't at their goal…There are 60 amputations per day [in the U.S.] due to the consequences of diabetes."
But it could be difficult to convince a certain class of patients that a long-acting and powerful med like Toujeo is the right way to go—particularly those who are averse to injections in any form. And that’s where Afrezza enters the picture.
"Afrezza, inhaled insulin, as much as we work on convincing patients to move into insulin, some patients are very resistant to insulin," said Witz. An inhaled (and eminently portable) inhaled option like Afrezza could at least convince diabetics to try out insulin, and perhaps even convince them to eventually transition to a stronger product like Toujeo.
"We're very optimistic about [Afrezza], but it's new in the field."
Beyond 2015: The most exciting launch of the future
BioPharma Dive asked Witz a simple question: What product launch, outside of the obvious insulin and cholesterol contenders, is she most excited to see go through in the coming years?
"I'm very excited about all of our product launches, of course,” said Witz. “Quite frankly, I think dupilumab is very exciting. It's one biological pathway that can express itself in different forms.”
Dupilumab, an IL-4 and IL-13 antibody, is still in early-stage clinical trials. But what makes it so exciting to Witz and Sanofi is that it could become the first approved, safe, and long-acting treatment for atopic dermatitis. And on top of that, it’s shown promise in completely different conditions such as asthma and nasal polyps thanks to the multitudinous nature of the pathways that it targets. (UPDATE: On Thursday, Sanofi announced that it had struck a monoclonal antibody manufacturing deal with Boehringer Ingelheim)
No CEO? No problem
C-suite exec gossip is like catnip to the biopharma industry. So in good conscience, we couldn’t end our interview with Witz without bringing up the elephant in the room: That Sanofi hasn’t had a full-time CEO since former chief Chris Viebacher was booted back in the fall, and that an active search for his replacement is underway.
Alas, BioPharma Dive will not be breaking anything major on that front in this particular piece. "I'm not part of the recruitment committee,” said Witz, laughing. “Our interim CEO, the chairman, he's very active, very engaged. We have wide access to him, we know him well, and all of us have a good relationship with him.”
In fact, for the time being, having a permanent CEO isn’t really a make-or-break objective for Sanofi.
“We are at a period where it's not as if we have big, big strategic decisions to make just right now,” Witz explained. “What we have is we have to deliver on very important steps, and the steps—they are known. They are launching these new products, it is continuing some of the ongoing clinical trials… We have to succeed with our launches, so this is where we're running all our troops.”
“This is just so much [to do] that the executive committee is working as a team. And we'll be ready.”
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