Regeneron and Sanofi land the big one, winning FDA approval for their megablockbuster hopeful Dupixent

George Yancopoulos, President and CSO, Regeneron

The FDA has approved the new eczema drug dupilumab from Regeneron and Sanofi, officially launching a new drug that is likely on course to creating a megablockbuster franchise for these two partners. Widely tapped as the biggest program in the industry’s pipeline this year, dupilumab now will be branded as Dupixent. And the market here could be worth upwards of $5 billion a year.

“People with moderate-to severe atopic dermatitis cope with intense, sometimes unbearable symptoms that can impact them for most of their lives,” said Julie Block, the CEO of the National Eczema Association. “To date, there have been few options available to treat people with moderate-to-severe atopic dermatitis who have uncontrolled disease. That’s why today’s approval of Dupixent is so important for our community. Now we have a treatment that is expected to help address patients suffering from this devastating disease.”

The drug will be priced at $37,000 a year, a shade higher than many analysts had expected, but not significantly out of line.

“We have set a fair and responsible price for Dupixent,” says a Sanofi spokesperson. “We are encouraged by the ongoing conversations we’ve had with health plans and pharmacy benefit managers about coverage for Dupixent for patients, and we have a shared commitment with them to ensure patients who should receive it can receive it.”

Geoffrey Porges, Leerink

Some top analysts wouldn’t disagree with that remark. Leerink’s Geoffrey Porges noted that the discount price should fall right around $30,000, which should be acceptable to payers. He noted:

While payers may still believe Dupixent is an expensive therapy, the drug is cost-effective for the indicated patients, according to the influential ICER report. Indeed, in today’s press Express Scripts’ (ESRX, MP) CMO Steven Miller commented that the manufacturers had set a “responsible price,” and payers appear to be taking credit for influencing the pricing decision. Recent drug launches have been harmed by unclear efficacy, broadly-labeled patient populations that do not match available clinical trial data, and high list prices. By contrast, Dupixent’s well-defined labelled indication and clear outcomes benefits, as well as the complete lack of FDA-approved medicines for post-topicals moderate-to-severe AD, should limit the impact of step-edits and prior authorization requirements.

Baird’s Brian Skorney ran a physician survey and found a large numbers of doctors are eager to start prescribing this drug.

Brian Skorney, Baird

Brian Skorney, Baird analyst

“Importantly, physician sentiment points to a market for Dupixent of about 300,000-350,000 patients, in line with management’s expectations,” he noted Tuesday morning. “We wouldn’t be surprised to see an exceptionally strong launch here, but we continue to point out that consensus expectations are already building that in.

The two biopharma partners — with Regeneron whipping up the IL-4/IL-13 antibody and Sanofi weighing in with its late-stage muscle — have divvied up the market 50/50. And they’ve already fired off a preemptive legal blast against a litigious Amgen, their arch nemesis which is sitting on IP for both targets.

Amgen has aggressively pursued a lawsuit against the Regeneron/Sanofi’s team for their PCSK9 drug Praluent, which competes against Amgen’s Repatha. At one point, Amgen scored a stunning upset, winning a court ruling in favor of shelving the rival drug, which has since been set aside.

In the partners’ suit against Amgen, they say that they’ve learned that Amgen has hired counsel to pursue a claim involving patent ‘487, which involves IL-4 and IL-13 drugs. Amgen tried, and failed, to develop their own IL4/IL-13 drug — AMG317 — and failed in Phase II. And Regeneron and Sanofi are seeking a preemptive ruling against Amgen, which loves to field its aggressive legal team whenever it suits their strategy or the lawyers believe there’s some revenue to grab off the table.

Regeneron and Sanofi have much to protect here, if the analysts are right. Pfizer scored an approval for its atopic dermatitis drug Eucrisa (crisaborole), a PDE-4 inhibitor, which has some blockbuster ambitions of its own. But Dupixent is expected to be game changer for patients.

Just a few weeks ago investigators spelled out a new batch of stellar data, completing a major Phase III effort that carefully reviewed safety and efficacy data for a wide range of patients.

In the new CHRONOS data reviewed at the annual meeting of the American Academy of Dermatology in Orlando earlier this month, investigators noted that the severe itching patients are afflicted by was reduced by 55% and 58% in the two drug arms after 16 weeks, compared to 29% of patients on TCS alone. And the disease score rating for patients dropped by 4 or more points among 77% of the patients in the drug arms compared to 37% of the placebo/topical corticosteroid group.

Regeneron and Sanofi need to make a quick success of this drug, and they’ll likely roll out an aggressive marketing effort now that they have received a long-awaited green light from the FDA. They still believe that they can make a big success of Repatha, but payers have kept it carefully bottled up, waiting for cardio outcomes. Revenue is marginal.

Then there’s sarilumab, held up by the FDA months ago so that Sanofi could clear up some embarrassing manufacturing issues.

Dupixent is a go. And the Regeneron/Sanofi team is now taking the marketing field with a carefully planned blitz. They can’t afford another setback.

Sanofi in particular, which has been saddled with a largely ineffective French R&D group, needs to show it can develop and field a major new drug. Now they have another shot at glory.

“Dupixent is the result of years of tireless research by our scientists into the underlying causes of allergic and atopic diseases. In atopic dermatitis, Dupixent was shown to help clear the skin and manage the intense itch caused by the disease,” said George D. Yancopoulos, the founding scientist and CSO at Regeneron. “Today’s approval would not be possible without the dedication of the clinical investigators and the participation of the patients who took part in the global LIBERTY AD clinical program.”

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Research Scientist - Immunology
Recursion Pharmaceuticals Salt Lake City, UT
Director of Operations
Atlas Venture Cambridge, MA

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