Regeneron And Sanofi Win FDA Approval For Their Expected Mega Blockbuster Eczema Drug Dupixent
The FDA has approved the eczema drug dupilumab (to be branded as Dupixent) from Regeneron Pharmaceuticals, Inc. (NASDAQ:REGN) and Sanofi SA (NYSE:SNY)...[which] is likely...[to become] a mega-blockbuster franchise worth upwards of $5 billion a year for these two partners.
Written by John Carroll
Said Julie Block, the CEO of the National Eczema Association:
“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, according to a Sanofi:
“We have set a fair and responsible price for Dupixent. 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.”
Baird’s Brian Skorney ran a physician survey and found a large numbers of doctors are eager to start prescribing this drug and noted on Tuesday morning that:
“Importantly, physician sentiment points to a market for Dupixent of about 300,000-350,000 patients, in line with management’s expectations. 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....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, Inc. (NYSE:PFE) 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...[Now that] Dupixent is a go the Regeneron/Sanofi team is taking to 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.
This article may have been edited ([ ]), abridged (...) and reformatted (structure, title/subtitles, font) by the editorial team of munKNEE.com (Your Key to Making Money!) to provide a ...
more