Immunology superstar Dupixent, which first brought Regeneron and Sanofi together in 2007, has entered its megablockbuster era. But even as the billions pile up, Regeneron isn't entirely happy with the current situation.
In a lawsuit that received little attention toward the end of last year, Regeneron has taken Sanofi to court over claims that its marketing and development partner violated the terms of a long-standing Dupixent collaboration by refusing to share certain commercialization details.
Regeneron’s main complaint is that Sanofi has allegedly withheld pharmacy benefit manager contracting information on Dupixent for fear of divulging info on other immunology drugs included in payer contracts via product bundling.
Regeneron disclosed the lawsuit—first filed in New York federal court in late November and amended the following month—Wednesday in its annual filing with the Securities and Exchange Commission.
Regeneron’s collaboration with Sanofi dates back to 2007, when the partners first joined forces on the development and commercialization of the promising antibody dupilumab.
Under the deal’s most recent incarnation, Sanofi shares the brunt of the development costs for Dupixent and records the antibody’s sales. Primary developer Regeneron holds the rights to co-commercialize the drug on a country-by-country basis, including in the U.S.
Sanofi, for its part, maintains that it is has not violated the conditions of the Dupixent partnership.
“We are in full compliance with the terms of our collaboration agreement with Regeneron,” a Sanofi spokesperson told Fierce Pharma on Thursday. “We remain focused on our shared priority with Regeneron—ensuring we continue to support the community of patients and caregivers who rely on Dupixent to treat their immunological conditions.”
The company declined to comment further on the litigation.
Digging into the lawsuit, Regeneron’s lawyers assert that Sanofi is required by the commercialization agreement to provide full access to Dupixent sales materials, including written and oral contracts with PBMs, payers and related organizations like group purchasers and specialty pharmacies. The problem is, Sanofi has allegedly “stonewalled” Regeneron’s “repeated requests” for full access to those PBM agreements, the lawsuit states.
Put another way, Regeneron’s lawyers argue that the French drugmaker has “effectively replaced [the collaboration’s] information-sharing provision with a ‘trust Sanofi’ provision.”
In turn, Regeneron says it has lost out on its rights—as defined in the collaboration pact—to weigh in on key Dupixent commercialization decisions, a situation Regeneron’s legal team calls “commercially unreasonable” given the magnitude of Dupixent sales in the U.S.
The lawsuit further contends that Sanofi is being cagey about its PBM deals because they contain agreements tied to other, non-partnered drugs beyond Dupixent. Regeneron argues that it can’t be certain the deals don’t unfairly advantage other Sanofi products at Dupixent’s expense.
Dupixent is a critical drug for both Regeneron and Sanofi, and it likely pained Regeneron to have to go down this route. That said, the company’s lawsuit claims in no uncertain terms that Sanofi is “wholly responsible for this dispute.”
“Defendants’ pattern of evasion can only raise the question, ‘What are Defendants trying to hide?’— and has forced Regeneron to bring this lawsuit,” Regeneron’s legal team said in its court filing.
The litigation has come to light shortly after Sanofi and Regeneron celebrated yet another banner year of sales for Dupixent.
The medication—approved across six indications in the U.S. including atopic dermatitis, asthma and chronic obstructive pulmonary disease (COPD)—grew fourth-quarter sales 16% to 3.5 billion euros ($3.6 billion) and beat a much-touted 13 billion-euro sales target for the full year, Sanofi said last week.
In the wake of a recent approval in COPD, some analysts think the drug could hit $20 billion in peak sales.