Regeneron Pharmaceuticals Inc. claims that a partner has broken a collaboration deal by refusing to reveal side deals for marketing its blockbuster eczema drug, Dupixent.
Regeneron, of Tarrytown, charged Paris-based Sanofi Biotechnology SAS and its affiliates with breach of contract, Nov. 18 in U.S. District Court, White Plains.
Sanofi’s alleged failure to adhere to the collaboration agreement and refusal to resolve the dispute outside of court, the complaint states, raises the question: “What are defendants trying to hide?”
A Sanofi spokesperson said in an email that the company is in full compliance with the collaboration deal and remains focused on supporting patients and caregivers who rely on Dupixent to treat immunological conditions.
Dupixent is an anti-inflammatory drug that is used to treat conditions such as eczema, asthma and chronic obstructive pulmonary disease.
About a million patients use the drug, according to the complaint, and net sales in the U.S. have grown from $776 million in 2018 to $8.8 billion last year.
The collaboration began in 2007, in a deal where Regeneron would discover and create new drugs, a Sanofi affiliate would provide the funding, and both companies would develop and commercialize the drugs.
Regeneron and Sanofi split the U.S. profits.
Side deals that Sanofi negotiated with pharmacy benefit managers (PBMs) –intermediaries between drug-makers, pharmacies, and insurance companies – are at the heart of the dispute. PBM contracts define how drugs are positioned in the market and include pricing, discounts and rebates.
Regeneron says Sanofi was required to negotiate the best arrangement for Dupixent, and not to bundle other Sanofi products in PMB deals in ways that create a disadvantage for the drug.
The complaint does not say that Sanofi has actually made deals that favored its own drugs, but it says there is a history of Sanofi doing so. For instance, the Federal Trade Commission reported this past July that Sanofi had bundled three drugs and secured preferential coverage from PBMs, according to the complaint.
Regeneron says Sanofi has not allowed full access to the PBM contracts and has “stonewalled” attempts to verify Sanofi’s Dupixent records, in violation of the collaboration agreement.
Full disclosure of the PBM deals “could reveal additional profit-sharing adjustments in favor of Regeneron,” the complaint states, and “protect Regeneron from being duped.”
Regeneron is asking the court to make Sanofi allow full access to the PBM contracts.
