Another issue from Sarepta?Sanofi is suing Sarepta Therapeutics,...

Another issue from Sarepta?

Sanofi is suing Sarepta Therapeutics, alleging that the company’s approved muscular dystrophy treatment infringes on its patents related to the chemical makeup of the product.

Sanofi’s rare disease arm, Genzyme, filed the complaint on July 26, focusing on two previously issued patents involving the chemistry of adeno-associated virus vector (AAV) constr
uction. Genzyme argues that the composition of Sarepta’s Duchenne muscular dystrophy treatment Elevidys infringes on both patents, which are expected to expire in June 2025.

A spokesperson for Sarepta declined to comment.

Genzyme’s suit also mentions drug manufacturer Catalent (though it is not a party in the complaint), which is the primary commercial manufacturer of Elevidys. A spokesperson for Catalent declined to comment.

Genzyme asked that if the court finds Sarepta liable for patent infringement, it should be awarded damages up to three times the amount found.

Elevidys became the first gene therapy to treat DMD when it snagged accelerated approval by the FDA in June 2023. The therapy received a significant label expansion in June to treat a larger swath of young boys, despite murky confirmatory trial data. Peter Marks, head of the FDA’s Center for Biologics Evaluation and Review, overruled some of his top reviewers in expanding the label. The treatment brought in $133.9 million in the first quarter of 2024 and $200 million in 2023.

Sarepta is fending off a separate battle in the court of public opinion, namely with patient advocates who have long stood by the company despite persistent concerns about the data underpinning its Duchenne portfolio. A leaked video from a recent conference sponsored by Parent Project Muscular Dystrophy shows one parent criticizing a Sarepta panelist over the company’s failure to produce confirmatory trial data.

“If you’re looking for your son who’s not ambulatory to get the results of some study from you, then fat chance,” she said. The clip was obtained and first reported on by STAT News.

https://endpts.com/sanofi-sues-sarepta-alleging-that-duchenne-treatment-elevidys-infringes-on-aav-patents/