Blog Big Molecule Watch March 06, 2020

Revance, Mylan Provide Updates on BOTOX Biosimilar Collaboration

As we previously reported, Revance Therapeutics and Mylan are collaborating in developing a biosimilar of Allergan’s BOTOX (onabotulinumtoxinA), and Mylan has an upcoming opportunity to opt in or out of the collaboration. Last week, Revance’s President and CEO, Mark Foley, announced on the company’s quarterly earnings call that “Mylan has up until April 30, 2020 to indicate whether or not they plan to opt-in.” Mr. Foley stated that, in the event Mylan opts out of the arrangement, “we feel like we would be back at that same decision point, which is, okay, where do we go now?” Mr. Foley explained: “We feel like the asset has been derisked based on some of the progress that’s been made on those [regulatory and characterization] fronts. And so I think if they choose not to opt in, we will take a pause and step back and reevaluate sort of where do we go from here.” He further added that “there was interest from others” before Revance entered into its agreement with Mylan, but Revance “felt Mylan was the best partner for us and it’s been great working with them.”

Rajiv Malik, President of Mylan, indicated on Mylan’s own quarterly earnings call that the company was still considering whether to extend its collaboration with Revance, and confirmed that it had until April 30 to do so. Mr. Malik said that Mylan was in the midst of “working with [Revance] very closely to evaluate some more data so that we can be very sure that we have a viable product.” Mr. Malik further stated that “if we go ahead, yes, we’ll be able to launch it before 2025.”

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