Mylan entered a global collaboration and license agreement with Revance Therapeutics for the development and commercialisation of a proposed biosimilar to Allergan's neuromodulator Botox (onabotulinumtoxinA), the companies announced. Under the deal, Mylan and Revance will work together to gain regulatory approval for the biosimilar product in the US, Europe and other markets.
"This will be a significant opportunity for Mylan as we add another difficult-to-manufacture product to our pipeline," remarked Mylan president Rajiv Malik. "Bringing an affordable biosimilar version of Botox to commercialisation will offer patients a safe alternative to this popular and highly effective treatment," Malik added.
As part of the agreement, Mylan will make an upfront payment of $25 million to Revance, with the latter eligible to receive milestone payments linked to additional clinical, regulatory and sales targets, plus sales royalties in all relevant markets.
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Botox generated sales of nearly $3.2 billion in 2017, with Bernstein analyst Ronny Gal calling the deal with Revance a "smart move for Mylan." However, the analyst noted that the product "is an unusual protein (aggregate of seven proteins) so exact replications will be a challenge. We expect this programme will take 4-5 years, at minimum, to get to market. There is also some risk — not all biosimilars make it across, especially the first in class."
Revance CEO Dan Browne explained that the deal with Mylan allows the company "to remain focused on the development and launch of our own premium, long-acting RT002 neuromodulator, while also benefitting financially from potential future milestones and sales royalties on a short-acting biosimilar to Botox." In December last year, Revance announced positive top-line results for RT002, also known as daxibotulinumtoxinA, in two Phase III studies for the treatment of glabellar lines.
For related analysis, see ViewPoints: RT002 can compete with Botox, but can Revance compete with Allergan?
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