The global collaboration and licence agreement covers the development and commercialization of a proposed biosimilar to Botox (onabotulinumtoxinA). Mylan will pay Revance an upfront amount of US$25 million, with milestone payments contingent upon achievement of additional clinical, regulatory and sales targets, plus sales royalties in all relevant markets.

The deal, according to Mylan, further solidifies the company’s long-term commitment to the development and commercialization of biosimilars and complex products globally, adding another difficult-to-manufacture product to the Mylan pipeline.

Mylan estimates global neuromodulator sales today to be around US$4 billion and says they are forecasted to grow steadily, exceeding US$7 billion by 2024.

Revance also has a rival biological to Botox, RT002 (daxibotulinumtoxinA), which it claims may be the first long-lasting injectable formulation of botulinum toxin type A. RT002 is not yet approved by the US Food and Drug Administration (FDA), although Revance reported positive phase III data for its longer-lasting wrinkle treatment in December 2017. The company also said then that it planned to launch the drug in 2020, pending FDA approval.

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