Mylan, Revance Pair Up to Create a Biosimilar of Botox

The companies hope to tap into a $4 billion market

Mylan N.V. and Revance Therapeutics, Inc., are teaming up to develop and market a biosimilar to Allergan’s Botox (onabotulinumtoxinA), the market-leading product in a neuromodulator market with overall sales estimated at $4 billion.

The two companies announced a global collaboration and license agreement for the development and commercialization of the proposed biosimilar to Botox, which is approved for the treatment of multiple indications in the United States.  The deal would add another difficult-to-manufacture product to Mylan’s pipeline.

The companies plan to work together to gain regulatory approval and commercialize the product.  The collaboration includes an upfront payment of $25 million to Revance, with contingent milestone payments upon achievement of additional clinical, regulatory, and sales targets, plus sales royalties in all relevant markets.

Global neuromodulator sales are forecasted to grow steadily, exceeding $7 billion by 2024.

Revance remains focused on the development and launch of its own long-acting RT002 neuromodulator, daxibotulinumtoxinA for Injection, which would treat glabellar lines, cervical dystonia, and plantar fasciitis. Revance has developed a proprietary, stabilizing excipient peptide technology designed to create differentiated therapies.

Sources: Mylan N.V. and Revance Therapeutics, Inc.; February 28, 2018.