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March 1, 2018

Mylan and Revance to develop and market Botox biosimilar

Mylan has signed a global collaboration and licence agreement with biotechnology firm Revance Therapeutics to develop and commercialise a proposed biosimilar to Botox (onabotulinumtoxinA).

Mylan has signed a global collaboration and licence agreement with biotechnology firm Revance Therapeutics to develop and commercialise a proposed biosimilar to Botox (onabotulinumtoxinA).

Botox is a neuromodulating medicine indicated for the treatment of various conditions such as urinary incontinence, muscle stiffness, abnormal head position and neck pain and some types of eye muscle problems in the US and other international markets.

The deal is in line with Mylan’s long-term commitment for the development and commercialisation of biosimilars and complex products globally through research and development (R&D) collaborations.

Mylan president Rajiv Malik said: “This will be a significant opportunity for Mylan as we add another difficult-to-manufacture product to our pipeline.

“We have reviewed the work done to date by Revance and we are extremely excited and confident about our ability to bring this important product to market.

“This will be a significant opportunity for Mylan as we add another difficult-to-manufacture product to our pipeline.”

“Mylan is pleased to partner with Revance in the global collaboration, and share our scientific, regulatory and manufacturing capabilities and commercialisation expertise.”

As per the agreement, the firms will jointly work towards the regulatory approvals for the development and marketing of this new product in various countries, including the US and Europe.

Mylan is set to make an upfront payment of $25m to Revance, which is also eligible for contingent milestone payments based on additional clinical, regulatory and sales targets, as well as sales royalties in all relevant markets.

According to Revance Therapeutics president and CEO Dan Browne, the alliance will strategically aid the firm in advancing its long-acting RT002 neuromodulator into market, while receiving financial support through potential future milestones and sales royalties on a short-acting Botox biosimilar.

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