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Revance Therapeutics focus on its own Botox biosimilar as work with Mylan is stalled Posted 13/09/2019

As Revance gives Mylan more time to decide whether to develop their joint Botox biosimilar, the firm is continuing to focus on its own Botox biosimilar, DAXI. It aims to launch the product in 2020.

Botulinum toxin, or Botox, is now famous for its use in cosmetic clinics. Isolated from a group of pathogenic bacteria, in extremely low doses the toxin can reduce facial wrinkles. It also has therapeutic applications in reducing spasms in muscle disorders and has recently shown benefits for migraine headaches.

US firm Revance Therapeutics is pursuing a range of possible therapeutic uses for botulinum toxin type A, including upper limb spasticity, migraine and cervical dystonia (involuntary contraction of the neck muscles).

In 2018, it teamed up with generics giant Mylan to make a biosimilar of Botox (onabotulinumtoxinA) [1], a market which is currently dominated by Allergan. However, the company recently announced an amendment to its agreement, which extends the target date to 30 April 2020 for Mylan to decide whether to continue development of the product.

Mylan has agreed to pay Revance US$5 million in consideration for the extended timeline (as well as contingent payments of up to US$100 million and sales milestones payments of up to US$225 million, plus royalties).

Revance also has a rival product called DAXI (daxibotulinumtoxinA), which it claims to be the first long-lasting injectable of botulinum toxin type A. In their second quarter 2019 conference call, Revance President and CEO Daniel Browne confirmed that DAXI is its lead candidate and could be used for both aesthetic and therapeutic purposes, offering ‘exceptional response rates and long-lasting results’.

Mr Browne went on to say that for the treatment of glabellar lines (frown lines), the largest aesthetic indication for neuromodulators, DAXI is expected to require only two treatments per year to provide persistent correction for patients.

The company expects approval, followed soon after by commercial launch, for DAXI in 2020. Mr Browne closed by saying: ‘Revance plans to transform the patient experience, raising the bar from what could be expected from a neuromodulator treatment today’.

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1. GaBI Online - Generics and Biosimilars Initiative. Mylan and Revance team up for botox biosimilar [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2019 Sep 13]. Available from: www.gabionline.net/Pharma-News/Mylan-and-Revance-team-up-for-botox-biosimilar

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Source: Revance Therapeutics

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