Revance Gives Mylan Additional Time to Decide on Botox Biosimilar Development

In a filing with the US Securities and Exchange Commission this month, Silicon Valley-based biotech company Revance Therapeutics said that it has entered into an amendment to a Collaboration and License Agreement with Mylan; the amendment extends the period of time Mylan has to decide whether to continue to develop and commercialize a biosimilar of Allergan’s onabotulinumtoxinA (Botox).

According to the Form 8-K filing, Mylan will be required to notify Revance by April of 2020—or 30 days from the date on which Revance provides Mylan with deliverables, the nature of which were not specified in the filing—of its decision. Mylan has agreed to pay Revance $5 million, incremental to a previously agreed upfront payment of $25 million, contingent payments of up to $100 million, and sales milestones payments of up to $225 million plus royalties.

Revance signed the collaboration and license agreement for the proposed biosimilar with Mylan in February 2018, and the agreement includes commercialization of the biosimilar in the United States, Europe, and other markets worldwide. In February 2019, Mylan said in an earnings call that it had conducted an initial advisory meeting with the FDA regarding the proposed biosimilar, and indicated that the agency’s feedback led the partnership to believe that the biosimilar approval pathway is viable for this product, and that Mylan could be the first developer to commercialize a biosimilar onabotulinumtoxinA.

The originator onabotulinumtoxinA, a neuromuscular blocking agent, is approved to treat conditions including incontinence due to neurological conditions, prophylaxis of headache in patients with migraine, upper limb spasticity, cervical dystonia, and strabismus, among other indications, such as its cosmetic uses.

Currently, Allergan, which is set to be acquired by AbbVie, faces no biosimilar competition for their drug in the United States. The FDA has approved prabotulinumtoxinA-xvfs, marketed as Jeuveau, but the drug was submitted to the FDA under a new Biologics License Application, and was not treated as a biosimilar of the innovator Botox despite the fact that it is a purified botulinum toxin type A, like Botox. Jeuveau was licensed only for aesthetic uses, and the product is not approved for any medical indications.

Revance is also advancing a novel drug candidate, daxibotulinumtoxinA, which is a botulinum toxin that does not contain human or animal-based components. The company has completed a phase 3 program for the proposed agent in frown lines and is pursuing FDA approval in 2020. The company says that it is evaluating the drug for other indications, such as therapeutic indications for cervical dystonia, adult upper limb spasticity, and plantar fasciitis.