November 25, 2024

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[THE INVESTOR] Allergan has confirmed it will soon begin pivotal phase 3 clinical trials of a liquid-type botulinum toxin it licensed from Korean biotech Medytox with hopes to get US marketing approval in 2022.

During its Medical Aesthetics Analyst Day held in Dublin on Sept. 14, Allergan introduced the neurotoxin, originally developed by Medytox, as one of its key drugs that will drive future growth. 

“Allergan is developing a liquid formulation of noel neurotoxin, nivobulinumtoxinA, and plans to initiate the development for glabellar lines and crow’s feet lines,” the company said in a statement.

According to a source, Allergan has yet to submit an Investigational New Drug application to the US Food and Drug Administration for the clinical program but is expected to initiate the study in the fourth quarter.

In the presentation, Allergan announced its plans for two new liquid formulations -- nivobotulinumtoxinA and Botox prefilled syringe -- to add more convenient options for its wrinkle-smoothing treatment product portfolio which typically involves power-type neurotoxin which is required to be mixed with saline solutions for injections.

The company said it expects to win US regulatory approval for the two new versions in 2022.

Allergan bought the global development and commercialization rights of nivobotulinumtoxinA from Medytox in a deal valued at up to US$362 million in 2013.

NivobotulinumtoxinA is approved and sold under the brand name Innotox in Korea.

As the collaboration between Allergan and Medytox to bring the toxin to the US market is making slow progress in the past five years, investors are skeptical about their partnership and the market potential of the drug candidate.

“Investors believe Allergan won’t be actively engaged in the development of Innotox due to their assumption that the existing Botox market will be hurt by the arrival of Innotox … but the general toxin market will grow bigger with Innotox,” said Sun Min-jung, an analyst at Hana Financial Investment.

By Park Han-na (hnpark@heraldcorp.com)