Allergan gave official confirmation Wednesday that it would initiate phase 3 clinical trials of Innotox, Medytox’s Type A liquid-type botulinum toxin in the fourth quarter of this year, as it expects to receive the needed clinical supplies from Medytox before June.

“Medytox plans to deliver phase 3 clinical supplies to Allergan this quarter. As previously stated, clinical development timelines can change, but based on the current timing, Allergan plans to commence Phase 3 in Q4 2018,” Allergan said in an emailed statement to The Korea Herald.

It is the first time in six months that Allergan has formally spoken up about its partnership with the Seoul-based drugmaker, as well as set a concrete development timetable for Innotox. 

Medytox followed up on the development with a statement that it is “currently working very smoothly with Allergan” and “expects that an IND (Investigational New Drug) application for phase 3 trials will be submitted (to the US FDA) in the near future.”

If Allergan begins the phase 3 clinical trials within this year as planned, the move will bring Medytox closer to launching its liquid-injectable anti-wrinkle treatment in the US and potentially heat up competition for BTX makers.

Innotox is the world’s first-ever liquid injectable BTX, which is currently approved and sold in Korea. Typically, BTX is created as a powder, a small amount of which is mixed with saline solution for clinical injections. 

In November, Allergan had indicated that Medytox oversees the manufacturing of MT10109L, known as the Innotox compound in Korea, adding that the US drugmaker would initiate phase 3 trials “as soon as reasonably possible” once Medytox provides the clinical supplies as planned.

Though Medytox refrained from commenting on the shipment, Korea’s latest BTX export data suggests that the firm delivered its Innotox clinical supplies to Allergan’s headquarters in Dublin, Ireland, this month. 

According to the Korea Customs Service’s data tracking the monthly volume of botulinum toxin exports, Ireland received $519,000 worth of BTX exports from Korea in May. Allergan has its headquarters in Dublin, Ireland.

“No Korean company has ever sold BTX products to Ireland, because there aren’t any products which have been approved by the European drug regulator. Considering this, all BTX shipments to the regions are for clinical testing purposes,” said Nomura Securities analyst Cara Song.

Allergan and Medytox struck a license partnership in 2013, when the Seoul-based company sold the global development and commercialization rights to Innotox to Allergan in a deal valued at up to $362 million.

However, Allergan did not initiate the drug’s phase 3 clinical trials in the years that followed, fueling concerns that the US drugmaker was not interested in commercializing the injectable BTX drug.

News that Allergan is pushing through with plans to develop Innotox heightens the competition for current and prospective BTX makers in the US, the world’s biggest market for the anti-wrinkle treatment.

Though Allergan currently dominates the segment with its flagship BTX brand Botox, new rivals like Korea’s Daewoong Pharmaceutical and Hugel are on the verge of launching their own products in the US at more affordable prices.

The fastest challenger is Daewoong and its US partner Evolus, which have filed a biologics license application with the US Food and Drug Administration for its Type A botulinum toxin drug Nabota, also known as DWP-450.

However, the US FDA declined to approve Nabota last week, citing deficiencies related to the chemistry, manufacturing and controls processes. Despite the dampened outlook, the companies said they would soon refile an application with supplementary documents, with the aim of obtaining the US regulator’s marketing approval next year.

If approved as planned, Nabota is expected to become the first Korea-made BTX to enter the US. And it is widely expected that Evolus will aggressively market the drug at a steep discount and reap benefits from being the only company to sell a Type A BTX drug at cheaper prices, Song said.

For Medytox, it’s a late runner in this race considering that it will take at least two years for Allergan to conclude its phase 3 trials for Innotox, and another year or so to obtain the FDA’s approval.

However, Allergan has cited plans to rise above the competition by positioning Innotox, a liquid-type BTX drug, as a premium product that is superior to the cheaper rivals available in the market, according to the Nomura Securities analyst.

By Sohn Ji-young (jys@heraldcorp.com)