] Allergan said on Nov. 3 that it would initiate phase 3 clinical trials of Innotox, Medytox’s type A liquid botulinum toxin product, “as soon as is reasonably possible.”
The announcement indicates that the trials for the cosmetic treatment, also known as BTX, would likely begin next year if Medytox supplies the testing batch as scheduled.
This is the first time in more than a year the US drugmaker has officially spoken up on its development plans for Innotox, and its partnership with Seoul-based Medytox.
“Allergan and Medytox are doing our best to start the MT10109L (known as the Innotox compound in Korea) clinical studies,” Allergan said in an emailed statement to The Korea Herald.
“As a reminder, Medytox oversees the manufacturing of MT10109L. If Medytox provides the phase 3 clinical supplies as planned (we understand from Medytox this will be in 2018) Allergan will initiate Phase 3 as soon as reasonably possible.”
Medytox told The Korea Herald that it was “wrapping up its preparations for the Innotox clinical supplies” and that they would be shipped to Allergan as soon as they were ready.
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 clinical trials for the next three years, fueling concerns that the US drugmaker was not interested in developing the injectable BTX drug.
Allergan announced in its second quarter earnings report in 2016 that it would begin the third-phase trials of Innotox in early 2017, but the plans were delayed due to issues with scaling-up production of the Innotox samples that would be used in the trials.
Since then, Allergan has kept silent about when it would begin clinical trials of Innotox.
When asked about its reasons for the delays, Allergan stated that “as with all clinical development programs, timing and plans for trial initiation can change.”
If Allergan begins the trial next year as planned, the move will bring Medytox a step closer to launching its liquid-injectable antiwrinkle fillers in the US and alleviate worries about the drug’s commercialization outlook.
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.
Medytox has been looking to commercialize the drug in global markets in partnership with Allergan. Right now, French company Ipsen is conducting phase 3 trials of its own liquid BTX product.
Meanwhile, Medytox is engaged in a legal dispute with another Korean botulinum toxin maker, Daewoong Pharmaceutical. Medytox claims that Daewoong stole its BTX bacteria and related trade secrets to develop its own type A botulinum toxin product, Nabota.
The case was first brought to a county court in the US, but the US court ruled that the case should be settled in Korea. Medytox filed a civil lawsuit against Daewoong in Korea on Oct. 30, seeking a stop to Daewoong’s use of its BTX strain and manufacturing methods and financial compensation.
The issue has contributed to a continued drop in Kosdaq-listed Medytox shares, which closed at 401,400 won ($361) on Nov. 2. The shares had reached a peak price of 647,500 won around three months ago on July 27.
By Sohn Ji-young/The Korea Herald (email@example.com