Medytox has sent out a pilot batch of its liquid-type botulinum toxin Innotox to its US partner Allergan to initiate the long-awaited phase 3 clinical trials of the drug candidate that treats frown lines, analysts said on May 29.
Allergan said it would start the clinical program if Medytox supplies the Innotox samples in the second quarter. Although Medytox has not officially confirmed whether it has sent the samples to Allergan, related data shows it did so, said Kim Mi-hyun, an analyst at Eugene Investment & Securities.
Botox maker Allergan recently decided to begin the final-stage clinical studies in the fourth quarter of this year on Innotox, also known as MT10109L that the US company bought a global license from Medytox in 2013.
According to data from the Korea Customs Service, Medytox exported some US$520,000 worth of Innotox to, to Allergans headquarters in Dublin, Ireland. Given that any botulinum toxin produced by Korean firm has not been approved for export to the country, analysts assume that the exported product are Innotox samples to be used for clinical trials.
The company seems to have shipped the samples from its plant No.2, as this facility is exclusively dedicated to Allergan products, said Song Eun-jeong, an analyst at Nomura Securities.
It appears that Medytoxs plans to enter the US market is being delayed, as Allergan had initially planned for the clinical trials in 2015. The latest setback occurred in 2017 when the trials faced another delay due to scale-up production issues with Medytox, following Allergans announcement in its 2016 second-quarter earnings report that it would begin the phase 3 trials of Innotox in early 2017.
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