[Asia Economy Reporter Chunhee Lee] The dispute between Daewoong Pharmaceutical and Medytox over botulinum toxin is intensifying once again.
On the 26th (local time), Daewoong Pharmaceutical announced on the 27th that it had submitted a request for investigation to the U.S. Food and Drug Administration (FDA) regarding data manipulation in the liquid botulinum toxin formulation produced by Medytox. It also disclosed that it had reported Medytox to the Korea Financial Supervisory Service for violations of disclosure obligations.
In January this year, the Ministry of Food and Drug Safety received notification from the prosecution that Medytox had forged stability test data during the approval and change approval application process for the botulinum toxin formulation 'Innotox,' and consequently revoked the product approval. In relation to this, Daewoong Pharmaceutical requested confirmation on whether similar manipulation occurred in the approval documents submitted by Medytox to the FDA. The investigation request also included urging the suspension of clinical trials of Medytox products currently underway in the United States.
Daewoong Pharmaceutical stated, "Although Medytox filed a lawsuit in the U.S. citing infringement of rights related to Innotox, the lawsuit itself is invalid as Innotox is based on false data."
Additionally, Daewoong Pharmaceutical reported Medytox to the Financial Supervisory Service for violations of disclosure obligations and other reasons.
Daewoong Pharmaceutical explained the reason for the report, stating that Medytox "has not clearly disclosed the results of the prosecution's investigation and the Ministry of Food and Drug Safety's inquiry into illegal activities such as unauthorized raw material use and test data manipulation, the fact that the product exported to Allergan under technology transfer and the revoked Innotox are the same, and involvement in smuggling to China."
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