We sincerely apologize to all our customers and investors for causing concerns regarding the recent administrative actions by the MFDS (KFDA).
Medytox, which was established in 2000 as a venture biotech company, developed Meditoxin as the first botulinum toxin product in Korea and fourth in the world.
In 2013, Medytox developed INNOTOX, which is the first ever liquid botulinum toxin product. In 2016, Medytox also developed Coretox, which reduces the immune response risk by using non-animal sourced media in the manufacturing process for the first time in the world. Medytox now exports these three products to 60 countries.
In addition, Medytox achieved 121.6 billion won in exports, which is 60 percent of total sales, in 2019. We are also anticipating the approval of the license in China this year, which will result in even greater sales.
There have been no reports to date of any severe adverse effects for using Meditoxin, which has manufactured 1,690 vials (100 unit equivalent) from the date of initial launching in the market to 2019.
The Meditoxin issue was initiated by actions by MFDS based on a report in 2019 to the Korea Anti-Corruption & Civil Right Commission by a former Medytox employee, surnamed A, who was working for Daewoong pharmaceutical in 2019.
The issue arose from prosecution investigation based on a report that Medytox used ingredients without change of permission for some of Meditoxin products manufactured from December 2012 to June 2015.
Following the above report, the MFDS and prosecution have investigated Medytox several times and currently related hearings are ongoing.
On April 17, the MFDS suspended manufacturing and sales of Meditoxin 50 unit, 100 unit and 150 unit products, based on Article 71 of the Pharmaceutical Act.
Medytox's position in regard to such decision by the MFDS is as follow
1. Actions of MFDS are based on the article 71 of the Pharmaceutical Act pertains to concerns over current “public health” based on sales and manufacturing. However, the period related to the Meditoxin issues was from the manufacturing period of December 2012 to June 2015. Meditoxin products manufactured during such period have all been used a long time ago and no longer exist. Therefore, no harm to public health can currently exist.
2. The Meditoxin products that are currently being distributed were manufactured after April 2017. Medytox not only received a conformity decision on the inspection for distributed products which was undertaken in 2016 and 2018 by the MFDS, but also had no issues whatsoever during the MFDS' numerous inspections concerning special observations and random collections for distributed products in terms of efficacy and safety within the shelf life.
In this connection, Medytox submitted a request for suspension of execution on the MFDS' order and for cancellation of the MFDS' order to the Daejeon District Court at 9pm on April 19.
Currently, based on the order by the MFDS, Medytox temporarily has suspended the manufacturing and sales of Meditoxin. In response to the above, Medytox plans to increase revenue by promoting INNOTOX and Coretox, which are advanced new botulinum toxin type A products.
As a leading global company in the botulinum toxin industry, Medytox has developed the world's first pre-filled syringe botulinum toxin products for maximizing usage convenience. Also the R&D division, comprised of 20 percent of all employees, will soon develop innovative new bio products.
Medytox again offers a sincere apology to its shareholders and customers. Taking this opportunity, Medytox will do our best to prevent this from occurring again in the future by preparing internal verification processes and strengthening a continuous monitoring system.
Finally, the recent order of the MFDS is related to the production process of Meditoxin which occurred in the past. We note that this issue is a separate and unrelated issue from the legal disputes with Daewoong Pharmaceutical at the U.S International Trade Commission (ITC) and the civil and criminal cases with respect to the theft of Medytox's botulinum toxin strain and manufacturing process. The truth will start to unfold with the ITC's initial determination on June 5.