[의학신문·일간보사=김영주 기자]’When you need to try to expand exports It’s a pity.’
One of the related industry officials lamented that Nabota’s exports to the United States ended in a’stop once’.
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| Reporter Kim Young-joo |
From 0 o’clock on the 15th local time (0 o’clock on the 16th Korean time), exports of Daewoong Pharmaceutical’s Nabota (US export name bulletin) to the US stopped. It follows President Biden’s signature of the US ITC’s final decision on a ’21-month import and sale ban’ for Nabota.
It has been about 1 year and 9 months since the product was approved by the US FDA in February 2019, and officially released in the US in May of that year.
As expected, the President of the United States signed the final ITC decision and exports of Nabota were banned.
Although it is ’21 months’, which is significantly reduced from the ’10 years’ of the ITC preliminary decision, it is expected that a huge blow to the market settlement will be inevitable with a’stop once’ at the time when the market needs to be fully targeted.
Unlike in the case of technology export, Nabota raised high expectations in that Daewoong Pharmaceutical is the leading export type of finished products. In 2013, it signed an export contract with Evolus, a US partner, of 300 billion won within five years of its release, and passed its sales and distribution rights to the US and Europe. After that, Ebolus proceeds with clinical and approval, and has the right to license, but Daewoong Pharmaceutical supplies the finished product as an export. Daewoong Pharmaceutical is expected to export to more than 100 countries, including the US and Europe, and annual sales of trillions.
In addition, the only botulinum toxin formulation approved by the FDA was Allergan (Botox) Ibsen-Galderma (Dsport) Mertz (Zeomin), and Nabota was a new product after 10 years of FDA approval. In addition, it has been evaluated as the closest new drug to the global blockbuster as it has price competitiveness.
In fact, Nabota’s U.S. sales reached 44.5 billion won in 2019, a 256.4% increase from 12.5 billion a year earlier. Last year’s Nabota sales, which were recently announced last year, slowed down significantly to KRW 40.4 billion, and it is self-analysis that the decrease in US sales has had an effect despite the increase in exports to third countries such as Brazil and Thailand.
In relation to the presidential signature and the decision to ban US sales, Daewoong Pharmaceutical immediately announced an appeal to the U.S. Federal Appeal Court, while Medytox referred to “a rush of domestic civil and criminal court litigation” to foresee an unending war.
A related industry official said, “The more important part of botulinum toxin is to advance into the global market through quality enhancement,” and that “the total distrust of domestic toxins is accumulating only among domestic companies.”
Reporter Kim Young-joo [email protected]
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