[Asia Economy Reporter Hyungsoo Park] Hugel has entered the final preparations to enter the US botulinum toxin market.
On the 31st of last month (local time), Hugel announced that it submitted a Biologics License Application (BLA) to the US Food and Drug Administration (FDA) for its botulinum toxin product "Letybo" 50 units and 100 units, with the indication for glabellar lines.
The US botulinum toxin market, valued at about 2 trillion KRW, is one of the major markets for botulinum toxin products along with Europe and China. Together with the European market, it accounts for 70% of the global market worth approximately 5 trillion KRW. It is the largest single-country market in the world.
Previously, Hugel began Phase 3 clinical trials in the US local market in 2015 and completed the trials in January 2019. In April of the same year, through its US subsidiary "Hugel America," it started the final clinical trial and is currently completing the finishing work.
In September last year, Hugel held a pre-BLA meeting with the US FDA and submitted the BLA. Since it generally takes about a year to obtain approval, it is expected to acquire product approval next year.
In 2018, Hugel, together with the Austria-based medical aesthetic pharmaceutical company Croma, established Hugel America. Hugel holds a 70% stake. Hugel America holds exclusive distribution rights in the US for Hugel’s botulinum toxin products for which approval has been applied and Croma’s hyaluronic acid fillers. Clinical trials for filler approval in the US are also currently underway.
Hugel America has secured exclusive distribution rights not only in the US but also in Canada, Australia, and New Zealand. Hugel plans to aggressively expand its overseas markets by applying for product approvals in these countries soon after submitting the BLA. Through direct distribution and marketing activities in the US market via Hugel America, the company aims to maximize profitability and accelerate market expansion in the US.
To prepare for full-scale US operations, Hugel appointed James P. Hartman, an expert in the medical aesthetic field, as the head of Hugel America in May last year. Ahead of entering the US market, they have established an aggressive marketing strategy with the goal of entering the US market 'Top 3' within three years after product launch.
A Hugel official said, "The US is the largest botulinum toxin market in the world, but the actual consumer procedure experience rate is not high," adding, "There will be an opportunity to reshape the market structure based on the academic and educational programs related to procedures accumulated by Hugel and the proven quality of its products."
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