Hugel said that it has submitted a new drug application (NDA) in Europe for Letybo, its botulinum toxin product.
|Hugel submitted its NDA to the European health regulators on Monday. (Hugel)|
Hugel and its European distribution partner, Croma Pharma, completed phase 3 clinical trials in January 2019. Considering that the standard review process for an NDA lasts about 12 months, the company expects to receive marketing approval in mid-2021.
“European botulinum toxin market is estimated at about $1 billion, and, together with the U.S., accounts for 70 percent of global botulinum toxin market,” the company said.
For successful market penetration, Hugel signed a partnership agreement with Croma Pharma. The company will distribute Letybo in Europe based on its extensive knowledge and data on European medical aesthetics market and practitioners, Hugel added.
Hugel and Croma expect to create synergy between Hugel’s Letybo botulinum toxin and Croma’s hyaluronic acid filler and win 10 to 15 percent market share in the European botulinum toxin market by 2025, the company added.
“Europe is a major global market for botulinum toxin products. Hugel is expecting to win approval in China in mid-2020 and submitting NDA to the U.S. by the end of this year.” Hugel CEO Sohn Ji-hoon said,
With the successful entry into all major markets, the company will have the opportunity to expand its global footprint and record continuous sales growth, Sohn added.
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