Hugel expects to begin distributing its wrinkle-smoothening botulinum toxin in the $1 billion European market in mid-2021, the company announced Tuesday.

Hugel and its European distribution partner, Croma Pharma, have successfully completed phase 3 clinical trials in January 2019 and completed the submission of New Drug Application with the European Medicines Agency on Monday.

As the standard review process takes roughly a year, Hugel expects to receive the approval in mid-2021.

“Europe is a major global market for botulinum toxin products, together with China and the US. Our submission of the NDA in Europe is a significant milestone as we expedite our entry into the global market,” said Sohn Ji-hoon, the CEO of Hugel.

“Hugel is also expecting approval in China in the middle of this year and NDA submission in the US at the end of this year. With successful entry to all major markets, we’ll have the opportunity to greatly expand our global footprint and experience continued sales growth,“ Sohn said.

European botulinum toxin market is estimated to be approximately 1 billion dollars. Together with US toxin market, it accounts for 70 percent of global BTX market.

Hugel‘s partner Croma Pharma is an Austrian pharmaceutical company that produces and distributes dermal filler, skincare products, lifting threads and tissue-healing platelet-rich plasma devices. It has 40 years of business know-how in Europe and an extensive knowledge of the practitioners in the region.

Hugel and Croma Pharma expect to create synergy between Hugel’s Letybo BTX and Croma’s Saypha hyaluronic acide filler. Together, the two companies may take up 10 to 15 percent of market share in the European BTX market by 2025.

Croma will distribut Hugel‘s BTX under the brand name Letybo.

By Lim Jeong-yeo (kaylalim@heraldcorp.com)