[Infostock Daily= Reporter Park Sang-In] Hugel begins its last step in preparing entry to European botulinum toxin market, which is estimated to be a billion dollar in market size.
Hugel, Inc., a global total medical aesthetics company, announced today that it has submitted a New Drug Application (NDA) in Europe for its botulinum toxin product.
Hugel and its European distribution partner, Croma Pharm, have successfully completed phase 3 clinical trials (Bless 1, 2) in January 2019 and submitted NDA on June 29th European time after finalizing the paperwork. Considering that the standard review process for a NDA lasts about 12 months, Hugel expects to receive marketing approval in mid-2021.
European botulinum toxin market is estimated to be approximately 1 billion dollar, and together with US toxin market accounts for 70% of global botulinum toxin market. In order for successful market penetration, Hugel signed a partnership agreement with Croma Pharma, an Austrian pharmaceutical company. Croma pharma will distribute ‘Letybo(export brand name in Europe for Hugel’s botulinum toxin product)’ in Europe.
Croma Pharma is a medical aesthetics company in Europe producing and distributing dermal filler, skincare products, lifting threads, PRP devices, etc. The company boasts its extensive knowledge and data on European medical aesthetics market and practitioners, and over 40 years of successful marketing experience and knowhow. Hugel and Croma Pharma expect to create synergy between Hugel’s ‘Letybo’ botulinum toxin and Croma’s ‘Saypha’ HA filler and win 10-15% market share in European botulinum toxin market by 2025.
“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 Jihoon Sohn, Hugel’s CEO. “Hugel is also expecting approval in China mid 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.”
Reporter Park Sang-In si2020@infostock.co.kr
