CROMA-PHARMA-GMBH
8.7.2020 15:02:07 CEST | Business Wire | Press release
On July the 8th , Croma-Pharma GmbH (Croma) has stated that the company submitted the drug file of its botulinum toxin product to the German authority BfArM. The filing of the dossier stands for the next essential step towards Croma’s complete aesthetic portfolio in Europe, which already comprises of a comprehensive HA filler range, threads, PRP and skincare products.
Croma has licensed the product from the Korean toxin producer Hugel Inc. for Europe and established a joint venture company in 2018 with Hugel, Inc., in order to develop and commercialize Croma’s HA filler products together with Hugel’s botulinum toxin product in the US, Canada, Australia and New Zealand.
The filing to BfArM marks the first milestone in Croma’s approach to a European wide regulatory approval.
“We are pleased to announce that our toxin has finally been submitted – since quite some time hence, a European company will launch a botulinum toxin, which makes us both, happy and proud. Combining our present product and service offering with the last “missing link” will definitely boost our business and will have a feelable impact not only on our marketing and sales approach, but for sure also on our corporate culture.”, CEO Andreas Prinz points out in a first statement.
Croma’s botulinum toxin submission in Europe is based on 2 completed randomized, placebo-controlled Phase III pivotal trials (BLESS I and II) that enrolled a total of 917 subjects in Europe and the US. A third confirmatory pivotal trial to support the US submission (BLESS III) is currently ongoing in sites in Europe and the US and has completed its interim analysis after all 355 patients completed their visits for the primary endpoint.
About Croma-Pharma GmbH
Founded in 1976, Croma-Pharma GmbH (Croma) is an Austrian family-owned company that specializes in the industrial production of hyaluronic acid syringes for the fields of medical aesthetics, ophthalmology and orthopaedics. Croma currently runs 12 international sales companies and distributes its products in more than 70 countries. Within its global sales network, Croma focuses with own branded products on minimally invasive aesthetic medicine. Besides a broad range of HA fillers from the own production site, Croma markets PDO lifting threads, a Platelet Rich Plasma (PRP) system and a personalized skincare technology in its core strategic markets.
About Hugel, Inc:
Established in Korea in 2001, Hugel is a global leader in medical aesthetics providing botulinum toxin formulation BOTULAX / LETYBO, HA filler The CHAEUM / DERMALAX, and derma cosmetic WELLAGE / PR4 brands. Dedicated to provide proven, high quality medical aesthetic solutions that satisfy both consumers’ and practitioners’ needs, Hugel is leading Korean market for both botulinum toxin and HA filler products and is distributing its products to over 40 countries. Visit: www.hugel.co.kr
View source version on businesswire.com: https://www.businesswire.com/news/home/20200708005060/en/
Link:
About Business Wire
Subscribe to releases from Business Wire
Subscribe to all the latest releases from Business Wire by registering your e-mail address below. You can unsubscribe at any time.
Latest releases from Business Wire
Solana Becomes Presenting Sponsor of the World Series of Poker®10.6.2026 15:00:00 CEST | Press release
WSOP to Bring Crypto to Global Events Through Solana-Powered Tournament Ticket Purchases The World Series of Poker (WSOP®), the longest-running and most prestigious poker tournament series in the world, today announced a first-of-its-kind collaboration with the Solana Foundation to bring crypto directly into the global poker experience. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260610344534/en/ The World Series of Poker TV production set in Las Vegas, presented by Solana Beginning today at the 57th annual summer event at Paris Las Vegas and Horseshoe Las Vegas, players will be able to purchase tournament tickets using Solana, powered by MoonPay’s payment infrastructure. This will be the first time in WSOP history where players can buy tournament tickets directly with crypto, and by leveraging Solana’s technology, this payment method will have zero processing fees. The integration will expand further at the 2026 WSOP Par
Capcom’s Dragon’s Dogma 2: Dark Arisen Scheduled to Launch on October 9, 2026!10.6.2026 15:00:00 CEST | Press release
– Capcom seeks to further broaden its user base through expansion content and a new platform launch – Capcom Co., Ltd. (TOKYO:9697) today announced that Dragon’s Dogma 2: Dark Arisen, which includes an expansion for Dragon’s Dogma 2, is scheduled to be released on October 9, 2026. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260610422753/en/ Dragon's Dogma 2: Dark Arisen logo The Dragon’s Dogma series consists of action games in a fantasy setting where players adventure in an expansive open world of swords and magic. Since the release of the first game in 2012, the series garnered praise worldwide for gameplay features such as its “pawn” adventure companions who can carry out actions on their own, leading the series to over 14 million* units sold cumulatively. Dragon’s Dogma 2: Dark Arisen is a paid expansion title that adds a new story to Dragon’s Dogma 2, which was released in March 2024. Based on the wide range of feedb
Xsolla to Sponsor First Playable Florence 2026, Equipping Indie PC Developers With Publisher Pitch Strategies and a Scalable Alternative to Paid Acquisition10.6.2026 15:00:00 CEST | Press release
Xsolla Brings Game Commerce Expertise and Developer Programming to Europe's Premier Indie Publishing Event Xsolla, a leading global video game commerce company, today announced its sponsorship of First Playable Florence (FPF) 2026, Europe's premier annual gathering for independent game developers seeking publishing deals, investment, and platform partnerships. On June 11 in Florence, Italy, Xsolla will host two developer-focused programming activations led by Inês Ramalho, Xsolla's expert in partner-driven growth and publishing strategy. Together, the sessions are designed to give indie PC studios concrete tools for two of the most consequential conversations they will have in the current market: the one that gets them published, and the one they have with themselves about how to grow sustainably once they are. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260610191923/en/ Graphic: Xsolla First Playable Florence is purpose-
SLB to Host 2026 Digital Investor Day10.6.2026 14:30:00 CEST | Press release
SLB (NYSE: SLB) will host an Investor Day on Wednesday, June 17, 2026, in New York, where leadership will outline their vision for SLB’s Digital business as digital technologies and AI continue to reshape the energy industry. The presentation will highlight SLB’s integrated digital strategy and portfolio, scalable growth opportunities powered by AI, and financial profile and outlook. Olivier Le Peuch, chief executive officer, SLB, will present at 9:00 a.m. U.S. Eastern Time (ET), and will discuss SLB’s digital strategy and business outlook. Stephane Biguet, chief financial officer, SLB, will present at approximately 11:00 a.m. ET, and will discuss the financial profile of SLB’s Digital business, the market opportunity and SLB’s 2030 digital ambitions. Mr. Le Peuch and Mr. Biguet will be joined by divisional leadership, who will provide further insight into Digital’s competitive differentiation supported by its mission-critical platform, driving transformation for customers. A live webc
Wolters Kluwer expands its Libra AI workspace with authoritative Swiss legal content from leading publisher Stämpfli10.6.2026 14:00:00 CEST | Press release
Collaboration brings trusted Swiss legal expertise directly into AI‑supported legal research, drafting and review Wolters Kluwer Legal & Regulatory today announced the expansion of Libra by Wolters Kluwer, its AI-powered legal workspace, to include professional legal content from Stämpfli Publishers, one of Switzerland’s most respected legal publishers. As a result, Swiss legal professionals using Libra by Wolters Kluwer gain direct access to the legal literature that shapes their daily work – fully integrated into a single AI-supported workflow. The content offering includes commentaries, practitioner guides, yearbooks and selected journals from Stämpfli Publishers – including the renowned “Berner Kommentar”, and the company’s succinct commentaries and legal textbooks. In addition, primary sources of Swiss law at both federal and cantonal level are integrated into the workspace. The offering will be continuously expanded over time, with additional titles gradually integrated into the
In our pressroom you can read all our latest releases, find our press contacts, images, documents and other relevant information about us.
Visit our pressroom