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
The Smarter E Europe Sends a Strong Message: the Energy Future Is Renewable17.6.2026 16:09:00 CEST | Press release
Europe is once again facing an energy crisis, another reminder of just how vulnerable our fossil fuel-based energy system is. Yet the current crisis is also accelerating the energy transition and the adoption of electromobility. The objective is to reduce dependence on imports of fossil-based raw materials and thereby increase resilience. This year, The smarter E Europe, Europe’s largest alliance of exhibitions for the energy industry, is sending a strong and clear message with its new special exhibit Renewables 24/7: Renewable energies ensure a secure, reliable and affordable energy supply every day, around the clock. This message is scientifically supported by a new study from the Fraunhofer Institute for Solar Energy Systems ISE, which will be presented on June 23. From June 23–25, around 2,800 exhibitors will present groundbreaking, market-ready and cross-system technologies for a 24/7 renewable energy supply at Messe München. More than 100,000 visitors are expected. This press rel
Xsolla Sponsors Game Camp France, Reinforcing Commitment to France’s Dynamic Games Ecosystem17.6.2026 15:47:00 CEST | Press release
Game Camp France supports regional developer communities across the French games ecosystem Xsolla, a global video game commerce company that helps developers launch, grow, and monetize their games, today announced its sponsorship of Game Camp France this 18-19 June 2026. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260617351463/en/ Graphic: Xsolla The French video game industry is widely recognized as one of the most vibrant in Europe, with revenue reaching approximately €5.8 billion in 2025. Rather than a centralized market, it is a patchwork of regional scenes, each with its own communities, creative identity, and business dynamics. Game Camp France plays a key role in bringing these diverse voices together, creating a centralized space for collaboration, exchange, and growth. By sponsoring Game Camp France, Xsolla is investing directly in the local ecosystem and the developers who power it. Xsolla will be on-site to eng
The Estée Lauder Companies and Jo Malone London Launch Experience That Turns Visual Taste into a Personalized Fragrance Wardrobe, exclusively on Pinterest17.6.2026 15:26:00 CEST | Press release
The Estée Lauder Companies Inc. (NYSE: EL) and Jo Malone London today announced the launch of Scent Scanner, a first-of-its-kind experience available exclusively on Pinterest and rolling out in the US and France. The experience translates the visual preferences people have expressed across their Pinterest boards into personalized Jo Malone London fragrance recommendations. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260617962807/en/ Building on the success of Jo Malone London's AI Scent Advisor, introduced in 2025, Scent Scanner offers a new way for consumers to find their personalized scent, shifting the starting point from words to images. While the AI Scent Advisor invited consumers to describe the scent they were seeking, Scent Scanner reads visual inspiration – imagery, color palettes, textures, destinations, rituals and aesthetics – to suggest fragrances suited to each individual. The custom Pinterest experience bri
Azul Addresses the Java Runtime Security Blind Spot Autonomous AI Can Now Exploit17.6.2026 15:00:00 CEST | Press release
Launches free JVM vulnerability risk assessment to give enterprises estate visibility before AI threat actors find the gaps Azul, the trusted leader in enterprise Java for today’s AI and cloud-first world, today launched a free JVM vulnerability risk assessment to address the blind spot that autonomous AI exploitation tools are increasingly able to find. With mean time to exploit (MTTE) collapsing from months to days or hours, the unmanaged Java estate has become an urgent enterprise security vulnerability. Azul’s assessment gives DevOps and SecOps teams complete visibility into the hidden risks embedded in the runtime of their Java estate before threat actors get there first, and is designed to complement the broader security, licensing and compliance solutions and services delivered by Azul’s trusted partners. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260617352753/en/ Azul's JVM Vulnerability Risk Assessment dashboard
Fortegra Strengthens Actuarial Leadership with Appointment of Anthony Katz as SVP, Reserving17.6.2026 15:00:00 CEST | Press release
The Fortegra Group, Inc., a global specialty insurer, today announced the appointment of Anthony Katz as Senior Vice President, Reserving. Mr. Katz will lead Fortegra’s team of professional actuaries, with responsibility for reserving, credit insurance, statistical reporting, and key initiatives including IFRS 17. “Anthony brings more than 30 years of actuarial expertise and a genuine commitment to building the capabilities our distribution partners depend on,” said Rick Kahlbaugh, Chief Executive Officer at Fortegra. “His background across reserving, actuarial transformation, and international markets will be instrumental as we continue to support our distribution partners.” A credentialed actuary holding FCAS, FSA, and MAAA designations, Mr. Katz brings more than 30 years of experience across reserving, pricing, and actuarial transformation. He has held senior leadership roles at ToaRe, Everest Re, Arch Insurance, Ernst & Young, and ACE, and most recently served as an independent con
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