Business Wire

Galderma receives a positive outcome through the European Decentralised Procedure for AKLIEF® (trifarotene 50 mcg/g cream), the first new retinoid molecule for acne in the European Union in 25 years1

Share

Galderma today announced that AKLIEF® (trifarotene 50 mcg/g cream) has concluded its European decentralised procedure resulting in the approval of its summary of product characteristics, package leaflet, and labelling, by all involved European member states. Each of the 16 concerned member states will now issue individual national marketing authorisations for the cutaneous treatment of acne vulgaris of the face and/or the trunk in patients from 12 years of age and older, when many comedones, papules and pustules are present. Once approved, trifarotene 50 mcg/g cream will be the first new retinoid molecule launched in the European Union in 25 years.1

“Although retinoids are the cornerstone of acne treatment, there have been few significant advances or developments in decades,” said Professor Thomas Dirschka, University of Witten-Herdecke, Germany. “It is encouraging to see innovative approaches to tackling one of the most common and frustrating skin diseases.”

“Truncal acne can affect almost half of those with facial acne. It often goes under-reported and underdiagnosed, despite a desire from patients to have it treated,” said Professor Jerry Tan, University of Western Ontario, Windsor, ON, Canada. “To date, there has been a lack of scientific evidence on the management of truncal acne and as such, it is important to investigate new treatment options that specifically address this unmet need.”

Trifarotene 50 mcg/g cream is the first treatment to selectively target retinoic acid receptor gamma (RAR-γ), the most common RAR found in the skin.2,3,4 Trifarotene 50 mcg/g cream was assessed by regulators on data from two large, randomised Phase III clinical trials (PERFECT 1 & 2). Data have demonstrated that the systemic exposure of trifarotene 50 mcg/g cream is low as it is rapidly metabolised in the liver, with a half-life of just five minutes.3 Therefore, as well as treating facial acne, it can be used on large body surface areas of the trunk.3

“Acne can severely impact the quality of life and psychological well-being of those who suffer from it. The approval of AKLIEF® will provide patients across Europe with a next-generation retinoid cream that has been shown to be fast and effective at treating acne on both the face and trunk,” said Dr Thibaud Portal, Galderma Global Vice President of Prescription Medicines. “This underscores Galderma’s commitment to providing innovative solutions for the most common and frustrating skin diseases.”

Trifarotene 50 mcg/g cream has been shown to significantly reduce inflammatory lesions as early as two weeks on the face and four weeks on the back, shoulders and chest compared with vehicle (control) (p<0.001).2 Trifarotene 50 mcg/g cream was well tolerated on the face and trunk. Treatment-related adverse events included mild-to-moderate application site reactions, such as skin irritation, mainly characterised by scaling, dryness, erythema and burning/stinging.2

-END-

About Acne
Acne is one of the most common skin disorders and affects approximately 70 million people across Europe.5 Acne can occur on the face and trunk (shoulders, back and chest)6,7 and it is estimated that around half of people with facial acne also have truncal acne.7 Despite the clear need for treatments that target both facial and truncal acne, there has been a lack of scientific evidence on the management of truncal acne, with the majority of studies focusing on the treatment of facial acne alone.8,9

About AKLIEF®
In the European Union, AKLIEF ® (trifarotene 50 mcg/g cream) is indicated for the cutaneous treatment of acne vulgaris of the face and/or the trunk in patients from 12 years of age and older, when many comedones, papules and pustules are present. It is the only topical retinoid that specifically targets retinoic acid receptor gamma (RAR-γ), the most common RAR in the skin.3,4 National marketing authorisations across concerned European member states will follow in 2020.

AKLIEF ® received approval from the US Food and Drug Administration (FDA) in October 2019.10 It also received approval from Health Canada in November 2019.11

About Galderma
Galderma, the world's largest independent global dermatology company, was created in 1981 and is now present in over 100 countries with an extensive product portfolio to treat a range of dermatological conditions. The company partners with health care practitioners around the world to meet the skin health needs of people throughout their lifetime. Galderma is a leader in research and development of scientifically-defined and medically-proven solutions for the skin. For more information, please visit www.galderma.com

References

  1. EMA. List of European Union reference dates frequency of submission of periodic safety update reports. Available at https://www.ema.europa.eu/en/human-regulatory/post-authorisation/pharmacovigilance/periodic-safety-update-reports-psurs (Last access December 2019)
  2. Tan J, et al. J Am Acad Dermatol 2019;80(6):1691–9.
  3. Aubert J, et al. Br J Dermatol 2018;179:442–56.
  4. Fisher GJ, et al. J Biol Chem 1994;269(32):20629–35.
  5. Hay RJ, et al. J Invest Dermatol 2014;134(6 Suppl 1):S2.
  6. Dréno B, et al. J Eur Acad Dermatol Venereol 2015;291096-1106.
  7. Del Rosso JQ, et al. J Drugs Dermatol 2007;6(6):597–600.
  8. Liu CW & Tan J. Skin Therapy Lett 2017;12.
  9. Asai Y, et al. CMAJ 2016;188:118–26.
  10. FDA. Approval of Aklief. Available at: https://www.fda.gov/drugs/new-drugs-fda-cders-new-molecular-entities-and-new-therapeutic-biological-products/novel-drug-approvals-2019 (Last access December 2019)
  11. Health Canada. Approval of Aklief. Available at: https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/applications-submissions/register-innovative-drugs/register.html (Last access December 2019)

Contact information

Media Contact
Sébastien Cros
Head of Corporate Communications
media@galderma.com

About Business Wire

For more than 50 years, Business Wire has been the global leader in press release distribution and regulatory disclosure.

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

Piper Sandler Advises Momentive Performance Materials on the Sale of its Consumer Sealants Business to Henkel Corporation7.8.2020 21:55:00 EESTPress release

Piper Sandler &Co., a leading investment bank and institutional securities firm, served as financial advisor to Momentive Performance Materials Inc. (Momentive) in the sale of its consumer sealants business to Henkel Corporation. The deal, which remains subject to customary closing conditions including regulatory clearances, is expected to close in 2020. Momentive’s consumer sealants business encompasses GE-branded consumer sealants sold under license from the General Electric Company and available through home-improvement centers, major retailers and hardware stores. Momentive will continue to manufacture consumer sealants through 2021 under a transition supply agreement. (Source: Momentive Performance Materials Inc.) “In the midst of a pandemic, we are delighted to have helped Momentive, reach this agreement and achieve the goals of the company and its shareholders,” said Telly Zachariades, managing director, chemicals and materials, at Piper Sandler. “We are looking forward to aidin

ENA Investment Capital Publishes Open Letter to Ontex Shareholders7.8.2020 14:00:00 EESTPress release

ENA Investment Capital (“ENA”), a long-term, value-oriented investment firm and the second-largest shareholder in Ontex Group NV (“Ontex” or the “Company”) owning c.15% of the Company’s outstanding shares, today issued the following public letter to Ontex’s shareholders. Dear Fellow Ontex Shareholders, ENA Investment Capital, owning c.15% of the voting shares of Ontex, has devoted considerable time and resources to conduct a thorough analysis of Ontex. This includes acquiring a comprehensive understanding of the personal hygiene segment and, more importantly, of the Company’s turnaround potential which we are convinced, if effectively executed, can deliver significant value for shareholders. As part of this extensive 18-month due diligence effort, we have consulted with former executives from Ontex as well as its main competitors, industry experts, investment bankers, lawyers and specialist consultants on a wide range of topics critical to Ontex’s business such as raw material trends a

Novavax and Takeda Announce Collaboration for Novavax’ COVID-19 Vaccine Candidate in Japan7.8.2020 12:28:00 EESTPress release

Novavax, Inc. (Nasdaq: NVAX), a late stage biotechnology company developing next-generation vaccines for serious infectious diseases, and Takeda Pharmaceutical Company Limited (TSE:4502/NYSE:TAK), today announced a partnership for the development, manufacturing and commercialization of NVX‑CoV2373, Novavax’ COVID‑19 vaccine candidate, in Japan. NVX‑CoV2373 is a stable, prefusion protein made using Novavax’ recombinant protein nanoparticle technology and includes Novavax’ proprietary Matrix‑M™ adjuvant. Takeda will receive funding from the Government of Japan’s Ministry of Health, Labour and Welfare (MHLW) to support the technology transfer, establishment of infrastructure and scale-up of manufacturing. Takeda anticipates the capacity to manufacture over 250 million doses of the COVID-19 vaccine per year1. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20200807005160/en/ “Takeda’s leading position in Japan, technical expertise,

SES S.A.: Half Year 2020 Results7.8.2020 08:30:00 EESTPress release

SES S.A. announced financial results for the six months ended 30 June 2020. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20200806006164/en/ SES S.A.: Half Year 2020 Results (Photo: Business Wire) Solid H1 performance in line with expectations and continued underlying growth in Networks of +7.1% year-on-year(1,2) Revenue of EUR 947.5 million, -1.5% as reported with underlying revenue 2.4%(1,2) lower than H1 2019 Adjusted EBITDA(3) of EUR 582.0 million, -2.3% as reported (-3.5% at constant FX(2)) compared with H1 2019 and representing an Adjusted EBITDA(3) margin of 61.4% including a 2.2% year-on-year reduction in recurring operating expenses Limited COVID-19 impact in H1 reflecting business resilience with measures in place to mitigate increased headwinds in H2 2020 Updated FY 2020 group revenue outlook to EUR 1,860 - 1,900 million(4) in view of expected COVID-19 related revenue development FY 2020 Adjusted EBITDA(3) outlook

Western Union Stands in Solidarity with Lebanon6.8.2020 23:47:00 EESTPress release

Western Union, a leader in cross-border, cross-currency money movement and payments, today announced that it is offering zero-feei international money transfers paid out in U.S. dollars to Lebanon, as the country grapples with its recent tragedy amidst other economic and pandemic related threats. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20200806006068/en/ Western Union Stands in Solidarity with Lebanon; Money Transfers to Lebanon Zero-Fee Paid out in US Dollars (Graphic: Business Wire) “We stand in solidarity with the people of Lebanon as they confront this latest tragedy following the horrific explosion in Beirut on August 4. Our thoughts and prayers are with families of those injured and have lost their lives,” said Jean Claude Farah, President, Global Network, Western Union. Farah said: “We know the people of Lebanon will stand strong as they grapple with this latest issue amidst other pressures of economic and COVID-

Pacific Drilling Announces Second-Quarter 2020 Results; Pacific Sharav Awarded a New 10-Well Contract in U.S. Gulf of Mexico6.8.2020 23:04:00 EESTPress release

Pacific Drilling S.A. (NYSE: PACD) (“Pacific Drilling” or the “Company”) today reported results for the second quarter of 2020. Net loss for second-quarter 2020 was $87.4 million or $1.16 per diluted share, compared to net loss of $61.0 million or $0.81 per diluted share in first-quarter 2020. Pacific Drilling CEO Bernie Wolford commented, “In the second quarter, our crews and leadership continued to exemplify our commitment to safe and efficient operations, including adopting measures to manage risks associated with COVID-19 transmission, delivering exceptional results for our clients, efficiently preserving the value of our assets and significantly reducing overhead costs.” Mr. Wolford continued, “Although oil prices began to rebound during the second quarter, clients have generally reduced their drilling investments, as evidenced by Equinor’s decision to cancel the previously exercised third firm well for Pacific Khamsin, and Murphy’s decision to cancel the two well Mexico contract

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