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

Bermuda Confirmed as a Global Leader in the Fight Against Money Laundering and the Financing of Terrorism and Proliferation18.1.2020 00:11:00 EETPress release

Bermuda’s regulatory regime has been assessed by the Caribbean Financial Action Task Force (CFATF), and the global inter-governmental Financial Action Task Force (FATF), and confirmed for having some of the highest international standards when it comes to combatting money laundering and the financing of terrorism and proliferation. The mutual evaluation report (MER) of Bermuda’s systems and framework, published today by the CFATF, highlights the outstanding work that has been done to comply with the FATF 40 Recommendations, used by 180 governments to protect the integrity of the international financial system. Of the more than 75 MERs published to date, Bermuda ranks first against the Technical compliance requirements, with 39 of the 40 Recommendations rated as Compliant or Largely Compliant, is in the top six for overall level of effectiveness and one of only two jurisdictions with a high level of effectiveness in relation to its risk assessment and domestic coordination mechanisms. S

Moody’s Analytics Wins an Artificial Intelligence Award17.1.2020 16:00:00 EETPress release

Moody’s Analytics, a global provider of financial intelligence, has won the Best Financial Services AI Solution category at the 2019 Artificial Intelligence Awards. We won this award for the QUIQspread™ solution, which helps institutions automate the spreading of financial statements. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20200117005191/en/ Our extensive financial spreading expertise and data resources are at the heart of the QUIQspread tool, which uses machine learning to understand an institution’s financial data spreading policies. Increased accuracy, shorter processing times, and lower costs are achieved as the tool gets smarter with every spread. As a software-as-a-service platform, QUIQspread is scalable with business growth. It contains data on the financials of more than 22 million private firms, which immediately helps it to improve spreading accuracy. The QUIQspread tool easily integrates with clients’ inter

L&T Technology Services Reports a 10% Increase in Q3FY20 Net Profit17.1.2020 15:36:00 EETPress release

L&T Technology Services Limited (BSE: 540115, NSE: LTTS), India’s leading pure-play engineering services company, announced its results for the third quarter ended December 31, 2019. Highlights for Q3FY20 include: USD Revenue at $199 million; growth of 7% YoY Revenue at Rs 14,230 million; growth of 8% YoY EBIT margin at 16.8%; up 30bps YoY Net profit at Rs 2,041 million; growth of 10% YoY During the quarter, LTTS won 9 multi-million dollar deals across all major industry segments which includes 2 deals having TCV of USD30mn+ each. On a YoY basis, LTTS has increased its USD20mn+ clients by 2 and its USD10mn+ clients by 4. “Q3 results were consistent with our expectations. We had a strong performance in three segments - Transportation, Plant Engineering, and Medical Devices that are each growing in excess of 20% on YoY basis. Digital & leading-edge technologies - the growth driver for ER&D, contributed to 41% of Q3 revenues and grew by 29% YoY. We are seeing a new set of opportunities as

Schlumberger Announces Full-Year and Fourth-Quarter 2019 Results17.1.2020 14:50:00 EETPress release

Schlumberger Limited (NYSE: SLB) today reported results for full-year 2019 and the fourth quarter of 2019. Full-Year Results (Stated in millions, except per share amounts) Twelve Months Ended Change Dec. 31, 2019 Dec. 31, 2018 Year-on-year Revenue $32,917 $32,815 0% Income (loss) before taxes - GAAP basis $(10,418 ) $2,624 n/m Pretax segment operating income* $3,978 $4,187 -5% Pretax segment operating margin* 12.1 % 12.8 % -68 bps Net income (loss) - GAAP basis $(10,137 ) $2,138 n/m Net income, excluding charges & credits* $2,054 $2,261 -9% Diluted EPS (loss per share) - GAAP basis $(7.32 ) $1.53 n/m Diluted EPS, excluding charges and credits* $1.47 $1.62 -9% Full-Year Revenue by Area North America $10,843 11,984 -10% Latin America 4,149 3,745 11% Europe/CIS/Africa 7,683 7,158 7% Middle East & Asia 10,017 9,543 5% Other 225 385 n/m $32,917 $32,815 0% North America revenue $10,843 $11,984 -10% International revenue $21,849 $20,446 7% North America revenue, excluding Cameron $8,525 $9,55

H.I.G. Capital Invests in Luxury Complex Near Venice17.1.2020 14:46:00 EETPress release

H.I.G. Capital, LLC ("H.I.G."), a leading global private equity investment firm with over $35 billion of equity capital under management, announced today that one of its affiliates has recently completed an investment in Portopiccolo, a state of the art, self-contained luxury complex near Venice which includes 203 high-end residential apartments, a five-star hotel with a spa and 110 marina berths. Terms were not disclosed. H.I.G. continues to add to its sizeable holdings of real estate assets across Europe, consisting of both equity as well as debt investments, with a focus on its target market of value-add small and midcap opportunities. Riccardo Dallolio, Managing Director and Head of H.I.G. Realty Partners Europe, commented: “This marks our 10th real estate investment in Italy. The Italian real estate markets represent a key part of our European value-add strategy and we continue to actively look at opportunities in the small/midcap sector across the capital structure.” Gabriele Mag

Philip Morris International Recognized for Business Excellence in 4th Annual One Planet Awards17.1.2020 14:21:00 EETPress release

Philip Morris International Inc. (PMI) (NYSE: PM) has been recognized among this year’s most awarded winners in the One Planet Awards program, an initiative acknowledging business and professional excellence in industries around the world. The company earned four awards for its achievements in delivering a smoke-free future from the more than 50 judges, who represent a wide spectrum of global industry experts. PMI received Gold awards in the Achievement of the Year in Diversity and Milestone of the Year categories in recognition of becoming the first multinational company to achieve global EQUAL-SALARY certification; PMI’s president of South & Southeast Asia, Stacey Kennedy, was awarded Gold in the Woman of the Year in Business & the Professions category; and the company earned a Grand Trophy for being among this year’s most-awarded winners. “We are passionate about our work at PMI to achieve a smoke-free future and make better alternatives to cigarettes available for men and women who

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