Business Wire

MC2 Therapeutics Announces Submission of Marketing Authorization Application in EU for Wynzora® Cream (50 µg/g calcipotriol and 0.5 mg/g betamethasone (as dipropionate))


MC2 Therapeutics, a commercial stage pharmaceutical company focused on topical therapies for chronic inflammatory conditions, today announced the submission of its Marketing Authorization Application (MAA) in EU for Wynzora® Cream (50 µg/g calcipotriol and 0.5 mg/g betamethasone (as dipropionate)) for the treatment of plaque psoriasis. The European filing follows the submission of a New Drug Application on Wynzora® Cream to the U.S. Food and Drug Administration (FDA) in September 2019.

The MAA is supported by two comprehensive Phase 3 trials1 including a trial conducted in EU evaluating the efficacy and safety of Wynzora® Cream compared to vehicle and active comparator Dovobet/Daivobet® Gel in patients with psoriasis vulgaris. The trial enrolled 490 patients at 32 clinical centers. Patients applied trial medication topically once daily for eight weeks. Dovobet/Daivobet® Gel is marketed as Taclonex® Topical Suspension in the US.

In this EU Phase 3 trial Wynzora® Cream demonstrated significantly greater treatment success compared to Dovobet/Daivobet® Gel, assessed by the proportion of subjects obtaining minimum two-points improvement in the Physician Global Assessment (PGA). Wynzora® Cream reached 51% PGA treatment success and a reduction from baseline in mPASI of 68%. In addition, the patient reported acceptability of treatment and the dermatology life quality index (DLQI) were rated significantly better for Wynzora® Cream than for Dovobet/Daivobet® Gel.

The pooled safety data from the two Phase 3 trials shows a favorable safety profile with no drug-related dermal adverse reactions exceeding 1%.

"With this submission we stay on track in our global development of Wynzora® Cream,” said Jesper J. Lange, CEO of MC2 Therapeutics and added: “Enabled by our PAD™ Technology, Wynzora® Cream is uniquely designed to address the three essentials of topical drugs - high efficacy, a favorable safety profile and a formulation that allows patients to quickly move on in daily routines within minutes of a toothbrushing. We want to use PAD™ Technology to set a new standard and release the full potential of novel topical drugs for the benefit of patients, physicians, payers and societies. Wynzora ® Cream represents all of that - no compromises”.

Psoriasis is a common, non-contagious, chronic skin disease, with no clear cause or cure. The negative impact of plaque psoriasis on people’s lives can be immense as it affects the appearance of the skin with red, scaly plaques and itching. Psoriasis affects people of all ages, and in all countries. The reported prevalence of psoriasis is 2-4% of the population making psoriasis a serious global problem with more than 100 million individuals affected worldwide. The flares of psoriasis can be unpredictable and significant comorbidities are common, including arthritis, cardiovascular diseases, metabolic syndrome, inflammatory bowel disease and depression.2

"More than 90% of psoriasis patients use topical drugs. However, there is a need for a significant upgrade of topicals to address the problem of treatment discontinuation and low adherence in topical therapies,” said Prof. Dr. Med. Matthias Augustin, Director Institute of Health Care Research in Dermatology and Nursing, University of Hamburg and lead principal investigator in the EU Phase 3 trial and continues: “Of course the efficacy and safety profile of a topical drug has to be compelling, but ease of use in daily routines is a third key element that can motivate patients to be adherent to topical treatment and thereby obtain satisfactory treatment outcomes and improved quality of life in the real-world setting. From a health economics point of view, optimizing real-world topical treatment satisfaction can be an important element in controlling the cost for our societies. As I see it, the clinical profile of Wynzora® Cream is a prime example of a treatment of plaque psoriasis that can address these challenges.”

About Wynzora® Cream

Wynzora® Cream is a cream-based fixed dose combination of calcipotriol and betamethasone dipropionate for topical treatment of plaque psoriasis. Wynzora® Cream is based on PAD™ Technology, which uniquely enables stability of both calcipotriol and betamethasone dipropionate in a convenient-to-use aqueous formulation. In the phase 3 trials conducted at multiple sites in the US and the EU, Wynzora® Cream has demonstrated significantly greater efficacy compared to Taclonex® Topical Suspension and Dovobet/Daivobet® gel. The unique combination of significant clinical efficacy, a favorable safety profile and high convenience of Wynzora® Cream holds promise to less treatment discontinuation and overall better patient satisfaction in topical treatment of plaque psoriasis in the real-world setting.

About MC2 Therapeutics

MC2 Therapeutics is a privately held commercial stage pharmaceutical company focused on novel topical therapies for chronic inflammatory conditions. Using its PAD™ Technology it aims to set a new standard of treatment experience for patients and to release the full potential of novel topical drugs for the benefit of patients, physicians, payers and societies. PAD™ Technology is the basis for its innovative pipeline of drug candidates within atopic dermatitis, uremic pruritus, lichen sclerosus and dry eye.

For additional information on MC2 Therapeutics, please visit

1EudraCT no: 2018-001970-66 / NCT03802344 (EU Phase 3 trial); NCT03308799 (US Phase 3 trial)
2WHO Global report on Psoriasis 2016

Contact information

MC2 Therapeutics
Investors: Lonni Goltermann, +45 2018 1111 or

EU: Molecule A/S: Mette Thorn Sorensen, +45 4138 4300 or
US: Amy Phillips, +1 412.327.9499 or

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

Eaton Launches New Line of Wireless Mobile Control Solutions for Heavy Machinery and Field Operations14.8.2020 00:51:00 EESTPress release

Power management company Eaton today announced its eMobility business has launched a new and improved line of Eaton OMNEX Trusted Wireless™ mobile control solutions for heavy machinery and field operations. The 900 MHz two-way remote-control units allow for the wireless control of high-value machinery in harsh environments, including mining, construction, agriculture, locomotive and marine markets. This press release features multimedia. View the full release here: Eaton's new OMNEX Trusted Wireless™ controllers can remotely operate heavy machinery, such as vacuum trucks, tow trucks, concrete mixers and cranes. (Photo: Business Wire) “Our next generation of rugged, weatherproof OMNEX wireless controllers were designed with customer input, and offer a number of benefits, including enhanced safety and productivity for machine operators,” said Scott Adams, president, eMobility, Eaton. “Overall, we’ve improved upon the reliability a

IFF to Hold Virtual Special Meeting of Shareholders on August 2713.8.2020 23:15:00 EESTPress release

Regulatory News: IFF (NYSE: IFF) (Euronext Paris: IFF) (TASE: IFF), a leading innovator of taste, scent, and nutrition, announced today that the previously communicated special meeting of shareholders to consider and vote on the issuance of shares of IFF common stock in connection with the previously announced proposed merger of IFF and DuPont’s Nutrition & Biosciences (“N&B”) business pursuant to a Reverse Morris Trust transaction (the “special meeting”) has been changed to a virtual-only meeting due to the continued public health concerns over the COVID-19 outbreak and the health and safety of its shareholders and employees. Accordingly, the special meeting, to be held on Thursday, August 27, 2020 at 10:00 a.m. Eastern Time, will be held only virtually on the Internet at Shareholders will not be able to attend the meeting or vote physically in person. We have designed the format of the special meeting to provide shareholders the same right

PTC Makes Enterprise Version of Onshape Education Suite Available Free of Charge13.8.2020 23:00:00 EESTPress release

In advance of the 2020-2021 school year, PTC (NASDAQ: PTC) has made the Onshape® Education Suite’s newly-released Enterprise plan available free-of-charge for K-12 schools and universities that register through November 20, 2020. The newest version of the cloud-based, remote learning suite is offered alongside the Onshape Education Standard plan to help alleviate the burden experienced by educational STEM programs during the COVID-19 pandemic. This press release features multimedia. View the full release here: The Onshape Education plans are the educational versions of PTC’s Software as a Service product, designed to enable computer-aided design (CAD) activities in a remote learning environment. The Education Standard plan has been free to educational institutions since 2016 and is available to students and educators who want to use professional-grade CAD that is completely online. The newly released Education Enterprise plan bu

DeltaTrak Enhances Its Cold Chain Restart Program to Help Customers Battle COVID-1913.8.2020 19:00:00 EESTPress release

DeltaTrak®, a leading innovator of cold chain solutions, is enhancing its Cold Chain Restart Program to offer customers safer and more efficient methods to protect their employees and clients from the COVID-19 pandemic. The program was created to help companies reopen on a safe footing by providing access to critically needed PPE solutions. Following an extremely positive response, DeltaTrak has added the ThermoTrace Auto-Check Non-Contact Infrared Forehead Thermometer and Touchless Hand Sanitizer Dispenser to address the need for effective, contactless and hands-free options for temperature measurement and sanitization. “The increased demand for safety and sanitization equipment is driven by our customers’ need to conduct business safely without jeopardizing the health of employees and customers when it comes to using thermometers and hand sanitizers,” said Frederick Wu, President and CEO of DeltaTrak. “Gaining access to these solutions remains a major challenge and we are confident t

Verimatrix to Sponsor Virtual SportsPro Media INSIDER Series Featuring Broadcasting Experts From the NFL, Octagon, Astro, The FA, European Tour & More13.8.2020 18:35:00 EESTPress release

Regulatory News: Verimatrix (Paris:VMX) (Euronext Paris: VMX), the leader in powering the modern connected world with people-centered security, today announced that Chief Revenue Officer Lu Bolden will join a lineup of sports broadcasting experts to speak on the future of the industry with today’s new need to protect ever-growing amounts of streamed sports and esports. Registration is free. Visit With an eye on highlighting the largely unchartered challenges that come with new methods of reaching all types of sports fans, the SportsPro Media INSIDER Series serves as a valuable venue for those seeking to protect revenues when fans are at home instead of stadiums. Traditional sports have found themselves facing the same new business model decisions that esports has organically addressed over the last several years. That makes for a big shift – where new revenue streams are created at warp speed with various streaming and broadcast options for countless typ

Andersen Global Continues African Expansion in Key Markets; Debuts in Mali13.8.2020 16:30:00 EESTPress release

Andersen Global announces its debut in Mali through a Collaboration Agreement with Bamako-based tax and legal firm Juri-Partner, adding a complementary presence as the organization continues its expansion in key markets throughout Africa. One of the largest firms in Mali, Juri-Partner has grown to include three partners and more than 20 professionals, including two tax specialists. Managing Partner Mamadou Diarra and his team offer a full range of tax and legal services such as business, mining, telecommunications, tax, arbitration and general commercial tax and legal services to private and institutional operations both domestically and internationally. “We strive to create client relationships built on trust and transparency and are committed to stewardship and independence,” Mamadou said. “Business is becoming increasingly global, and clients’ needs can vary depending on country and jurisdiction. By combining Andersen Global’s breadth of coverage and expertise with our local depth o

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