EPI Health and MC2 Therapeutics announces U.S. Launch of Wynzora® Cream for Plaque Psoriasis (calcipotriene and betamethasone dipropionate w/w 0.005%/0.064%)

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EPI Health , MC2 Therapeutics

19 Jul, 2021, 13:00 BST

 Now available: Wynzora® Cream (calcipotriene and betamethasone dipropionate, w/w 0.005%/0.064%) once-daily topical treatment of plaque psoriasis in adults 18 years of age or older introduces use of PAD™ Technology. 

·  Wynzora is the first and only water-based cream that uses PAD™ technology to help optimize the treatment of plaque psoriasis (ref. USPI)

·  For 95% of adult psoriasis patients in the US a topical therapy is the first-line therapy used1

·  When measured on a 50-point treatment convenience scale, patients rated Wynzora at 84% on ease of application, non-greasy application, and minimal disruption of daily routine among other measures

Wynzora® Cream will be available for commercial supply starting July 19, 2021, in the United States.

CHARLESTON, S.C. and COPENHAGEN, Denmark, July 19, 2021 /PRNewswire/ -- EPI Health and MC2 Therapeutics, announced today commercial availability in the United States of Wynzora® Cream (calcipotriene and betamethasone dipropionate, w/w 0.005%/0.064%) for the topical treatment of plaque psoriasis in adults, 18 years of age or older.

"Calcipotriene and betamethasone dipropionate are well-established molecules for the treatment of plaque psoriasis, with proven efficacy, safety and tolerability. Until now they could not be combined into an aqueous cream, which is less greasy and more user-friendly than other formulations." – John Koo MD, Professor of Dermatology at University of California San Francisco medical center and Co- Director, UCSF Psoriasis Treatment Center, Phototherapy unit and Psychodermatology clinic. Board certified in Dermatology and Psychiatry.

"As a leader in Dermatology, expanding our portfolio to help address some of the issues faced by almost 8 million people 2 in the US with psoriasis aligns with our mission to provide safe, beneficial, and effective medications, such as Wynzora®, to the dermatology community." said John Donofrio, President of EPI Health.

"The development and unique design of Wynzora® was aimed at providing efficacy, safety, and convenience in a single topical product." commented Jesper J. Lange, CEO of MC2 Therapeutics, and continues, "Our collaboration with EPI Health in the preparation of the launch has been excellent and we are excited that Wynzora® is now available for patients."

About Plaque Psoriasis

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. The appearance of flares of psoriasis can be unpredictable and affects people of all ages. With a reported prevalence of 2-4% of the population psoriasis constitutes a serious health problem with more than 100 million individuals affected worldwide. More than 90% of patients receiving treatment use topical drugs. According to the National Psoriasis Foundation, itch is present in between 70 and 90 percent of psoriasis patients, and together with flaking and scaling, itching is the most burdensome symptom to patients.3,4 Patients with psoriatic disease are at an elevated risk of developing other chronic and serious health conditions, including arthritis, cardiovascular diseases, metabolic syndrome, inflammatory bowel disease and depression.3

About Wynzora® Cream

Wynzora Cream is a cream-based fixed dose combination of calcipotriene and betamethasone dipropionate for topical treatment of plaque psoriasis. Wynzora® Cream is based on PAD™ Technology, which uniquely enables stability of both calcipotriene and betamethasone dipropionate in a convenient-to-use aqueous formulation. Wynzora® Cream was uniquely designed to provide patients a new treatment option in their daily routines by combining the three essentials of a topical therapy in one single product: high efficacy, a favorable safety profile and convenience of use. In the phase 3 trials conducted at multiple sites in the US and the EU, Wynzora® Cream has demonstrated a unique combination of compelling clinical efficacy, a favorable safety profile and high convenience.

For more information, please visit www.wynzora.com.

Wynzora® Cream (calcipotriene and betamethasone dipropionate, w/w 0.005%/0.064%) Indication and ISI4

Indication and Usage

Wynzora® (calcipotriene and betamethasone dipropionate) Cream is indicated for plaque psoriasis in adults. It is not known if Wynzora Cream is safe and effective in children.

Important Safety Information

  • Wynzora Cream is for topical use only.
  • Patients should not use more than 100g of Wynzora Cream per week.
  • Wynzora Cream should not be used near or in the mouth, eyes, or intravaginally.
  • Patients should avoid using Wynzora Cream on the face, groin, or armpits, or if they have atrophy at the treatment site.
  • Patients should apply Wynzora Cream to the affected areas of the skin once a day for up to 8 weeks.
  • Patients should discontinue use once the plaque psoriasis is under control.
  • Patients should not use with occlusive dressings.
  • Hypercalcemia and hypercalciuria have been observed with use of topical calcipotriene.
  • Wynzora Cream can cause reversible HPA axis suppression with the potential for clinical glucocorticosteroid insufficiency during and after withdrawal of treatment.
  • Wynzora Cream may cause vision problems, including increasing the risk of cataracts and glaucoma.
  • It is not known whether Wynzora Cream may harm your unborn baby.
  • Breastfeeding women should not apply Wynzora Cream directly to the nipple and areola.
  • It is not known whether topically administered calcipotriene and betamethasone dipropionate is absorbed in human milk.

Please see accompanying full Prescribing Information for Wynzora cream.

You are encouraged to report side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call1-800-FDA-1088.

About EPI Health

Headquartered in Charleston, South Carolina, EPI Health is a specialty pharmaceutical company established as a leader and one of the fastest growing companies in the US dermatology community. EPI is committed to delivering innovative prescription therapies to dermatologists while improving the quality of life for patients and providing outstanding medical services. Its current portfolio includes medicines to patients with rosacea, atopic dermatitis, cold sores, and acne. EPI Health is a wholly owned subsidiary of Evening Post Industries.

For additional information please visit www.epihealth.com

About MC2 Therapeutics

MC2 Therapeutics is a privately held commercial stage pharmaceutical company developing a new standard of 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 cornerstone for the innovative pipeline of drug candidates within atopic dermatitis, dry eye, ocular rosacea, uremic pruritus and lichen sclerosis.

For additional information please visit www.mc2therapeutics.com

About PAD™ Technology

PAD™ Technology formulations are tailor-made to meet the target product profile for a selected product candidate. PAD™ Technology enables the mixing of oil and water into a cream using just a fraction of the emulsifier required in conventional creams and lotions. Key features of PAD™ Technology formulations are high penetration of active ingredients to the target tissue, improved solubility and stability of active ingredients, high tolerability and excellent treatment convenience.

1 Murage MJ, Kern DM, Chang L, Sonawane K, Malatestinic WN, Quimbo RA, Feldman SR, Muram TM, Araujo AB. Treatment patterns among patients with psoriasis using a large national payer database in the United States: a retrospective study. J Med Econ. 2018 Oct 25:1-9.

2 https://www.psoriasis.org/psoriasis-statistics/

3 WHO Global report on Psoriasis 2016, p.13 - 16

4 Prescribing Information for Wynzora. July 2020.

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SOURCE EPI Health; MC2 Therapeutics