EPI Health and MC2 Therapeutics announced the launch of Wynzora® Cream for Plaque Psoriasis in the United States (calcipotriene and betamethasone dipropionate w/w 0.005%/0.064%)

2021-11-25 07:58:42 By : Ms. Ella i

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Now on the market: Wynzora® Cream (calcipotriene and betamethasone dipropionate, w/w 0.005%/0.064%) once a day topical treatment of plaque psoriasis in adults 18 years of age or older. Introduced PAD™ Use of technology.

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

· For 95% of adult psoriasis patients in the United States, topical treatment is the first-line treatment used1

· When measured on a 50-point treatment convenience scale, patients rated Wynzora as 84% ​​ease of use, non-greasy application, minimal interference with daily life, and other measures

Wynzora® Cream will be commercially available in the United States on July 19, 2021.

Charleston, South Carolina and Copenhagen, Denmark, July 19, 2021/PRNewswire/ - EPI Health and MC2 Therapeutics today announced Wynzora® Cream (Cacipotriene and Betamethasone Dipropionate, w/w 0.005% /0.064%) is marketed in the United States for the local treatment of plaque psoriasis in adults 18 years of age or older.

"Cacipotriene and betamethasone dipropionate are mature molecules for the treatment of plaque psoriasis, with proven efficacy, safety and tolerability. So far, they cannot be combined into an aqueous emulsion Cream, compared to other formulas, this cream is less greasy and easier to use." – John Koo, MD, Professor of Dermatology, University of California, San Francisco Medical Center, Psoriasis Treatment Center, University of California, San Francisco, Department of Phototherapy And co-director of the Psychological Dermatology Clinic. Obtained certification from the Dermatology and Psychiatry Committee.

"As a leader in dermatology, expanding our product portfolio to help solve some of the problems faced by nearly 8 million patients with psoriasis in the United States is in line with our ability to provide patients with safe, beneficial and effective drugs (such as Wynzora®) The mission is the same. The dermatology community.” said John Donofrio, President of EPI Health.

"Wynzora ® was developed and uniquely designed to provide efficacy, safety and convenience in a single topical product." MC2 Therapeutics CEO Jesper J. Lange commented and continued: "We and EPI Health are preparing for the release The collaboration with the company has been excellent and we are very happy that Wynzora ® is now available for patients."

Psoriasis is a common, non-infectious chronic skin disease with no clear cause or cure. The negative impact of plaque psoriasis on people's lives can be huge because it affects the appearance of skin with red scaly patches. The appearance of psoriasis episodes can be unpredictable and affect people of all ages. According to reports, the prevalence of psoriasis is 2-4% of the population. It is a serious health problem, affecting more than 100 million people worldwide. More than 90% of patients receiving treatment use topical drugs. According to data from the National Psoriasis Foundation, 70% to 90% of psoriasis patients will experience itching, which is accompanied by exfoliation and scaling. Itching is the most troublesome symptom for patients. 3,4 People with psoriasis are at higher risk of psoriasis and other chronic and serious health conditions, including arthritis, cardiovascular disease, metabolic syndrome, inflammatory bowel disease, and depression. 3

Wynzora Cream is a fixed-dose cream-based combination consisting of calcipotriene and betamethasone dipropionate for the topical treatment of plaque psoriasis. Wynzora® Cream is based on PAD™ technology, which uniquely stabilizes calcipotriene and betamethasone dipropionate in an easy-to-use aqueous formulation. The unique design of Wynzora® Cream aims to provide new treatment options for patients' daily lives by combining the three elements of topical treatment in one product: high efficiency, good safety and easy use. In Phase 3 trials conducted in multiple locations in the United States and the European Union, Wynzora ® Cream demonstrated a unique combination of compelling clinical efficacy, good safety and high convenience.

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

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

Wynzora® (calcipotriene and betamethasone dipropionate) cream is suitable for plaque psoriasis in adults. It is not clear whether Wynzora Cream is safe and effective for children.

Please see the complete prescribing information for Wynzora cream attached.

We encourage you to report the side effects of prescription drugs to the FDA. Please visit www.fda.gov/medwatch or call 1-800-FDA-1088.

Headquartered in Charleston, South Carolina, EPI Health is a professional pharmaceutical company, a leader and one of the fastest growing companies in the dermatology field in the United States. EPI is committed to providing dermatologists with innovative prescription therapies, while improving the quality of life of patients and providing excellent medical services. Its current product portfolio includes drugs for patients with rosacea, atopic dermatitis, cold sores and acne. EPI Health is a wholly-owned subsidiary of Evening Post Industries.

For more information, please visit www.epihealth.com

MC2 Therapeutics is a privately held, commercial-stage pharmaceutical company that develops new standards for topical therapies for chronic inflammatory diseases. Using its PAD™ technology, it aims to set a new standard of treatment experience for patients and release the full potential of new topical drugs to benefit patients, doctors, payers and society. PAD ™ technology is the cornerstone of the innovative pipeline of drug candidates for atopic dermatitis, dry eye, ocular rosacea, uremic itching and lichen sclerosis.

For more information, please visit www.mc2therapeutics.com

PAD™ technology formulations are tailored to meet the target product profile of selected product candidates. PAD™ technology uses only a small fraction of the emulsifiers required for traditional creams and lotions to mix oil and water into the cream. The main features of the PAD™ technical formula are the high permeability of the active ingredient to the target tissue, the improved solubility and stability of the active ingredient, high tolerance and convenient treatment.

1 Murage MJ, Kern DM, Chang L, Sonawane K, Malatestinic WN, Quimbo RA, Feldman SR, Muram TM, Araujo AB. The treatment model of psoriasis patients using a large national payer database in the United States: a retrospective study. J Medical Economics. October 2018 25:1-9.

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

3 WHO Global Psoriasis Report 2016, pages 13-16

4 Prescription information for Wynzora. July 2020.

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Source EPI Health; MC2 Therapy

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