EPI Health and MC2 Therapeutics Announce Wynzora® Cream (calcipotriene and betamethasone dipropionate w/w 0.005%/0.064%) now covered on Express Scripts National Preferred Formulary

Wynzora^® Cream (calcipotriene and betamethasone dipropionate, w/w 0.005%/0.064%) for once-daily topical treatment of plaque psoriasis in adults 18 years of age or older.

CHARLESTON, S.C. and COPENHAGEN, Denmark, Nov. 9, 2021 /PRNewswire/ -- EPI Health, LLC, a specialty pharmaceutical company committed to delivering innovative prescription therapies to dermatologists and MC2 Therapeutics, a commercial stage pharmaceutical company developing a new standard within topical therapies for plaque psoriasis today announced that Express Scripts, a large pharmacy benefit manager (PBM) has provided access to Wynzora^® Cream (calcipotriene and betamethasone dipropionate, w/w 0.005%/0.064%) for once-daily topical treatment of plaque psoriasis in adults 18 years of age or older on its National Preferred, National Preferred Flex, High Performance, and Basic formularies.

"Access through Express Scripts' commercial formularies reflects our continued commitment to provide patients affordable availability to Wynzora^® Cream, fulfilling an important unmet need in plaque psoriasis" said John Donofrio, President of EPI Health.

Jesper J. Lange, CEO of MC2 Therapeutics commented "We believe this coverage with Express Scripts demonstrates that our launch of Wynzora^® Cream in the US, provides a valuable tool for payers and PBMs to manage plaque psoriasis treatment."

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. According to the National Psoriasis Foundation, itch is present in between 70 and 90% of psoriasis patients, and together with flaking and scaling, itching is the most burdensome symptom to patients.^1,2,3 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. 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.¹

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 namely high efficacy, a favorable safety profile and convenience of use. The unique combination of all three essentials in topical therapy holds promise to less treatment discontinuation and overall better patient satisfaction in topical treatment of plaque psoriasis in a real-world setting. 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 a prescription medicine indicated for the topical treatment of plaque psoriasis in patients 18 years of age and older.

Apply Wynzora^® Cream to affected areas once daily for up to 8 weeks and not more than 100 grams per week. Patients should stop treatment when the plaque psoriasis is under control unless a healthcare provider gives other instructions.

Wynzora^® Cream is for use on skin only (topical). Do not get Wynzora^® Cream near or in your mouth, eyes, or vagina. Avoid using Wynzora^® Cream on your face, groin, or armpits, or if you have thinning of your skin (atrophy) at the treatment site.

It is not known if Wynzora^® Cream is safe and effective in children.

Important Safety Information
Tell your healthcare provider about all your medical conditions and all the medicines you take, including any corticosteroid medicines and any other products containing calcipotriene.

Do not use other products containing calcipotriene or a corticosteroid medicine without talking to your healthcare provider first.

Wynzora^® Cream may cause side effects, including:

• Too much calcium in your blood or urine and/or adrenal gland problems
• Cushing's syndrome, a condition that happens when your body is exposed to large amounts of the hormone cortisol
• High blood sugar and sugar in your urine
• Vision problems, including an increased risk of developing cataracts and glaucoma.

The most common side effects include upper respiratory infection, headache, and application site irritation. These are not all the possible side effects. Call your healthcare provider for medical advice about side effects.

This summary is not comprehensive. Please visit www.wynzora.com to obtain the FDA-approved Full Prescribing Information.

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.

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 Group.

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 PAD^™ Technology we aim 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, CKD-ap (uremic pruritus) and lichen sclerosis.

For additional information please visit www.mc2therapeutics.com

1. https://www.psoriasis.org/psoriasis-statistics/
2. WHO Global report on Psoriasis 2016, p.13 - 16
3. 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.
4. Prescribing Information for Wynzora. July 2020

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SOURCE MC2 Therapeutics; EPI Health