August 24, 2020

MC2 Therapeutics Announces Collaboration Agreement with EPI Health on Commercialization of Newly Approved Psoriasis Drug, WYNZORA® Cream, in the US

  • Collaboration accelerates a Q1 2021 comprehensive launch of MC2’s WYNZORA® Cream to patients with plaque psoriasis in the US
  • WYNZORA® Cream is the first drug based on PADTM Technology – providing innovative solutions to unmet needs in chronic inflammatory conditions
  • WYNZORA® Cream offers a unique combination of high efficacy, favorable safety, and excellent treatment convenience in a single product

Copenhagen, August 24th, 2020 – MC2 Therapeutics, a commercial stage pharmaceutical company focused on innovative topical therapies for chronic inflammatory conditions, announced today its Collaboration Agreement with EPI Health, LLC on the commercialization of WYNZORA Cream (calcipotriene and betamethasone dipropionate, w/w 0.005%/0.064%) in the US. WYNZORA Cream was approved by the U.S. Food and Drug Administration (FDA) on July 20th, 2020 for the topical treatment of plaque psoriasis in adults, 18 years of age or older.

“The upcoming launch of WYNZORA Cream, in the US, will bring an important new treatment experience to people with plaque psoriasis that will set a new standard. WYNZORA Cream is an excellent example of how our PAD™ Technology can bring value to all key stakeholders – patients, physicians and payers alike,” said Jesper J. Lange, CEO of MC2 Therapeutics and added: “Since Phase 3 data read-out we have planned for a strong market entry and launch of WYNZORA Cream in the US. We are very excited to have the opportunity to accelerate the roll-out through a partnership with EPI Health. Under the leadership of its President, John Donofrio, EPI Health has built a culture of excellence in commercialization of dermatological drugs. Combined with its strong commitment to WYNZORA Cream and our shared corporate values – this is a timely and perfect match for WYNZORA Cream, MC2 Therapeutics and EPI Health.”

MC2 Therapeutics retains full ownership of WYNZORA Cream under the Collaboration Agreement and MC2 Therapeutics and EPI Health will utilize their combined resources to make WYNZORA Cream a leading patient preferred topical treatment of psoriasis in the US. EPI Health will utilize its commercial infrastructure to promote and sell WYNZORA Cream in return of a share of net sales.

“We are excited to partner with MC2 Therapeutics on their journey to launch and commercialize WYNZORA Cream in the US. The clinical profile of WYNZORA Cream and the treatment experience in daily routines are what patients have been waiting for and will also benefit physicians and payers. This collaboration emphasizes EPI Health’s commitment to the medical dermatology community,” said John Donofrio, President of EPI Health and continued: “We share the vision of re-defining topical treatment of plaque psoriasis and the patient centric approach within chronic inflammatory skin conditions. Our teams have demonstrated similar cultures, values, and enthusiasm and we are committed to the trust MC2 Therapeutics has placed in EPI Health to collaborate on the successful commercialization of WYNZORA Cream.”

MC2 Therapeutics is pursuing a global strategy to make the WYNZORA Cream treatment experience available to as many patients as possible and has submitted its Marketing Authorization Application for WYNZORA Cream in EU in June 2020.

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. 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. These features of WYNZORA Cream hold promise to lead to less treatment discontinuation and overall better patient satisfaction in topical treatment of plaque psoriasis in the real-world setting. See important safety information below or visit www.wynzora.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 basis for its innovative pipeline of drug candidates within atopic dermatitis, uremic pruritus, lichen sclerosus and dry eye. PAD™ Technology enables a new type of cream that provides key features in topical therapies for chronic inflammatory conditions thereby releasing the full potential of the therapy. For additional information on PAD™ Technology please visit www.padcream.com.

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 of 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 on EPI Health, please visit www.epihealth.com

WYNZORA Cream – 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. Visit www.wynzora.com to obtain the FDA-approved Full Prescribing Information.