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MC2 Therapeutics and EPI Health announce they have entered into a collaboration agreement for the commercialization of calcipotriene and betamethasone dipropionate, w/w 0.005%/0.064% (Wynzora Cream), a newly U.S. FDA-approved topical treatment for plaque psoriasis in adults.
MC2 Therapeutics announced its collaboration agreement with EPI Health to commercialize calcipotriene and betamethasone dipropionate, w/w 0.005%/0.064% (Wynzora Cream) . The topical was approved by the U.S. Food and Drug Administration (FDA) in July for the treatment of plaque psoriasis in adults ages 18 years and older.
Wynzora utilizes a patented PAD Technology, which enables the topical combination to remain stable in an aqueous formulation that quickly absorbs into the skin without feeling greasy.1
"The upcoming launch of Wynzora Cream, in the U.S., 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," says Jesper J. Lange, CEO, MC2 Therapeutics.
The collaboration agreement will pool both companies’ resources to make Wynzora widely available to all patients with plaque psoriasis in the Unites States, according to the company. EPI Health will promote and sell the topical in exchange for a share of net sales while MC2 will retain full ownership.1
"Since phase 3 data read-out, we have planned for a strong market entry and launch,” Lange says. “We are very excited to have the opportunity to accelerate the roll-out through a partnership with EPI Health.”
Results from a phase 3 study investigating Wynzora versus Taclonex (active comparator) and placebo found the Physician Global Assessment (PGA) success difference between Wynzora and Taclonex was 14.6% (95% CI; 7.6%, 21.6%), with results in favor of Wynzora, respectively. PGA success in the study was defined as a minimum of a two-grade improvement from baseline in PGA to “clear” or “almost clear”.2
Itch reduction was evaluated and described as a minimum of a four-point improvement in the 11-point peak pruritic numeric rating scale (NRS) from baseline to week four in patients who had at least a baseline peak pruritus NRS score of four. Study results show a larger proportion of patients reached reduction of pruritus in the Wynzora arm (60.3%) versus vehicle (21.4%).2
"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," says John Donofrio, president, EPI Health. “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."
1. MC2 Therapeutics Announces Collaboration Agreement with EPI Health on Commercialization of Newly Approved Psoriasis Drug, WYNZORA® Cream, in the US. (2020, August 24). Retrieved August 27, 2020, from https://www.businesswire.com/news/home/20200824005377/en/MC2-Therapeutics-Announces-Collaboration-Agreement-EPI-Health
2. Petronelli, M. (2020, July 23). FDA approves plaque psoriasis topical. Retrieved September 02, 2020, from https://www.dermatologytimes.com/view/fda-approves-plaque-psoriasis-topical