DGAP-News: MC2 Therapeutics
/ Key word(s): Agreement/Market launch
Almirall and MC2 Therapeutics Enter a License, Collaboration and Commercialization Agreement for European Rights to Wynzora(R) Cream for Treatment of Plaque Psoriasis
In this collaboration Almirall will commercialize Wynzora(R) Cream for treatment of plaque psoriasis in Europe and MC2 Therapeutics will be responsible for manufacturing and supply.
- MC2 Therapeutics and Almirall partner to make Wynzora(R) Cream a leading topical product for Plaque Psoriasis in Europe
- In a large European based Phase 3 clinical trial (n=490), Wynzora(R) Cream has demonstrated substantial efficacy with a PGA treatment success of 51% and beneficial treatment convenience (1)
- Marketing Authorization Application (MAA) in Europe of Wynzora(R) Cream has been filed and approval is expected this year
BARCELONA, Spain and COPENHAGEN, Denmark, February 17, 2021 - Almirall S.A. (BME: ALM), a global biopharmaceutical company and MC2 Therapeutics, a commercial stage pharmaceutical company developing a new standard within topical therapies for autoimmune and chronic inflammatory conditions, announced today an agreement under which MC2 Therapeutics has granted Almirall exclusive European rights to commercialize Wynzora(R) Cream for treatment of plaque psoriasis. In exchange, MC2 Therapeutics is eligible to receive upfront to launch payments of EUR 15 million in addition to significant sales milestone payments and double-digit royalties on the European sales of Wynzora(R) Cream. Almirall and MC2 Therapeutics partner to make Wynzora(R) Cream a leading topical product for treatment of plaque psoriasis in Europe - a market, which currently is more than 25 million units in sales volume annually (2). The market represents a significant opportunity for Wynzora(R) Cream as the calcipotriene and betamethasone dipropionate segment accounts for approximately 35% of share of volume and annual sales of more than $300 million (2).
Wynzora(R) Cream (50 µg/g calcipotriol and 0.5 mg/g betamethasone as dipropionate) received US FDA approval on 20th July 2020. Wynzora(R) Cream is currently under review in Europe supported by two Phase 3 trials (1), including an EU head-to-head trial against active comparator Dovobet/Daivobet(R) Gel. The Physician Global Assessment (PGA) treatment success defined as a minimum two-point decrease in the PGA score to clear or almost clear disease at Week 8 was 51% for Wynzora(R) Cream vs. 6% for vehicle (p<0.0001). The treatment satisfaction score using the Psoriasis Treatment Convenience Scale (PTCS) was superior compared to Dovobet/Daivobet(R) Gel. Using MC2 Therapeutics' PAD(TM) Technology, Wynzora(R) 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.
Mike Mcclellan, Chief Financial Officer (CFO) and interim Chief Executive Officer (CEO) said: "We are thrilled with this agreement with MC2 Therapeutics. Wynzora(R) Cream has demonstrated significant improvements in the skin clearance of psoriasis patients. It is the perfect addition to our growing psoriasis portfolio, which includes multiple treatment options, covering the whole spectrum of the disease. We are delighted that soon we will be able to offer this novel topical treatment to European dermatologists and their patients."
Jesper J. Lange, CEO of MC2 Therapeutics, commented: "We are excited to partner with Almirall, an established company with deep expertise in dermatology and psoriasis and with the focus to improve patients' needs. Bringing together Almirall's excellence in commercial operations and MC2 Therapeutics' commitment to ensure a global roll-out of Wynzora(R) Cream we will, upon approval, ensure a strong launch of Wynzora(R) Cream for the benefit of the many patients living with plaque psoriasis and for the healthcare practitioners who provide care. We believe that the unique combination of compelling clinical efficacy, a favorable safety profile and treatment convenience are key components to treatment adherence and overall better patient satisfaction in topical treatment of plaque psoriasis in a real-world setting."
About Plaque Psoriasis
About Wynzora(R) Cream
The company, founded in 1943 and headquartered in Barcelona, is public traded on the Spanish Stock Exchange and is a member of the IBEX 35 (BME: ALM). Throughout its 77-year history, Almirall has retained a strong focus on the needs of patients. Currently, Almirall has a direct presence in 21 countries and strategic agreements in over 70, through 13 subsidiaries, with about 1,800 employees. Total revenues in 2019 were 908.4 million euros.
For additional information on Almirall, please visit www.almirall.com
About MC2 Therapeutics
Using PAD(TM) Technology we are introducing a new standard of topical treatment experience for the benefit of patients, physicians, payers and societies. Our innovative pipeline is comprised of drug candidates within uremic pruritus, lichen sclerosis, Sjogren's syndrome dry eye, ocular rosacea and atopic dermatitis.
For additional information on MC2 Therapeutics Group, please visit www.mc2therapeutics.com
1. Clinical trial IDs: NCT03802344 and NCT03308799 on Clinicaltrials.gov
17.02.2021 Dissemination of a Corporate News, transmitted by DGAP - a service of EQS Group AG.