Hyphens Pharma licenses Wynzora® Cream for ASEAN countries from MC2 Therapeutics

13 March 2024 | Wednesday | News


Wynzora® Cream is approved and marketed in Italy, Germany, Spain, the United Kingdom, and the United States.
Image Source : Public Domain

Image Source : Public Domain

Hyphens Pharma International Limited (“Hyphens Pharma”, “凯帆药剂国际 有限公司”, or the “Company”, and together with its subsidiaries, the “Group”), Singapore’s leading  specialty pharmaceutical and consumer healthcare group, is pleased to announce that its subsidiary,  Hyphens Pharma Pte. Ltd., has entered into an exclusive license, supply and commercialisation agreement (the “Agreement”) with MC2 Therapeutics (“MC2”) for the exclusive rights to register and commercialise  Wynzora® Cream and all future product extensions and/or improvements for the topical treatment of  plaque psoriasis in the 10 ASEAN countries.  

Wynzora® Cream is a leading topical treatment for plaque psoriasis, including scalp  psoriasis in adults. Psoriasis sufferers endure a significant psychological burden due to the visible nature  of the skin lesions, its comorbidity, and its chronicity.

Wynzora® Cream is a cream-based fixed dose combination of calcipotriene and betamethasone  dipropionate that has demonstrated high efficacy with quick improvement within 1 week in clinical  studies2. Its dual mode of action targets the hallmark cytokines IL-23 and IL-17A/F immune axis and TNF α expression in a single product. It is uniquely enabled by MC2’s formulation and drug delivery system  PAD Technology™, allowing for an effectful convenient-to-use aqueous formulation. Wynzora® Cream has  been approved and marketed in key markets including Italy, Germany, Spain, the United Kingdom, and  the United States.  

“Hyphens Pharma is a leading specialty pharma company focused on the commercialisation of innovative  pharmaceutical products in the ASEAN region. It has a clear ambition and strategy to grow its dermatology  franchise and is an excellent partner for MC2 to leverage Wynzora® in the region, a large and growing  market with over 600 million people,” said Mr Jesper J. Lange, Chief Executive Officer of MC2, “This deal  substantiates our strategy to make Wynzora® available to as many patients suffering from plaque  psoriasis as possible globally, as we continue to develop and expand our pipeline of innovative first-in-class  drug candidates within immunology and inflammation”, added Mr Lange. 

Mr Lim See Wah (林世华), Chairman and CEO of Hyphens Pharma remarked: “MC2’s commitment to  develop novel treatment paradigms for skin diseases is synergistic with Hyphens’ presence and ambition  to be a regional leader in ASEAN. Wynzora® is a proven effective treatment for plaque psoriasis in the  United States and Europe. Leveraging our strong regulatory and commercial capabilities, we will work  closely with MC2 to accelerate the launch of Wynzora® in the ASEAN region, which will benefit Asian  patients suffering from psoriasis.” 

1Lim DS, Bewley A, Oon HH. Psychological Profile of Patients with Psoriasis. Ann Acad Med Singap. 2018 Dec;47(12):516-522. 2 Pinter A, Green LJ, Selmer J, Praestegaard M, Gold LS, Augustin M; trial investigator group. A pooled analysis of randomized, controlled, phase 3 trials investigating the efficacy and safety of a novel, fixed dose calcipotriene and betamethasone  dipropionate cream for the topical treatment of plaque psoriasis. J Eur Acad Dermatol Venereol. 2022 Feb;36(2):228-236.

 

Pursuant to the Agreement, the Group will pay MC2 a total of EUR 2.5 million, which includes an upfront  payment and fees upon reaching certain regulatory milestones. In addition, MC2 will be entitled to receive  fees for sales milestones and double-digit royalties on net sales. The Agreement will not have a material  effect on the net tangible assets or earnings per share of the Group for the financial year ending 31  December 2024.

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