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MarketScreener Homepage  >  Equities  >  Swiss Exchange  >  Cosmo Pharmaceuticals N.V.    COPN   NL0011832936

COSMO PHARMACEUTICALS N.V.

(COPN)
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Cosmo Pharmaceuticals announces FDA Approval for Cassiopea's Winlevi® (clascoterone cream 1%), First-in-Class Topical Acne Treatment Targeting the Androgen Receptor

08/27/2020 | 01:05am EST

Cosmo Pharmaceuticals announces FDA Approval for Cassiopea's Winlevi® (clascoterone cream 1%), First-in-Class Topical Acne Treatment Targeting the Androgen Receptor

The approval of WINLEVI brings the first truly new mechanism of action in acne treatment in nearly 40 years

Dublin, Ireland - August 27, 2020 -Cosmo Pharmaceuticals NV announced today that Cassiopea SpA (SIX: SKIN), a company in which it holds 46.56% of the shares, today announced that the United States Food and Drug Administration (FDA) approved Winlevi® (clascoterone cream 1%) for the treatment of acne in patients 12 years and older.

Notwithstanding acne being the most prevalent skin condition in the U.S. affecting up to 50 million Americans annually1, the last FDA approval of an acne drug with a new mechanism of action (MOA) occurred nearly 40 years ago.

Acne is a multifactorial skin condition, affected by four distinct pathways: excess oil (sebum) production, clogged pores (hyperkeratinization), bacteria growth (C. acnes), and inflammation2. Topical treatment options that target androgens, which largely drive sebum production and inflammation, presented a significant unmet need in the acne treatment market until now.

Cassiopea's first-in-class topical androgen receptor inhibitor, WINLEVI, tackles the androgen hormone component of acne in both males and females. Androgen receptor inhibitors act by limiting the effects of these hormones on increasing sebum production and inflammation3.

In pivotal clinical trials, WINLEVI demonstrated treatment success and reductions in acne lesions and was well tolerated when used twice a day. The most frequently observed local skin reaction was mild erythema4,5.

Diana Harbort, CEO of Cassiopea, said: "This milestone approval marks the introduction of a new class of topical medication in Dermatology. Dermatologists have said targeting androgen hormonal activity in the skin is 'the holy grail' of acne treatment for both males and females. We are proud to bring this new innovation to acne patients and thank Cosmo Pharmaceuticals for its continued support throughout the development of this important achievement. This approval positions Cassiopea as a leader in Dermatology. Now we look forward to expanding our franchise and advancing our next investigational drug candidate for androgenetic alopecia."

Alessandro Della Chà, CEO of Cosmo, stated: "We congratulate the Cassiopea team on this great achievement and are proud to have been part of this. We founded Cassiopea and spun the company off listing it on the SIX in 2015. Cosmo has been supporting the development of Cassiopea through a comprehensive service agreement and has provided extensive financing."

WINLEVI is expected to be available in the United States in early 2021. Complete prescribing information is available on www.WINLEVI.com.




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EQS Group Ltd., Switzerland
switzerland.eqs.com


newsbox.ch
www.newsbox.ch


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cs.switzerland@eqs.com
+41 41 763 00 50
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Financials
Sales 2020 53,1 M 63,2 M 63,2 M
Net income 2020 -8,53 M -10,2 M -10,2 M
Net cash 2020 51,0 M 60,7 M 60,7 M
P/E ratio 2020 -131x
Yield 2020 -
Capitalization 1 114 M 1 325 M 1 325 M
EV / Sales 2020 20,0x
EV / Sales 2021 16,6x
Nbr of Employees 261
Free-Float 45,8%
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Technical analysis trends COSMO PHARMACEUTICALS N.V.
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Mean consensus OUTPERFORM
Number of Analysts 4
Average target price 102,69 €
Last Close Price 77,00 €
Spread / Highest target 44,6%
Spread / Average Target 33,4%
Spread / Lowest Target 22,5%
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Managers
NameTitle
Alessandro E. Della Chà Chief Executive Officer & Executive Director
Mauro Severino Ajani Executive Chairman
Giuseppe Cipriano Chief Operating Officer
Niall Donnelly Chief Financial Officer & Head-Investor Relations
Davide Malavasi Director-Qualified Person & Technical
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