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

08/27/2020 | 01:16am EST

2020
27.08.2020 - COSMO Pharmaceuticals N.V. Cosmo Pharmaceuticals announces FDA Approval for Cassiopea's Winlevi ® (clascoterone cream 1%), First-in-Class Topical Acne Treatment Targeting the Androgen Receptor

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.

About Winlevi® (clascoterone cream 1%):

Winlevi® (clascoterone cream 1%) is approved for the treatment of acne vulgaris in people aged 12 and older. Although WINLEVI's exact mechanism of action is unknown, laboratory studies suggest the active ingredient, clascoterone, competes with androgens, specifically dihydrotestosterone (DHT), for binding to the androgen receptors within the sebaceous gland and hair follicles6.

Indication

Winlevi® (clascoterone cream 1%), is an androgen receptor inhibitor indicated for the topical treatment of acne vulgaris in patients 12 years of age and older.

Important Safety Information

CONTRAINDICATIONS:

None.

WARNINGS

Local Irritation: Pruritus, burning, skin redness or peeling may be experienced with WINLEVI cream. If these effects occur, discontinue or reduce the frequency of application of WINLEVI cream.

Hypothalamic-pituitary-adrenal (HPA) axis suppression may occur during or after treatment with WINLEVI. In the PK trial, HPA axis suppression was observed in 1/20 (5%) of adult subjects and 2/22 (9%) of adolescent subjects at Day 14. All subjects returned to normal HPA axis function at follow-up 4 weeks after stopping treatment. Conditions which augment systemic absorption include use over large surface areas, prolonged use, and the use of occlusive dressings. Attempt to withdraw use if HPA axis suppression develops.

Pediatric patients may be more susceptible to systemic toxicity.

Hyperkalemia: Elevated potassium levels were observed in some subjects during the clinical trials. Shifts from normal to elevated potassium levels were observed in 5% of WINLEVI-treated subjects and 4% of vehicle-treated subjects.

ADVERSE REACTIONS

Most common adverse reactions occurring in 7 to 12% of patients are erythema/reddening, pruritus and scaling/dryness. Additionally, edema, stinging, and burning occurred in >3% of patients and were reported in a similar percentage of subjects treated with vehicle.

About Cosmo Pharmaceuticals

Cosmo is a specialty pharmaceutical company focused in treating selected Gastrointestinal Disorders and Endoscopy. The Company's proprietary clinical development pipeline specifically addresses innovative treatments for IBD, Colonic Infections and detection of colonic lesions. Cosmo has also developed medical devices for endoscopy and has recently entered into a partnership with Medtronic for the global distribution of its novel Artificial Intelligence device to be used in coloscopies and GI procedures. Further, Cosmo has licensed Aemcolo™ to Red Hill Biopharma and is the licensee for U.S. of the novel agent for procedural sedation, remimazolam, which it has sub-licensed to Acacia. For additional information on Cosmo and its products please visit the Company's website:www.cosmopharma.com

Calendar

Investora, Zurich

September 23, 2020

Jefferies Global Health Care Conference

17-19 November 2020, London

Credit Suisse Small & Mid Cap Conference

18-20 November 2020, Zurich

Contact:

Niall Donnelly, Chief Financial Officer & Head of Investor Relations

Cosmo Pharmaceuticals N.V.

Tel: +353 1 817 03 70

ndonnelly@cosmopharma.com

  1. The American Academy of Dermatology. Skin conditions by the numbers. American Academy of Dermatology. https://www.aad.org/media/stats/conditions/skin-conditions-by-the-numbers. Accessed August 20, 2020.
  2. Lai J-J, Chang P, Lai K-P, et al. Arch Derm Res. 2012;304(7):499-510
  3. Elsaie ML. Clin Cosmet Investig Dermatol 2016;9:241-8.
  4. Hebert A, et al JAMA Dermatol. 2020;156(6):621-630
  5. Eichenfield, L., et al. JAAD Published: April 26, 2020.. https://www.jaad.org/article/S0190-9622(20)30703-9/fulltext

Some of the information contained in this press release contains forward-looking statements. Readers are cautioned that any such forward-looking statements are not guarantees of future performance and involve risks and uncertainties, and that actual results may differ materially from those in the forward-looking statements as a result of various factors. Cosmo undertakes no obligation to publicly update or revise any forward-looking statements.

This communication is not an offer of securities of any issuer. Securities may not be offered or sold in the United States absent registration or an exemption from the registration requirement of the US Securities Act of 1933.

This press release constitutes neither an offer to sell nor a solicitation to buy securities and it does not constitute a prospectus within the meaning of article 652a and/or 1156 of the Swiss Code of Obligations or a listing prospectus within the meaning of the listing rules of the SIX Swiss Exchange or any similar document. The offer will be made solely by means of, and on the basis of, a securities prospectus to be published. An investment decision regarding the securities to be publicly offered should only be made on the basis of the securities prospectus.

This press release is made to and directed only at (i) persons outside the United Kingdom, (ii) investment professionals falling within Article 19(5) of the Financial Services and Markets Act 2000 (Financial Promotion) Order 2005 (the 'Order'), and (iii) high net worth individuals, and other persons to whom it may lawfully be communicated, falling within Article 49(2)(a) to (d) of the Order. Any person who is not a relevant person should not act or rely on this press release or any of its contents.

This press release does not constitute an 'offer of securities to the public' within the meaning of Directive 2003/71/EC of the European Union (the 'Prospectus Directive') of the securities referred to in it (the 'Securities') in any member state of the European Economic Area (the 'EEA'). Any offers of the Securities to persons in the EEA will be made pursuant to an exemption under the Prospectus Directive, as implemented in member states of the EEA, from the requirement to produce a prospectus for offers of the Securities.


Disclaimer

Cosmo Pharmaceuticals NV published this content on 27 August 2020 and is solely responsible for the information contained therein. Distributed by Public, unedited and unaltered, on 27 August 2020 05:16:02 UTC


© Publicnow 2020
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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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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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