Cassiopea S.p.A. / Key word(s): Miscellaneous
25-March-2021 / 07:00 CET/CEST
Release of an ad hoc announcement pursuant to Art. 53 KR
The issuer is solely responsible for the content of this announcement.
Lainate, Italy – March 25, 2021 – Cassiopea SpA (SIX: SKIN), a specialty pharmaceutical company developing and preparing to commercialize prescription drugs with novel mechanisms of action (MOA) to address long-standing and essential dermatological conditions, today announced financial results for the year ended 31 December 2020.
Diana Harbort, CEO of Cassiopea SpA, commented: ‘The highlight of the year 2020 was the US FDA approval of Winlevi, our first-in-class topical androgen receptor inhibitor for the treatment of acne in patients twelve years and older. This milestone marks the approval of the first new mechanism of action for the treatment of acne in nearly forty years. During the course of the year, we have made substantial progress in medical affairs, market access, commercial launch planning and product supply. Thousands of dermatologists are now aware of the new mechanism of action in acne and scientific platform of Winlevi. Our priority now is optimizing the US commercial strategy for Winlevi, taking into account the dynamics of COVID-19 affecting the entire pharmaceutical industry.’
Key financial figures
Financial Results for the Year Ended December 31, 2020
2020 results conference call at 16:00 CEST on 25 March 2021
The Annual Report 2020 and the presentation with further information were published today, 25 March 2021 at 07:00 CEST, and are available for download at the Company’s website:
Cassiopea is a specialty pharmaceutical company developing and commercializing prescription drugs with novel mechanisms of action (MOA) to address long-standing and essential dermatological conditions, particularly acne, androgenetic alopecia (or AGA) and genital warts. Cassiopea is investing in innovation that is driving scientific advancement in areas that have been largely ignored for decades. The portfolio comprises four unencumbered clinical candidates, for which Cassiopea owns the worldwide rights. The Company’s strategy is to leverage this expertise to optimize the commercial potential for its products directly or with a partner. For further information on Cassiopea, please visit www.cassiopea.com.
Winlevi(R) (clascoterone cream 1%) is approved for the topical 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 follicles.6Complete prescribing information is available at www.WINLEVI.com
Winlevi(R) (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
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.
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.
Some of the information contained in this press release may contain 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. Cassiopea has no obligation to publicly update or revise any forward-looking statements.
End of ad hoc announcement
|Via Cristoforo Colombo 1|
|Listed:||SIX Swiss Exchange|
|EQS News ID:||1178292|
|End of Announcement||EQS Group News Service|