Cassiopea SpA: Cassiopea is applying for a drug (NDA) for Clascoteron 1% cream at the FDA ... 2

Cassiopea SpA: Cassiopea is applying for a drug (NDA) for Clascoteron 1% cream at the FDA …

Cassiopeiumapply for a drug (NDA)forClascoteron1% creamat the FDA – the first new mechanism of actionfor the treatment of acnefromfor almost 40 years

Lainate, Italy – August 20, 2019 – Cassiopea SpA (SIX: SKIN), a specialty pharmaceutical company that develops and markets prescription drugs with new treatments (MOAs) to treat previously unresolved and major dermatological conditions, has filed a new drug application with the US Food and Drug Administration (FDA). NDA) for approval of Clascoteron 1% acne treatment cream.

Clascoteron 1% cream is being developed as a new topical androgen receptor inhibitor for the treatment of acne. Clascoterone is a locally administered small molecule that penetrates the skin to reach the androgen receptors of the sebaceous glands. It will be the first effective and safe androgen therapy that has no systemic side effects.

Clascoterone 1% cream targets androgen receptors at the site of use and inhibits the local effects of dihydrotestosterone (DHT), a major cause of acne treatment. Laboratory studies show that clocoteron inhibits the production of lipids by oil-producing cells (sebocytes) and reduces proinflammatory cytokines, which are considered to be mediated and influenced by androgens. Consequently, clusterherons are disrupted mechanisms that trigger the development of acne lesions. Unlike oral hormone therapies for the treatment of acne, Clascoteron can be used by men and women.

It has been a long time since there has been a new molecule for acne treatment, especially considering that topical treatment targets androgen receptors directly to the sebocytes to reduce lipid production and inflammation. "said Dr. Lawrence Eichenfield, Head of Pediatric and Adolescent Dermatology at Rady Children's Hospital, San Diego." Dermatologists now have another option to treat their acne patients, which is invaluable. "

Cassiopea released the results of two key phase III clinical trials of Clascoterone 1% cream last year, which showed statistically significant improvements in all primary endpoints. Clinical trials have found no significant adverse reactions resulting from treatment; if local skin reactions were found to be similar to the vehicle and were classified predominantly as mild. The safety results, released earlier this year, were confirmed in an open-label safety study over a one-year treatment period. The face was treated, as was the trunk. The prolonged duration and increased scope of administration did not increase the incidence of significant adverse reactions.

"If approved, Clascoteron 1% Cream will be the first approved new mechanism of action for the treatment of acne in nearly 40 years, providing a new and effective therapeutic alternative to dermatologists and patients," said Diana Harbort, director of Cassiope. "We are focused on treating urgent skin diseases that can leave not only physical but also mental scars. Innovation is so important, and we are committed to finding a way to treat acne, which is the cause of the disease."

About Cassiopeia

Cassiopea SpA is a specialty pharmaceutical company under development, specializing in the development and commercialization of innovative and differentiated dermatology medical products. The company is currently focused on the topical treatment of acne, androgenetic alopecia and genital warts. The four proprietary clinical candidates are based on three new drugs ("NCE"). They address unmet medical needs and represent significant opportunities in the medical dermatology market to which the Company has worldwide rights. The company plans to produce products directly with overseas partners after approval. For more information on Cassiopea, visit our homepage:

About Clascoteron

Clascoterone is a new, late-stage chemical body for the treatment of acne (in 1% cream) and androgenetic alopecia (in higher concentration solution). It is a locally administered small molecule that penetrates the skin to access the androgen receptors of the sebaceous glands and the hair follicle. The goal is to be the first effective and safe anticapigen for topical use that has no systemic effects.

Event Calendar

CS Small & Mid Cap Conference, Zurich

13. November 15, 2019

Jefferies Health Conference, London

November 20 – 21, 2019

2019 Annual Financial Statements

February 2020

Cassiopea SpA

Dr. Chris Tanner, CEO and Head of Investor Relations

Tel: +39 02 868 91 124

Some of the information contained in this release may contain forward-looking statements. Readers are cautioned not to anticipate future results and consequences and that actual results may differ materially from those expressed in forward-looking statements. Cassiopea has no obligation to update or revise any forward-looking statements.