November 4, 2020
ALBANY, N.Y.–(BUSINESS WIRE)–Albany Molecular Research, Inc. (AMRI) today announced that it has been named as the exclusive supplier of the active pharmaceutical ingredient (API) in Cassiopea SpA’s (SIX: SKIN) recently approved acne treatment, Winlevi® (clascoterone) cream 1%.
The United States Food and Drug Administration (FDA) approved Winlevi® (clascoterone) cream 1% in August 2020, marking a significant milestone in the treatment of acne vulgaris in patients 12 years and older. The FDA last approved an acne drug with a new mechanism of action about 40 years ago.1
“AMRI was chosen as the exclusive supplier for the API because of its outstanding expertise in steroid and hormone development and manufacturing,” said Teresa Pallotta, VP, API Sales. “Our team is pleased to support Cassiopea in providing this novel treatment for acne. We take pride in our customer intimacy approach, which ensures that we are in tune with their specific needs and drives our commitment to the highest level of customer service.”
“We are pleased to work with the AMRI team in Spain to establish ongoing supply for the API for Winlevi®,” said Diana Harbort, CEO of Cassiopea. “AMRI’s quality, reliability, and expertise in the development and manufacture of APIs are key to helping us to provide this innovative treatment and to help improve the quality of life for those suffering from acne.”
Winlevi®, a first-in-class topical androgen receptor inhibitor, is expected to be available by prescription only in the United States in the first quarter of 2021. Complete prescribing information is available at www.winlevi.com.
About Winlevi® (clascoterone cream 1%)
Winlevi® (clascoterone cream 1%) is approved for the treatment of acne vulgaris in people age 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.2
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
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 four 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.
AMRI, a contract research development and manufacturing organization, partners with the pharmaceutical and biotechnology industries to improve patient outcomes and quality of life. AMRI’s team combines scientific expertise and market-leading technology to provide a complete suite of solutions in discovery, development, analytical services, and API and drug product manufacturing.
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. Once approved, the Company plans to commercialize the products directly in the U.S. and partner the products for countries outside of the U.S. For further information on Cassiopea, please visit www.cassiopea.com.