Amzeeq (minocycline) topical foam was approved by the US Food and Drug Administration (FDA) last week for the treatment of inflammatory lesions of non-nodular moderate to severe acne vulgaris.
Upon approval, Amzeeq became the first topical formulation of the antibiotic minocycline to be approved for any condition. The company noted that oral formulations of minocycline can cause side-effects and previous topical treatments did not receive approval due ‘instability’.
Following the approval, Foamix Pharmaceuticals announced it had signed a manufacturing and supply agreement with ASM Aerosol-Service to commercialize the product.
In addition, the agreement covers Foamix’s lead candidate, FMX103, a minocycline foam for the treatment of moderate to severe papulopustular rosacea in adults. The company has submitted a new drug application (NDA) to the FDA for the drug candidate and expects a decision in the second quarter of 2020.
Both products will be manufactured at ASM’s facility in Möhlin, Switzerland.
As a result of securing a contract manufacturing agreement for its lead products, Foamix stated that it will now receive $20m (€17.9m) in financing under an existing credit agreement with Perceptive and OrbiMed to fund the commercial launch of its portfolio.