Mayne Pharma Acquires FDA-approved Halobetasol Foam


Mayne Pharma has acquired the US and Australian rights to halobetasol foam 0.05% for an investment of up to $32 million (comprising $10 million in cash up front, $5 million at commercial launch plus contingent payments of up to $17 million based on reaching cumulative net sales targets, patent issuance and potential capital spend to support the project). In addition, there is an ongoing earn-out payment based as a percentage of net sales over a 10-year period. Under the terms of the asset purchase, license and commercialization agreement, Mayne Pharma has also acquired the approved US regulatory filing, medical and technical data, and a portfolio of pending US patent applications.

This product was FDA approved in May 2018 and Mayne Pharma is planning for the commercial launch of this product in early 2019. The product received three years of marketing exclusivity and has four pending patent applications with the US Patent and Trademark Office.

Halobetasol foam is a potent corticosteroid used to treat plaque psoriasis. Plaque psoriasis affects more than 7.5 million Americans with potent topical corticosteroids prescribed to approximately 80% of psoriasis patients diagnosed. The market for potent topical corticosteroids is estimated at US$600m with approximately 10 million units sold per annum, of which halobetasol dosage forms (cream, ointment and lotion) account for US$64 million and 0.8 million units.  The halobetasol market has been growing 10% per annum over the last three years.

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