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 received US Food and Drug Administration approval 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.
Rationale for the acquisition
Mayne Pharma CEO Scott Richards said: “Halobetasol foam is a new formulation that provides a highly desirable treatment option for patients in the management of plaque psoriasis. Adding halobetasol foam to our dermatology product portfolio is a material step forward in supporting psoriasis patients.
“We can now offer a potent steroid along with steroid-free Sorilux for psoriasis treatment giving our patients more treatment options with the benefits of an elegant foam formulation.
“The acquisition broadens our portfolio of innovative dermatology products with strong growth potential, further diversifies earnings and strengthens Mayne Pharma’s position in the US dermatology market.
“Halobetasol foam will be supported by our existing psoriasis focused sales team, leveraging existing commercial infrastructure across market access, customer service, medical affairs and supply chain.”
New leadership talent on board to drive Specialty Brands
Brant Schofield has joined Mayne Pharma as Executive Vice President (EVP) of Specialty Brands. Brant brings more than 25 years of pharmaceutical industry experience including more than 15 years at Galderma Laboratories, a leading global dermatology and skin health company.
Previously, he was Vice President and General Manager Dermatology at Sandoz US where he was responsible for the brand and generic product portfolio with revenues of approximately US$500m.
Prior to Sandoz, he was Vice President of New Business for Nestlé Skin Health (parent entity of Galderma) and he was also Vice President of Sales and Marketing for Galderma US, where he led a 300+ person sales and marketing team and was responsible for more than US$1.0b of sales across prescription, over-the-counter and aesthetic dermatology markets.
Richards said: “I am extremely pleased that Brant Schofield has joined the leadership team at Mayne Pharma. Brant will be a valuable addition to our business, bringing a proven track record of success in commercialising and growing specialty product portfolios.
“Brant brings a wealth of experience across sales and marketing, strategy, finance, supply chain and business development activities.
“Our specialty product portfolio is poised for growth with the pipeline of products under development including the New Drug Application for SUBA-Itraconazole capsules which the Company filed with the US Food and Drug Administration earlier this year as well as our on-market portfolio of dermatology products which have significant untapped potential.”
Source: Company Press Release