Mayne Pharma Group Limited (ASX: MYX) has licensed the Australian rights to specialist skin treatment products SOLARAZE gel and ACTIKERAL topical solution from Almirall, SA.
Both products are approved by the Australian Therapeutic Goods Administration (TGA). In addition, Mayne Pharma has filed FABIOR (tazarotene) foam, 0.1% with the TGA. FABIOR was acquired from GlaxoSmithKline and re-launched into the US dermatology market in 2016.
SOLARAZE and ACTIKERALL are indicated for the treatment of actinic keratosis (AK, also known as solar keratosis) which affects approximately 40 to 60% of Australians over the age of 40.
Australia has the highest incidence of AK globally with the main cause being long-term sun exposure. SOLARAZE was launched in Australia in 2007 and has captured around 5% share of the $18 million topical prescription AK market.
ACTIKERALL was approved in 2019 and is yet to be launched in Australia. The transfer of SOLARAZE full distribution rights has commenced and is expected to be completed by July 1, 2021 with ACKTIKERALL transfer and launch planning already complete.
Associate Professor Peter Foley, Director of Research at Skin Health Institute, said AKs are precancerous lesions that have the potential to transform into skin cancers.
“SOLARAZE is an effective therapy for multiple thin lesions of AK, whilst ACTIKERALL is effective for the treatment of palpable and/or moderately thick hyperkeratotic AK. Both products have been shown in clinical trials to be highly effective and well tolerated causing less irritation and inflammation of the skin compared with other currently available AK treatments.”
FABIOR is a topical retinoid indicated in the US for the treatment of acne in patients aged 12 years or older. Acne affects 2.5 million Australians or 12% of the population over the age of 20 and is common in teenagers with prevalence peaking at 93% of people aged 16-18 years.
Mayne Pharma’s CEO, Scott Richards, said the annual sales of topical prescription acne products in Australia were $12m in 2020.
We are pleased to partner with Almirall, a global biopharmaceutical company focused on skin health and expand our Australian portfolio with these new differentiated dermatology products,” Mr Richards said.
“SOLARAZE and ACTIKERALL will be promoted by the existing Australian sales team focusing on dermatologists and general practitioners that specialise in skin cancer.
“Mayne Pharma looks forward to further broadening the Australian specialty portfolio in calendar 2022 with the potential commercialisation of FABIOR foam and NEXTSTELLIS (E4/DRSP) an oral contraceptive, both pending at the TGA.”
