Pharmaceutical Business review

Sol-Gel, Beimei sign deal for TWYNEO commercialisation

The agreement will allow Beimei to manage the commercialisation, which includes licenses rights and purchases, of TWYNEO in the specified territories. Credit: Kjerstin_Michaela/Pixabay.

TWYNEO is claimed to be the first and only US Food and Drug Administration (FDA)-approved fixed-dose cream which combines tretinoin and benzoyl peroxide for treating acne vulgaris in adults as well as paediatric patients aged nine and above. 

As per the terms of latest agreement, Beimei will handle the commercialisation, which includes purchases and licenses rights of TWYNEO in the specified territories.  

Meanwhile, Sol-Gel is set to receive upfront and milestone payments totalling $10m, however it is currently subject to government approvals. 

The company will also receive royalty payments on net sales that could reach up to $5m. 

Beimei Pharma founder and CEO Wu Guangmei said: “The clinical need in acne market remains unmet for a long time in China, especially for adolescents. TWYNEO as an innovative combination formulation approved by the US FDA, and its efficacy in treating acne has been proven by clinical trials.  

“Beimei Pharma will perform registration and commercialisation process of TWYNEO in its territories to bring a new treatment to the vast population of acne patients. I believe this deal encourages Beimei Pharma to deeper cultivate our paediatric pipeline layout in the field of dermatology, leading Beimei Pharma into a new stage.” 

Sol-Gel Technologies specialises in developing and commercialising drug products for skin diseases. 

The company is currently conducting a Phase III clinical trial for SGT-610 (patidegib gel, 2%) targeting Gorlin syndrome. 

In addition to TWYNEO, Sol-Gel has developed another FDA-approved dermatology product, EPSOLAY, for treating inflammatory lesions of rosacea in adults.  

Both TWYNEO and EPSOLAY are licensed to Galderma for commercialisation in the US and to Searchlight in Canada. 

Sol-Gel CEO Alon Seri-Levy said: “This agreement demonstrates potential of TWYNEO outside of the US, and we expect to announce other agreements regarding commercialisation of both our FDA-approved assets, TWYNEO and EPSOLAY, in other territories.”