Menlo Therapeutics announces its wholly-owned subsidiary Foamix Pharmaceuticals Ltd. is entering a licensing with Cutia Therapeutics for the company’s FDA-approved 4% topical minocycline foam (AMZEEQ, Foamix) for acne vulgaris in pediatric and adult patients.
Coming off the heels Menlo Therapeutics’ (“Menlo”) merger with its now wholly-owned subsidiary Foamix Pharmaceuticals Ltd. (“Foamix”), Menlo is now announcing Foamix has entered into a license agreement with Cutia Therapeutics for the company’s 4% topical minocycline foam (AMZEEQ, Foamix) and, once approved, other topical minocycline products, on an exclusive basis with Greater China.
The U.S. Food and Drug Administration approved the 4% minocycline foam for the treatment of non-nodular inflammatory moderate-to-severe acne vulgaris in pediatric and adult patients 9 years and older in October 2019.
"We recognized the value of Foamix's unique foam technology for dermatology and looked to license its minocycline products as anchor assets as we aim to build China's leading dermatology platform," says Lele Zhang, CEO of Cutia Therapeutics.
Cutia will have the exclusive license to acquire regulatory approval and commercialization of the 4% minocycline foam in Greater China, according to the terms of the agreement. Also, if FMX103 and FCD105 are approved in the U.S., those drugs will be included, according to a press release.1
FMX103 is an investigational topical 1.5% minocycline foam for the treatment of inflammatory lesions of rosacea in adult patients, with an expected PDUFA action date of June 2, 2020. FCD105 is a topical foam combination of minocycline and adapalene for the treatment of acne vulgaris currently being investigated in phase 2 clinical trials with results expected in the second quarter of 2020.
Additionally, in the deal, Foamix agrees to provide the completed licensed products for clinical and commercial use to Cutia, and will receive a $10 million upfront cash payment and the eligibility to receive a supplemental $1 million, on top of royalties on net sales of any licensed products, when the first product obtains marketing approval in China.
“We believe that this agreement with Cutia speaks to the importance of our topical minocycline technology and the strong demand for AMZEEQ worldwide," says David Domzalski, CEO of Menlo Therapeutics. "We intend to partner with other companies outside the U.S. to extend our commercial reach in order to bring AMZEEQ and our topical minocycline product candidates to the hundreds of millions of patients suffering from acne and rosacea."
1. Menlo Therapeutics and Cutia Therapeutics Enter into Exclusive License Agreement for AMZEEQ and Approved Topical Minocycline Products in Greater China. FirstWord Pharma. https://www.firstwordpharma.com/node/1718052?al=3a2380-a882871cf1564cc5f229595ac3bb61d7^|^MTEwOTc4MA==^|^NQ==&cp1=bmV3c2xldHRlcl9yZWdpb25faWQ9c3Rvcnlfd2F0Y2g. Published April 23, 2020. Accessed April 24, 2020.