BRIDGEWATER, N.J., April 23, 2020 (GLOBE NEWSWIRE) -- Menlo Therapeutics Inc. (MNLO) (“Menlo” or the “Company”), a specialty pharmaceutical company focused on developing and commercializing proprietary therapies to address unmet needs in dermatology, today announced that its wholly-owned subsidiary, Foamix Pharmaceuticals Ltd. (“Foamix”), has entered into a licensing agreement with specialty pharmaceutical company Cutia Therapeutics (HK) Limited, an affiliate of Cutia Therapeutics (“Cutia”) for AMZEEQ™ (minocycline) topical foam, 4% as well as its other topical minocycline product candidates, once approved, on an exclusive basis in Greater China.
Under the terms of the agreement, Cutia will have an exclusive license to obtain regulatory approval of and commercialize AMZEEQ™ and, if approved in the U.S., FMX103 and FCD105 in the Greater China territory. Foamix will supply the finished licensed products to Cutia for clinical and commercial use. Foamix will receive an upfront cash payment of $10 million and will be eligible to receive an additional $1 million payment upon the receipt of marketing approval in China of the first licensed product. Foamix will also receive royalties on net sales of any licensed products.
“We believe that this agreement with Cutia speaks to the importance of our topical minocycline technology and the strong demand for AMZEEQ worldwide,” said David Domzalski, CEO of Menlo. “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.”
“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,” said Lele Zhang, CEO of Cutia. Cutia is a portfolio company of 6 Dimensions Capital, a leading global investment firm with a focus on life sciences and healthcare with over 10B RMB ($1.5B USD) currently under management.
In October 2019, Foamix received U.S. Food and Drug Administration (FDA) approval for AMZEEQ, a minocycline topical foam, 4%, for the treatment of non-nodular inflammatory moderate-to-severe acne vulgaris in adults and pediatric patients 9 years of age and older. In addition to AMZEEQ, the Company is working to develop and commercialize in the U.S. a topical minocycline foam, 1.5% (FMX103) for the potential treatment of inflammatory lesions (papules and pustules) of rosacea in adults, which is currently being reviewed by the FDA with a PDUFA action date of June 2, 2020, and FCD105, a topical foam combination of minocycline and adapalene therapy for the potential treatment of acne vulgaris, which is currently in Phase 2 clinical development with top line results expected in the second quarter of 2020.
With over 200 granted patents worldwide Menlo is a leader in innovative topical technologies and has out-licensed novel delivery platforms to pharmaceutical companies for the development of proprietary topical products containing various active pharmaceutical ingredients.
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