VYNE stock rose in morning trade on January 25, 2021, after the company announced a major new deal.
On January 21, 2021, VYNE Therapeutics Inc. (Nasdaq: VYNE) announced the execution of a contract with a major PBM for its novel AMZEEQ® (minocycline) topical foam, 4% and ZILXI® (minocycline) topical foam, 1.5%. AMZEEQ, the first topical minocycline to be approved by the U.S. Food and Drug Administration (“FDA”) for any condition, is indicated for the treatment of inflammatory lesions of non-nodular moderate to severe acne vulgaris in adults and pediatric patients 9 years of age and older. ZILXI is indicated for the treatment of inflammatory lesions of rosacea in adults and is the first minocycline product of any form to be approved by the FDA for use in rosacea.
The PBM under contract is one of the largest pharmacy benefit managers in the U.S., representing millions of covered lives.
“The execution of this agreement is an important milestone for the launches of AMZEEQ and ZILXI, and we are pleased that this contract provides access to both products for plans representing millions of commercial lives,” said David Domzalski, Chief Executive Officer of VYNE. “Completion of this agreement is consistent with our ambition to achieve broad commercial coverage of AMZEEQ, and we will now continue to focus on achieving similar coverage for ZILXI.”
Minocycline, a broad-spectrum antibiotic known for its efficacy and anti-inflammatory properties, has not previously been available as a topical treatment due to its instability in traditional topical formulations. In ZILXI and AMZEEQ, VYNE has leveraged its proprietary Molecule Stabilizing Technology (MST™) platform to effectively deliver minocycline in a foam-based vehicle that contains naturally moisturizing ingredients, such as coconut and soybean oil, and is free of surfactants and drying agents.
AMZEEQ was FDA approved in October 2019 and ZILXI was approved by the FDA in May 2020. Both products are available nationwide.
ZILXI and AMZEEQ Important Safety Information
ZILXI® (minocycline) topical foam, 1.5% is for the treatment of adults with pimples and bumps caused by a condition called rosacea. It is not known if ZILXI is safe and effective in children.
AMZEEQ® (minocycline) topical foam, 4% is for the treatment of pimples and red bumps (non-nodular inflammatory lesions) that happen with moderate to severe acne in patients 9 years age and older. It is not known if AMZEEQ is safe and effective in children under 9 years of age or older.
ZILXI and AMZEEQ are both topical forms of the antibiotic minocycline and are available by prescription only. ZILXI and AMZEEQ are for use on skin only (topical use). ZILXI and AMZEEQ are not for use in the mouth, eyes or vagina.