BRIDGEWATER -
AMZEEQ, the first topical minocycline to be approved by the
The PBM under contract is one of the largest pharmacy benefit managers in the
'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
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
About Acne
Acne is a chronic, inflammatory skin condition that affects the skin's sebaceous glands and hair follicles. It is characterized by both inflammatory lesions (papules and pustules) and non-inflammatory lesions (open and closed comedones) affecting primarily the face and truncal areas of the body. Acne affects approximately 40 to 50 million people in the
About Rosacea
Rosacea is a diverse skin condition that most commonly presents with symptoms such as deep facial redness, spider veins (telangiectasia) and acne-like inflammatory lesions (papules and pustules). It can create psychosocial burdens, such as embarrassment, anxiety and low self-esteem that can adversely affect quality of life. Rosacea is most frequently seen in adults between 30 and 50 years of age. It affects more than 16 million people in
About
With expertise in topical medicine innovation as a springboard, VYNE is working to develop and commercialize a variety of solutions using its proprietary Molecule Stabilizing Technology (MST), and has received FDA approval for AMZEEQ (minocycline) topical foam, 4%, the world's first topical minocycline, and for ZILXI (minocycline) topical foam, 1.5%, the first minocycline product of any kind to be approved by the FDA for use in rosacea.
Contact:
Tel: 312-358-2950
Email: bridgette.potratz@zenogroup.com
Cautionary Statement Regarding Forward-Looking Statements
This release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including, but not limited to, statements regarding the development and commercialization of VYNE's products and product candidates and other statements regarding the future expectations, plans and prospects of VYNE. All statements in this press release which are not historical facts are forward-looking statements. Any forward-looking statements are based on VYNE's current knowledge and its present beliefs and expectations regarding possible future events and are subject to risks, uncertainties and assumptions that could cause actual results to differ materially and adversely from those set forth or implied by such forward-looking statements. These risks and uncertainties include, but are not limited to: the COVID-19 pandemic and its impact on our business operations; adverse events associated with the commercialization of AMZEEQ and ZILXI; the outcome and cost of clinical trials for current and future product candidates; determination by the FDA that results from VYNE's clinical trials are not sufficient to support registration or marketing approval of product candidates; the outcome of pricing, coverage and reimbursement negotiations with third party payors for AMZEEQ, ZILXI or any other products or product candidates that VYNE may commercialize in the future; whether, and to what extent, third party payors impose additional requirements before approving AMZEEQ and ZILXI prescription reimbursement; the eligible patient base and commercial potential of AMZEEQ, ZILXI or any of VYNE's other products or product candidates; risks that VYNE's intellectual property rights, such as patents, may fail to provide adequate protection, may be challenged and one or more claims may be revoked or interpreted narrowly or will not be infringed; risks that any of VYNE's patents may be held to be narrowed, invalid or unenforceable or one or more of VYNE's patent applications may not be granted and potential competitors may also seek to design around VYNE's granted patents or patent applications; additional competition in the acne and dermatology markets; risks related to our indebtedness; inability to raise additional capital on favorable terms or at all; VYNE's ability to recruit and retain key employees and VYNE's ability to stay in compliance with applicable laws, rules and regulations. Although VYNE believes these forward-looking statements are reasonable, they speak only as of the date of this announcement and VYNE undertakes no obligation to update publicly such forward-looking statements to reflect subsequent events or circumstances, except as otherwise required by law. Given these risks and uncertainties, you should not rely upon forward-looking statements as predictions of future events.
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