VYNE Therapeutics Inc. announced that its novel ZILXI™ (minocycline) topical foam, 1.5% is available as of today, October 1, 2020 by prescription for the treatment of inflammatory lesions of rosacea in adults. Approved by the U.S. Food and Drug Administration (FDA) in May 2020, ZILXI is the first minocycline product of any form to be approved by the FDA for use in rosacea, 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). This new once-daily therapy will be available in retail, community and specialty pharmacies nationwide.
“Patients and physicians have been seeking new treatment options for rosacea, a condition that can be difficult to treat, leaving many patients dissatisfied and, in some cases, switching treatments multiple times or discontinuing altogether,” said David Domzalski, Chief Executive Officer of VYNE. “By combining a unique topical delivery system for minocycline with strong efficacy and tolerability, ZILXI is positioned to address a very challenging skin condition in a way that could change treatment considerations for rosacea.”
The Company also announced that the annual list price of ZILXI will be $485 per 30-gram canister, in parity with the wholesale price of AMZEEQ® (minocycline) topical foam, 4%, the Company’s topical minocycline 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. The Company is working to align contracts with commercial insurers, expanding efforts previously undertaken for AMZEEQ, to offer the broadest possible access to ZILXI for patients and healthcare professionals.
VYNE has also developed a multi-channel tactical marketing plan to reach customers, including deployment of the existing sales force to targeted rosacea-treating providers.
Minocycline is one of several broad-spectrum antibiotics known as tetracyclines with anti-inflammatory properties; their use in some patients is limited due to systemic side effects when taken orally. In ZILXI, VYNE has once more 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.
ZILXI and AMZEEQ Important Safety Information
ZILXITM (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.
ZILXI and AMZEEQ should not be used for the treatment of infections.
Important Safety Information
ZILXI and AMZEEQ are both topical foams that contain minocycline, a tetracycline medicine. They are not taken by mouth. However, tetracyclines, when taken by mouth (capsules or tablets), may cause serious side effects, including: diarrhea, including watery or bloody stools; loss of appetite; tiredness; yellowing of the skin or eyes; bleeding more easily than normal; confusion; sleepiness; vision changes, including blurred vision, double vision, or permanent vision loss; unusual headaches; fever; rash; joint pain; body weakness; discoloration or darkening of the skin, scars, teeth, or gums. People should call their doctor right away if these side effects occur.
The most common side effect of ZILXI is diarrhea. The most common side effect of AMZEEQ is headache.
These are not all of the possible side effects for ZILXI or AMZEEQ. People should contact their doctor for medical advice about side effects and be sure to tell their doctor about all of their medical conditions and medicines they take before using ZILXI or AMZEEQ.
People are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.
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 life1. Rosacea is most frequently seen in adults between 30 and 50 years of age. It affects more than 16 million people in the United States; up to 28% of these sufferers have rosacea with inflammatory lesions2.
About VYNE Therapeutics Inc.
VYNE Therapeutics’ mission is to improve the lives of patients by developing proprietary, innovative and differentiated therapies in dermatology and beyond.
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. For more information about our approved products, please see AMZEEQ’s Full Prescribing Information at amzeeq.com and ZILXI’s Full Prescribing Information at zilxi.com.
For more information about VYNE Therapeutics Inc. or its investigational products, visit www. vynetherapeutics.com or follow VYNE on Twitter. VYNE may use its website to comply with its disclosure obligations under Regulation FD. Therefore, investors should monitor VYNE’s website in addition to following its press releases, filings with the U.S. Securities and Exchange Commission, public conference calls, and webcasts.
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Chief Financial Officer