GlobeNewswire Inc | Oct 7, 2020 08:00AM EDT

October 07, 2020

BRIDGEWATER, N.J., Oct. 07, 2020 (GLOBE NEWSWIRE) -- VYNE Therapeutics Inc. (Nasdaq: VYNE) (VYNE or the Company) today announced a coverage update for its novel ZILXI(minocycline) topical foam, 1.5%. ZILXI is the first minocycline product of any form to be FDA approved for use in rosacea for the treatment of inflammatory lesions in adults and is just recently available in pharmacies nationwide.

Express Scripts, one of the nations leading pharmacy benefit managers (PBMs), has elected to cover ZILXI effective October 2, 2020 on Express Scripts National Preferred, Flex, and Basic commercial formularies, representing millions of additional covered lives in the U.S. that follow these formularies.

The addition of Express Scripts to our national coverage for ZILXI is a significant milestone as it represents a large portion of the U.S. commercial coverage patient population, said David Domzalski, Chief Executive Officer of VYNE. We are pleased that our contract provides access to this important new option for physicians and patients who have not previously had the rosacea treatment outcomes they are seeking.

The annual list price of ZILXI is $485per 30-gram canister. ZILXI was approved by the U.S. Food and Drug Administration inMay 2020.

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 Important Safety Information

IndicationZILXITM(minocycline) topical foam, 1.5%is atopical form of the antibiotic minocyclinefor the treatment ofadults withpimples and bumpscaused by a condition called rosacea.ZILXIis available by prescription only.

ZILXIshould not be used for the treatment of infections.It is not known ifZILXIis safe and effective in children.ZILXIis for use on skin only (topical use).ZILXIis not for use inthemouth, eyes or vagina.

Important Safety Information

-- ZILXIshould not be used in people whoare allergic toZILXIorany tetracycline medicine.Use ofZILXIshould be stoppedright away if arash or other allergic symptomoccurs. -- ZILXIshouldnotbeusedin women whoare pregnant, may become pregnant or are nursing. Ifa womanbecomespregnant whileusingZILXI,sheshouldtalk toherdoctor.Tetracycline medicine when taken by mouthduring pregnancy, infancy and/or childhood up to the age of 8 yearsmay permanentlydiscolorteeth(yellow-gray-brown)and may slow the growth of bones. -- ZILXIis flammableandfire, flames, and smokingmust be avoidedwhen applying and right after applyingZILXI. -- People should protecttheirskin fromthesunwhileusingZILXIand avoid sunlight or artificial sunlight such as sunlamps or tanning beds.Use ofZILXIshould be stoppedifskin issunburned. -- Whentaken by mouth, minocyclinemay causefeelings oflightheadedness,dizzinessor spinning.Peopleshould not drive or operate dangerous machinery iftheyhave these symptoms.

ZILXIis a topical foam thatcontains minocycline, a tetracycline medicine.It is not taken by mouth.However,tetracyclines,when taken by mouth(capsulesor tablets), may causeserious side effects, including:diarrhea, which may be caused by an infection and can cause watery or bloody stools;loss of appetite;tiredness;yellowing oftheskinor eyes (jaundice);bleeding more easily than normal;confusion;sleepiness;vision changes,includingblurred vision,double vision,or permanent vision loss;unusual headaches;fever;rash;joint pain;body weakness;discolorationordarkening oftheskin, scars, teeth, or gums.People should call theirdoctorright away if these side effects occur.

The most common side effect ofZILXIisdiarrhea.

These are not allofthe possible side effects withZILXI.Peopleshould contact theirdoctor for medical advice about side effectsand be sure to tell their doctor about all of their medical conditions and medicines they take before usingZILXI.

Peopleare encouraged toreportnegative sideeffectsof prescription drugs to theFDA. Visitwww.fda.gov/medwatchor call 1-800-FDA-1088.

Please see full Prescribing Information for ZILXI.

About RosaceaRosacea 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 worlds 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 AMZEEQs Full Prescribing Information atamzeeq.comand ZILXIs Full Prescribing Information atzilxi.com.

For more information about VYNE Therapeutics Inc. or its investigational products, visit www.vynetherapeutics.com or follow VYNE onTwitter. VYNE may use its website to comply with its disclosure obligations under Regulation FD. Therefore, investors should monitor VYNEs website in addition to following its press releases, filings with the U.S. Securities and Exchange Commission, public conference calls, and webcasts.

Media Relations:Bridgette PotratzZeno Group312-358-2950bridgette.potratz@zenogroup.com

Investor Relations:Joyce AllaireLifeSci Advisors, LLC646-889-1200jallaire@lifesciadvisors.com

Andrew SaikChief Financial OfficerVYNE Therapeutics908-731-6180Andrew.Saik@vynetx.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 VYNEs 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 VYNEs 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 VYNEs 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 VYNEs other products or product candidates; risks that VYNEs 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 VYNEs patents may be held to be narrowed, invalid or unenforceable or one or more of VYNEs patent applications may not be granted and potential competitors may also seek to design around VYNEs 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; VYNEs ability to recruit and retain key employees; and VYNEs ability to stay in compliance with applicable laws, rules and regulations. For a discussion of other risks and uncertainties, and other important factors, any of which could cause VYNEs actual results to differ from those contained in the forward-looking statements, see the section titled Risk Factors in VYNEs Quarterly Report on Form 10-Q for the quarter ended March 31, 2020, as well as discussions of potential risks, uncertainties, and other important factors in VYNEs subsequent filings with the U.S. Securities and Exchange Commission. 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.

-- Aksoy, B., AltaykanHapa, A., Egemen, D., Karagz, F. and Atakan, N. (2010), The impact of rosacea on quality of life: effects of demographic and clinical characteristics and various treatment modalities. British Journal of Dermatology, 163: 719-725. -- Gether et al. Incidence and prevalence of rosacea: a systematic review and meta-analysis. British Journal of Dermatology 25 Feb 2018.179: 282-289.

2020 VYNE Therapeutics Inc. All rights reserved.COM-ZIL-US-200045 9/2020