{"id":399741,"date":"2020-12-15T08:03:15","date_gmt":"2020-12-15T13:03:15","guid":{"rendered":"http:\/\/www.marketnewsdesk.com\/?p=399741"},"modified":"2020-12-15T08:03:15","modified_gmt":"2020-12-15T13:03:15","slug":"vyne-therapeutics-announces-new-u-s-patent-expiring-in-2037-for-amzeeq-minocycline-topical-foam-4","status":"publish","type":"post","link":"https:\/\/www.marketnewsdesk.com\/index.php\/vyne-therapeutics-announces-new-u-s-patent-expiring-in-2037-for-amzeeq-minocycline-topical-foam-4\/","title":{"rendered":"VYNE Therapeutics Announces New U.S. Patent Expiring in 2037 for AMZEEQ\u00ae (minocycline) topical foam, 4%"},"content":{"rendered":"<h2>\nNew Granted Patent Listed in FDA\u2019s Orange Book for AMZEEQ<br \/>\n<\/h2>\n<div class=\"mw_release\">\n<p align=\"left\">BRIDGEWATER, N.J., Dec.  15, 2020  (GLOBE NEWSWIRE) &#8212; VYNE Therapeutics Inc. (Nasdaq: VYNE) (\u201cVYNE\u201d or the \u201cCompany\u201d), a specialty pharmaceutical company focused on developing and commercializing proprietary therapies to address unmet needs in dermatology, today announced listing another U.S. patent in the FDA\u2019s <em>Approved Drug Products with Therapeutic Equivalence Evaluations<\/em> (the \u201cOrange Book\u201d) for AMZEEQ<sup><em>\u00ae<\/em><\/sup> (minocycline) topical foam, 4%, for the topical\u00a0treatment\u00a0of inflammatory lesions of non-nodular moderate to severe acne\u00a0vulgaris in\u00a0adults\u00a0and pediatric patients 9 years of age and older. The patent\u2019s term expires in September 2037.<\/p>\n<p align=\"left\">This newly issued patent, U.S.10,849,847, is the latest U.S. patent to issue in connection with AMZEEQ. With the addition of this U.S. patent, there are now twelve U.S. patents listed in the FDA\u2019s Orange Book for AMZEEQ.<\/p>\n<p align=\"left\">\u201cWe continue to develop, extend and consolidate our robust patent portfolio and are pleased with the addition of this new patent, which provides further coverage for our novel topical minocycline product for moderate to severe acne vulgaris,\u201d said David Domzalski, CEO of VYNE. \u201cOur patents are a testament to our innovative scientific approach to solving difficult therapeutic problems in dermatology.\u201d\u00a0\u00a0<\/p>\n<p align=\"left\">\n        <strong>Indication<\/strong>\n      <\/p>\n<p align=\"left\">AMZEEQ<sup>\u00ae<\/sup> (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.<\/p>\n<p align=\"left\">AMZEEQ is a topical form of the antibiotic minocycline and is available by prescription only. <strong>AMZEEQ is for use on skin only (topical use). AMZEEQ are not for use in the mouth, eyes or vagina.<\/strong><\/p>\n<p align=\"left\">AMZEEQ should not be used for the treatment of infections.<\/p>\n<p align=\"left\">\n        <strong>Important Safety Information<\/strong>\n      <\/p>\n<ul type=\"disc\">\n<li>AMZEEQ should not be used in people who are allergic to AMZEEQ, or any tetracycline medicine. Use of AMZEEQ should be stopped right away if a rash or other allergic symptom occurs.<\/li>\n<li>AMZEEQ should not be used in women who are pregnant, may become pregnant or are nursing. If a woman becomes pregnant while using AMZEEQ, she should talk to her doctor. Tetracycline medicine when taken by mouth during pregnancy, infancy and\/or childhood up to the age of 8 years may permanently discolor teeth (yellow-gray-brown) and may slow the growth of bones.<\/li>\n<li>AMZEEQ is flammable and fire, flame, and smoking must be avoided when applying and right after applying AMZEEQ.<\/li>\n<li>People should protect their skin from the sun while using AMZEEQ and avoid sunlight or artificial sunlight such as sunlamps or tanning beds. Use of AMZEEQ should be stopped if skin is sunburned.<\/li>\n<li>When taken by mouth, minocycline may cause feelings of lightheadedness, dizziness or spinning. People should not drive or operate dangerous machinery if they have these symptoms.<\/li>\n<\/ul>\n<p align=\"left\">AMZEEQ is a topical foam that contains minocycline, a tetracycline medicine. It is not taken by mouth. However, tetracyclines, <u>when taken by mouth (capsules or tablets)<\/u>, may cause serious side effects, including: diarrhea which may be caused by an infection and cause watery or bloody stools; loss of appetite; tiredness; yellowing of the skin or eyes (jaundice); 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.<\/p>\n<p align=\"left\">The most common side effect of AMZEEQ is headache.<\/p>\n<p align=\"left\">These are not all of the possible side effects for 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 AMZEEQ.<\/p>\n<p align=\"left\">People are encouraged to report negative side effects of prescription drugs to the FDA. Visit <a href=\"https:\/\/www.globenewswire.com\/Tracker?data=XIUXTdyB5tv4V0vLGzgoybd8IilzrzM1BFx6LosoANvIJ_xhpCjHkMeZMeHjJZdHoDYOgaBBczbNCvzpR5f5jpYmw_a6fgGSaQtT3N-NC5I=\" rel=\"nofollow noopener noreferrer\" target=\"_blank\"><u>www.fda.gov\/medwatch<\/u><\/a> or call 1-800-FDA-1088.<\/p>\n<p align=\"left\">Please see full Prescribing Information for <a href=\"https:\/\/www.globenewswire.com\/Tracker?data=0SsNqu6wIXR6qVkx0D28CeXABvhmrLfO2Hy6Lrg_V8GOO8g3640MWkozKVmwgfAU6RMnUC8v8Sd0H8l4aSZ-UKOBdWDO0oYrJrglOIzmPQ2YW-mg0tE0KVHsEQLUu_BWZdD90irrYY6LseO_XL9OEg==\" rel=\"nofollow noopener noreferrer\" target=\"_blank\"><u>AMZEEQ<\/u><\/a>.<\/p>\n<p align=\"left\">\n        <strong>About Acne<\/strong><br \/>\n        <br \/>Acne is a chronic, inflammatory skin condition that affects the skin\u2019s 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 U.S. alone, of whom approximately 10 million have moderate to severe disease that may impact self-esteem and quality of life. For most people, acne diminishes over time and tends to disappear or decrease, by age 25. However, some individuals, particularly women, can experience acne much later in life.<\/p>\n<p align=\"left\">\n        <strong>About VYNE Therapeutics Inc.<\/strong>\n      <\/p>\n<p align=\"left\">In March 2020, Menlo Therapeutics Inc. (&#8220;Menlo&#8221;) and Foamix Pharmaceuticals Ltd. (&#8220;Foamix&#8221;) combined to form what is now known as VYNE Therapeutics Inc. VYNE&#8217;s mission is to improve the lives of patients by developing proprietary, innovative and differentiated therapies in dermatology and beyond.<\/p>\n<p align=\"left\">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\u2122), and has received FDA approval for AMZEEQ<sup>\u00ae<\/sup> (minocycline) topical foam, 4%, the world\u2019s first topical minocycline, and for ZILXI\u2122 (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\u2019s Full Prescribing Information at <a href=\"https:\/\/www.globenewswire.com\/Tracker?data=0SsNqu6wIXR6qVkx0D28CXnzPFf_6PmDpylaFTGYKasWAL8FSIoFx0ERTzKX14LkDg7kPpdXZp6n6VxSJny5wsWaa7v2ktNGctJUDdV_sL3HGfKxUHsacUhVpsLvKOAVmTlpYHEKNlNWGDgdVjzCJifOrelWUTPmnZixF9JpvKw=\" rel=\"nofollow noopener noreferrer\" target=\"_blank\">AMZEEQ.com<\/a> and ZILXI\u2019s Full Prescribing Information at ZILXI.com.<\/p>\n<p align=\"left\">For more information about VYNE Therapeutics Inc. or its investigational products, visit <a href=\"https:\/\/www.globenewswire.com\/Tracker?data=rzciMnQ_9tSPv-1RKrjCv1jxGuFkCdFiMrZys60p2O6ZGO1v064gROXcazPCfCyOjnYRI-Ixaom95XzqMKyHCU-zc0QRMX55F7X65wOXeng=\" rel=\"nofollow noopener noreferrer\" target=\"_blank\">www.vynetherapeutics.com<\/a>\u00a0or follow VYNE on\u00a0<a href=\"https:\/\/www.globenewswire.com\/Tracker?data=4zfBOp76cp4EmhW9TxewAhsBrG4gGNY4vIdLM-w5CZ_G6tFkI_YlEF3H5nTtFrZaPJmrs65FWyWVrcByUbwq1LEwUQLwENaasY2GFZucMGalcZjyf0kR7EyaVJSSY39z95ClHkVFPtPuSeC0AqyC9JPVZw4rjjYtQpyMH0P-L4aJbUYVuBNoggcNPyt2zHcwUubKUm7EniCqbo9bcvOGwAXMQYjjW7KowNREPineU6o=\" rel=\"nofollow noopener noreferrer\" target=\"_blank\"><u>Twitter<\/u><\/a>. VYNE may use its website to comply with its disclosure obligations under Regulation FD. Therefore, investors should monitor VYNE\u2019s website in addition to following its press releases, filings with the U.S. Securities and Exchange Commission, public conference calls, and webcasts.<\/p>\n<p align=\"left\">Media Relations:<br \/>Bridgette Potratz<br \/>Zeno Group<br \/>312-358-2950<br \/>bridgette.potratz@zenogroup.com<\/p>\n<p align=\"left\">Investor Relations:<br \/>Joyce Allaire<br \/>LifeSci Advisors, LLC<br \/>646-889-1200<br \/>jallaire@lifesciadvisors.com<\/p>\n<p align=\"left\">Andrew Saik<br \/>Chief Financial Officer<br \/>VYNE Therapeutics<br \/>908-731-6180<br \/>Andrew.Saik@vynetx.com<\/p>\n<p align=\"left\">\n        <strong>Cautionary Statement Regarding Forward-Looking Statements<\/strong>\n      <\/p>\n<p align=\"left\">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\u2019s 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\u2019s 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\u2019s 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\u2019s other products or product candidates; risks that VYNE\u2019s 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\u2019s patents may be held to be narrowed, invalid or unenforceable or one or more of VYNE\u2019s patent applications may not be granted and potential competitors may also seek to design around VYNE\u2019s 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\u2019s ability to recruit and retain key employees; and VYNE\u2019s 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 VYNE\u2019s actual results to differ from those contained in the forward-looking statements, see the section titled \u201cRisk Factors\u201d in VYNE\u2019s 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 VYNE\u2019s 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.<\/p>\n<p>      <img loading=\"lazy\" decoding=\"async\" class=\"__GNW8366DE3E__IMG\" src=\"https:\/\/www.globenewswire.com\/newsroom\/ti?nf=ODExMTg4NSMzODgwNDYxIzIwOTM4MDM=\" width=\"1\" height=\"1\" \/><br \/>\n      <br \/>\n      <img loading=\"lazy\" decoding=\"async\" class=\"__GNW8366DE3E__IMG\" src=\"https:\/\/ml.globenewswire.com\/release\/track\/3f82c7c1-4e44-44b0-94b5-3d7ecfb57e39\" width=\"1\" height=\"1\" \/>\n    <\/div>\n<div class=\"mw_contactinfo\"><\/div>\n","protected":false},"excerpt":{"rendered":"<p>New Granted Patent Listed in FDA\u2019s Orange Book for AMZEEQ BRIDGEWATER, N.J., Dec. 15, 2020 (GLOBE NEWSWIRE) &#8212; VYNE Therapeutics Inc. (Nasdaq: VYNE) (\u201cVYNE\u201d or the \u201cCompany\u201d), a specialty pharmaceutical company focused on developing and commercializing proprietary therapies to address unmet needs in dermatology, today announced listing another U.S. patent in the FDA\u2019s Approved Drug Products with Therapeutic Equivalence Evaluations (the \u201cOrange Book\u201d) for AMZEEQ\u00ae (minocycline) topical foam, 4%, for the topical\u00a0treatment\u00a0of inflammatory lesions of non-nodular moderate to severe acne\u00a0vulgaris in\u00a0adults\u00a0and pediatric patients 9 years of age and older. The patent\u2019s term expires in September 2037. This newly issued patent, U.S.10,849,847, is the latest U.S. patent to issue in connection with AMZEEQ. With the addition of this U.S. patent, there &hellip; <\/p>\n<p class=\"link-more\"><a href=\"https:\/\/www.marketnewsdesk.com\/index.php\/vyne-therapeutics-announces-new-u-s-patent-expiring-in-2037-for-amzeeq-minocycline-topical-foam-4\/\" class=\"more-link\">Continue reading<span class=\"screen-reader-text\"> &#8220;VYNE Therapeutics Announces New U.S. Patent Expiring in 2037 for AMZEEQ\u00ae (minocycline) topical foam, 4%&#8221;<\/span><\/a><\/p>\n","protected":false},"author":2,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[],"tags":[],"class_list":["post-399741","post","type-post","status-publish","format-standard","hentry"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.4 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>VYNE Therapeutics Announces New U.S. Patent Expiring in 2037 for AMZEEQ\u00ae (minocycline) topical foam, 4% - Market Newsdesk<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/www.marketnewsdesk.com\/index.php\/vyne-therapeutics-announces-new-u-s-patent-expiring-in-2037-for-amzeeq-minocycline-topical-foam-4\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"VYNE Therapeutics Announces New U.S. Patent Expiring in 2037 for AMZEEQ\u00ae (minocycline) topical foam, 4% - Market Newsdesk\" \/>\n<meta property=\"og:description\" content=\"New Granted Patent Listed in FDA\u2019s Orange Book for AMZEEQ BRIDGEWATER, N.J., Dec. 15, 2020 (GLOBE NEWSWIRE) &#8212; VYNE Therapeutics Inc. (Nasdaq: VYNE) (\u201cVYNE\u201d or the \u201cCompany\u201d), a specialty pharmaceutical company focused on developing and commercializing proprietary therapies to address unmet needs in dermatology, today announced listing another U.S. patent in the FDA\u2019s Approved Drug Products with Therapeutic Equivalence Evaluations (the \u201cOrange Book\u201d) for AMZEEQ\u00ae (minocycline) topical foam, 4%, for the topical\u00a0treatment\u00a0of inflammatory lesions of non-nodular moderate to severe acne\u00a0vulgaris in\u00a0adults\u00a0and pediatric patients 9 years of age and older. The patent\u2019s term expires in September 2037. This newly issued patent, U.S.10,849,847, is the latest U.S. patent to issue in connection with AMZEEQ. With the addition of this U.S. patent, there &hellip; Continue reading &quot;VYNE Therapeutics Announces New U.S. Patent Expiring in 2037 for AMZEEQ\u00ae (minocycline) topical foam, 4%&quot;\" \/>\n<meta property=\"og:url\" content=\"https:\/\/www.marketnewsdesk.com\/index.php\/vyne-therapeutics-announces-new-u-s-patent-expiring-in-2037-for-amzeeq-minocycline-topical-foam-4\/\" \/>\n<meta property=\"og:site_name\" content=\"Market Newsdesk\" \/>\n<meta property=\"article:published_time\" content=\"2020-12-15T13:03:15+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/www.globenewswire.com\/newsroom\/ti?nf=ODExMTg4NSMzODgwNDYxIzIwOTM4MDM=\" \/>\n<meta name=\"author\" content=\"Newsdesk\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:label1\" content=\"Written by\" \/>\n\t<meta name=\"twitter:data1\" content=\"Newsdesk\" \/>\n\t<meta name=\"twitter:label2\" content=\"Est. reading time\" \/>\n\t<meta name=\"twitter:data2\" content=\"7 minutes\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\\\/\\\/schema.org\",\"@graph\":[{\"@type\":\"Article\",\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/vyne-therapeutics-announces-new-u-s-patent-expiring-in-2037-for-amzeeq-minocycline-topical-foam-4\\\/#article\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/vyne-therapeutics-announces-new-u-s-patent-expiring-in-2037-for-amzeeq-minocycline-topical-foam-4\\\/\"},\"author\":{\"name\":\"Newsdesk\",\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/#\\\/schema\\\/person\\\/482f27a394d4fda80ecb5499e519d979\"},\"headline\":\"VYNE Therapeutics Announces New U.S. Patent Expiring in 2037 for AMZEEQ\u00ae (minocycline) topical foam, 4%\",\"datePublished\":\"2020-12-15T13:03:15+00:00\",\"mainEntityOfPage\":{\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/vyne-therapeutics-announces-new-u-s-patent-expiring-in-2037-for-amzeeq-minocycline-topical-foam-4\\\/\"},\"wordCount\":1507,\"image\":{\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/vyne-therapeutics-announces-new-u-s-patent-expiring-in-2037-for-amzeeq-minocycline-topical-foam-4\\\/#primaryimage\"},\"thumbnailUrl\":\"https:\\\/\\\/www.globenewswire.com\\\/newsroom\\\/ti?nf=ODExMTg4NSMzODgwNDYxIzIwOTM4MDM=\",\"inLanguage\":\"en-US\"},{\"@type\":\"WebPage\",\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/vyne-therapeutics-announces-new-u-s-patent-expiring-in-2037-for-amzeeq-minocycline-topical-foam-4\\\/\",\"url\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/vyne-therapeutics-announces-new-u-s-patent-expiring-in-2037-for-amzeeq-minocycline-topical-foam-4\\\/\",\"name\":\"VYNE Therapeutics Announces New U.S. Patent Expiring in 2037 for AMZEEQ\u00ae (minocycline) topical foam, 4% - 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Market Newsdesk","robots":{"index":"index","follow":"follow","max-snippet":"max-snippet:-1","max-image-preview":"max-image-preview:large","max-video-preview":"max-video-preview:-1"},"canonical":"https:\/\/www.marketnewsdesk.com\/index.php\/vyne-therapeutics-announces-new-u-s-patent-expiring-in-2037-for-amzeeq-minocycline-topical-foam-4\/","og_locale":"en_US","og_type":"article","og_title":"VYNE Therapeutics Announces New U.S. Patent Expiring in 2037 for AMZEEQ\u00ae (minocycline) topical foam, 4% - Market Newsdesk","og_description":"New Granted Patent Listed in FDA\u2019s Orange Book for AMZEEQ BRIDGEWATER, N.J., Dec. 15, 2020 (GLOBE NEWSWIRE) &#8212; VYNE Therapeutics Inc. (Nasdaq: VYNE) (\u201cVYNE\u201d or the \u201cCompany\u201d), a specialty pharmaceutical company focused on developing and commercializing proprietary therapies to address unmet needs in dermatology, today announced listing another U.S. patent in the FDA\u2019s Approved Drug Products with Therapeutic Equivalence Evaluations (the \u201cOrange Book\u201d) for AMZEEQ\u00ae (minocycline) topical foam, 4%, for the topical\u00a0treatment\u00a0of inflammatory lesions of non-nodular moderate to severe acne\u00a0vulgaris in\u00a0adults\u00a0and pediatric patients 9 years of age and older. The patent\u2019s term expires in September 2037. This newly issued patent, U.S.10,849,847, is the latest U.S. patent to issue in connection with AMZEEQ. 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