{"id":500618,"date":"2021-06-03T16:04:38","date_gmt":"2021-06-03T20:04:38","guid":{"rendered":"https:\/\/www.marketnewsdesk.com\/index.php\/strongbridge-biopharma-plc-announces-issuance-of-patent-for-recorlev-levoketoconazole-for-the-treatment-of-cushings-syndrome\/"},"modified":"2021-06-03T16:04:38","modified_gmt":"2021-06-03T20:04:38","slug":"strongbridge-biopharma-plc-announces-issuance-of-patent-for-recorlev-levoketoconazole-for-the-treatment-of-cushings-syndrome","status":"publish","type":"post","link":"https:\/\/www.marketnewsdesk.com\/index.php\/strongbridge-biopharma-plc-announces-issuance-of-patent-for-recorlev-levoketoconazole-for-the-treatment-of-cushings-syndrome\/","title":{"rendered":"Strongbridge Biopharma plc Announces Issuance of Patent for RECORLEV\u00ae (levoketoconazole) for the Treatment of Cushing\u2019s Syndrome"},"content":{"rendered":"<div class=\"mw_release\">\n<p align=\"justify\">DUBLIN, Ireland and TREVOSE, Pa., June  03, 2021  (GLOBE NEWSWIRE) &#8212; Strongbridge Biopharma plc, (Nasdaq: SBBP), a global commercial-stage biopharmaceutical company focused on the development and commercialization of therapies for rare diseases with significant unmet needs, today announced that the United States Patent and Trademark Office (USPTO) has issued U.S. Patent No. 11,020,393 entitled, \u201cMethods of Treating Disease with Levoketoconazole\u201d which covers a method of treating Cushing\u2019s syndrome patients with RECORLEV<sup>\u00ae<\/sup> (levoketoconazole) who also take metformin for Type 2 diabetes. The term of the U.S. patent will expire on March 2, 2040.<\/p>\n<p align=\"justify\">This will be the third patent issued in the U.S. relating to RECORLEV. The first, U.S. Patent No. 9,198,906, covers methods of reducing C-reactive protein levels and systemic inflammation through administration of a once-daily dose of RECORLEV and will expire on December 29, 2030. The second, U.S. patent No. 9,918,984, covers methods of treating Cushing\u2019s syndrome with levoketoconazole and will expire on January 10, 2026.<\/p>\n<p align=\"justify\">RECORLEV is an adrenal steroidogenesis inhibitor with a New Drug Application that is currently under review by the U.S. Food and Drug Administration for the treatment of endogenous Cushing\u2019s syndrome.<\/p>\n<p align=\"justify\">\n        <strong>About Cushing\u2019s Syndrome<\/strong><br \/>\n        <br \/>Endogenous Cushing\u2019s syndrome, is a rare, serious and potentially lethal endocrine disease caused by chronic elevated cortisol exposure &#8211; often the result of a benign tumor of the pituitary gland. This benign tumor tells the body to overproduce high levels of cortisol for a sustained period of time, and this often results in undesirable physical changes. The disease is most common among adults between the ages of 30 to 50, and it affects women two times more often than men. Women with Cushing&#8217;s syndrome may experience a variety of health issues including menstrual problems, difficulty becoming pregnant, excess male hormones (androgens), primarily testosterone which can cause hirsutism (growth of coarse body hair in a male pattern), oily skin, and acne. Additionally, the internal manifestations of the disease are potentially life threatening. These include metabolic changes such as high blood sugar, or diabetes, high blood pressure, high cholesterol, fragility of various tissues including blood vessels, skin, muscle and bone, and psychologic disturbances such as depression, anxiety and insomnia. Untreated, the five-year survival rate is only approximately 50 percent.<\/p>\n<p align=\"justify\">\n        <strong>About RECORLEV<\/strong><br \/>\n        <br \/>RECORLEV<sup>\u00ae<\/sup> (levoketoconazole) is an investigational adrenal steroidogenesis inhibitor in development for the treatment of patients with endogenous Cushing\u2019s syndrome, a rare but serious and potentially lethal endocrine disease caused by chronic elevated cortisol exposure. RECORLEV is the pure 2S,4R enantiomer of ketoconazole, a steroidogenesis inhibitor. RECORLEV has demonstrated in two successful Phase 3 studies to significantly suppress serum cortisol and has the potential to be a next-generation cortisol inhibitor.<\/p>\n<p align=\"justify\">The Phase 3 program for RECORLEV includes SONICS and LOGICS: two multinational studies designed to evaluate the safety and efficacy of RECORLEV when used to treat endogenous Cushing\u2019s syndrome. The SONICS study met its primary and secondary endpoints, demonstrating a statistically significant normalization rate of urinary free cortisol at six months. The LOGICS study, which met its primary endpoint and key secondary endpoint, is a double-blind, placebo-controlled randomized-withdrawal study of RECORLEV that is designed to supplement the long-term efficacy and safety information supplied by SONICS. The ongoing long-term open label OPTICS study will gather further useful information related to the long-term use of RECORLEV.<\/p>\n<p align=\"justify\">RECORLEV has received orphan drug designation from the FDA and the\u00a0European Medicines Agency\u00a0for the treatment of endogenous Cushing&#8217;s syndrome.<\/p>\n<p align=\"justify\">\n        <strong>About Strongbridge Biopharma<\/strong><br \/>\n        <br \/>Strongbridge Biopharma is a global commercial-stage biopharmaceutical company focused on the development and commercialization of therapies for rare diseases with significant unmet needs. Strongbridge\u2019s rare endocrine franchise includes RECORLEV<sup>\u00ae<\/sup>\u00a0(levoketoconazole), an adrenal steroidogenesis inhibitor with a New Drug Application that is currently under review by the FDA for the treatment of endogenous Cushing\u2019s syndrome, and veldoreotide extended release, a pre-clinical next-generation somatostatin analog being investigated for the treatment of acromegaly and potential additional applications in other conditions amenable to somatostatin receptor activation. Both RECORLEV and veldoreotide have received orphan drug designation from the FDA and the European Medicines Agency. The company\u2019s rare neuromuscular franchise includes KEVEYIS<sup>\u00ae<\/sup>\u00a0(dichlorphenamide), the first and only FDA-approved treatment for hyperkalemic, hypokalemic, and related variants of primary periodic paralysis. KEVEYIS has orphan drug exclusivity in the United States.<\/p>\n<p align=\"justify\">\n        <strong>Forward-Looking Statements<br \/><\/strong><br \/>\n        <em>This press release contains forward-looking statements within the meaning of the federal securities laws. The words \u201canticipate,\u201d \u201cestimate,\u201d \u201cexpect,\u201d \u201cintend,\u201d \u201cmay,\u201d \u201cplan,\u201d \u201cpotential,\u201d \u201cproject,\u201d \u201ctarget,\u201d \u201cwill,\u201d \u201cwould,\u201d or the negative of these terms or other similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. All statements, other than statements of historical facts, contained in this press release, are forward-looking statements, including statements related\u00a0to\u00a0Strongbridge\u2019s strategy, plans, intellectual property portfolio, outcomes of product development efforts and objectives of management for future operations. Forward-looking statements involve risks and uncertainties that could cause actual results to differ materially from those expressed in such statement, including risks and uncertainties associated with clinical development and the regulatory approval process, the reproducibility of any reported results showing the benefits of RECORLEV, the adoption of RECORLEV by physicians, if approved, as treatment for any disease and the emergence of unexpected adverse events following regulatory approval and use of the product by patients.\u00a0 Additional risks and uncertainties relating to Strongbridge and its business can be found under the heading \u201cRisk Factors\u201d in Strongbridge\u2019s Annual Report on Form 10-K for the year ended\u00a0December 31, 2020\u00a0and its subsequent Quarterly Reports on Form 10-Q, as well as its other filings with the\u00a0SEC. These forward-looking statements are based on current expectations, estimates, forecasts and projections and are not guarantees of future performance or development and involve known and unknown risks, uncertainties and other factors. The forward-looking statements contained in this press release are made as of the date of this press release, and\u00a0Strongbridge Biopharma\u00a0does not assume any obligation to update any forward-looking statements except as required by applicable law.<\/em>\n      <\/p>\n<p align=\"justify\">\n        <strong>Contacts:<\/strong>\n      <\/p>\n<p>\n        <strong>Corporate and Media Relations<\/strong><br \/>\n        <br \/>Elixir Health Public Relations<br \/>Lindsay Rocco<br \/>+1 862-596-1304<br \/><a href=\"https:\/\/www.globenewswire.com\/Tracker?data=eAAyD6N-BusVR5dcKHPbfIbYW_YdMHHRrOX5lXzFUZ6gAsXuGLfX6aKbrFLSO2u9Y-bJnmHwBeZ7qCtJUiQksworVCa2zcTadmfMDE5vCOk=\" rel=\"nofollow noopener\" target=\"_blank\"><strong>lrocco@elixirhealthpr.com<\/strong><\/a><\/p>\n<p>\n        <strong>Investor Relations<\/strong><br \/>\n        <br \/>Solebury Trout<br \/>Mike Biega<br \/>+1 617-221-9660<br \/><a href=\"https:\/\/www.globenewswire.com\/Tracker?data=qTr3FZuffUgxEr1Li2aoMYoMAeIFbU3BHeJ9x_z3PhJoezXzbgVYuLyDuAeGkfVoEk4YFX2hOK5qeYPMFhMJbUcrJFnMboqTKnwnLHmW3gI=\" rel=\"nofollow noopener\" target=\"_blank\"><strong>mbiega@soleburytrout.com<\/strong><\/a><\/p>\n<p>      <img loading=\"lazy\" decoding=\"async\" class=\"__GNW8366DE3E__IMG\" src=\"https:\/\/www.globenewswire.com\/newsroom\/ti?nf=ODI0ODUzOCM0MjI2NzcxIzIwMjAwMjU=\" width=\"1\" height=\"1\" \/><br \/>\n      <br \/>\n      <img loading=\"lazy\" decoding=\"async\" class=\"__GNW8366DE3E__IMG\" src=\"https:\/\/ml.globenewswire.com\/release\/track\/708b956a-4f82-469b-962e-fdd38b8b35b7\" width=\"1\" height=\"1\" \/>\n    <\/div>\n<div class=\"mw_contactinfo\"><\/div>\n","protected":false},"excerpt":{"rendered":"<p>DUBLIN, Ireland and TREVOSE, Pa., June 03, 2021 (GLOBE NEWSWIRE) &#8212; Strongbridge Biopharma plc, (Nasdaq: SBBP), a global commercial-stage biopharmaceutical company focused on the development and commercialization of therapies for rare diseases with significant unmet needs, today announced that the United States Patent and Trademark Office (USPTO) has issued U.S. Patent No. 11,020,393 entitled, \u201cMethods of Treating Disease with Levoketoconazole\u201d which covers a method of treating Cushing\u2019s syndrome patients with RECORLEV\u00ae (levoketoconazole) who also take metformin for Type 2 diabetes. The term of the U.S. patent will expire on March 2, 2040. This will be the third patent issued in the U.S. relating to RECORLEV. The first, U.S. Patent No. 9,198,906, covers methods of reducing C-reactive protein levels and systemic &hellip; <\/p>\n<p class=\"link-more\"><a href=\"https:\/\/www.marketnewsdesk.com\/index.php\/strongbridge-biopharma-plc-announces-issuance-of-patent-for-recorlev-levoketoconazole-for-the-treatment-of-cushings-syndrome\/\" class=\"more-link\">Continue reading<span class=\"screen-reader-text\"> &#8220;Strongbridge Biopharma plc Announces Issuance of Patent for RECORLEV\u00ae (levoketoconazole) for the Treatment of Cushing\u2019s Syndrome&#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-500618","post","type-post","status-publish","format-standard","hentry"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.8 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Strongbridge Biopharma plc Announces Issuance of Patent for RECORLEV\u00ae (levoketoconazole) for the Treatment of Cushing\u2019s Syndrome - 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\/strongbridge-biopharma-plc-announces-issuance-of-patent-for-recorlev-levoketoconazole-for-the-treatment-of-cushings-syndrome\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Strongbridge Biopharma plc Announces Issuance of Patent for RECORLEV\u00ae (levoketoconazole) for the Treatment of Cushing\u2019s Syndrome - Market Newsdesk\" \/>\n<meta property=\"og:description\" content=\"DUBLIN, Ireland and TREVOSE, Pa., June 03, 2021 (GLOBE NEWSWIRE) &#8212; Strongbridge Biopharma plc, (Nasdaq: SBBP), a global commercial-stage biopharmaceutical company focused on the development and commercialization of therapies for rare diseases with significant unmet needs, today announced that the United States Patent and Trademark Office (USPTO) has issued U.S. Patent No. 11,020,393 entitled, \u201cMethods of Treating Disease with Levoketoconazole\u201d which covers a method of treating Cushing\u2019s syndrome patients with RECORLEV\u00ae (levoketoconazole) who also take metformin for Type 2 diabetes. The term of the U.S. patent will expire on March 2, 2040. This will be the third patent issued in the U.S. relating to RECORLEV. The first, U.S. Patent No. 9,198,906, covers methods of reducing C-reactive protein levels and systemic &hellip; Continue reading &quot;Strongbridge Biopharma plc Announces Issuance of Patent for RECORLEV\u00ae (levoketoconazole) for the Treatment of Cushing\u2019s Syndrome&quot;\" \/>\n<meta property=\"og:url\" content=\"https:\/\/www.marketnewsdesk.com\/index.php\/strongbridge-biopharma-plc-announces-issuance-of-patent-for-recorlev-levoketoconazole-for-the-treatment-of-cushings-syndrome\/\" \/>\n<meta property=\"og:site_name\" content=\"Market Newsdesk\" \/>\n<meta property=\"article:published_time\" content=\"2021-06-03T20:04:38+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/www.globenewswire.com\/newsroom\/ti?nf=ODI0ODUzOCM0MjI2NzcxIzIwMjAwMjU=\" \/>\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=\"5 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\\\/strongbridge-biopharma-plc-announces-issuance-of-patent-for-recorlev-levoketoconazole-for-the-treatment-of-cushings-syndrome\\\/#article\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/strongbridge-biopharma-plc-announces-issuance-of-patent-for-recorlev-levoketoconazole-for-the-treatment-of-cushings-syndrome\\\/\"},\"author\":{\"name\":\"Newsdesk\",\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/#\\\/schema\\\/person\\\/482f27a394d4fda80ecb5499e519d979\"},\"headline\":\"Strongbridge Biopharma plc Announces Issuance of Patent for RECORLEV\u00ae (levoketoconazole) for the Treatment of Cushing\u2019s Syndrome\",\"datePublished\":\"2021-06-03T20:04:38+00:00\",\"mainEntityOfPage\":{\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/strongbridge-biopharma-plc-announces-issuance-of-patent-for-recorlev-levoketoconazole-for-the-treatment-of-cushings-syndrome\\\/\"},\"wordCount\":1023,\"image\":{\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/strongbridge-biopharma-plc-announces-issuance-of-patent-for-recorlev-levoketoconazole-for-the-treatment-of-cushings-syndrome\\\/#primaryimage\"},\"thumbnailUrl\":\"https:\\\/\\\/www.globenewswire.com\\\/newsroom\\\/ti?nf=ODI0ODUzOCM0MjI2NzcxIzIwMjAwMjU=\",\"inLanguage\":\"en-US\"},{\"@type\":\"WebPage\",\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/strongbridge-biopharma-plc-announces-issuance-of-patent-for-recorlev-levoketoconazole-for-the-treatment-of-cushings-syndrome\\\/\",\"url\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/strongbridge-biopharma-plc-announces-issuance-of-patent-for-recorlev-levoketoconazole-for-the-treatment-of-cushings-syndrome\\\/\",\"name\":\"Strongbridge Biopharma plc Announces Issuance of Patent for RECORLEV\u00ae (levoketoconazole) for the Treatment of Cushing\u2019s Syndrome - 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The term of the U.S. patent will expire on March 2, 2040. This will be the third patent issued in the U.S. relating to RECORLEV. The first, U.S. Patent No. 9,198,906, covers methods of reducing C-reactive protein levels and systemic &hellip; Continue reading \"Strongbridge Biopharma plc Announces Issuance of Patent for RECORLEV\u00ae (levoketoconazole) for the Treatment of Cushing\u2019s Syndrome\"","og_url":"https:\/\/www.marketnewsdesk.com\/index.php\/strongbridge-biopharma-plc-announces-issuance-of-patent-for-recorlev-levoketoconazole-for-the-treatment-of-cushings-syndrome\/","og_site_name":"Market Newsdesk","article_published_time":"2021-06-03T20:04:38+00:00","og_image":[{"url":"https:\/\/www.globenewswire.com\/newsroom\/ti?nf=ODI0ODUzOCM0MjI2NzcxIzIwMjAwMjU=","type":"","width":"","height":""}],"author":"Newsdesk","twitter_card":"summary_large_image","twitter_misc":{"Written by":"Newsdesk","Est. reading time":"5 minutes"},"schema":{"@context":"https:\/\/schema.org","@graph":[{"@type":"Article","@id":"https:\/\/www.marketnewsdesk.com\/index.php\/strongbridge-biopharma-plc-announces-issuance-of-patent-for-recorlev-levoketoconazole-for-the-treatment-of-cushings-syndrome\/#article","isPartOf":{"@id":"https:\/\/www.marketnewsdesk.com\/index.php\/strongbridge-biopharma-plc-announces-issuance-of-patent-for-recorlev-levoketoconazole-for-the-treatment-of-cushings-syndrome\/"},"author":{"name":"Newsdesk","@id":"https:\/\/www.marketnewsdesk.com\/#\/schema\/person\/482f27a394d4fda80ecb5499e519d979"},"headline":"Strongbridge Biopharma plc Announces Issuance of Patent for RECORLEV\u00ae (levoketoconazole) for the Treatment of Cushing\u2019s Syndrome","datePublished":"2021-06-03T20:04:38+00:00","mainEntityOfPage":{"@id":"https:\/\/www.marketnewsdesk.com\/index.php\/strongbridge-biopharma-plc-announces-issuance-of-patent-for-recorlev-levoketoconazole-for-the-treatment-of-cushings-syndrome\/"},"wordCount":1023,"image":{"@id":"https:\/\/www.marketnewsdesk.com\/index.php\/strongbridge-biopharma-plc-announces-issuance-of-patent-for-recorlev-levoketoconazole-for-the-treatment-of-cushings-syndrome\/#primaryimage"},"thumbnailUrl":"https:\/\/www.globenewswire.com\/newsroom\/ti?nf=ODI0ODUzOCM0MjI2NzcxIzIwMjAwMjU=","inLanguage":"en-US"},{"@type":"WebPage","@id":"https:\/\/www.marketnewsdesk.com\/index.php\/strongbridge-biopharma-plc-announces-issuance-of-patent-for-recorlev-levoketoconazole-for-the-treatment-of-cushings-syndrome\/","url":"https:\/\/www.marketnewsdesk.com\/index.php\/strongbridge-biopharma-plc-announces-issuance-of-patent-for-recorlev-levoketoconazole-for-the-treatment-of-cushings-syndrome\/","name":"Strongbridge Biopharma plc Announces Issuance of Patent for RECORLEV\u00ae (levoketoconazole) for the Treatment of Cushing\u2019s Syndrome - 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