{"id":796063,"date":"2024-12-19T07:05:12","date_gmt":"2024-12-19T12:05:12","guid":{"rendered":"https:\/\/www.marketnewsdesk.com\/index.php\/lifecore-biomedical-selected-by-nirsum-labs-to-provide-cdmo-services-supporting-clinical-development-of-innovative-opioid-use-disorder-treatment\/"},"modified":"2024-12-19T07:05:12","modified_gmt":"2024-12-19T12:05:12","slug":"lifecore-biomedical-selected-by-nirsum-labs-to-provide-cdmo-services-supporting-clinical-development-of-innovative-opioid-use-disorder-treatment","status":"publish","type":"post","link":"https:\/\/www.marketnewsdesk.com\/index.php\/lifecore-biomedical-selected-by-nirsum-labs-to-provide-cdmo-services-supporting-clinical-development-of-innovative-opioid-use-disorder-treatment\/","title":{"rendered":"Lifecore Biomedical Selected by Nirsum Labs to Provide CDMO Services Supporting Clinical Development of Innovative Opioid Use Disorder Treatment"},"content":{"rendered":"<div class=\"mw_release\">\n<p align=\"center\">\n        <em>Development Services Span Tech Transfer, Process Assessment and Method Validation for Fill and Finish of NRS-033 for Planned Phase 2 Trial<\/em>\n      <\/p>\n<p align=\"center\">\n        <em>Lifecore to Leverage Differentiated Capabilities and Knowledge in Fill and Finish to Support Nirsum\u2019s NIH-Funded NRS-033 Development Program<\/em>\n      <\/p>\n<p align=\"justify\">CHASKA, Minn., Dec.  19, 2024  (GLOBE NEWSWIRE) &#8212; Lifecore Biomedical, Inc. (NASDAQ: <a href=\"https:\/\/www.globenewswire.com\/Tracker?data=mFPG9O4t9VW_eJez6Tuhuuvrb0kNMTWcHuZbDAmQoovfI5OGumrW7stfJMQ3nK29P7r84OEeaP-0DOaE9ybWn_Yl6fYBvY8ghT8d-WrvfJ8=\" rel=\"nofollow\" target=\"_blank\">LFCR<\/a>) (\u201cLifecore\u201d), a fully integrated contract development and manufacturing organization (\u201cCDMO\u201d), today announced that it has been selected by Nirsum Laboratories, Inc. (\u201cNirsum\u201d) to provide CDMO services focused on supporting Nirsum\u2019s clinical development of its lead development candidate, NRS-033. The activities to be conducted under the agreement include the assessment and technology transfer of the fill and finish process for NRS-033. These assessments will rely upon Lifecore\u2019s differentiated expertise in the fill and finish of sterile injectable pharmaceutical products, potentially allowing Lifecore to create an overarching development and commercialization plan for the entire fill and finish process for NRS-033.<\/p>\n<p align=\"justify\">NRS-033 is a novel treatment for opioid use disorder (OUD) and alcohol use disorder (AUD). NRS-033, which is wholly owned and internally discovered by Nirsum, is currently entering Phase 2 clinical development. The newly signed agreement will position Lifecore to provide Nirsum with filled syringes for use in clinical development of NRS-033.<\/p>\n<p align=\"justify\">\u201cWith growing concerns about opioid and alcohol addiction in the U.S. and beyond, we\u2019re grateful for the opportunity to support Nirsum on this important and promising treatment. Our agreement will enable Lifecore to apply our experience with complex formulations to the assessment, enhancement and validation of the fill and finish process for NRS-033,\u201d said Paul Josephs, chief executive officer of Lifecore. \u201cWe are excited to add Nirsum to our growing list of customers and appreciative that their team has entrusted us to collaborate with them on these activities.\u201d<\/p>\n<p align=\"justify\">\u201cWe believe that opioid and alcohol use disorders are enormous unmet needs, each with just a few decades-old, FDA-approved treatment options available. We believe NRS-033 will be a key innovation, solving the critical problem of short therapeutic retention of available therapies that results in high relapse rates for abstinence-seeking patients with OUD and AUD. By improving therapeutic retention with NRS-033, Nirsum aims to give hope to the millions of Americans with OUD and AUD,\u201d said Nikej Shah, M.D., chief executive officer of Nirsum Labs. \u201cWe are excited to begin our work with Lifecore to potentially help bring our important therapy through further clinical development and commercialization.\u201d<\/p>\n<p align=\"justify\">\n        <strong>About Lifecore Biomedical <\/strong>\n      <\/p>\n<p align=\"justify\">Lifecore Biomedical, Inc. (Nasdaq: <a href=\"https:\/\/www.globenewswire.com\/Tracker?data=mFPG9O4t9VW_eJez6TuhunxeQI_T0zW3Amu_4OYNqQNScVYCDO9SuNo1f57_Frm8fJjLcnlFQQ023R6tpGLnrYL68NnSrjofrrL_RDUb3P0=\" rel=\"nofollow\" target=\"_blank\">LFCR<\/a>) is a fully integrated contract development and manufacturing organization (CDMO) that offers highly differentiated capabilities in the development, fill and finish of sterile injectable pharmaceutical products in syringes, vials, and cartridges, including complex formulations. As a leading manufacturer of premium, injectable-grade hyaluronic acid, Lifecore brings more than 40 years of expertise as a partner for global and emerging biopharmaceutical and biotechnology companies across multiple therapeutic categories to bring their innovations to market. For more information about the company, visit Lifecore\u2019s website at <a href=\"https:\/\/www.globenewswire.com\/Tracker?data=SASNvsMeKBWLbbVYDtYZ94KZSh-kbGYKA0TSlua-0TtupazmTiXLAzkEnjtZ04Dj6gBobgnlnnnZ1GPm6E8cpw==\" rel=\"nofollow\" target=\"_blank\">www.lifecore.com<\/a>.<\/p>\n<p align=\"justify\">\n        <strong>About Nirsum Labs <\/strong>\n      <\/p>\n<p align=\"justify\">Nirsum Laboratories, Inc. is a development stage biotechnology company committed to making addiction curable. Nirsum is developing NRS-033 in OUD and AUD, which are high unmet needs with pressing public health urgency. NRS-033\u2019s\u00a0development is funded in part through a Cooperative Agreement with the United States National Institutes of Health (HEAL Initiative award <a href=\"https:\/\/www.globenewswire.com\/Tracker?data=sQ98hQ1scTk6-YEDQ8TmiVK7-vXIhG-keCP5BSYskxNAcNNsn9f_o6d5VYKbXLqD1nuhimyIm1PMfIOzbXxhFZjocWZyF9qXWcK_QBqB9DUThJpr6O894OXTWIkdJD9oKC220K-TK7H5P65YH7R6tLTgEDBy_ZTBxEtmndr2l4E=\" rel=\"nofollow\" target=\"_blank\">UH3DA048234<\/a> and <a href=\"https:\/\/www.globenewswire.com\/Tracker?data=WvdiLUX4sH47MN4_yLVUnbVKTIQrvFSGkR5nUGENW1yY1N8jMONd5OP8tCW4XZE4x9jk8bgr_uNNIZszFyiChkLuCowr6weCG0FMqvOQbaQS157BrC7ZMiScLp_fxMkDePnkB2kYl8Y4LoUEaTt67w4gP6eIHJpF3I47dt9HIhw=\" rel=\"nofollow\" target=\"_blank\">U01DA061643<\/a>).\u00a0 For more information about the company, visit Nirsum\u2019s website at <a href=\"https:\/\/www.globenewswire.com\/Tracker?data=sl9LQgCPUDn_fFFIth9D3shlbCTr0LahimTP95dkCSWWmWU6m7fF9pyzeJxNtWLXym5rWp3lC3ia4ax9hZLCUA==\" rel=\"nofollow\" target=\"_blank\">www.nirsum.com<\/a>.<\/p>\n<p align=\"justify\">\n        <strong><br \/>\n          <em>Important Cautions Regarding Forward-Looking Statements<\/em><br \/>\n        <\/strong>\n      <\/p>\n<p align=\"justify\">\n        <em>This press release contains forward-looking statements regarding future events and our future results that are subject to the safe harbor created under the Private Securities Litigation Reform Act of 1995 and other safe harbors under the Securities Act of 1933 and the Securities Exchange Act of 1934. Words such as \u201canticipate\u201d, \u201cestimate\u201d, \u201cexpect\u201d, \u201cproject\u201d, \u201cplan\u201d, \u201cintend\u201d, \u201cbelieve\u201d, \u201cmay\u201d, \u201cmight\u201d, \u201cwill\u201d, \u201cshould\u201d, \u201ccan have\u201d, \u201clikely\u201d and similar expressions are used to identify forward-looking statements. In addition, all statements regarding our anticipated future operating and financial expectations, customer opportunities and relationships, and potential market size or opportunities for customer products are forward-looking statements. All forward-looking statements involve certain risks and uncertainties that could cause actual results to differ materially, including such factors among others, as the company\u2019s ability to successfully enact its business strategies, including with respect to installation, capacity generation and its ability to attract demand for its services, and its ability expand its relationship with its existing customers or attract new customers; the scope or anticipated markets for any products to be manufactured by Lifecore, the abiltiy for customers to obtain regulatory approvals on their anticipated timing, or at all, the nature of the competitive landscape for us or our customers, the impact of inflation on Lifecore\u2019s business and financial condition; changes in business conditions and general economic conditions both domestically and globally, including rising interest rates and fluctuation in foreign currency exchange rates; Lifecore\u2019s ability to access sufficient capital to fund its business strategies; and other risk factors set forth from time to time in Lifecore\u2019s SEC filings, including, but not limited to, the Annual Report on Form 10-K for the year ended May 26, 2024 (the \u201c2024 10-K\u201d). For additional information about factors that could cause actual results to differ materially from those described in the forward-looking statements, please refer to our filings with the Securities and Exchange Commission, including the risk factors contained in the 2024 10-K. Forward-looking statements represent management\u2019s current expectations as of the date hereof and are inherently uncertain. Except as required by law, we do not undertake any obligation to update forward-looking statements made by us to reflect subsequent events or circumstances.<\/em>\n      <\/p>\n<p>      <img decoding=\"async\" alt=\"\" class=\"__GNW8366DE3E__IMG\" src=\"https:\/\/www.globenewswire.com\/newsroom\/ti?nf=OTMyMTY2NCM2NjQ0MjgxIzIwMDc3NTY=\" \/><br \/>\n      <br \/>\n      <img decoding=\"async\" alt=\"\" src=\"https:\/\/ml.globenewswire.com\/media\/ZDVkYmYwYjEtYTFjMy00NTkxLWIzMzktZWIwMjc4ZTA5YWY1LTEwMTkzMjk=\/tiny\/Lifecore-Biomedical-Inc-.png\" \/>\n    <\/div>\n<div class=\"mw_contactinfo\">\n<pre>Lifecore Biomedical, Inc. Contact Information:\r\n\r\nVida Strategic Partners\r\nStephanie Diaz (Investors)\r\n415-675-7401\r\nsdiaz@vidasp.com\u00a0\r\n\r\nTim Brons (Media)\r\n415-675-7402\r\ntbrons@vidasp.com\u00a0\r\n\r\nRyan D. Lake (CFO)\r\nLifecore Biomedical\r\n952-368-6244\r\nryan.lake@lifecore.com\r\n\r\nNirsum Laboratories, Inc. Contact Information:\r\n\r\nNikej Shah, M.D. (CEO)\r\nNirsum Laboratories, Inc.\r\nnshah@nirsum.com<\/pre>\n<\/p><\/div>\n","protected":false},"excerpt":{"rendered":"<p>Development Services Span Tech Transfer, Process Assessment and Method Validation for Fill and Finish of NRS-033 for Planned Phase 2 Trial Lifecore to Leverage Differentiated Capabilities and Knowledge in Fill and Finish to Support Nirsum\u2019s NIH-Funded NRS-033 Development Program CHASKA, Minn., Dec. 19, 2024 (GLOBE NEWSWIRE) &#8212; Lifecore Biomedical, Inc. (NASDAQ: LFCR) (\u201cLifecore\u201d), a fully integrated contract development and manufacturing organization (\u201cCDMO\u201d), today announced that it has been selected by Nirsum Laboratories, Inc. (\u201cNirsum\u201d) to provide CDMO services focused on supporting Nirsum\u2019s clinical development of its lead development candidate, NRS-033. The activities to be conducted under the agreement include the assessment and technology transfer of the fill and finish process for NRS-033. These assessments will rely upon Lifecore\u2019s differentiated expertise &hellip; <\/p>\n<p class=\"link-more\"><a href=\"https:\/\/www.marketnewsdesk.com\/index.php\/lifecore-biomedical-selected-by-nirsum-labs-to-provide-cdmo-services-supporting-clinical-development-of-innovative-opioid-use-disorder-treatment\/\" class=\"more-link\">Continue reading<span class=\"screen-reader-text\"> &#8220;Lifecore Biomedical Selected by Nirsum Labs to Provide CDMO Services Supporting Clinical Development of Innovative Opioid Use Disorder Treatment&#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-796063","post","type-post","status-publish","format-standard","hentry"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.5 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Lifecore Biomedical Selected by Nirsum Labs to Provide CDMO Services Supporting Clinical Development of Innovative Opioid Use Disorder Treatment - 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\/lifecore-biomedical-selected-by-nirsum-labs-to-provide-cdmo-services-supporting-clinical-development-of-innovative-opioid-use-disorder-treatment\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Lifecore Biomedical Selected by Nirsum Labs to Provide CDMO Services Supporting Clinical Development of Innovative Opioid Use Disorder Treatment - Market Newsdesk\" \/>\n<meta property=\"og:description\" content=\"Development Services Span Tech Transfer, Process Assessment and Method Validation for Fill and Finish of NRS-033 for Planned Phase 2 Trial Lifecore to Leverage Differentiated Capabilities and Knowledge in Fill and Finish to Support Nirsum\u2019s NIH-Funded NRS-033 Development Program CHASKA, Minn., Dec. 19, 2024 (GLOBE NEWSWIRE) &#8212; Lifecore Biomedical, Inc. (NASDAQ: LFCR) (\u201cLifecore\u201d), a fully integrated contract development and manufacturing organization (\u201cCDMO\u201d), today announced that it has been selected by Nirsum Laboratories, Inc. (\u201cNirsum\u201d) to provide CDMO services focused on supporting Nirsum\u2019s clinical development of its lead development candidate, NRS-033. The activities to be conducted under the agreement include the assessment and technology transfer of the fill and finish process for NRS-033. These assessments will rely upon Lifecore\u2019s differentiated expertise &hellip; Continue reading &quot;Lifecore Biomedical Selected by Nirsum Labs to Provide CDMO Services Supporting Clinical Development of Innovative Opioid Use Disorder Treatment&quot;\" \/>\n<meta property=\"og:url\" content=\"https:\/\/www.marketnewsdesk.com\/index.php\/lifecore-biomedical-selected-by-nirsum-labs-to-provide-cdmo-services-supporting-clinical-development-of-innovative-opioid-use-disorder-treatment\/\" \/>\n<meta property=\"og:site_name\" content=\"Market Newsdesk\" \/>\n<meta property=\"article:published_time\" content=\"2024-12-19T12:05:12+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/www.globenewswire.com\/newsroom\/ti?nf=OTMyMTY2NCM2NjQ0MjgxIzIwMDc3NTY=\" \/>\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\\\/lifecore-biomedical-selected-by-nirsum-labs-to-provide-cdmo-services-supporting-clinical-development-of-innovative-opioid-use-disorder-treatment\\\/#article\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/lifecore-biomedical-selected-by-nirsum-labs-to-provide-cdmo-services-supporting-clinical-development-of-innovative-opioid-use-disorder-treatment\\\/\"},\"author\":{\"name\":\"Newsdesk\",\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/#\\\/schema\\\/person\\\/482f27a394d4fda80ecb5499e519d979\"},\"headline\":\"Lifecore Biomedical Selected by Nirsum Labs to Provide CDMO Services Supporting Clinical Development of Innovative Opioid Use Disorder Treatment\",\"datePublished\":\"2024-12-19T12:05:12+00:00\",\"mainEntityOfPage\":{\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/lifecore-biomedical-selected-by-nirsum-labs-to-provide-cdmo-services-supporting-clinical-development-of-innovative-opioid-use-disorder-treatment\\\/\"},\"wordCount\":948,\"image\":{\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/lifecore-biomedical-selected-by-nirsum-labs-to-provide-cdmo-services-supporting-clinical-development-of-innovative-opioid-use-disorder-treatment\\\/#primaryimage\"},\"thumbnailUrl\":\"https:\\\/\\\/www.globenewswire.com\\\/newsroom\\\/ti?nf=OTMyMTY2NCM2NjQ0MjgxIzIwMDc3NTY=\",\"inLanguage\":\"en-US\"},{\"@type\":\"WebPage\",\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/lifecore-biomedical-selected-by-nirsum-labs-to-provide-cdmo-services-supporting-clinical-development-of-innovative-opioid-use-disorder-treatment\\\/\",\"url\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/lifecore-biomedical-selected-by-nirsum-labs-to-provide-cdmo-services-supporting-clinical-development-of-innovative-opioid-use-disorder-treatment\\\/\",\"name\":\"Lifecore Biomedical Selected by Nirsum Labs to Provide CDMO Services Supporting Clinical Development of Innovative Opioid Use Disorder Treatment - 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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\/lifecore-biomedical-selected-by-nirsum-labs-to-provide-cdmo-services-supporting-clinical-development-of-innovative-opioid-use-disorder-treatment\/","og_locale":"en_US","og_type":"article","og_title":"Lifecore Biomedical Selected by Nirsum Labs to Provide CDMO Services Supporting Clinical Development of Innovative Opioid Use Disorder Treatment - Market Newsdesk","og_description":"Development Services Span Tech Transfer, Process Assessment and Method Validation for Fill and Finish of NRS-033 for Planned Phase 2 Trial Lifecore to Leverage Differentiated Capabilities and Knowledge in Fill and Finish to Support Nirsum\u2019s NIH-Funded NRS-033 Development Program CHASKA, Minn., Dec. 19, 2024 (GLOBE NEWSWIRE) &#8212; Lifecore Biomedical, Inc. (NASDAQ: LFCR) (\u201cLifecore\u201d), a fully integrated contract development and manufacturing organization (\u201cCDMO\u201d), today announced that it has been selected by Nirsum Laboratories, Inc. (\u201cNirsum\u201d) to provide CDMO services focused on supporting Nirsum\u2019s clinical development of its lead development candidate, NRS-033. The activities to be conducted under the agreement include the assessment and technology transfer of the fill and finish process for NRS-033. These assessments will rely upon Lifecore\u2019s differentiated expertise &hellip; Continue reading \"Lifecore Biomedical Selected by Nirsum Labs to Provide CDMO Services Supporting Clinical Development of Innovative Opioid Use Disorder Treatment\"","og_url":"https:\/\/www.marketnewsdesk.com\/index.php\/lifecore-biomedical-selected-by-nirsum-labs-to-provide-cdmo-services-supporting-clinical-development-of-innovative-opioid-use-disorder-treatment\/","og_site_name":"Market Newsdesk","article_published_time":"2024-12-19T12:05:12+00:00","og_image":[{"url":"https:\/\/www.globenewswire.com\/newsroom\/ti?nf=OTMyMTY2NCM2NjQ0MjgxIzIwMDc3NTY=","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\/lifecore-biomedical-selected-by-nirsum-labs-to-provide-cdmo-services-supporting-clinical-development-of-innovative-opioid-use-disorder-treatment\/#article","isPartOf":{"@id":"https:\/\/www.marketnewsdesk.com\/index.php\/lifecore-biomedical-selected-by-nirsum-labs-to-provide-cdmo-services-supporting-clinical-development-of-innovative-opioid-use-disorder-treatment\/"},"author":{"name":"Newsdesk","@id":"https:\/\/www.marketnewsdesk.com\/#\/schema\/person\/482f27a394d4fda80ecb5499e519d979"},"headline":"Lifecore Biomedical Selected by Nirsum Labs to Provide CDMO Services Supporting Clinical Development of Innovative Opioid Use Disorder Treatment","datePublished":"2024-12-19T12:05:12+00:00","mainEntityOfPage":{"@id":"https:\/\/www.marketnewsdesk.com\/index.php\/lifecore-biomedical-selected-by-nirsum-labs-to-provide-cdmo-services-supporting-clinical-development-of-innovative-opioid-use-disorder-treatment\/"},"wordCount":948,"image":{"@id":"https:\/\/www.marketnewsdesk.com\/index.php\/lifecore-biomedical-selected-by-nirsum-labs-to-provide-cdmo-services-supporting-clinical-development-of-innovative-opioid-use-disorder-treatment\/#primaryimage"},"thumbnailUrl":"https:\/\/www.globenewswire.com\/newsroom\/ti?nf=OTMyMTY2NCM2NjQ0MjgxIzIwMDc3NTY=","inLanguage":"en-US"},{"@type":"WebPage","@id":"https:\/\/www.marketnewsdesk.com\/index.php\/lifecore-biomedical-selected-by-nirsum-labs-to-provide-cdmo-services-supporting-clinical-development-of-innovative-opioid-use-disorder-treatment\/","url":"https:\/\/www.marketnewsdesk.com\/index.php\/lifecore-biomedical-selected-by-nirsum-labs-to-provide-cdmo-services-supporting-clinical-development-of-innovative-opioid-use-disorder-treatment\/","name":"Lifecore Biomedical Selected by Nirsum Labs to Provide CDMO Services Supporting Clinical Development of Innovative Opioid Use Disorder Treatment - 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