Lifecore Biomedical Selected by Nirsum Labs to Provide CDMO Services Supporting Clinical Development of Innovative Opioid Use Disorder Treatment
Lifecore Biomedical Selected by Nirsum Labs to Provide CDMO Services Supporting Clinical Development of Innovative Opioid Use Disorder Treatment
Development Services Span Tech Transfer, Process Assessment and Method Validation for Fill and Finish of NRS-033 for Planned Phase 2 Trial
開發服務涵蓋技術轉移、工藝評估和NRS-033填充和封閉的驗證,旨在爲計劃中的第二階段試驗提供支持。
Lifecore to Leverage Differentiated Capabilities and Knowledge in Fill and Finish to Support Nirsum's NIH-Funded NRS-033 Development Program
Lifecore將利用其在填充和封閉中的差異化能力和知識,支持Nirsum獲得NIH資助的NRS-033開發計劃。
CHASKA, Minn., Dec. 19, 2024 (GLOBE NEWSWIRE) -- Lifecore Biomedical, Inc. (NASDAQ: LFCR) ("Lifecore"), a fully integrated contract development and manufacturing organization ("CDMO"), today announced that it has been selected by Nirsum Laboratories, Inc. ("Nirsum") to provide CDMO services focused on supporting Nirsum's 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's 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.
明尼蘇達州CHASKA,2024年12月19日(全球新聞網)-- Lifecore Biomedical, Inc.(納斯達克:LFCR)("Lifecore"),一家全方位整合的合同開發與製造組織("CDMO"),今天宣佈已被Nirsum Laboratories, Inc.("Nirsum")選擇,提供CDMO服務,專注於支持Nirsum的主要開發候選藥物NRS-033的臨牀開發。根據協議進行的活動包括對NRS-033填充和封閉工藝的評估和技術轉移。這些評估將依賴於Lifecore在無菌可注射藥品填充和封閉方面的差異化專業知識,可能使Lifecore能夠爲NRS-033的整個填充和封閉過程創建一個全面的開發和商業化計劃。
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.
NRS-033是一種新型的阿片類藥物使用障礙(OUD)和酒精使用障礙(AUD)的治療方法。NRS-033完全由Nirsum擁有並在內部開發,目前正進入第二階段臨牀開發。新簽署的協議將使Lifecore能夠爲Nirsum提供用於NRS-033臨牀開發的填充藥桶。
"With growing concerns about opioid and alcohol addiction in the U.S. and beyond, we're 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," said Paul Josephs, chief executive officer of Lifecore. "We 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."
「隨着對美國及其他地區阿片類藥物和酒精成癮問題的關注日益增加,我們很感激能有機會支持Nirsum進行這一重要且有前景的治療。我們的協議將使Lifecore能夠利用我們在複雜製劑方面的經驗,對NRS-033的填充和封閉過程進行評估、增強和驗證,」Lifecore首席執行官Paul Josephs說。「我們很高興能將Nirsum增加到我們不斷增長的客戶名單中,也感激他們的團隊信任我們與他們合作這些工作。」
"We 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," said Nikej Shah, M.D., chief executive officer of Nirsum Labs. "We are excited to begin our work with Lifecore to potentially help bring our important therapy through further clinical development and commercialization."
「我們認爲阿片類藥物和酒精使用障礙是巨大的未滿足需求,每種障礙僅有幾個幾十年前獲得FDA批准的治療選項。我們相信NRS-033將成爲一項關鍵創新,解決 huidige therapies 的短期療效保持這一關鍵問題,導致尋求戒斷的OUD和AUD患者複發率高。通過改善NRS-033的療效保持,Nirsum的目標是爲數百萬患有OUD和AUD的美國人帶來希望,」Nirsum Labs首席執行官Nikej Shah萬.D.說。「我們很高興能開始與Lifecore合作,潛在幫助將我們的重要療法推進到進一步的臨牀開發和商業化。」
About Lifecore Biomedical
關於生活核心生物醫藥
Lifecore Biomedical, Inc. (Nasdaq: LFCR) 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's website at .
Lifecore Biomedical, Inc.(納斯達克:LFCR)是一家完全一體化的合同開發和製造組織(CDMO),提供在開發、填充和封閉無菌注射藥物產品方面的高度差異化能力,包括複雜製劑。作爲優質注射級透明質酸的領先製造商,Lifecore擁有超過40年的專業知識,致力於成爲全球和新興生物製藥及生物技術公司的合作伙伴,幫助他們將創新推向市場。欲了解更多有關公司的信息,請訪問Lifecore的網站。
About Nirsum Labs
關於Nirsum實驗室
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's development is funded in part through a Cooperative Agreement with the United States National Institutes of Health (HEAL Initiative award UH3DA048234 and U01DA061643). For more information about the company, visit Nirsum's website at .
Nirsum實驗室公司是一家發展階段的生物技術公司,致力於使成癮疾病可治癒。Nirsum正在開發用於阿片使用障礙(OUD)和酒精使用障礙(AUD)的NRS-033,這兩個領域都有迫切的公共健康需求。NRS-033的開發部分由與美國國立衛生研究院的合作協議資助(HEAL倡議獎UH3DA048234和U01DA061643)。有關公司更多信息,請訪問Nirsum的網站。
Important Cautions Regarding Forward-Looking Statements
關於前瞻性陳述的重要提醒
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 "anticipate", "estimate", "expect", "project", "plan", "intend", "believe", "may", "might", "will", "should", "can have", "likely" 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's 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's 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's ability to access sufficient capital to fund its business strategies; and other risk factors set forth from time to time in Lifecore's SEC filings, including, but not limited to, the Annual Report on Form 10-K for the year ended May 26, 2024 (the "2024 10-K"). 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's 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.
本新聞稿包含關於未來事件和我們未來結果的前瞻性聲明,這些聲明受1995年《私人證券訴訟改革法》和1933年《證券法》及1934年《證券交易法》下創造的安全港保護。諸如「預期」、「估計」、「期望」、「項目」、「計劃」、「打算」、「相信」、「可能」、「將」、「應該」、「能夠」、「可能會」和類似表述用來識別前瞻性聲明。此外,所有關於我們預期未來運營和財務期望、客戶機會和關係,以及潛在市場規模或客戶產品機會的聲明都是前瞻性聲明。所有前瞻性聲明都涉及某些風險和不確定性,這可能導致實際結果與預期結果有實質性不同,包括其他因素,公司成功實施其商業策略的能力,包括與安裝、產能生成和吸引服務需求的能力,以及擴展與現有客戶的關係或吸引新客戶的能力;將由Lifecore製造的任何產品的範圍或預期市場;客戶在預期時間內或根本上獲得監管審批的能力;我們或客戶的競爭格局性質;通貨膨脹對Lifecore業務和財務狀況的影響;國內和全球業務狀況和一般經濟條件的變化,包括利率上漲和外匯匯率波動;Lifecore獲取足夠資金以資助其商業策略的能力;以及Lifecore的SEC文件中不時列出的其他風險因素,包括但不限於截至2024年5月26日的年度報告(「2024 10-K」)。有關可能導致實際結果與前瞻性聲明描述存在實質性差異的因素的更多信息,請參考我們向證券交易委員會提交的文件,包括2024 10-K中的風險因素。前瞻性聲明代表管理層截至本日期的當前期望,固有不確定性。除非法律要求,我們不承擔更新我們作出的前瞻性聲明以反映後續事件或情況的任何義務。
CONTACT: Lifecore Biomedical, Inc. Contact Information:
Vida Strategic Partners
Stephanie Diaz (Investors)
415-675-7401
sdiaz@vidasp.com
Tim Brons (Media)
415-675-7402
tbrons@vidasp.com
Ryan D. Lake (CFO)
Lifecore Biomedical
952-368-6244
ryan.lake@lifecore.com
Nirsum Laboratories, Inc. Contact Information:
Nikej Shah, M.D. (CEO)
Nirsum Laboratories, Inc.
nshah@nirsum.com
聯繫人:生物醫藥公司Lifecore Biomedical, Inc. 聯繫信息:
Vida戰略合作伙伴
斯蒂芬妮·迪亞斯(投資者)
415-675-7401
sdiaz@vidasp.com
TIM Brons (媒體)
415-675-7402
tbrons@vidasp.com
賴安·D·萊克 (財務長)
Lifecore生物醫藥
952-368-6244
ryan.lake@lifecore.com
Nirsum實驗室公司聯繫方式:
Nikej Shah萬.D. (首席執行官)
Nirsum實驗室公司
nshah@nirsum.com
譯文內容由第三人軟體翻譯。