Theratechnologies Announces Resumed Production of EGRIFTA SV
Theratechnologies Announces Resumed Production of EGRIFTA SV
The Company will update the market on any further material developments.MONTREAL, Dec. 03, 2024 (GLOBE NEWSWIRE) -- Theratechnologies Inc. ("Theratechnologies" or the "Company") (TSX: TH) (NASDAQ: THTX), a biopharmaceutical company focused on the development and commercialization of innovative therapies, today announced that the production of EGRIFTA SV has resumed following a voluntary shutdown of the Company's contract manufacturer's facility to address observations from an inspection by the US Food and Drug Administration (FDA).
蒙特利爾，2024年12月3日(環球新聞通訊社) - 蒂拉科技有限公司("蒂拉科技"或"公司") (tsx: TH) (納斯達克: THTX)，一家專注於開發和商業化創新療法的生物製藥公司，今天宣佈，EGRIFTA SV的生產已經恢復，此前該公司的合同製造商設施自願停產，以解決美國食品和藥物管理局(FDA)檢查中的觀察問題。
One newly manufactured batch of EGRIFTA SV has completed standard quality control and will be available for release to the market upon approval from the FDA of a Prior Approval Supplement, which the Company is expected to file around mid-December 2024. The manufacturing of two additional batches of EGRIFTA SV is currently underway. The Company implemented measures to carefully manage existing inventory levels of EGRIFTA SV to meet patient demand until mid-January 2025.
一批新生產的EGRIFTA SV已經完成標準質量控制，待FDA批准先前批准補充申請後，即將上市。預計公司將於2024年12月中旬提交該申請。目前正在進行另外兩批EGRIFTA SV的製造。公司實施措施，仔細管理EGRIFTA SV的現有庫存水平，以滿足患者需求，直至2025年1月中旬。
Theratechnologies continues to collaborate closely with the relevant divisions of the FDA and other key stakeholders to avoid a shortage at the patient level in 2025.
蒂拉科技將繼續與FDA的相關部門和其他重要利益相關者密切合作，以避免2025年患者層面出現短缺。
The Company will update the market on any further material developments.
公司將就任何進一步的重要進展向市場更新。
EGRIFTA SV is distributed in the United States only.
EGRIFTA SV只在美國銷售。
About Theratechnologies
關於Theratechnologies
Theratechnologies (TSX: TH) (NASDAQ: THTX) is a biopharmaceutical company focused on the development and commercialization of innovative therapies addressing unmet medical needs. Further information about Theratechnologies is available on the Company's website at , on SEDAR+ at and on EDGAR at www.sec.gov. Follow Theratechnologies on Linkedin and Twitter.
Theratechnologies（TSX：TH）（NASDAQ：THTX）是一家生物製藥公司，專注於開發和商業化解決未滿足醫療需求的創新療法。更多關於Theratechnologies的信息，請訪問公司的網站。在SEDAR+上可以找到該行動的文件+和 www.sec.gov在領英 和 推特.
Forward-Looking Information This press release contains forward-looking statements and forward-looking information (collectively, the "Forward-Looking Statements") within the meaning of applicable securities laws, that are based on management's beliefs and assumptions and on information currently available to it. You can identify forward-looking statements by terms such as "may", "will", "should", "could", "promising", "would", "outlook", "believe", "plan", "envisage", "anticipate", "expect" and "estimate", or the negatives of these terms, or variations of them.
前瞻性信息 本新聞稿包含前瞻性陳述和前瞻性信息（統稱爲「前瞻性陳述」），這些陳述基於管理層的信念和假設，以及目前可獲得的信息。您可以通過術語"可能"，"將"，"應當"，"可能"，"有希望的"，"將會"，"前景"，"相信"，"計劃"，"設想"，"預期"和"估計"，或這些術語的否定形式或其變體來識別前瞻性陳述。
The Forward-Looking Statements contained in this press release include, but are not limited to, statements regarding the release of the newly manufactured batch of EGRIFTA SV, the time period related to the filing of the PAS and the availability of EGRIFTA SV to patients.
本新聞稿中包含的前瞻性聲明包括但不限於關於新制造的一批EGRIFTA SV的發佈，與PAS提交時間相關的聲明以及EGRIFTA SV對患者的可用性。
Although the Forward-Looking Statements contained in this press release are based upon what the Company believes are reasonable assumptions in light of the information currently available, investors are cautioned against placing undue reliance on these statements since actual results may vary from the Forward-Looking Statements contained in this press release. Certain assumptions made in preparing the Forward-Looking Statements include that: (i) the Company will receive all of the relevant information from its third party manufacturer to file a PAS within the timelines set forth herein; (ii) the FDA will review and approve the PAS before mid-January 2025; (iii) the two additional batches of EGRIFTA SV will be within specifications when manufacturing is completed; and (iv) current market demand for EGRIFTA SV will remain unaffected despite the risk of drug shortage.
儘管本新聞稿中包含的前瞻性聲明基於公司目前可獲得的信息做出的合理假設，但投資者應謹慎對待這些聲明，因爲實際結果可能會與本新聞稿中包含的前瞻性聲明有所不同。準備前瞻性聲明涉及的某些假設包括：(i) 公司將從第三方製造商處收到所有相關信息以便在此規定時間內提交PAS；(ii) FDA將在2025年1月中旬之前審核並批准PAS；(iii) 製造完成時，兩個額外批次的EGRIFTA SV將符合規格；和 (iv) 儘管存在藥物短缺的風險，但當前對EGRIFTA SV的市場需求將不受影響。
Forward-Looking Statements assumptions are subject to a number of risks and uncertainties, many of which are beyond the Company's control, that could cause actual results to differ materially from those that are disclosed in or implied by such Forward-Looking Statements. These risks and uncertainties include, but are not limited to: (i) drug shortage of EGRIFTA SV due to various factors, including delays in filing the PAS, rejection of the PAS for failure to meet regulatory requirements, the issuance of comments by the FDA on the PAS impacting its review timelines; and (ii) a decrease in demand for EGRIFTA SV due to the risk of shortage.
前瞻性聲明的假設受到多種風險和不確定性的影響，其中許多超出了公司的控制範圍，這些可能導致實際結果與此類前瞻性聲明中披露或暗示的結果大不相同。這些風險和不確定性包括但不限於：(i) EGRIFTA SV的短缺可能由於各種因素，包括PAS提交延遲，PAS由於未能符合監管要求而被拒絕，FDA就PAS發出意見影響其審核時間表；和 (ii) 由於短缺風險導致EGRIFTA SV需求下降。
The Company refers current and potential investors to the "Risk Factors" section of the Company's annual information form filed under Form 20-F dated February 21, 2024, available on SEDAR+ at and on EDGAR at www.sec.gov under Theratechnologies' public filings. The reader is cautioned to consider these and other risks and uncertainties carefully and not to put undue reliance on forward-looking statements. Forward-Looking Statements reflect current expectations regarding future events and speak only as of the date of this press release and represent the Company's expectations as of that date.
公司將目前和潛在投資者參考公司於2024年2月21日提交的Form 20-F下的年度信息文件"風險因素"部分，該文件可在SEDA半導體上找到。 和 www.sec.gov 請讀者注意，認真考慮這些和其他風險和不確定性，並不過度依賴前瞻性陳述。前瞻性陳述反映了關於未來事件的當前預期，僅在本新聞稿發表之日有效，並代表公司在那個日期的預期。
The Company undertakes no obligation to update or revise the information contained in this press release, whether as a result of new information, future events or circumstances or otherwise, except as may be required by applicable law.
公司無義務更新或修訂本新聞稿中包含的信息，除非根據適用法律的要求，有新的信息、未來事件或情況或其他情況。
Contacts:
聯繫人：
Investor inquiries:
Philippe Dubuc
Senior Vice President and Chief Financial Officer
pdubuc@theratech.com
438-315-6608
投資者查詢：
Philippe Dubuc
高級副總裁兼首席財務官
pdubuc@theratech.com
438-315-6608
Media inquiries:
Julie Schneiderman
Senior Director, Communications & Corporate Affairs
communications@theratech.com
1-514-336-7800
媒體查詢：
Julie Schneiderman
通信-半導體高級董事, 企業事務 和公共關係部
communications@theratech.com
1-514-336-7800
譯文內容由第三人軟體翻譯。
