Theratechnologies Announces Resumed Production of EGRIFTA SV®
Theratechnologies announced the resumption of EGRIFTA SV® production following a voluntary shutdown at their contract manufacturer's facility due to FDA inspection observations. One new batch has completed quality control and awaits FDA approval through a Prior Approval Supplement, expected to be filed mid-December 2024. Two additional batches are in production.
The company has managed existing inventory to meet patient demand until mid-January 2025 and is working with FDA divisions to prevent potential shortages in 2025. EGRIFTA SV® is exclusively distributed in the United States.
Theratechnologies ha annunciato la ripresa della produzione di EGRIFTA SV® dopo una chiusura volontaria presso l'impianto del produttore contrattuale a causa di osservazioni durante un'ispezione della FDA. Un nuovo lotto ha completato il controllo della qualità e attende l'approvazione della FDA tramite un Supplemento di Approvazione Precedente, previsto per essere presentato a metà dicembre 2024. Altri due lotti sono attualmente in produzione.
La società ha gestito l'inventario esistente per soddisfare la domanda dei pazienti fino a metà gennaio 2025 e sta collaborando con le divisioni della FDA per prevenire potenziali carenze nel 2025. EGRIFTA SV® è distribuito esclusivamente negli Stati Uniti.
Theratechnologies anunció la reanudación de la producción de EGRIFTA SV® tras un cierre voluntario en la instalación de su fabricante contratista debido a observaciones realizadas durante una inspección de la FDA. Un nuevo lote ha completado el control de calidad y espera la aprobación de la FDA a través de un Suplemento de Aprobación Previa, que se espera presentar a mediados de diciembre de 2024. Dos lotes adicionales están en producción.
La empresa ha gestionado el inventario existente para satisfacer la demanda de los pacientes hasta mediados de enero de 2025 y está trabajando con las divisiones de la FDA para prevenir posibles escasez en 2025. EGRIFTA SV® se distribuye exclusivamente en los Estados Unidos.
Theratechnologies는 FDA 검사의 관찰로 인해 계약 제조업체 시설에서 자발적인 가동 중단 후 EGRIFTA SV® 생산 재개를 발표했습니다. 하나의 새로운 배치가 품질 관리를 완료하고 있으며, 2024년 12월 중순경에 제출될 예정인 사전 승인 보충 문서를 통해 FDA 승인을 기다리고 있습니다. 두 개의 추가 배치가 생산 중입니다.
회사는 2025년 1월 중순까지 환자 수요를 충족하기 위해 기존 재고를 관리하였으며, 2025년 잠재적인 부족을 방지하기 위해 FDA 부서와 협력하고 있습니다. EGRIFTA SV®는 미국에서만 독점 배포됩니다.
Theratechnologies a annoncé la reprise de la production de EGRIFTA SV® suite à une fermeture volontaire de l'établissement de son fabricant sous contrat en raison des observations faites lors d'une inspection de la FDA. Un nouveau lot a terminé le contrôle qualité et attend l'approbation de la FDA par le biais d'un Supplément d'Approbation Préalable, qui devrait être déposé à la mi-décembre 2024. Deux lots supplémentaires sont en production.
L'entreprise a géré l'inventaire existant pour répondre à la demande des patients jusqu'à la mi-janvier 2025 et collabore avec les divisions de la FDA pour prévenir de potentielles pénuries en 2025. EGRIFTA SV® est distribué exclusivement aux États-Unis.
Theratechnologies hat die Wiederaufnahme der Produktion von EGRIFTA SV® nach einer freiwilligen Schließung seiner Vertragsfabrik aufgrund von Beobachtungen während einer FDA-Inspektion bekannt gegeben. Eine neue Charge hat die Qualitätskontrolle abgeschlossen und wartet auf die Genehmigung durch die FDA im Rahmen eines Antrags auf vorherige Genehmigung, der voraussichtlich Mitte Dezember 2024 eingereicht wird. Zwei weitere Chargen befinden sich in Produktion.
Das Unternehmen hat bestehenden Bestand verwaltet, um die Patientennachfrage bis Mitte Januar 2025 zu decken, und arbeitet mit den Abteilungen der FDA zusammen, um potenzielle Engpässe im Jahr 2025 zu verhindern. EGRIFTA SV® wird ausschließlich in den Vereinigten Staaten vertrieben.
- Production of EGRIFTA SV® has resumed
- One batch has completed quality control
- Two additional batches are in production
- Current inventory sufficient until mid-January 2025
- Manufacturing facility required shutdown due to FDA observations
- New batch requires FDA approval before market release
- Potential supply shortage risk in 2025
Insights
The resumption of EGRIFTA SV® production represents a critical operational milestone for Theratechnologies. The successful completion of one batch and ongoing production of two additional batches indicates positive progress in addressing manufacturing compliance issues. However, several key challenges remain: FDA approval is still pending for the Prior Approval Supplement and current inventory is projected to last only until mid-January 2025.
The timing is particularly tight - with the FDA filing expected mid-December, the approval timeline will be important to prevent potential supply disruptions. While the company has implemented inventory management measures, the narrow buffer between current stock depletion (mid-January) and new batch availability creates elevated supply chain risk. The US-exclusive distribution model means any supply chain disruptions would impact the entire market for this product.
The regulatory pathway forward requires careful navigation. The Prior Approval Supplement filing in mid-December will trigger an FDA review process that typically takes 4-6 months for complex manufacturing changes. The fact that this follows a voluntary shutdown to address FDA inspection observations adds another layer of scrutiny. The company's proactive approach in managing inventory and maintaining FDA communication is prudent, but the timeline leaves little room for extended regulatory review periods.
The successful resolution of the FDA observations and resumption of manufacturing activities is positive, but the pending regulatory approval represents a critical gating factor for market release. This creates material uncertainty around the timing of new product availability and potential impact on supply continuity.
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).
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.
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.
The Company will update the market on any further material developments.
EGRIFTA SV® is distributed in the United States only.
About 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 www.theratech.com, on SEDAR+ at www.sedarplus.ca and on EDGAR at www.sec.gov. Follow Theratechnologies on Linkedin and Twitter.
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.
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.
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.
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.
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 www.sedarplus.ca 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.
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.
Contacts:
Investor inquiries:
Philippe Dubuc
Senior Vice President and Chief Financial Officer
pdubuc@theratech.com
438-315-6608
Media inquiries:
Julie Schneiderman
Senior Director, Communications & Corporate Affairs
communications@theratech.com
1-514-336-7800
FAQ
When did Theratechnologies (THTX) resume EGRIFTA SV production?
How long will current EGRIFTA SV inventory last for Theratechnologies (THTX)?
When will Theratechnologies (THTX) file the Prior Approval Supplement for EGRIFTA SV?
Where is EGRIFTA SV distributed by Theratechnologies (THTX)?
