Perspective Therapeutics Begins Shipping Investigational Products from State-of-the-Art Radiopharmaceutical Manufacturing Facility in Somerset, New Jersey
Perspective Therapeutics (NYSE AMERICAN: CATX) has begun shipping investigational products from its new radiopharmaceutical manufacturing facility in Somerset, New Jersey. This state-of-the-art facility is now operational, supporting VMT-α-NET clinical studies alongside the existing Coralville, Iowa facility. With three cGMP-compliant manufacturing suites, it's expected to meet future clinical trial and commercial demands in the Northeastern U.S.
The Somerset facility, acquired from Lantheus Holdings in March 2024, previously produced FDA-approved Azedra for rare adrenal gland tumors. This milestone comes just seven months after acquisition, accelerating Perspective's efforts in delivering investigational products and potential new radiopharmaceutical therapies. The company aims to replicate this approach, adding strategic sites to enhance its network supporting key treatment hubs across the U.S.
Perspective Therapeutics (NYSE AMERICAN: CATX) ha iniziato a spedire prodotti investigativi dalla sua nuova struttura di produzione di radiofarmaci a Somerset, New Jersey. Questa struttura all'avanguardia è ora operativa e supporta gli studi clinici VMT-α-NET insieme all'esistente impianto di Coralville, Iowa. Con tre camere di produzione conformi cGMP, si prevede che soddisfi le future esigenze di trial clinici e commerciali nel nord-est degli Stati Uniti.
La struttura di Somerset, acquisita da Lantheus Holdings nel marzo 2024, in precedenza produceva Azedra approvato dalla FDA per i tumori rari della ghiandola surrenale. Questo traguardo arriva solo sette mesi dopo l'acquisizione, accelerando gli sforzi di Perspective nel fornire prodotti investigativi e potenziali nuove terapie radiofarmaceutiche. L'azienda intende replicare questo approccio, aggiungendo siti strategici per migliorare la sua rete a supporto dei principali hub di trattamento negli Stati Uniti.
Perspective Therapeutics (NYSE AMERICAN: CATX) ha comenzado a enviar productos de investigación desde su nueva instalación de fabricación de radiofármacos en Somerset, Nueva Jersey. Esta instalación de última generación ya está operativa, apoyando los estudios clínicos de VMT-α-NET junto con la instalación existente en Coralville, Iowa. Con tres salas de fabricación conformes a cGMP, se espera que satisfaga las futuras demandas de ensayos clínicos y comerciales en el noreste de EE.UU.
La instalación de Somerset, adquirida de Lantheus Holdings en marzo de 2024, anteriormente producía Azedra, aprobado por la FDA, para tumores raros de glándulas suprarrenales. Este hito llega apenas siete meses después de la adquisición, acelerando los esfuerzos de Perspective para entregar productos de investigación y posibles nuevas terapias de radiofármacos. La compañía tiene como objetivo replicar este enfoque, añadiendo sitios estratégicos para mejorar su red en apoyo a los principales centros de tratamiento en EE.UU.
Perspective Therapeutics (NYSE AMERICAN: CATX)는 뉴저지주 소머셋에 있는 새로운 방사성 의약품 제조 시설에서 조사 제품의 출하를 시작했습니다. 이 최첨단 시설은 현재 운영 중이며, 아이오와주 코럴빌에 있는 기존 시설과 함께 VMT-α-NET 임상 연구를 지원합니다. cGMP 준수 제조 공간 3개를 갖추고 있어 북동부 미국에서의 미래 임상 시험 및 상업적 수요를 충족할 것으로 기대됩니다.
2024년 3월 Lantheus Holdings로부터 인수한 소머셋 시설은 이전에 드문 부신 종양을 위한 FDA 승인 Azedra를 생산했습니다. 이 이정표는 인수 후 단 7개월 만에 도달하여, 조사 제품과 잠재적 새로운 방사성 의약품 치료법을 제공하기 위한 Perspective의 노력을 가속화하고 있습니다. 이 회사는 이 접근 방식을 복제하여 미국 전역의 주요 치료 허브를 지원하는 네트워크를 강화하기 위해 전략적인 장소를 추가할 계획입니다.
Perspective Therapeutics (NYSE AMERICAN: CATX) a commencé à expédier des produits d'investigation depuis sa nouvelle installation de fabrication de radio-pharmaceutiques à Somerset, dans le New Jersey. Cette installation à la pointe de la technologie est désormais opérationnelle et soutient les études cliniques VMT-α-NET en parallèle de l'installation existante à Coralville, Iowa. Avec trois suites de fabrication conformes aux cGMP, elle devrait répondre aux futures demandes d'essais cliniques et commerciales dans le nord-est des États-Unis.
L'installation de Somerset, acquise auprès de Lantheus Holdings en mars 2024, produisait auparavant de l'Azedra approuvé par la FDA pour des tumeurs rares des glandes surrénales. Ce jalon intervient seulement sept mois après l'acquisition, accélérant les efforts de Perspective pour fournir des produits d'investigation et de potentielles nouvelles thérapies radiopharmaceutiques. L'entreprise vise à reproduire cette approche en ajoutant des sites stratégiques pour améliorer son réseau soutenant les principaux centres de traitement à travers les États-Unis.
Perspective Therapeutics (NYSE AMERICAN: CATX) hat mit dem Versand von Prüfprodukten aus seiner neuen Anlage zur Herstellung von Radiopharmazeutika in Somerset, New Jersey, begonnen. Diese moderne Einrichtung ist nun betriebsbereit und unterstützt klinische Studien zu VMT-α-NET neben der bestehenden Anlage in Coralville, Iowa. Mit drei cGMP-konformen Produktionsstätten wird erwartet, dass sie die zukünftigen Anforderungen an klinische Studien und kommerzielle Nachfrage im Nordosten der USA erfüllt.
Die Einrichtung in Somerset, die im März 2024 von Lantheus Holdings übernommen wurde, produzierte zuvor das von der FDA genehmigte Azedra für seltene Nebennierentumoren. Dieser Meilenstein erfolgt nur sieben Monate nach der Übernahme und beschleunigt die Bemühungen von Perspective, Prüfprodukte und potenzielle neue Radiopharmazeutika bereitzustellen. Das Unternehmen beabsichtigt, diesen Ansatz zu replizieren und strategische Standorte hinzuzufügen, um sein Netzwerk zur Unterstützung wichtiger Behandlungszentren in den USA zu verbessern.
- New manufacturing facility in Somerset, NJ is now operational
- Facility capable of producing 203Pb- and 212Pb-labeled radiopharmaceuticals
- Three manufacturing suites meeting cGMP requirements
- Expanded capacity to meet future clinical trial and commercial demands
- Accelerated operational timeline, going live 7 months post-acquisition
- None.
Insights
The operational launch of Perspective Therapeutics' second manufacturing facility in Somerset, NJ, is a significant development for the company's radiopharmaceutical production capabilities. This facility, with its three cGMP-compliant manufacturing suites, substantially increases the company's capacity to produce 203Pb- and 212Pb-labeled radiopharmaceuticals for clinical trials and potential future commercial demands.
The facility's strategic location in the Northeastern U.S. and its history of FDA-approved radiopharmaceutical production (Azedra) under Lantheus Holdings' management add credibility to its potential. The rapid seven-month turnaround from acquisition to operational status demonstrates efficient execution, which is important in the competitive radiopharmaceutical market.
This expansion aligns with the company's network approach, which is essential for radiopharmaceuticals with short half-lives. The ability to produce closer to major cancer treatment centers could significantly improve logistics and product viability, potentially leading to better patient outcomes and market penetration.
Perspective Therapeutics' expansion of manufacturing capabilities is a positive indicator for their clinical development pipeline, particularly for the VMT-α-NET studies. The ability to supply investigational products from multiple facilities enhances the reliability of clinical trial supply chains, which is important for maintaining study timelines and data integrity.
The company's focus on alpha-particle therapies is noteworthy in the evolving landscape of targeted cancer treatments. Alpha emitters like lead-212 (212Pb) offer potential advantages in terms of high linear energy transfer and short tissue penetration, which could lead to more effective and localized tumor treatment with potentially reduced side effects.
The strategic positioning of manufacturing facilities near major cancer centers could accelerate patient enrollment in clinical trials and, if products are approved, facilitate faster adoption by oncologists. This approach may give Perspective a competitive edge in the rapidly growing radiopharmaceutical market, especially for rare and difficult-to-treat cancers.
SEATTLE, Oct. 16, 2024 (GLOBE NEWSWIRE) -- Perspective Therapeutics, Inc. (“Perspective” or the “Company”) (NYSE AMERICAN: CATX), a radiopharmaceutical company that is pioneering advanced treatment applications for cancers throughout the body, today is celebrating the first shipment and patient dosing from its second manufacturing facility for the production of its 203Pb- and 212Pb-labeled radiopharmaceuticals.
Located in Somerset, New Jersey, this facility is now operational to supply investigational products to support VMT-α-NET clinical studies, in addition to the Coralville, Iowa facility which has been producing the Company’s investigational products for over 15 months. With three manufacturing suites that can meet Current Good Manufacturing Practice (cGMP) requirements, the Somerset facility is expected to have the capacity to meet future clinical trial and commercial demands at major cancer treatment centers throughout the Northeastern U.S. Until the close of its acquisition by Perspective in March 2024, this facility was operated by Lantheus Holdings, Inc., the leading radiopharmaceutical-focused company. This facility previously produced Azedra, which contained a form of radioactive iodine and received approval from the U.S. Food & Drug Administration (FDA) in 2018 for the treatment of rare tumors of the adrenal gland.
"Today marks an exciting milestone as we start shipping investigational products from this state-of-the-art facility,” commented Shane Cobb, Perspective’s Executive Vice President of Operations. “Going operational seven months after taking possession of the facility allows us to accelerate our efforts in delivering investigational products and, pending approval, new radiopharmaceutical therapies."
"We are thrilled to celebrate the opening of this facility, which is a step forward in building out our manufacturing and supply chain capabilities,” said Thijs Spoor, Perspective’s Chief Executive Officer. “It reflects our commitment to delivering targeted alpha-particle therapies to patients in critical need. We believe our network approach aligns with patient interest and the half-life profiles of isotopes contained in our investigational products. We look forward to replicating this effort and adding sites strategically to enhance our network to support key treatment hubs across the U.S."
About Perspective Therapeutics, Inc.
Perspective Therapeutics, Inc., is a radiopharmaceutical development company that is pioneering advanced treatment applications for cancers throughout the body. The Company has proprietary technology that utilizes the alpha emitting isotope 212Pb to deliver powerful radiation specifically to cancer cells via specialized targeting peptides. The Company is also developing complementary imaging diagnostics that incorporate the same targeting peptides which provide the opportunity to personalize treatment and optimize patient outcomes. This "theranostic" approach enables the ability to see the specific tumor and then treat it to potentially improve efficacy and minimize toxicity.
The Company's melanoma (VMT01) and neuroendocrine tumor (VMT-α-NET) programs have entered Phase 1/2a imaging and therapy trials for the treatment of metastatic melanoma and neuroendocrine tumors at several leading academic institutions. The Company has also developed a proprietary 212Pb generator to secure key isotopes for clinical trial and commercial operations.
For more information, please visit the Company's website at www.perspectivetherapeutics.com.
Safe Harbor Statement
This press release contains forward-looking statements within the meaning of the United States Private Securities Litigation Reform Act of 1995. Statements in this press release that are not statements of historical fact are forward-looking statements. Words such as "may," "will," "should," "expect," "plan," "anticipate," "could," "intend," "target," "project," "estimate," "believe," "predict," "potential" or "continue" or the negative of these terms or other similar expressions are intended to identify forward-looking statements, though not all forward-looking statements contain these identifying words. Forward-looking statements in this press release include statements concerning, among other things, the Company's ability to pioneer advanced treatment applications for cancers throughout the body; the ability of the Company’s manufacturing suites in Somerset, New Jersey to meet cGMP requirements; the capacity of the Company’s Somerset, New Jersey facility to meet future clinical trial and commercial demands at major cancer treatment centers throughout the Northeastern U.S.; the Company’s ability to “accelerate [its] efforts in delivering investigational products and, pending approval, new radiopharmaceutical therapies;” the Company’s plans to build out its manufacturing and supply chain capabilities and to “replicat[e] this effort and add[ ] sites strategically to enhance [its] network to support key treatment hubs across the U.S.;” the Company's prediction that complementary imaging diagnostics that incorporate certain targeting peptides provide the opportunity to personalize treatment and optimize patient outcomes; the Company's expectation that its "theranostic" approach enables the ability to see specific tumors and then treat it to potentially improve efficacy and minimize toxicity; the Company's ability to develop a proprietary 212Pb generator to secure key isotopes for clinical trial and commercial operations; the Company's clinical development plans and the expected timing thereof; the expected timing for availability and release of data; expectations regarding the potential market opportunities for the Company's product candidates; the potential functionality, capabilities, the benefits of the Company's product candidates, and the potential application of these product candidates for other disease indications; the Company's expectations, beliefs, intentions, and strategies regarding the future; the Company's intentions to improve important aspects of care in cancer treatment; and other statements that are not historical fact.
The Company may not actually achieve the plans, intentions or expectations disclosed in the forward-looking statements, and you should not place undue reliance on the forward-looking statements. These forward-looking statements involve risks and uncertainties that could cause the Company's actual results to differ materially from the results described in or implied by the forward-looking statements. Certain factors that may cause the Company's actual results to differ materially from those expressed or implied in the forward-looking statements in this press release are described under the heading "Risk Factors" in the Company's most recent Annual Report on Form 10-K and Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission (the "SEC"), in the Company's other filings with the SEC, and in the Company's future reports to be filed with the SEC and available at www.sec.gov. Forward-looking statements contained in this news release are made as of this date. Unless required to do so by law, we undertake no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise.
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