ImmuCell Announces Initiation of Investigational Product Use of Re-Tain®
ImmuCell (Nasdaq: ICCC) has announced the initiation of Investigational Product use of Re-Tain®, its novel treatment for subclinical mastitis in dairy cows. This controlled launch will help test market acceptance and utilize available inventory before shelf-life expiration, though it's not expected to generate significant revenue or profit.
The company submitted its Non-Administrative New Animal Drug Application (NADA) in early January 2025, including its fourth CMC Technical Section submission along with minor technical sections for All Other Information and Product Labeling. The critical path to NADA approval remains contingent on clearing inspectional observations at the facilities of ImmuCell's contract manufacturer.
This investigational strategy allows ImmuCell to gather product performance data while awaiting full NADA approval. Re-Tain® aims to provide an alternative to traditional antibiotics without FDA-required milk discard or pre-slaughter withdrawal label restrictions.
ImmuCell (Nasdaq: ICCC) ha annunciato l'inizio dell'uso del Prodotto Sperimentale Re-Tain®, un trattamento innovativo per la mastite subclinica nelle mucche da latte. Questo lancio controllato aiuterà a testare l'accettazione del mercato e a utilizzare l'inventario disponibile prima della scadenza, anche se non ci si aspetta che generi significativi ricavi o profitti.
L'azienda ha presentato la sua Domanda di Nuovo Farmaco Veterinario Non Amministrativo (NADA) all'inizio di gennaio 2025, inclusa la sua quarta presentazione della Sezione Tecnica CMC insieme a sezioni tecniche minori per Tutte le Altre Informazioni e Etichettatura del Prodotto. Il percorso critico per l'approvazione della NADA rimane subordinato alla risoluzione delle osservazioni ispettive presso gli impianti del produttore a contratto di ImmuCell.
Questa strategia investigativa consente a ImmuCell di raccogliere dati sulle prestazioni del prodotto mentre attende l'approvazione completa della NADA. Re-Tain® mira a fornire un'alternativa agli antibiotici tradizionali senza le restrizioni di etichettatura richieste dalla FDA per il rigetto del latte o il ritiro pre-mattanza.
ImmuCell (Nasdaq: ICCC) ha anunciado el inicio del uso del Producto en Investigación Re-Tain®, su novedoso tratamiento para la mastitis subclínica en vacas lecheras. Este lanzamiento controlado ayudará a probar la aceptación del mercado y a utilizar el inventario disponible antes de la expiración de la vida útil, aunque no se espera que genere ingresos o beneficios significativos.
La empresa presentó su Solicitud de Nuevo Medicamento Veterinario No Administrativo (NADA) a principios de enero de 2025, incluyendo su cuarta presentación de la Sección Técnica CMC junto con secciones técnicas menores para Toda Otra Información y Etiquetado del Producto. El camino crítico para la aprobación de la NADA sigue dependiendo de la resolución de las observaciones de inspección en las instalaciones del fabricante por contrato de ImmuCell.
Esta estrategia investigativa permite a ImmuCell recopilar datos sobre el rendimiento del producto mientras espera la aprobación completa de la NADA. Re-Tain® tiene como objetivo proporcionar una alternativa a los antibióticos tradicionales sin las restricciones de etiquetado requeridas por la FDA para el descarte de leche o el retiro previo al sacrificio.
ImmuCell (Nasdaq: ICCC)는 유제품 소의 아급성 유선염 치료를 위한 혁신적인 치료제 Re-Tain®의 연구 제품 사용을 시작했다고 발표했습니다. 이 통제된 출시는 시장 수용성을 시험하고 유통기한 만료 전에 사용 가능한 재고를 활용하는 데 도움이 될 것이지만, 상당한 수익이나 이익을 창출할 것으로 예상되지는 않습니다.
회사는 2025년 1월 초에 비관리형 신규 동물 의약품 신청서(NADA)를 제출했으며, 네 번째 CMC 기술 섹션 제출과 함께 기타 모든 정보 및 제품 라벨링에 대한 소규모 기술 섹션을 포함했습니다. NADA 승인을 위한 중요한 경로는 ImmuCell의 계약 제조업체 시설에서의 검사 관찰을 정리하는 데 달려 있습니다.
이 연구 전략은 ImmuCell이 NADA의 전체 승인을 기다리는 동안 제품 성능 데이터를 수집할 수 있게 합니다. Re-Tain®은 FDA에서 요구하는 우유 폐기 또는 도축 전 철회 라벨 제한 없이 전통적인 항생제에 대한 대안을 제공하는 것을 목표로 합니다.
ImmuCell (Nasdaq: ICCC) a annoncé le lancement de l'utilisation du Produit d'Investigation Re-Tain®, son nouveau traitement pour la mastite subclinique chez les vaches laitières. Ce lancement contrôlé aidera à tester l'acceptation du marché et à utiliser l'inventaire disponible avant l'expiration de la durée de conservation, bien qu'il ne soit pas prévu qu'il génère des revenus ou des bénéfices significatifs.
L'entreprise a soumis sa Demande de Nouveau Médicament Vétérinaire Non Administratif (NADA) début janvier 2025, y compris sa quatrième soumission de la Section Technique CMC ainsi que des sections techniques mineures pour Toutes les Autres Informations et l'Étiquetage du Produit. Le chemin critique vers l'approbation de la NADA reste conditionné à la levée des observations d'inspection dans les installations du fabricant sous contrat d'ImmuCell.
Cette stratégie d'investigation permet à ImmuCell de recueillir des données sur les performances du produit tout en attendant l'approbation complète de la NADA. Re-Tain® vise à offrir une alternative aux antibiotiques traditionnels sans les restrictions d'étiquetage requises par la FDA concernant le rejet de lait ou les restrictions de retrait avant l'abattage.
ImmuCell (Nasdaq: ICCC) hat den Beginn der Nutzung des Prüfprodukts Re-Tain®, seiner neuartigen Behandlung von subklinischer Mastitis bei Milchkühen, angekündigt. Diese kontrollierte Markteinführung wird helfen, die Marktakzeptanz zu testen und vorhandene Bestände vor Ablauf der Haltbarkeit zu nutzen, obwohl nicht erwartet wird, dass sie signifikante Einnahmen oder Gewinne generiert.
Das Unternehmen reichte Anfang Januar 2025 seinen Antrag auf ein nicht verwaltetes neues Tierarzneimittel (NADA) ein, einschließlich seiner vierten Einreichung des CMC-Technikbereichs sowie kleinerer technischer Abschnitte für alle anderen Informationen und Produktkennzeichnung. Der kritische Weg zur Genehmigung der NADA hängt weiterhin von der Klärung der Inspektionsbeobachtungen in den Einrichtungen des Vertragsherstellers von ImmuCell ab.
Diese Forschungsstrategie ermöglicht es ImmuCell, Produktleistungsdaten zu sammeln, während es auf die vollständige Genehmigung der NADA wartet. Re-Tain® zielt darauf ab, eine Alternative zu herkömmlichen Antibiotika ohne die von der FDA geforderten Beschränkungen für Milchverwerfung oder vor der Schlachtung geltende Rückzugsbeschränkungen zu bieten.
- Initiation of Investigational Product use allows early market testing and data collection
- Progress in regulatory process with NADA submission completed
- Product offers competitive advantage with no milk discard or withdrawal restrictions
- Not expected to generate significant revenue or profit from investigational use
- Regulatory approval still pending inspection clearance at contract manufacturer
- Potential inventory shelf-life concerns driving investigational use decision
Insights
ImmuCell's initiation of Investigational Product use for Re-Tain® represents a strategic intermediate step in their regulatory pathway, but comes with significant limitations. This controlled launch allows the company to gather real-world performance data while their Non-Administrative New Animal Drug Application (NADA) remains under FDA review, with the critical constraint being the resolution of inspectional observations at their contract manufacturer's facilities.
The company is explicitly tempering financial expectations, stating this initiative "is not expected to generate significant revenue or profit". Instead, this appears to be a practical measure to utilize existing inventory approaching shelf-life expiration while simultaneously collecting valuable market feedback.
From a regulatory perspective, this represents measured progress but falls well short of full commercialization. The company's January 2025 submission included their fourth CMC Technical Section submission alongside minor technical sections covering labeling and other information - indicating a complex, iterative approval process typical of novel animal health products. The regulatory timeline remains uncertain, with manufacturing compliance issues representing the primary hurdle to NADA approval.
This controlled rollout allows ImmuCell to maintain momentum and gather performance data, potentially strengthening their regulatory position, but investors should recognize this is primarily a strategic maneuver rather than a significant commercial milestone.
PORTLAND, Maine, April 02, 2025 (GLOBE NEWSWIRE) -- ImmuCell Corporation (Nasdaq: ICCC) (“ImmuCell” or the “Company”), a growing animal health company that develops, manufactures and markets scientifically proven and practical products that improve the health and productivity of dairy and beef cattle, today announced that it is initiating Investigational Product use of Re-Tain®.
The Company intends to use this opportunity to test market acceptance of the product through a controlled launch. This initiative also helps the Company utilize available inventory before shelf-life expiration. This opportunity is not expected to generate significant revenue or profit.
The Company made its Non-Administrative New Animal Drug Application (NADA) submission, that included its fourth submission of the CMC Technical Section, together with the minor technical sections covering All Other Information and Product Labeling during early January of 2025. Clearing inspectional observations at the facilities of the Company’s contract manufacturer is still the critical path constraint to NADA approval.
“This investigational strategy allows us to collect product performance data on Re-Tain® while full NADA approval is pending the final stages of review,” commented Michael F. Brigham, President and CEO. “After all these years in drug development, we can soon begin to see how this product performs on farms.”
Cautionary Note Regarding Forward-Looking Statements (Safe Harbor Statement):
This Press Release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements can be identified by the fact that they do not relate strictly to historical or current facts and will often include words such as “expects”, “may”, “anticipates”, “aims”, “intends”, “would”, “could”, “should”, “will”, “plans”, “believes”, “estimates”, “targets”, “projects”, “forecasts”, “seeks” and similar words and expressions. Such statements include, but are not limited to, any forward-looking statements relating to: our plans, goals and strategies for our business; projections of future financial or operational performance; the timing and outcome of pending or anticipated applications for regulatory approvals and pending or anticipated regulatory inspections of our facilities and those of our contract manufacturers; future demand for our products; future adoption of Re-Tain® by dairy producers; growth in acceptance of our First Defense® product line by dairy and beef producers; the impact of international disputes (including Russia’s invasion of Ukraine and unrest in the Middle East) on the world economy including inflation and the price and availability of grain and oil; the impact of the global supply-chain disruptions on our ability to obtain, in a timely and cost-effective fashion, all the supplies and components we need to produce our products; the impact of inflation and rising interest rates on our operating expenses and financial results; the scope and timing of ongoing and future product development work and commercialization of our products; future costs of product development efforts; future incidence rates of subclinical mastitis and producers’ level of interest in treating subclinical mastitis; the expected efficacy of new products; estimates about the market size for our products; future market share of and revenue generated by current products and products still in development; our ability to increase production output and reduce costs of goods sold per unit; the adequacy of our own manufacturing facilities or those of third parties with which we have contractual relationships to meet demand for our products on a timely basis; the impacts of backlogs on customer relationships; the efficacy of our contamination remediation efforts; whether or not we will experience future contamination events; the anticipated costs of (or time to complete) planned expansions of our manufacturing facilities and the adequacy of our funds available for these projects; the robustness of our manufacturing processes to meet future demand and related technical issues; estimates about our future production capacity, efficiency and yield; the salability of products currently held in inventory pending regulatory approval; future regulatory requirements relating to our products; future expense ratios and margins; the future consequences and effectiveness of our investments in our business; future compliance with, or waivers of, bank debt covenants; anticipated changes in our manufacturing capabilities and efficiencies; our future effectiveness in competing against competitors within both our existing and our anticipated product markets; projections about depreciation expense and its impact on income for book and tax return purposes; and any other statements that are not historical facts. These statements are intended to provide management's current expectation of future events as of the date of this earnings release, are based on management's estimates, projections, beliefs and assumptions as of the date hereof; and are not guarantees of future performance. Such statements involve known and unknown risks and uncertainties that may cause the Company's actual results, financial or operational performance or achievements to be materially different from those expressed or implied by these forward-looking statements, including, but not limited to, those risks and uncertainties relating to: difficulties or delays in development, testing, regulatory approval, production and marketing of our products (including the First Defense® product line and Re-Tain®), competition within our anticipated product markets, customer acceptance of our new and existing products, product performance, alignment between our manufacturing resources and product demand (including the consequences of backlogs), uncertainty associated with the timing and volume of customer orders as we come out of a prolonged backlog, adverse impacts of supply chain disruptions on our operations and customer and supplier relationships, commercial and operational risks relating to our current and planned expansion of production capacity, and other risks and uncertainties detailed from time to time in filings we make with the Securities and Exchange Commission (SEC), including our Quarterly Reports on Form 10-Q, our Annual Reports on Form 10-K and our Current Reports on Form 8-K. Such statements involve risks and uncertainties and are based on our current expectations, but actual results may differ materially due to various factors. In addition, there can be no assurance that future risks, uncertainties or developments affecting us will be those that we anticipate. We undertake no obligation to update any forward-looking statement, whether written or oral, that may be made from time to time, whether as a result of new information, future developments or otherwise.
About ImmuCell:
ImmuCell Corporation's (Nasdaq: ICCC) purpose is to create scientifically proven and practical products that improve the health and productivity of dairy and beef cattle. ImmuCell manufactures and markets First Defense®, providing Immediate Immunity™ to newborn dairy and beef calves, and is in the late stages of developing Re-Tain®, a novel treatment for subclinical mastitis in dairy cows without FDA-required milk discard or pre-slaughter withdrawal label restrictions that provides an alternative to traditional antibiotics. Press releases and other information about the Company are available at: http://www.immucell.com.
| Contacts: | Michael F. Brigham, President and CEO ImmuCell Corporation (207) 878-2770 |
| Joe Diaz, Robert Blum and Joe Dorame Lytham Partners, LLC (602) 889-9700 iccc@lythampartners.com |
FAQ
What is the current status of ImmuCell's (ICCC) Re-Tain® drug approval process?
How will the Investigational Product use of Re-Tain® benefit ICCC?
What distinguishes Re-Tain® from other mastitis treatments in dairy cows?
When did ImmuCell (ICCC) submit its latest NADA application for Re-Tain®?
