Heron Therapeutics Reaffirms Availability and Ample Supply of CINVANTI®, SUSTOL®, and APONVIE® as Alternatives During the Potential Shortage of Intravenous Fluids
Heron Therapeutics (Nasdaq: HRTX) has reaffirmed its ability to supply CINVANTI®, SUSTOL®, and APONVIE® as alternatives during a potential shortage of intravenous (IV) fluids caused by Hurricane Helene. These products are ready-to-administer formulations that don't require additional dilution with IV fluids, making them important during this potential shortage.
The IV fluid shortage is expected due to the temporary closure of a major supplier's manufacturing site in Marion, North Carolina, which reportedly supplies up to 60% of the U.S. IV fluid market. Heron has received outreach from several health systems preparing to maintain continuity of care. The company is committed to ensuring timely delivery of its products throughout the U.S. during this potential shortage.
Heron Therapeutics (Nasdaq: HRTX) ha ribadito la sua capacità di fornire CINVANTI®, SUSTOL® e APONVIE® come alternative durante un potenziale deficit di soluzioni endovenose (IV) a causa dell'uragano Helene. Questi prodotti sono formulazioni pronte all'uso che non richiedono ulteriori diluizioni con soluzioni IV, rendendoli importanti durante questo possibile deficit.
Il deficit di soluzioni IV è previsto a causa della chiusura temporanea del sito di produzione di un importante fornitore a Marion, Carolina del Nord, che fornisce, si dice, fino al 60% del mercato IV degli Stati Uniti. Heron ha ricevuto richieste da diversi sistemi sanitari che si preparano a mantenere la continuità delle cure. L'azienda è impegnata a garantire una consegna tempestiva dei propri prodotti in tutto il territorio degli Stati Uniti durante questo potenziale deficit.
Heron Therapeutics (Nasdaq: HRTX) ha reafirmado su capacidad para suministrar CINVANTI®, SUSTOL® y APONVIE® como alternativas durante una posible escasez de soluciones intravenosas (IV) causada por el huracán Helene. Estos productos son formulaciones listas para administrar que no requieren dilución adicional con soluciones IV, lo que los hace importantes durante esta posible escasez.
Se espera una escasez de soluciones IV debido al cierre temporal del sitio de fabricación de un importante proveedor en Marion, Carolina del Norte, que según informes suministra hasta el 60% del mercado de soluciones IV en los EE. UU.. Heron ha recibido solicitudes de varios sistemas de salud que se están preparando para mantener la continuidad de la atención. La compañía está comprometida a garantizar la entrega oportuna de sus productos en todo el país durante esta posible escasez.
헤론 테라퓨틱스(Nasdaq: HRTX)는 허리케인 헬렌으로 인해 발생할 수 있는 정맥 주사(IV) 액체의 공급 부족 상황에서 CINVANTI®, SUSTOL®, APONVIE®를 대체제로 공급할 수 있는 능력을 재확인했습니다. 이들 제품은 사용 준비가 된 제형으로, IV 액체와의 추가 희석이 필요 없으므로 이 공급 부족 상황에서 중요성이 큰 제품입니다.
IV 액체 부족이 예상되는 이유는 미국 노스캐롤라이나주 마리온에 있는 주요 공급업체의 제조 시설이 일시적으로 폐쇄되었기 때문이며, 이 공급업체는 보고된 바에 따르면 미국 IV 액체 시장의 60%까지 공급한다고 합니다. 헤론은 치료의 연속성을 유지하기 위해 준비 중인 여러 건강 시스템으로부터 연락을 받았습니다. 회사는 이 공급 부족 상황에서도 미국 전역에 제때 제품을 배송할 수 있도록 최선을 다하고 있습니다.
Heron Therapeutics (Nasdaq: HRTX) a réaffirmé sa capacité à fournir CINVANTI®, SUSTOL® et APONVIE® comme alternatives en cas de pénurie potentielle de solutions intraveineuses (IV) causée par l'ouragan Helene. Ces produits sont des formulations prêtes à l'emploi qui ne nécessitent pas de dilution supplémentaire avec des solutions IV, ce qui les rend importants dans cette éventuelle pénurie.
La pénurie de solutions IV est prévue en raison de la fermeture temporaire d'un site de fabrication d'un important fournisseur à Marion, Caroline du Nord, qui, selon les rapports, fournit jusqu'à 60 % du marché des solutions IV aux États-Unis. Heron a reçu des demandes de plusieurs systèmes de santé se préparant à maintenir la continuité des soins. L'entreprise s'engage à garantir une livraison rapide de ses produits à travers les États-Unis pendant cette pénurie potentielle.
Heron Therapeutics (Nasdaq: HRTX) hat seine Fähigkeit bekräftigt, CINVANTI®, SUSTOL® und APONVIE® als Alternativen während einer potenziellen Knappheit bei intravenösen (IV) Flüssigkeiten aufgrund des Hurrikans Helene zur Verfügung zu stellen. Diese Produkte sind fertig zur Anwendung und benötigen keine zusätzliche Verdünnung mit IV-Flüssigkeiten, was sie in dieser potentiellen Knappheit wichtig macht.
Die Knappheit an IV-Flüssigkeiten wird aufgrund der vorübergehenden Schließung eines wichtigen Herstellers in Marion, North Carolina, erwartet, der Berichten zufolge bis zu 60 % des US-Marktes für IV-Flüssigkeiten versorgt. Heron hat Anfragen von mehreren Gesundheitssystemen erhalten, die sich auf die Aufrechterhaltung der Kontinuität der Versorgung vorbereiten. Das Unternehmen verpflichtet sich, die pünktliche Lieferung seiner Produkte in den gesamten USA während dieser möglichen Knappheit sicherzustellen.
- Heron's products (CINVANTI, SUSTOL, APONVIE) do not require dilution with IV fluids, positioning them as important alternatives during the potential shortage
- Increased demand potential for Heron's products due to outreach from health systems preparing for IV fluid shortage
- Heron's commitment to ensuring timely product delivery may lead to increased market share and customer loyalty
- None.
Insights
The potential shortage of IV fluids due to Hurricane Helene's impact on a major manufacturing facility presents both challenges and opportunities in the medical supply chain. Heron Therapeutics' ready-to-administer formulations of CINVANTI, SUSTOL and APONVIE could see increased demand as alternatives to products requiring IV fluid dilution.
This situation highlights the vulnerability of centralized manufacturing in the pharmaceutical supply chain. With up to
For investors, this could translate to a short-term boost in Heron's sales and market share. However, it's important to consider whether this potential uptick is sustainable long-term or if it's a temporary shift that will normalize once IV fluid supply stabilizes. The company's ability to scale production and distribution to meet sudden increased demand will be key to capitalizing on this opportunity.
Heron's proactive approach in reaffirming product availability during a potential crisis demonstrates strong operational readiness. This could enhance the company's reputation among healthcare providers and potentially lead to long-term customer retention even after the IV fluid shortage is resolved.
The situation underscores the importance of diverse product formulations in healthcare. Heron's ready-to-administer products offer a clear advantage in resource-constrained environments, which could lead to broader adoption and integration into standard care protocols. This event may serve as a catalyst for healthcare systems to reevaluate their supply chain resilience and product choices.
Investors should watch for indicators of Heron's ability to meet increased demand, such as changes in inventory levels, production capacity and distribution network performance. The company's response to this situation could provide insights into its operational agility and market responsiveness, which are valuable attributes in the volatile biotech sector.
As widely reported, the potential disruption in the supply of intravenously administered fluids is a result of the temporary closure of a major suppliers' manufacturing site in
"In the wake of Hurricane Helene, and with the recently announced potential supply disruption for IV fluids, Heron has received outreach from several health systems preparing to maintain continuity of care," said Craig Collard, Chief Executive Officer of Heron. "Our team is committed to ensuring timely delivery of our products throughout the
CINVANTI, SUSTOL, and APONVIE are available through major wholesalers and specialty distributors, and further information can be obtained by calling the Company's information line at 844-HERON11 (844-437-6611).
About CINVANTI for Chemotherapy Induced Nausea and Vomiting (CINV) Prevention
CINVANTI, in combination with other antiemetic agents, is indicated in adults for the prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of highly emetogenic cancer chemotherapy (HEC) including high-dose cisplatin as a single-dose regimen, delayed nausea and vomiting associated with initial and repeat courses of moderately emetogenic cancer chemotherapy (MEC) as a single-dose regimen, and nausea and vomiting associated with initial and repeat courses of MEC as a 3-day regimen. CINVANTI is an IV formulation of aprepitant, an NK1 RA. CINVANTI is the first IV formulation to directly deliver aprepitant, the active ingredient in EMEND® capsules. Aprepitant (including its prodrug, fosaprepitant) is a single-agent NK1 RA to significantly reduce nausea and vomiting in both the acute phase (0–24 hours after chemotherapy) and the delayed phase (24–120 hours after chemotherapy). The FDA-approved dosing administration included in the
Please see full prescribing information at www.CINVANTI.com.
About SUSTOL for CINV Prevention
SUSTOL is indicated in combination with other antiemetics in adults for the prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of moderately emetogenic chemotherapy (MEC) or anthracycline and cyclophosphamide (AC) combination chemotherapy regimens. SUSTOL is an extended-release, injectable 5-hydroxytryptamine type 3 RA that utilizes Heron's Biochronomer® drug delivery technology to maintain therapeutic levels of granisetron for ≥5 days. The SUSTOL global Phase 3 development program was comprised of two, large, guideline-based clinical studies that evaluated SUSTOL's efficacy and safety in more than 2,000 patients with cancer. SUSTOL's efficacy in preventing nausea and vomiting was evaluated in both the acute phase (0–24 hours after chemotherapy) and delayed phase (24–120 hours after chemotherapy).
Please see full prescribing information at www.SUSTOL.com.
About APONVIE for Postoperative Nausea and Vomiting (PONV)
APONVIE is a substance NK1 Receptor Antagonist (RA), indicated for the prevention of PONV in adults. Delivered via a 30-second IV push, APONVIE 32 mg was demonstrated to be bioequivalent to oral aprepitant 40 mg with rapid achievement of therapeutic drug levels. APONVIE is the same formulation as Heron's approved drug product CINVANTI. APONVIE is supplied in a single-dose vial that delivers the full 32 mg dose for PONV. APONVIE was approved by the FDA in September 2022 and became commercially available in the
Please see full prescribing information at www.APONVIE.com.
About Heron Therapeutics, Inc.
Heron Therapeutics, Inc. is a commercial-stage biotechnology company focused on improving the lives of patients by developing and commercializing therapeutic innovations that improve medical care. Our advanced science, patented technologies, and innovative approach to drug discovery and development have allowed us to create and commercialize a portfolio of products that aim to advance the standard-of-care for acute care and oncology patients. For more information, visit www.herontx.com.
Forward-looking Statements
This news release contains "forward-looking statements" as defined by the Private Securities Litigation Reform Act of 1995. Heron cautions readers that forward-looking statements are based on management's expectations and assumptions as of the date of this news release and are subject to certain risks and uncertainties that could cause actual results to differ materially. Therefore, you should not place undue reliance on forward-looking statements. Examples of forward-looking statements include, among others, statements we make regarding the potential market opportunities for APONVIE®, CINVANTI® and SUSTOL®. Important factors that could cause actual results to differ materially from those in the forward-looking statements are set forth in our most recent Annual Report on Form 10-K and any subsequent Quarterly Reports on Form 10-Q, and in our other reports filed with the Securities and Exchange Commission, including under the caption "Risk Factors." Forward-looking statements reflect our analysis only on their stated date, and Heron takes no obligation to update or revise these statements except as may be required by law.
Investor Relations and Media Contact:
Ira Duarte
Executive Vice President, Chief Financial Officer
Heron Therapeutics, Inc.
iduarte@herontx.com
858-251-4400
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