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Cosmos Health Secures Exclusivity Agreement with Virax Biolabs to Distribute mpox PCR Kits across the GCC, including the UAE, Saudi Arabia, Bahrain, Kuwait, Oman, and Qatar

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Cosmos Health (NASDAQ:COSM) has expanded its exclusive distribution agreement with Virax Biolabs (NASDAQ:VRAX) to commercialize mpox virus real-time PCR detection kits in Gulf Cooperation Council (GCC) countries. This extension builds upon their previous agreement for Greece, Cyprus, and non-exclusive distribution across Europe. The kits, CE-marked and MHRA-authorized, offer 96.7% sensitivity and 93.72% specificity, delivering results in under 70 minutes.

The agreement comes in response to the WHO's declaration of mpox as a public health emergency in August 2024, with cases spreading beyond Africa to Europe and Asia. Cosmos Health aims to support governments and public health authorities in Europe and the Gulf by enhancing preparedness and ensuring rapid detection of mpox cases.

Cosmos Health (NASDAQ:COSM) ha ampliato il suo accordo di distribuzione esclusiva con Virax Biolabs (NASDAQ:VRAX) per commercializzare kit di rilevazione del virus mpox tramite PCR in tempo reale nei paesi del Consiglio di Cooperazione del Golfo (GCC). Questa estensione si basa sul loro precedente accordo per Grecia, Cipro e distribuzione non esclusiva in Europa. I kit, con marcatura CE e autorizzazione MHRA, offrono il 96,7% di sensibilità e il 93,72% di specificità, fornendo risultati in meno di 70 minuti.

L'accordo è stato stipulato in risposta alla dichiarazione dell'OMS che classifica il mpox come emergenza sanitaria pubblica nell'agosto 2024, con casi che si diffondono oltre l'Africa in Europa e Asia. Cosmos Health mira a supportare i governi e le autorità sanitarie pubbliche in Europa e nel Golfo migliorando la preparazione e garantendo una rapida rilevazione dei casi di mpox.

Cosmos Health (NASDAQ:COSM) ha ampliado su acuerdo de distribución exclusiva con Virax Biolabs (NASDAQ:VRAX) para comercializar kits de detección del virus mpox mediante PCR en tiempo real en los países del Consejo de Cooperación del Golfo (GCC). Esta extensión se basa en su acuerdo anterior para Grecia, Chipre y distribución no exclusiva en Europa. Los kits, marcados CE y autorizados por MHRA, ofrecen 96,7% de sensibilidad y 93,72% de especificidad, proporcionando resultados en menos de 70 minutos.

El acuerdo responde a la declaración de la OMS sobre el mpox como emergencia de salud pública en agosto de 2024, con casos que se están extendiendo más allá de África hacia Europa y Asia. Cosmos Health tiene como objetivo apoyar a los gobiernos y a las autoridades de salud pública en Europa y en el Golfo mejorando la preparación y asegurando una rápida detección de los casos de mpox.

코스모스 헬스(Cosmos Health, NASDAQ:COSM)는 비락스 바이오랩스(Virax Biolabs, NASDAQ:VRAX)와의 독점 배급 계약을 확대하였습니다.mpox 바이러스 실시간 PCR 검출 키트를 걸프 협력 회의(GCC) 국가에 상용화하기 위해 진행되었습니다. 이번 확대는 그리스, 키프로스 및 유럽에서의 비독점 배급에 대한 이전 계약을 바탕으로 하였습니다. 이 키트는 CE 인증 및 MHRA 승인을 받았으며, 96.7%의 민감도와 93.72%의 특이성을 제공하며, 70분 이내에 결과를 제공합니다.

이번 계약은 WHO가 mpox를 공공 보건 비상 사태로 선언한 것에 대한 응답으로 2024년 8월에 체결되었습니다. 과연 케이스가 아프리카를 넘어 유럽과 아시아로 확산되고 있습니다. 코스모스 헬스는 유럽과 걸프 지역의 정부 및 공공 보건 당국을 지원하여 대비 태세를 강화하고 mpox 사례의 신속한 검출을 보장하는 것을 목표로 하고 있습니다.

Cosmos Health (NASDAQ:COSM) a élargi son accord de distribution exclusif avec Virax Biolabs (NASDAQ:VRAX) pour commercialiser des kits de détection du virus mpox par PCR en temps réel dans les pays du Conseil de coopération du Golfe (CCG). Cette extension repose sur leur précédent accord pour la Grèce, Chypre et une distribution non exclusive en Europe. Les kits, marqués CE et autorisés par la MHRA, offrent 96,7% de sensibilité et 93,72% de spécificité, fournissant des résultats en moins de 70 minutes.

L'accord a été conclu en réponse à la déclaration de l'OMS classant le mpox comme une urgence sanitaire publique en août 2024, avec des cas se répandant au-delà de l'Afrique vers l'Europe et l'Asie. Cosmos Health vise à soutenir les gouvernements et les autorités de santé publique en Europe et dans le Golfe en renforçant la préparation et en garantissant la détection rapide des cas de mpox.

Cosmos Health (NASDAQ:COSM) hat sein exklusives Vertriebsabkommen mit Virax Biolabs (NASDAQ:VRAX) ausgeweitet, um mpox-Virus Echtzeit-PCR-Diagnosetests in den Ländern des Golf-Kooperationsrates (GCC) zu vermarkten. Diese Erweiterung baut auf ihrem vorherigen Abkommen für Griechenland, Zypern und die nicht-exklusive Verteilung in Europa auf. Die Tests, CE-gekennzeichnet und von der MHRA autorisiert, bieten 96,7% Sensitivität und 93,72% Spezifität und liefern Ergebnisse in weniger als 70 Minuten.

Das Abkommen erfolgt als Reaktion auf die Erklärung der WHO, mpox als Gesundheitsnotstand einzustufen im August 2024, wobei sich die Fälle über Afrika hinaus nach Europa und Asien ausbreiten. Cosmos Health zielt darauf ab, Regierungen und Gesundheitsbehörden in Europa und im Golf zu unterstützen, indem es die Einsatzbereitschaft erhöht und eine schnelle Erkennung von mpox-Fällen gewährleistet.

Positive
  • Exclusive distribution rights secured for mpox PCR kits in GCC countries
  • Expansion of existing agreement with Virax Biolabs, potentially increasing market reach
  • High sensitivity (96.7%) and specificity (93.72%) of the mpox detection kits
  • CE-marked and MHRA-authorized kits, ensuring regulatory compliance
  • Rapid test results in under 70 minutes, enhancing diagnostic efficiency
Negative
  • Dependence on Virax Biolabs for product supply
  • Potential competition from other diagnostic test providers in the market
  • Success relies on the continued spread and concern over mpox virus

The exclusive distribution agreement between Cosmos Health and Virax Biolabs for mpox PCR kits in the GCC region is a strategic move in response to the growing global concern over mpox. The WHO's recent declaration of mpox as a public health emergency underscores the timeliness and relevance of this partnership. The 96.7% sensitivity and 93.72% specificity of these CE-marked and MHRA-authorized tests indicate high accuracy, which is important for effective disease control. However, it's important to note that while this agreement expands market reach, the actual impact on revenues will depend on the prevalence of mpox cases in the GCC region and the adoption rate of these kits by local healthcare systems.

This exclusive distribution agreement represents a significant market opportunity for both Cosmos Health and Virax Biolabs. The GCC region, with its six member states, offers a substantial new market for mpox detection kits. The timing is opportune, given the recent WHO declaration and the spread of mpox beyond Africa. However, investors should consider that the market potential is contingent on several factors, including the evolution of the mpox outbreak, government health policies and competition from other diagnostic tools. The exclusivity clause provides a competitive advantage, but the long-term success will depend on the companies' ability to establish strong relationships with local health authorities and navigate regulatory landscapes in these new markets.

While this agreement expands Cosmos Health's product portfolio and geographical reach, its financial impact remains uncertain. The company has not provided specific revenue projections or pricing details for these kits. Investors should note that diagnostic test sales can be highly variable, depending on disease prevalence and testing policies. The exclusivity clause could potentially lead to higher margins, but this will depend on the pricing strategy and local market dynamics. It's also worth considering the potential costs associated with entering new markets, including regulatory compliance and marketing expenses. Overall, while this deal diversifies Cosmos Health's offerings, its contribution to the bottom line will need to be closely monitored in upcoming financial reports.

CHICAGO, IL / ACCESSWIRE / September 16, 2024 / Cosmos Health Inc. ("Cosmos Health" or the "Company'') (NASDAQ:COSM), a diversified, vertically integrated global healthcare group engaged in innovative R&D, owner of proprietary pharmaceutical and nutraceutical brands, manufacturer and distributor of healthcare products, and operator of a telehealth platform, announced today that it has entered into an extension of its existing exclusive distribution agreement with Virax Biolabs (NASDAQ: VRAX) to commercialize mpox virus real-time PCR detection kits in countries within the Gulf Cooperation Council ("GCC"). It had previously signed an agreement for exclusive distribution in Greece and Cyprus, as well as for non-exclusive distribution throughout Europe.

Under the agreement, Cosmos Health is now also authorized to import, sell, and distribute Virax-branded mpox Virus Nucleic Acid Detection Kits throughout the GCC, including Bahrain, Kuwait, Oman, Qatar, Saudi Arabia, and the United Arab Emirates.

The RT-PCR mpox virus detection kits are CE-marked for sale in Europe and authorized by the UK's Medicines and Healthcare products Regulatory Agency (MHRA). These tests offer a sensitivity of 96.7% and a specificity of 93.72%, providing results in under 70 minutes.

On August 14, 2024, Dr. Tedros Adhanom Ghebreyesus, Director-General of the World Health Organization (WHO), declared the rise of mpox cases in the Democratic Republic of the Congo and other African nations a public health emergency of international concern under the International Health Regulations. Since then, mpox has spread beyond Africa, with confirmed cases in Europe and Asia, signaling growing global concern.

Greg Siokas, CEO of Cosmos Health, stated: " We are excited to strengthen our partnership with Virax to help curb the spread of mpox. With strong demand for detection kits, we are well-positioned to support governments and public health authorities in Europe and the Gulf countries by enhancing preparedness, planning, and awareness, ensuring rapid detection and an effective response."

James Foster, CEO of Virax Biolabs, stated: "We are thrilled to deepen our partnership with Cosmos. This exclusive agreement extends our geographic reach, equipping more healthcare professionals with vital tools to diagnose and manage the spread of the mpox virus. We look forward to collaborating closely with Cosmos and leveraging its robust distribution network."

About Virax Biolabs Group Limited

Virax Biolabs Group Limited is an innovative biotechnology company focused on the detection of immune responses to and diagnosis of viral diseases. Virax Biolabs Group Limited is currently developing T-Cell-based test technologies with the intention of providing an immunology profiling platform. T-Cell testing can be particularly effective in the diagnosis and therapeutics of post-viral syndromes such as Long COVID and other chronic conditions linked to immune dysregulation. For more information, please visit www.viraxbiolabs.com.

About Cosmos Health Inc.

Cosmos Health Inc. (Nasdaq:COSM), incorporated in 2009 in Nevada, is a diversified, vertically integrated global healthcare group. The Company owns a portfolio of proprietary pharmaceutical and nutraceutical brands, including Sky Premium Life®, Mediterranation®, bio-bebe® and C-Sept®. Through its subsidiary Cana Laboratories S.A., licensed under European Good Manufacturing Practices (GMP) and certified by the European Medicines Agency (EMA), it manufactures pharmaceuticals, food supplements, cosmetics, biocides, and medical devices within the European Union. Cosmos Health also distributes a broad line of pharmaceuticals and parapharmaceuticals, including branded generics and OTC medications, to retail pharmacies and wholesale distributors through its subsidiaries in Greece and the UK. Furthermore, the Company has established R&D partnerships targeting major health disorders such as obesity, diabetes, and cancer, enhanced by artificial intelligence drug repurposing technologies, and focuses on the R&D of novel patented nutraceuticals, specialized root extracts, proprietary complex generics, and innovative OTC products. Cosmos Health has also entered the telehealth space through the acquisition of ZipDoctor, Inc., based in Texas, USA. With a global distribution platform, the Company is currently expanding throughout Europe, Asia, and North America, and has offices and distribution centers in Thessaloniki and Athens, Greece, and in Harlow, UK. More information is available at www.cosmoshealthinc.com, www.skypremiumlife.com, www.cana.gr, www.zipdoctor.co, as well as LinkedIn and X.

Forward-Looking Statements

With the exception of the historical information contained in this news release, the matters described herein, may contain forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Statements preceded by, followed by, or that otherwise, include the words "believes," "expects," "anticipates," "intends," "projects," "estimates," "plans" and similar expressions or future or conditional verbs such as "will," "should," "would," "may" and "could", are generally forward-looking in nature and not historical facts, although not all forward-looking statements include the foregoing. These statements, involve unknown risks and uncertainties that may individually or materially impact the matters discussed, herein for a variety of reasons that are outside the control of the Company, including, but not limited to, the Company's ability to raise sufficient financing to implement its business plan, the impact of the COVID-19 pandemic and the war in Ukraine, on the Company's business, operations and the economy in general, and the Company's ability to successfully develop and commercialize its proprietary products and technologies. Readers are cautioned not to place undue reliance on these forward- looking statements, as actual results could differ materially from those described in the forward-looking statements contained herein. Readers are urged to read the risk factors set forth in the Company's filings with the SEC, which are available at the SEC's website (www.sec.gov). The Company disclaims any intention or obligation to update, or revise any forward-looking statements, whether as a result of new information, future events or otherwise.

Investor Relations Contact:

BDG Communications
cosm@bdgcommunications.com
+44 207 0971 653

SOURCE: Cosmos Health Inc.



View the original press release on accesswire.com

FAQ

What new markets has Cosmos Health (COSM) secured for mpox PCR kit distribution?

Cosmos Health has secured exclusive distribution rights for mpox PCR kits in Gulf Cooperation Council (GCC) countries, including Bahrain, Kuwait, Oman, Qatar, Saudi Arabia, and the United Arab Emirates.

What are the performance metrics of the mpox PCR kits distributed by Cosmos Health (COSM)?

The mpox PCR kits distributed by Cosmos Health offer a sensitivity of 96.7% and a specificity of 93.72%, providing results in under 70 minutes.

When did the WHO declare mpox a public health emergency, leading to increased demand for Cosmos Health's (COSM) PCR kits?

On August 14, 2024, the WHO declared the rise of mpox cases a public health emergency of international concern, potentially increasing demand for Cosmos Health's PCR kits.

What regulatory approvals do the mpox PCR kits distributed by Cosmos Health (COSM) have?

The mpox PCR kits distributed by Cosmos Health are CE-marked for sale in Europe and authorized by the UK's Medicines and Healthcare products Regulatory Agency (MHRA).

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