M8 Pharmaceuticals obtains market authorization for Carragelose nasal spray in Mexico – Biotech Investments

Marinomed Biotech AG: M8 Pharmaceuticals obtains market authorization for Carragelose nasal spray in Mexico

• Marinomeds distribution partner M8 Pharmaceuticals obtained market approval for distribution and marketing of a Carragelose nasal spray in Mexico
• Launch of the product under the trade name Barlo® is planned for the upcoming season
• Promising Mexican OTC (over-the-counter) cough & cold market holds significant Carragelose revenue potential

Korneuburg, Austria, 27 July 2023 – Marinomed Biotech AG (VSE:MARI) announced today the market approval of a Carragelose nasal spray in Mexico. In 2021, Marinomed disclosed a licence agreement with the Latin American based specialty pharmaceutical company M8 pharmaceuticals (formerly moksha8) for the distribution of Carragelose nasal sprays in Mexican and Brazilian markets. M8 is responsible for pursuing the local market authorization and marketing of the product in the region. The approval for the Carragelose nasal spray has now been granted in Mexico, which clears the way for a market launch. The launch of the Carragelose nasal spray, which will be available under the trade name Barlo®, is envisaged for the next season. With a population of over 130 million, Mexico is Latin America’s second largest OTC and Rx market. The Mexican consumer healthcare market is forecasted to keep growing at an annual rate of up to 10%, reaching five billion USD by 2035. With a share of 32%, cough, cold and allergy is the leading Mexican OTC segment and represents a significant sales potential for Carragelose products.

Andreas Grassauer, CEO of Marinomed, commented: “We are very satisfied to have received the marketing authorization with our strong partner M8, while regulatory requirements for these products became more demanding worldwide. This aligns with our primary strategic goal of achieving sustainable growth for our Carragelose business by closing geographical gaps, targeting new indications and developing new products. Recently, we reported positive clinical data for the use of Carragelose in allergic indications, announced the launch of a new Carragelose eye drop product, obtained a new patent and are now expanding our respiratory product repertoire in Mexico. We are delighted by this positive development, which further motivates us to pursue our growth trajectory and leverage the success of this platform.”

Joel Barlan, CEO of M8, commented: “We are very pleased about the recent approval of the product by COFEPRIS and are now in the midst of launch preparations. We continue to build a market leading respiratory franchise in Mexico and throughout Latin America focused on bringing novel therapeutic solutions to patients and prescribers.”

Carragelose has gained reputation as a safe, effective and broadly active way to prevent and treat viral respiratory infections. Several studies have shown the virus-blocking effectiveness of Carragelose against a variety of respiratory viruses, such as rhinoviruses, Influenza A or Coronaviruses, including SARS-CoV-2. Carragelose is available in nasal and throat sprays as well as lozenges and has been outlicensed to partners in over 40 countries.

About Carragelose®

Carragelose® is a sulfated polymer from red seaweed and a unique, broadly active virus-blocking compound. It is known as a gentle, effective, and safe prevention and treatment of various viral respiratory infections. Several clinical and preclinical studies have shown that Carragelose® forms a protective layer on the mucosa that prevents viruses from infecting cells. Laboratory and clinical data have demonstrated that Carragelose® can also inhibit the spreading of SARS-CoV-2.[1],[2] Marinomed is the holder of the IP rights and has licensed Carragelose® for marketing in Europe, North America, Australia, and parts of Asia and Latin America. Marinomed’s portfolio of Carragelose®-containing nasal sprays and oral products can be accessed at https://www.carragelose.com/en/portfolio/launched-products, scientific publications on Carragelose® at https://www.carragelose.com/en/publications.

About Marinomed Biotech AG

Marinomed Biotech AG is an Austrian, science-based biotech company with a growing development pipeline and globally marketed therapeutics. The Company develops innovative patent-protected products in the therapeutic areas immunology and virology based on the platform Marinosolv® and the virus-blocking activity of Carragelose®. The Marinosolv® technology improves the solubility and bioavailability of hardly soluble compounds and is used to develop new therapeutics for autoreactive immune disorders. The virology segment includes Carragelose®-based over-the-counter (OTC) products to prevent and treat respiratory viral infections that are partnered in more than 40 countries. The Company is headquartered in Korneuburg, Austria, and is listed on the prime market of the Vienna Stock Exchange (VSE:MARI). For further information, please visit: https://www.marinomed.com.

About M8 PHARMACEUTICALS

M8 is a specialty biopharmaceutical company focused on licensing, marketing and distributing innovative and established therapeutics in Latin America: Brazil and Mexico. We aim to become the preferred pharmaceutical partner for the licensing of high-value innovative and proven therapies across our main therapeutic areas CNS, Respiratory, Cardiometabolic, Immunology, Gastroenterology, Onco-hematology and Rare Diseases. Our mission is to provide the people of Latin America with access to the proven and innovative medicines they need to transform their lives. For further information, please visit: https://www.m8pharmaceuticals.com/

For further inquiries contact:

Disclaimer

This press release contains forward-looking statements, which are based on current views, expectations and projections of the management of Marinomed Biotech AG about future events. These forward-looking statements are subject to risks, uncertainties and assumptions that could cause actual results, performance or events to differ materially from those described in, or expressed or implied by, such statements. The current views, expectations and projections of the management of Marinomed Biotech AG may be identified by the context of such statements or words such as “anticipate,” “believe”, “estimate”, “expect”, “intend”, “plan”, “project” and “target”. Forward-looking statements are only valid as of the date they are made and Marinomed Biotech AG does not assume any obligation to update, review or revise any forward-looking statements contained in this press release whether as a result of new information, future developments or otherwise. Marinomed, Marinosolv® and Carragelose® are registered trademarks of Marinomed Biotech AG. These trademarks may be owned or licensed in select locations only.

^[1]  https://www.dovepress.com/efficacy-of-a-nasal-spray-containing-iota-carrageenan-in-the-postexpos-peer-reviewed-fulltext-article-IJGM

^[2]  https://www.marinomed.com/en/news/marinomed-biotech-ag-shares-positive-clinical-trial-results-for-iota-carrageenan-nasal-spray-in-the-prevention-of-covid-19-1