Marinomed Biotech AG: Marinomed applies for drug approval for new decongestant nasal spray in Europe

Korneuburg (pta012/08.09.2020/09:00 UTC+2) 08 September 2020

* Broadening of the successful Carragelose® platform
* Approval for a first group of EU countries
* Two marketing partners for roll-out already acquired
* Market launch planned for the 2021/22 season
* Carragelose® with high effectiveness against SARS-CoV-2 and other respiratory viruses

Marinomed Biotech AG has applied for approval of the new decongestant Carragelose® nasal spray in a first group of EU countries. It is the first product from the Carragelose® platform to be approved as a medicinal product. The spray aims to treat viral infections of the respiratory tract and reduce the swelling of the mucous membranes of the nose and throat, which enables free breathing through the nose. "With this decongestant nasal spray, we are expanding our successful Carragelose® product range by including a non-prescription drug for the first time. This will give many people in Europe access to the advantages of Carragelose® as a broad-spectrum virus blocker. As a company, we are strengthening our presence in the important market for decongestant nasal sprays," explains CEO Andreas Grassauer.

The nasal spray contains Carragelose® and the decongestant xylometazoline. Carragelose® forms a moisturizing protective film on the nasal mucosa and thus slows down the spread and multiplication of viruses. In addition, Carragelose® supports the active ingredient xylometazoline in reducing the duration and intensity of symptoms in the event of a viral infection of the respiratory tract.

Austria is the reference state in a decentralized marketing authorization procedure. Marinomed expects the product to be launched in important EU markets in the 2021/22 season. Marinomed has already won two new marketing partners for this product.

Effectiveness of Carragelose® against SARS-CoV-2 and other respiratory viruses

Products containing Carragelose® have been on the market for several years as nasal sprays, throat sprays and lozenges as therapeutic agents against respiratory infections in more than 40 countries. Because of the solely physical mechanism of action, the products are certified as medical device products and are characterized by their very broad effectiveness against various respiratory viruses.

Several independent studies confirm the effectiveness against SARS-CoV-2. A study from Tennessee / USA together with Argentinean researchers shows that Carragelose® can reduce the multiplication of the virus by almost 100% even at extremely low doses. A clinical study, which was also carried out in Argentina, shows that a nasal spray with Carragelose® in combination with the drug Ivermectin offers a very high level of protection as a prophylaxis. 229 healthy hospital employees took part in the study. The group treated with Carragelose and Ivermectin did not register a single infection with SARS-CoV-2, while in the control group 11% of the participants tested positive for SARS-CoV-2 within 28 days.

Carragelose® has been shown in-vitro to be active against human rhinoviruses, human coronaviruses (SARS-CoV-2, OC43 and 229E), human influenza viruses A (nH1N1 and H3N2), non-human pathogenic influenza A viruses (H7N7 and H5N1), respiratory syncytial virus and human parainfluenza virus type 3.

This broad effectiveness could also be shown clinically in four studies. Patients suffering from early symptoms of influenza infections were treated with a nasal spray containing Carragelose®. The results showed that patients treated with the Carragelose®-containing nasal spray exhibited significantly shorter symptoms than placebo patients and that the viral load and the recurrence of symptoms were significantly reduced. A subgroup analysis with those patients who were infected with either human rhinoviruses, human coronaviruses or human influenza A viruses showed that similar results were achieved in all three groups as in the group of all virus-positive patients. The greatest reduction in symptoms was achieved in coronavirus-infected patients who, in the case of treatment with a Carragelose®-containing nasal spray, were symptom-free almost 4 days earlier than the comparison group with placebo treatment.

About Marinomed Biotech AG
Marinomed Biotech AG is a biopharmaceutical company with headquarters in Vienna (Austria) and listed on the Prime Market of the Vienna Stock Exchange. The company focuses on the development of innovative products based on patent-protected technology platforms in the field of respiratory and ophthalmological diseases. The Marinosolv® technology platform increases the efficacy of hardly soluble compounds for the treatment of sensitive tissues such as the eyes and nose. The Carragelose® platform comprises innovative patent-protected products targeting viral infections of the respiratory tract. Carragelose® is used in nasal sprays, throat sprays and lozenges, which are sold via international partners in over 40 countries worldwide. Further information is available at: www.marinomed.com.

For further enquiries please contact:

Dr. Eva Prieschl-Grassauer
Chief Scientific Officer, Marinomed
Hovengasse 25, 2100 Korneuburg, Austria
T +43 2262 90300
E-Mail: eva.prieschl@marinomed.com
http://www.marinomed.com
Roland Mayrl
Managing Partner, Metrum Communications
Bauernmarkt 10/19, 1010 Vienna, Austria
T +43 (0) 1 504 69 87 331
E-Mail: r.mayrl@metrum.at
http://www.metrum.at

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.

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Emitter:	Marinomed Biotech AG Hovengasse 25 2100 Korneuburg Austria
Contact Person:	Dr. Eva Prieschl-Grassauer
Phone:	+43 2262 90300
E-Mail:	eva.prieschl@marinomed.com
Website:	www.marinomed.com
ISIN(s):	ATMARINOMED6 (Share)
Stock Exchange(s):	Vienna Stock Exchange (Official Trade)