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Wednesday, December 29, 2021

Altamira Updates on Antiviral Nasal Spray

 Altamira Therapeutics Ltd. (NASDAQ:CYTO), a company dedicated to addressing unmet medical needs through RNA therapeutics, allergy and viral infection protection, and inner ear therapeutics, today provided a business update on Bentrio™, its nasal spray for protection against airborne viruses and allergens.

  • European roll-out: Since November, the Company has set up contracts with wholesalers in its lead market Germany, covering >50% of German pharmacies. Sales through these "brick and mortar" pharmacies, which still represent the vast majority of the OTC market in Germany, have since been increasing steadily and are expected to be boosted further through various marketing initiatives planned for Q1 2022. Bentrio™ has now also become available in Germany on the Amazon platform, further strengthening the product's online channel presence. The Amazon platform will be expanded to other European markets, shortly. In Switzerland, Bentrio™ will become available in early January under a distribution agreement with Akos Santé.

  • 510(k) submission in United States: The U.S. Food and Drug Administration ("FDA") started the substantive review of the Company's 510(k) application for premarket clearance for protection against airborne allergens in mid-October. As part of the review process, the Company has been in dialogue with the Agency and is looking forward to continuing working with it, aiming to make Bentrio™ available to people suffering from allergic rhinitis also in the U.S.

  • International distribution: The Company and Wellesta Holdings Pte Ltd, Singapore, entered today into a definite marketing and distribution agreement for six Asian countries - India, Indonesia, Malaysia, Singapore, Taiwan and Vietnam. A Letter of Understanding had been signed between the two companies in October, under which Wellesta has since obtained the first of the national registrations for Bentrio™ in their sales territory. Based on various ongoing discussions, the Company expects to expand the geographic footprint for Bentrio™ further through agreements with additional international distributors.

  • Omicron variant: Following successful testing of Bentrio™ against the Delta variant of SARS-CoV-2 in a human nasal epithelia model, the Company is now planning to also evaluate the product's effectiveness against the Omicron variant. Given the broad applicability of Bentrio™, the Company expects to observe protective effects in this assay also against this new and fast-spreading variant.

  • Clinical trial in COVID-19: Preparations for the conduct of a clinical trial to further confirm the efficacy and safety of Bentrio™ are progressing. Following formal classification of Bentrio™ as a medical device, the trial application is now going through the regular approval process with the Drugs Controller General of India. Meanwhile, the Company has decided to broaden the geographic scope of the study and include two countries in Southeast Europe for which trial applications will be submitted shortly under "fast track" conditions.

  • Clinical trials in allergy: In recent weeks, two clinical trials with Bentrio™ started enrolling patients suffering from allergies due to airborne allergens. In the "NASAR" trial, the Company plans to enroll 100 patients suffering from seasonal allergic rhinitis for a two-week treatment course, and in the second trial, 36 patients suffering from perennial allergic rhinitis due to house dust mite exposure. Results from the studies are expected in the first half of 2022.

"We are pleased to report further progress with the international roll-out of Bentrio, as well as with the further preclinical and clinical evaluation of Bentrio's protective effects against airborne viruses and allergens," commented Thomas Meyer, Altamira Therapeutics' founder, Chairman and CEO. "The rapid and global spread of the Omicron variant of SARS-CoV-2 is highlighting once more the need for simple, yet versatile protective measures to complement classic approaches such as vaccination, protective mask wearing or social distancing."

https://finance.yahoo.com/news/altamira-therapeutics-provides-bentrio-program-141500457.html

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