Benzinga | Sep 27, 2021 07:49AM EDT

Altamira Therapeutics Provides Update On Bentrio Program; Says 510(k) Premarket Notification For Allergy Indication Submitted to FDA, Distributors Signed Up For Two Southeast Asian Countries

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(tm), its nasal spray for protection against airborne viruses and allergens.

Bentrio(tm) was launched first in Germany under CE mark in late July and subsequently also in Austria. During the initial launch stage, the nasal spray product has been marketed solely through leading online pharmacies, supported by digital campaigns combined with classic instruments. The Bentrio.com website is currently receiving approximately 2,500 visitors per day in Germany, and traffic is continuing to grow. Promotional activities are being progressively expanded to further European countries. In the next phase of the European launch of Bentrio(tm), starting in Q4 2021, the Company will also target traditional 'brick-and-mortar' pharmacy stores.

With the goal of accessing the large potential U.S. market for Bentrio(tm), the Company has recently submitted a 510(k) premarket notification to the FDA. The claimed use for Bentrio(tm) is the treatment of hay fever and allergy sufferers by promoting alleviation of mild allergic symptoms triggered by the inhalation of various airborne allergens. These include indoor and outdoor environmental pollens, house dust, animal hair and dust mites. Once cleared, the Company anticipates partnering Bentrio(tm) for the U.S. market rather than commercializing it there on its own.

Altamira also sees significant business development opportunities for Bentrio(tm) in international markets. In that regard, the Company recently executed letters of understanding with distributors in two key Southeast Asian countries, with national registrations being initiated. Based on a growing number of leads and strong interest in the product, Altamira expects to expand the geographic footprint for Bentrio(tm) rapidly through agreements with additional distributors.

Concurrent with the commercial activities outlined above, the Company is also advancing its clinical development programs for Bentrio(tm). In allergy, two studies are moving through the approval process: one for house dust allergy as a challenge study, and another for seasonal allergic rhinitis. These studies will be conducted in Canada and Australia, with data read-outs expected for Q1 and Q2 2022. In viral infection, Altamira is awaiting the approval of a placebo-controlled COVID-19 study by the Drugs Controller General of India.

"While we have been making significant progress in all of our development programs, in many ways, we just recently crossed the starting line, with the European launch of Bentrio(tm) marking our transition to a commercial-stage company," commented Thomas Meyer, Altamira Therapeutics' founder, Chairman and CEO. "Now, based on the early success we are seeing in Germany, our focus for the product will be on both geographic and treatment market expansion. We look forward to updating our stakeholders as we progress."