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Building Bentrio™ brand and expanding in European markets
510(k) premarket notification for allergy indication submitted to the U.S. Food and Drug Administration ("FDA")
Distributors signed up for two key South East Asian countries, highlighting international expansion potential
HAMILTON, BERMUDA / ACCESSWIRE / September 27, 2021 / 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.
Bentrio™ 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™, 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™, the Company has recently submitted a 510(k) premarket notification to the FDA. The claimed use for Bentrio™ 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™ for the U.S. market rather than commercializing it there on its own.
Altamira also sees significant business development opportunities for Bentrio™ 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™ rapidly through agreements with additional distributors.
Concurrent with the commercial activities outlined above, the Company is also advancing its clinical development programs for Bentrio™. 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™ 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."
Conference Call & Webcast Details
Alamira is pleased to invite all interested parties to participate in a conference call today at 8:00 AM Eastern Time, during which more details will be provided on its Bentrio™ commercial, development and regulatory activities and plans. To participate telephonically, please dial (888) 506-0062 (U.S.) or (973) 528-0011 (international), conference code 590321. A live, listen-only webcast of the conference call, which will include accompanying slides, can be accessed by visiting the Company's website at www.altamiratherapeutics.com under "Events & Presentations" in the "Investors & Media" section. An archive of the webcast will also be available following the conclusion of the conference call.
Bentrio™ (AM-301) is a drug-free nasal spray intended for personal protection against airborne viruses and allergens. Upon application into the nose, Bentrio™ forms a protective gel layer on the nasal mucosa. This thin film is designed to prevent the contact of viruses or allergens with cells; in addition, the composition serves to bind such particles and help with their discharge and to humidify the nasal mucosa. Together, this is designed to reduce the risk of upper respiratory tract viral infections and promote alleviation of allergic symptoms. In human nasal epithelium cells infected by SARS-CoV-2, Bentrio™ was shown to reduce the infectious viral load by more than 99% when used for prevention. Further, Bentrio™ was effective in slowing the growth of the viral titer when treatment started only 24 or 30 hours after infection. In allergy, a clinical investigation in a pollen challenge chamber demonstrated a significant reduction in the main symptoms of allergic rhinitis with the protective effect setting in rapidly and lasting for 4 hours.
About Altamira Therapeutics
Altamira Therapeutics is dedicated to developing therapeutics that address important unmet medical needs. The Company is currently active in three areas: the development of RNA therapeutics for extrahepatic therapeutic targets (OligoPhore™ / SemaPhore™ platforms; preclinical), nasal sprays for protection against airborne viruses and allergens (Bentrio™; commercial) or the treatment of vertigo (AM-125; Phase 2), and the development of therapeutics for intratympanic treatment of tinnitus or hearing loss (Keyzilen® and Sonsuvi®, Phase 3). The Company was founded in 2003 and is headquartered in Hamilton, Bermuda with its main operations in Basel, Switzerland. The shares of Altamira Therapeutics Ltd. trade on the NASDAQ Capital Market under the symbol "CYTO."
This press release may contain statements that constitute "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Forward-looking statements are statements other than historical facts and may include statements that address future operating, financial or business performance or Altamira Therapeutics' strategies or expectations. In some cases, you can identify these statements by forward-looking words such as "may", "might", "will", "should", "expects", "plans", "anticipates", "believes", "estimates", "predicts", "projects", "potential", "outlook" or "continue", or the negative of these terms or other comparable terminology. Forward-looking statements are based on management's current expectations and beliefs and involve significant risks and uncertainties that could cause actual results, developments and business decisions to differ materially from those contemplated by these statements. These risks and uncertainties include, but are not limited to, the approval and timing of commercialization of AM-301, Altamira Therapeutics' need for and ability to raise substantial additional funding to continue the development of its product candidates, the timing and conduct of clinical trials of Altamira Therapeutics' product candidates, the clinical utility of Altamira Therapeutics' product candidates, the timing or likelihood of regulatory filings and approvals, Altamira Therapeutics' intellectual property position and Altamira Therapeutics' financial position, including the impact of any future acquisitions, dispositions, partnerships, license transactions or changes to Altamira Therapeutics' capital structure, including future securities offerings. These risks and uncertainties also include, but are not limited to, those described under the caption "Risk Factors" in Altamira Therapeutics' Annual Report on Form 20-F for the year ended December 31, 2020, and in Altamira Therapeutics' other filings with the SEC, which are available free of charge on the Securities Exchange Commission's website at: www.sec.gov. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those indicated. All forward-looking statements and all subsequent written and oral forward-looking statements attributable to Altamira Therapeutics or to persons acting on behalf of Altamira Therapeutics are expressly qualified in their entirety by reference to these risks and uncertainties. You should not place undue reliance on forward-looking statements. Forward-looking statements speak only as of the date they are made, and Altamira Therapeutics does not undertake any obligation to update them in light of new information, future developments or otherwise, except as may be required under applicable law.
SOURCE: Altamira Therapeutics Ltd.
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