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Altamira Therapeutics Re-launches Bentrio in Europe for Allergic Rhinitis

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Altamira Therapeutics Ltd. (NASDAQ:CYTO) announces the re-launch of its Bentrio nasal spray in selected European countries, starting in Germany in early October 2022. The product aims to alleviate allergic symptoms from airborne allergens like pollen and dust mites. Bentrio's protective effects have been supported by clinical trials. The company is also engaged in partnership discussions for distribution in Europe and the US, expected to conclude by Q4 2022. Additionally, interim data from ongoing clinical studies may support further labeling expansions.

Positive
  • Re-launch of Bentrio nasal spray in Germany, enhancing market presence.
  • Clinical support for Bentrio's efficacy against airborne allergens.
  • Partnership discussions aimed at expanding distribution in key markets.
Negative
  • Bentrio previously removed from the market due to viral indication issues.
  • Ongoing COVAMID trial for COVID-19 lacks definitive results until Q4 2022.

HAMILTON, BERMUDA , Sept. 27, 2022 (GLOBE NEWSWIRE) --

  • BentrioTM nasal spray becomes available again in selected European countries 
  • Marketing focus is on protection against airborne allergens
  • Partnering discussions for distribution in Europe and US expected to conclude in Q4 2022

Altamira Therapeutics Ltd. (NASDAQ:CYTO), a company dedicated to developing therapeutics that address important unmet medical needs, today announced that its Bentrio nasal spray will be re-launched in Europe, initially in Germany, beginning in early October of 2022.

Altamira will market Bentrio for helping to prevent onset and alleviate allergic symptoms caused by airborne allergens such as pollen, house dust mites or animal dander. Bentrio’s protective effects have already been demonstrated clinically with controlled exposure to house dust mites and grass pollen in allergen challenge chambers for three and four hours, respectively.

A larger clinical trial comparing Bentrio with a seawater nasal spray (the “NASAR” study) in Australia under “everyday conditions” over 14 days was started in 2021 and is ongoing. Interim safety and efficacy data from the trial helped to support the successful 510(k) application to the FDA.

Previously, Bentrio had also been marketed in Europe for protection against airborne viral particles. Altamira considers that Bentrio’s mode of action is the same, regardless of whether it provides a barrier against airborne virus or allergen particles, as was demonstrated in various relevant in vitro assays. However, certain countries and regions require specifically clinical performance data to clear Bentrio for such viral indication, and in particular related to COVID-19. Therefore, the Company recently stopped marketing Bentrio in the viral infection indication in the EU and Switzerland.  

“We look forward to bringing Bentrio back to the market in Europe with a labeling specifically for allergic rhinitis,” commented Thomas Meyer, the Company’s founder, CEO and Chairman. “We sincerely apologize to pharmacies and consumers for the interruption in their supplies over the past few weeks, following the removal from the market of Bentrio with viral infection co-labelling. Since then, we have advanced our COVAMID trial to evaluate Bentrio in the treatment of acute COVID-19. Here, we expect to report clinical data in Q4 2022 which might support a potential label expansion in those countries and regions requesting such data in viral infection.”

In parallel with its European re-launch, Altamira is actively advancing its plans to partner Bentrio for marketing and distribution in Europe, the US and other key markets, to leverage established resources in the dynamic OTC consumer health market. Altamira is confident to conclude its discussions with prospective partners during Q4 2022. 

About Altamira Therapeutics
Altamira Therapeutics (NASDAQ:CYTO) 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 allergens and, where approved, viruses (Bentrio™; commercial) or for the treatment of vertigo (AM-125; post Phase 2), and the development of therapeutics for intratympanic treatment of tinnitus or hearing loss (Keyzilen® and Sonsuvi®; Phase 3). Founded in 2003, it is headquartered in Hamilton, Bermuda, with its main operations in Basel, Switzerland. For more information, visit: www.altamiratherapeutics.com   

Forward-Looking Statements
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, 2021, 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.


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FAQ

When will Bentrio nasal spray be available in Germany?

Bentrio nasal spray will be available in Germany starting in early October 2022.

What is Bentrio nasal spray used for?

Bentrio nasal spray is designed to alleviate allergic symptoms caused by airborne allergens such as pollen and house dust mites.

What are the expected outcomes of Altamira's partnership discussions?

Partnering discussions for Bentrio in Europe and the US are expected to conclude in Q4 2022.

What clinical trials are ongoing for Bentrio?

A larger NASAR study in Australia is ongoing, comparing Bentrio to a seawater nasal spray.

What challenges did Altamira face with Bentrio?

Bentrio was previously removed from the market in the EU and Switzerland due to the need for specific clinical performance data regarding viral indications.

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