Altamira Therapeutics Receives Philippines' FDA Approval of Bentrio Nasal Spray
Altamira Therapeutics Ltd. (NASDAQ: CYTO) announced that the Philippines' FDA has approved Bentrio, its nasal spray, for commercialization in the country. Bentrio offers protection against airborne allergens and viruses and will be distributed by Wellesta Holdings across various Asian countries. Positive data from recent clinical trials indicate Bentrio's efficacy against house dust mites, a common cause of allergies. This expansion into the Philippines presents a significant market opportunity, targeting a population of 115 million.
- FDA approval of Bentrio in the Philippines enables market entry for a population of 115 million.
- Bentrio is already approved in Singapore and Malaysia, indicating growing market presence.
- Positive clinical trial data showing significant reduction in nasal symptoms strengthens product credibility.
- None.
HAMILTON, BERMUDA / ACCESSWIRE / May 23, 2022 / Altamira Therapeutics Ltd. (NASDAQ:CYTO), a company dedicated to developing therapeutics that address important unmet medical needs, today announced that Bentrio™ has been approved by the Philippines' Food and Drug Administration (FDA) and is now cleared for commercialization in that country of 115 million people.
The product will be commercialized through the local affiliate of Wellesta Holdings Pte Ltd, Singapore ("Wellesta"). Under a previously announced marketing and distribution agreement with Altamira, expanded in February to include the Philippines, Wellesta will commercialize and distribute Bentrio in India, Indonesia, Malaysia, the Philippines, Singapore, Taiwan, Vietnam and Morocco (the "Territory"). Within that Territory, Bentrio had already received clearance in Singapore and Malaysia.
"We are excited to see the Philippines join the growing list of countries where Bentrio is approved," commented Thomas Meyer, Altamira Therapeutics' founder, Chairman and CEO. "Asia with its large population, and rapidly growing middle class, represents a significant sales opportunity for Bentrio. We look forward to expanding its availability, over the counter, to provide more consumers with protection against airborne allergens and viruses."
Last week, the Company reported positive top-line data from its house dust mite (HDM) challenge clinical trial, conducted in Canada, that demonstrated a statistically significant reduction of nasal symptoms vs. untreated controls as well as good tolerability and safety. HDM allergens constitute the prime cause of respiratory allergies (i.e. allergic rhinitis and allergic asthma). Unlike plant-related allergens, which tend to be seasonal (e.g. pollen / hay fever), HDMs may be present all year long.
About Bentrio
Bentrio is a drug-free nasal spray 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. For more info, visit:
https://altamiratherapeutics.com/our-products/bentrio.
Bentrio is being distributed in selected European countries and is expected to become available through distributors in further countries in Europe, Asia and MENA. In the US, Altamira submitted a 510(k) application for Bentrio in the treatment of allergic rhinitis, which is currently under review by the FDA.
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 viruses and allergens (Bentrio™; commercial) or for 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). Founded in 2003, it is headquartered in Hamilton, Bermuda, with its main operations in Basel, Switzerland. For more information, visit: https://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.
Contact
Investors@altamiratherapeutics.com
800-460-0183
SOURCE: Altamira Therapeutics
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