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Replies to post #3322 on Atossa Therapeutics Inc (ATOS)
The newly issued patent includes 100 claims directed to enteric oral formulations of highly pure (Z)-endoxifen free base, as well as methods of using those compositions to treat a range of hormone-dependent breast disorders and other estrogen-related conditions. The patent also covers specific solid oral dosage forms and stable formulations providing therapeutically meaningful and sustained systemic exposure to (Z)-endoxifen."We believe this patent meaningfully extends and reinforces our already robust endoxifen patent estate," said Steven Quay, M.D., Ph.D., Atossa's President and Chief Executive Officer. "By covering both scalable manufacturing processes and key methods of use, this patent supports our long-term strategy to position (Z)-endoxifen as a differentiated therapy across the breast cancer spectrum, from risk-reduction and neoadjuvant treatment through adjuvant and metastatic disease, while also enabling opportunities in other hormone-driven conditions. "Together with previously issued U.S. patents covering storage-stable and sustained-release endoxifen formulations, and broader formulation patents granted earlier this year, this new patent further consolidates our leadership position in endoxifen therapeutics. A strong and durable intellectual property foundation is essential as we invest in late-stage clinical trials and potential future commercialization," concluded Dr. Quay.Atossa is currently advancing its proprietary (Z)-endoxifen in multiple clinical settings, including:The Company's growing patent portfolio, which now includes multiple issued U.S. patents and corresponding applications worldwide, is intended to provide long-term exclusivity for (Z)-endoxifen formulations, manufacturing processes, and key therapeutic uses in breast cancer treatment and risk reduction.About U.S. Patent No. 12,479,790U.S. Patent No. 12,479,790 B2, "Methods for Making and Using Endoxifen," is assigned to Atossa Therapeutics, Inc. The patent has 100 claims directed to enteric oral formulations of highly pure (Z)-endoxifen free base, as well as methods of using those compositions to treat a range of hormone-dependent breast disorders and other estrogen-related conditions. The patent also covers specific solid oral dosage forms and stable formulations providing therapeutically meaningful and sustained systemic exposure to (Z)-endoxifen.About (Z)-Endoxifen(Z)-endoxifen is one of the most potent selective estrogen receptor modulators (SERMs) for estrogen receptor inhibition and may also promote estrogen receptor degradation. It has demonstrated activity in settings where tumors have developed resistance to other hormonal therapies and has been shown to target PKCß1, a known oncogenic protein, at clinically achievable concentrations. Atossa continues to optimize its proprietary oral formulation of (Z)-endoxifen, which is designed to minimize stomach exposure and maintain the active Z-isomer, and ensures consistent systemic exposure across a range of breast cancer prevention and treatment indications.About Atossa TherapeuticsAtossa Therapeutics, Inc. (Nasdaq: ATOS) is a clinical-stage biopharmaceutical company developing innovative therapies in areas of significant unmet need in breast cancer. The Company's lead product candidate, (Z)-endoxifen, is being developed as a highly potent SERM for use across the breast cancer continuum of care. For more information, please visit www.atossatherapeutics.com.
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