Everolimus

New intellectual property builds on Palvella’s multi-layered exclusivity strategy Patent term expected through at least 2038 WAYNE, Pa., June 18, 2025 (GLOBE NEWSWIRE) -- (Nasdaq: PVLA) Palvella Therapeutics, Inc . (Palvella), a clinical-stage biopharmaceutical company focused on developing and commercializing novel therapies to treat patients suffering from serious, rare genetic skin diseases for which there are no U.S. Food and Drug Administration (FDA)-approved therapies, today announced that the United States Patent and Trademark Office (USPTO) issued patent No. 12,329,748 for claims related to the Company's lead product candidate QTORIN™ 3.9% rapamycin anhydrous gel (QTORIN™ rapamycin). The patent provides broad protection for the proprietary anhydrous topical composition and methods of use for QTORIN™ rapamycin. “Our sixth issued U.S. patent marks another meaningful milestone in solidifying the exclusivity position of QTORIN™ rapamycin,” said Wes Kaupinen, Founder and Chief Executive Officer of Palvella. “We’re executing a multi-layered strategy to protect and maximize the long-term value of QTORIN™ rapamycin—anchored by strong intellectual property, proprietary formulation and manufacturing trade secrets, and regulatory exclusivities.” The newly granted U.S. patent encompasses a wide range of composition and method-of-use claims for QTORIN™ rapamycin and other mTOR inhibitors—including temsirolimus and everolimus—formulated in anhydrous compositions. It also covers treatment of a broad spectrum of dermatologic conditions, with emphasis on rare and difficult-to-treat diseases such as microcystic lymphatic malformations and venous malformations. QTORIN™ rapamycin has been granted Breakthrough Therapy, Orphan Drug, and Fast Track Designations by the FDA for the treatment of microcystic lymphatic malformations. If approved, QTORIN™ rapamycin is expected to qualify for seven years of orphan drug market exclusivity in the U.S. Palvella has also been named an awardee of an FDA Orphan Products Grant from the FDA’s Office of Orphan Products Development and is eligible to receive up to $2.6 million over the life of the grant to support the ongoing SELVA Phase 3 trial of QTORIN™ rapamycin. About Palvella Therapeutics Founded and led by rare disease drug development veterans, Palvella Therapeutics, Inc. (Nasdaq: PVLA) is a clinical-stage biopharmaceutical company focused on developing and commercializing novel therapies to treat patients suffering from serious, rare genetic skin diseases for which there are no FDA-approved therapies. Palvella is developing a broad pipeline of product candidates based on its patented QTORIN™ platform, with an initial focus on serious, rare genetic skin diseases, many of which are lifelong in nature. Palvella’s lead product candidate, QTORIN™ 3.9% rapamycin anhydrous gel (QTORIN™ rapamycin), is currently being evaluated in the Phase 3 SELVA clinical trial in microcystic lymphatic malformations and the Phase 2 TOIVA clinical trial in cutaneous venous malformations. For more information, please visit www.palvellatx.com or follow Palvella on LinkedIn or X (formerly known as Twitter). QTORIN™ rapamycin is for investigational use only and has not been approved or cleared by the FDA or by any other regulatory agency for any indication. Forward-Looking Statements This press release contains forward-looking statements (including within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended, and Section 27A of the Securities Act of 1933, as amended (Securities Act)). These statements may discuss goals, intentions, and expectations as to future plans, trends, events, results of operations or financial condition, or otherwise, based on current beliefs of the management of Palvella, as well as assumptions made by, and information currently available to, the management of Palvella. Forward-looking statements generally include statements that are predictive in nature and depend upon or refer to future events or conditions, and include words such as “may,” “will,” “should,” “would,” “expect,” “anticipate,” “plan,” “likely,” “believe,” “estimate,” “project,” “intend,” and other similar expressions or the negative or plural of these words, or other similar expressions that are predictions or indicate future events or prospects, although not all forward-looking statements contain these words. Statements that are not historical facts are forward-looking statements. Forward-looking statements include, but are not limited to, statements regarding the expected timing of the presentation of data from ongoing clinical trials, Palvella’s clinical development plans and related anticipated development milestones, Palvella’s cash and financial resources and expected cash runway, and the potential of, and expectations regarding, Palvella’s programs, including QTORIN™ rapamycin, and its research-stage opportunities, including its expected therapeutic potential and market opportunity. Forward-looking statements are based on current beliefs and assumptions that are subject to risks and uncertainties and are not guarantees of future performance. Actual results could differ materially from those contained in any forward-looking statement as a result of various factors, including, without limitation: the ability to raise additional capital to finance operations; the ability to advance product candidates through preclinical and clinical development; the ability to obtain regulatory approval for, and ultimately commercialize, Palvella’s product candidates, including QTORIN™ rapamycin; the outcome of early clinical trials for Palvella’s product candidates, including the ability of those trials to satisfy relevant governmental or regulatory requirements; the fact that data and results from clinical studies may not necessarily be indicative of future results; Palvella’s limited experience in designing clinical trials and lack of experience in conducting clinical trials; the ability to identify and pivot to other programs, product candidates, or indications that may be more profitable or successful than Palvella’s current product candidates; the substantial competition Palvella faces in discovering, developing, or commercializing products; the negative impacts of global events on operations, including ongoing and planned clinical trials and ongoing and planned preclinical studies; the ability to attract, hire, and retain skilled executive officers and employees; the ability of Palvella to protect its intellectual property and proprietary technologies; reliance on third parties, contract manufacturers, and contract research organizations; and the risks and uncertainties described in the filings made by Palvella with the Securities and Exchange Commission (SEC), including the annual report on Form 10-K, quarterly reports on Form 10-Q and current reports on Form 8-K, filed with or furnished to the SEC and available at www.sec.gov. The events and circumstances reflected in our forward-looking statements may not be achieved or occur, and actual results could differ materially from those projected in the forward-looking statements. New risk factors and uncertainties may emerge from time to time, and it is not possible for management to predict all risk factors and uncertainties that Palvella may face. Except as required by applicable law, Palvella does not plan to publicly update or revise any forward-looking statements contained herein, whether as a result of any new information, future events, changed circumstances or otherwise. This press release contains hyperlinks to information that is not deemed to be incorporated by reference into this press release. Contact Information Investors Wesley H. Kaupinen Founder and CEO, Palvella Therapeutics wes.kaupinen@palvellatx.com Media Marcy Nanus Managing Partner, Trilon Advisors LLC mnanus@trilonadvisors.com Legal Disclaimer: EIN Presswire provides this news content "as is" without warranty of any kind. We do not accept any responsibility or liability for the accuracy, content, images, videos, licenses, completeness, legality, or reliability of the information contained in this article. If you have any complaints or copyright issues related to this article, kindly contact the author above.

注：本文不构成任何投资意见和建议，以官方/公司公告为准；本文仅作医疗健康相关药物介绍，非治疗方案推荐（若涉及），不代表平台立场。任何文章转载需要得到授权。6月14日，据CDE官网显示，南京正大天晴制药有限公司提交的4类仿制化药西达本胺片上市申请已获受理。若顺利获批，将拿下该品种首仿！截图来源：CDE官网西达本胺（Chidamide；商品名为“爱谱沙/Epidaza”），是一款通过口服的亚型选择性组蛋白去乙酰化酶（HDAC）抑制剂，主要用于治疗复发或难治性的外周T细胞淋巴瘤（PTCL）患者。它是我国自主研发的国家1类创新药物，由微芯生物独家发现并开发，属于新分子实体药物。截图来源：摩熵医药全球药物研发数据库截至目前，西达本胺在中国已获批外周T细胞淋巴瘤、乳腺癌、弥漫大B细胞淋巴瘤三个适应证，在日本已获批成人白血病和外周T细胞淋巴瘤两个适应证，在中国台湾已获批乳腺癌适应证。另外，西达本胺在中国及国际也在推进联合不同抗肿瘤免疫治疗的多项临床试验研究。截图来源：摩熵医药全球药物研发数据库据摩熵医药数据库显示，西达苯胺在全国医院（全终端）累计销售额已突破20亿元，呈现出缓步攀升的增长态势，潜在应用前景广阔。2024上半年，西达本胺销量达2.26亿元，同比增长9.31%。截图来源：摩熵医药全国医院销售（全终端）数据库目前国内市场上，西达本胺仅原研获批上市，制剂产品只有片剂，20亿市场由微芯生物独享。截图来源：摩熵医药全国医院销售（全终端）数据库上市十余年，西达本胺仍然是微芯生物的拳头产品。据2023年报显示，报告期内微芯生物总营收为5.23亿元，其中仅西达本胺就贡献了4.6亿元的营收，占总营收比重近88%。南京正大天晴是首家以仿制4类递交西达本胺片上市申请的企业，先发优势明显。此次申报，正大天晴显然有备而来。其不仅完成了西达本胺片的BE生物等效实验，还主动发起了专利无效挑战。截图来源：摩熵医药中国药品审评数据库2024年12月30日，南京正大天晴申请将西达本胺”一种E构型苯甲酰胺类化合物及其药用制剂与应用“专利无效；2025年1月23日，再次申请将其“一种TRKA（G667C）和 FLT3 靶点抑制剂及其与西达本胺的组合物”专利无效。在药物专利挑战方面，正大天晴已经多次获得成功。2011年至2020年，正大天晴历时九年时间，成功无效了百时美施贵宝的恩替卡韦；2021年，正大天晴向诺华发起专利挑战，不仅成功拿下依维莫司首仿，还使其成为我国药品专利链接制度实施以来首个通过“首仿获批+专利挑战成功”获得12个月市场独占期的产品。2024年8月，正大天晴促使丹麦辉凌制药关于地加瑞克的两件专利被宣告无效。事实上，早在2023年6月，西达本胺的化合物专利就已正式到期。为了尽可能延缓仿制药对手进入市场，并延长产品的生命周期，微芯生物为西达本胺申请晶型专利、制剂专利、乳腺癌适应症专利和质量控制专利等，使得西达本胺仍然能获得良好的专利保护。截图来源：摩熵医药中国医药专利数据库对于微芯生物而言，西达本胺的重要性不言而喻。可以预见，这场 “首仿” 与 “原研” 的专利交锋，将会拉锯很长时间。小结西达本胺片仿制上市申报获受理，不仅彰显了正大天晴的抢仿实力，更可能改写T细胞淋巴瘤治疗格局——仿制药的“入场哨”吹响后，原研药的价格堡垒、基层患者的用药门槛、医保基金的支付压力，都将迎来系统性重构。若最终获批，这将是国产HDAC抑制剂领域首个首仿药物。一场关于创新与仿制、价格与可及性的深度博弈，已随一纸受理通知悄然拉开战幕。END本文为原创文章，转载请留言获取授权近期热门资源获取中国临床试验趋势与国际多中心临床展望-2025052024年医药企业综合实力排行榜-202505中国带状疱疹疫苗行业分析报告-2025052023H2-2024H1中国药品分析报告-202504数据透视：中药创新药、经典验方、改良型新药、同名同方的申报、获批、销售情况-2025032024年中国1类新药靶点白皮书-202503中国AI医疗健康企业创新发展百强榜单-202502解码护肤抗衰：消费偏好洞察与市场格局分析-2025022024年FDA批准上市的新药分析报告-202501小分子化药白皮书（上）-2025012024年中国医疗健康投融资全景洞察报告-2025012024年医保谈判及市场分析报告-202501近期更多摩熵咨询热门报告，识别下方二维码领取联系我们，体验摩熵医药更多专业服务会议合作园区服务数据库咨询定制服务媒体合作点击上方图片，即可开启摩熵化学数据查询点击阅读原文，申请摩熵医药企业版免费试用！