Metronidazole

-- Evofem now holds eleven Orange Book - listed patents covering SOLOSEC into late 2041 -- SAN DIEGO, Aug. 19, 2025 /PRNewswire/ -- Evofem Biosciences, Inc. (OTCID: EVFM) today announced that a newly-issued U.S. patent which covers SOLOSEC® (secnidazole) 2 g oral granules and one of its labeled indications is now listed in the U.S. Food and Drug Administration (FDA) publication Approved Drug Products with Therapeutic Equivalence Evaluations, commonly known as the Orange Book. "The Orange Book listing of this patent covering SOLOSEC's method, pharmaceutical composition, and use in trichomoniasis is an important step in further strengthening our patent portfolio," said Evofem Biosciences CEO Saundra Pelletier. "The patent itself extends SOLOSEC's intellectual property and market exclusivity into December 2041, which significantly benefits prescribers, patients, and our investors with a longer opportunity to build the SOLOSEC brand – the first and only single-dose oral treatment FDA-approved to treat BV as well as trichomoniasis – in the U.S." The newly listed U.S. Patent No. 12,280,037 (the '037 patent) covers "method and pharmaceutical composition for treating or preventing trichomoniasis and uses thereof". The '037 patent was issued by the U.S. Patent and Trademark Office (USPTO) on April 22, 2025 and is expected to expire in December 2041. It is directed to treatment of Trichomonas vaginalis infections (trichomoniasis) with SOLOSEC, with broad claims centered on pharmacokinetics and formulation features of Evofem's single-dose oral antimicrobial agent. Trichomoniasis is the most common non-viral sexually transmitted infection in the world. There are an estimated 6.9 million new infections with T. vaginalis in the U.S. each year.1 Undiagnosed infections and lack of compliance with multi-day treatment regimens are critical contributing factors. All sexual partners of people infected with trichomoniasis should be treated with the same dose and at the same time to prevent reinfection. SOLOSEC® is designed to be easy to take; one oral dose contains a complete course of treatment. Patient recruitment is underway in an investigator-led, NIH-funded Phase 4 clinical trial evaluating the effectiveness and cost-effectiveness of SOLOSEC (single-dose, one time) versus metronidazole (twice daily for seven days) for the treatment of T. vaginalis in men and women. Study investigators hypothesize that the rate of repeat infections with T. vaginalis will be 1.75 lower in the SOLOSEC arm versus the multi-dose oral metronidazole arm and that single-dose SOLOSEC will have higher initial cost but will be more cost effective compared to multi-dose metronidazole, largely due to lower breakthrough rates of infection. 2 About Evofem Biosciences Evofem is commercializing innovative products to address unmet needs in women's sexual and reproductive health. The Company generates revenue from the sale of two FDA-approved products. PHEXXI® (lactic acid, citric acid, and potassium bitartrate), is the first and only hormone-free, on-demand prescription contraceptive vaginal gel. It comes in a box of 12 pre-filled applicators and is applied 0-60 minutes before each act of sex. Visit phexxi.com to learn more and for important safety information. SOLOSEC® (secnidazole) 2g oral granules is an FDA-approved oral antibiotic for the treatment of two sexual health diseases: bacterial vaginosis (BV), a common vaginal infection, in females 12 years of age and older, and trichomoniasis, a common sexually transmitted infection (STI), in people 12 years of age and older. SOLOSEC provides a complete course of therapy in just one dose. Visit solosec.com to learn more and for important safety information. Evofem filed a preliminary proxy on July 24, 2025 regarding its planned Special Meeting of Stockholders at which stockholders of record may vote on a proposal to approve the transactions contemplated under the A&R Merger Agreement between the Company, Aditxt, Inc. (NASDAQ: ADTX) and Adifem, Inc., a wholly owned subsidiary of Aditxt. Under the A&R Merger Agreement, Adifem will merge with and into the Company, with Evofem surviving as a wholly owned subsidiary of Aditxt. A definitive proxy filing is expected in a few weeks. PHEXXI® and SOLOSEC® are registered trademarks of Evofem Biosciences, Inc. Sources Kreisel KM et al. Sexually Transmitted Infections Among US Women and Men: Prevalence and Incidence Estimates, 2018. Sex Transm Dis. 2021 Apr 1;48(4):208-214. doi: 10.1097/OLQ.0000000000001355. PMID: 33492089; PMCID: PMC10245608. National Institute of Allergy & Infectious Diseases (NIAID) of the National Institutes of Health. Award number R01AI183266: Refining Trichomonas vaginalis treatment in women and men. Forward-Looking Statements This press release includes "forward-looking statements," within the meaning of the safe harbor for forward-looking statements provided by Section 21E of the Securities Exchange Act of 1934, as amended, and the Private Securities Litigation Reform Act of 1995. Words such as, but not limited to, "anticipate," "aim," "believe," "contemplate," "continue," "could," "design," "estimate," "expect," "intend," "may," "might," "plan," "possible," "potential," "predict," "project," "seek," "should," "suggest," "strategy," "target," "will," "would," and similar expressions or phrases, or the negative of those expressions or phrases, are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. These statements include but are not limited to anticipated timing of the definitive proxy filing regarding the planned Special Meeting of Stockholders. The closing of the transactions with Evofem, Aditxt and Adifem, Inc., contemplated by the A&R Merger Agreement are subject to several conditions including, but not limited to, 1) approval of the transactions by a majority of the combined voting power of Evofem's E-1 and Common Stock, voting together as a single class, at a meeting where quorum is present, and 2) Aditxt raising sufficient capital to fund its closing obligations, notably a cash payment of approximately $15 million required to satisfy Evofem's senior secured noteholder. Should Aditxt fail to secure these funds, Evofem's senior secured noteholder is expected to seek to prevent the closing of the merger. No assurance can be provided that all of the conditions to closing will be obtained or satisfied or that the transaction will ultimately close. You are cautioned not to place undue reliance on these forward-looking statements, which are current only as of the date of this press release. Each of these forward-looking statements involves risks and uncertainties. Important factors that could cause actual results to differ materially from those discussed or implied in the forward-looking statements are disclosed in the Company's SEC filings, including its Annual Report on Form 10-K for the year ended December 31, 2024 filed with the SEC on March 24, 2025, amended on March 28, 2025, Quarterly Report on Form 10-Q for the quarter ended June 30, 2025, filed with the SEC on August 14, 2025, and any subsequent filings. All forward-looking statements are expressly qualified in their entirety by such factors. The Company does not undertake any duty to update any forward-looking statement except as required by law. No Offer or Solicitation This release shall not constitute a solicitation of a proxy, consent, or authorization with respect to any securities or in respect of the proposed transactions under the A&R Merger Agreement. This release shall also not constitute an offer to sell or the solicitation of an offer to buy any securities or a solicitation of any vote or approval, nor shall there be any sale of any securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of such other jurisdiction. No offering of securities shall be made except by means of a prospectus meeting the requirements of Section 10 of the Securities Act, or an exemption therefrom. Connect with Us Join the Dialogue Media [email protected] Investors and Potential Partners Amy Raskopf, Chief Business Development Officer Evofem Biosciences, Inc. [email protected] (917) 673-5775 SOURCE Evofem Biosciences, Inc. WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

药械追踪 No.1 / 默沙东抗菌药卓利达在中国正式商业上市 2025年8月13日，默沙东（NYSE：MSD）宣布，其新型头孢菌素酶抑制剂复方制剂——注射用头孢洛生他唑巴坦钠（商品名：卓利达）正式在中国境内上市，为临床应对铜绿假单胞菌（PA）和超广谱β-内酰胺酶肠杆菌（ESBL-E）等复杂耐药菌的感染提供了全新选择。 注射用头孢洛生他唑巴坦钠于今年2月获中国国家药品监督管理局（NMPA）批准，用于与甲硝唑联合治疗成人和儿童（出生至18岁以下）患者由敏感革兰阴性和革兰阳性微生物引起的复杂性腹腔感染（cIAI）；治疗成人和儿童（出生至18岁以下）患者由敏感革兰阴性微生物引起的复杂性尿路感染（cUTI）（包括肾盂肾炎）；治疗成人（18岁及以上）患者由敏感革兰阴性微生物引起的医院获得性细菌性肺炎（HABP）和呼吸机相关性细菌性肺炎（VABP）。 ->点击文末阅读原文，解锁完整双语新闻 No.2 / 诺华新型抗体Ianalumab报告多项III期临床积极结果 近日，诺华宣布，ianalumab（VAY736）用于治疗免疫性血小板减少症（ITP）的III期临床试验（VAYHIT2）达到主要终点，用于活动性干燥综合征成人患者的两项III期临床试验（NEPTUNUS-1和NEPTUNUS-2）也取得积极结果。 Ianalumab是一种新型全人源单克隆抗体，正在研究其治疗多种B细胞驱动的自身免疫性疾病的潜力，包括干燥综合征、免疫性血小板减少症（ITP）、系统性红斑狼疮（SLE）、狼疮性肾炎（LN）、温性自身免疫性溶血性贫血（wAIHA）和弥漫性皮肤系统性硬化症（dcSSc）。其可通过双重作用机制靶向B细胞，即通过抗体依赖性细胞毒性（ADCC）进行B细胞清除，并中断BAFF-R介导的B细胞功能和生存信号。Ianalumab源于与MorphoSys AG的早期合作，诺华于2024年收购了该公司。 ->点击文末阅读原文，解锁完整双语新闻 企业动态 No.1 / 恒瑞医药成立新的生物制药事业部 2025年8月14日，恒瑞医药（600276.SH；1276.HK）成立新的生物制药事业部（BBU）。新事业部由原综合事业部总经理，恒瑞医药副总裁霍仕文挂帅。 早在2024年1月，恒瑞原综合产品事业部与影像事业部合并，成立新的综合事业部，聚焦在代谢、自免、影像、减重及呼吸等领域。据公开数据显示，经过一年多的发展，综合事业部业绩大幅提升，其明星产品恒格列净市场份额持续攀升，在国内SGLT2产品赛道中已超过老牌糖尿病产品企业默沙东，排名跃居第二位。事业部另有多款1类新药持续获批上市，发展态势良好。此次成立新的生物制药事业部，也是恒瑞继续完善在麻醉和ICU领域的布局。 公开消息显示，新成立的生物制药事业部涉及已上市1类创新药10余款，涵盖代谢、自免、镇痛、麻醉、重症等领域。在刚刚公布的国谈初筛目录中，今年有数款1类创新药通过初筛，包含其白介素-17A抑制剂、JAK-1抑制剂、超长效PCSK9抑制剂等重磅产品。 ->点击文末阅读原文，解锁完整双语新闻 行业政策 No.1 / 三部门联合发布《医疗广告认定指南》，明确构成医疗广告的各种情形 近日，市场监管总局会同国家卫生健康委、国家中医药局制定并发布了《医疗广告认定指南》（以下简称《指南》），明确医疗广告是指利用一定的媒介和形式直接或者间接介绍医疗机构或者医疗服务的广告；除依法设立的医疗机构外，任何单位和个人不得自行或者委托他人发布医疗广告。市场监管部门应当综合相关医疗信息的发布内容、发布渠道、发布方式等多种因素认定医疗广告。 任何单位、组织或者个人开展科普宣传时，存在下列情形之一的，应当认定为以介绍健康、养生知识等形式变相发布医疗广告：①通过宣称其诊疗技术优势、硬件设备优势以及诊疗效果等，对具体医疗机构及其医疗服务进行推介；②明示或者暗示在具体医疗机构就医将获得更好的安全性保障、疗效或者价格优惠等；③直接或者间接推介本机构或者其他医疗机构的具体医疗服务；④以病例或者案例方式，对具体医疗机构或者其医疗服务进行推介；⑤在科普宣传的互联网页面内附加与科普宣传内容有关的医疗机构或者医疗服务项目的跳转入口，或者附加科普宣传对应的医疗服务所必需的药品、医疗器械等商品购买链接；⑥存在推介具体医疗机构或者其医疗服务的其他情形。除此之外的健康科普宣传不构成广告。 对于应当认定为医疗广告的，市场监管部门依照广告法律法规规定进行监管。医疗广告存在下列情形之一的被认定为“情节严重”：①致人死亡、重伤、毁容或者其他严重危及生命健康安全的；②涉嫌构成虚假广告罪，应当移送公安机关的；③为未依法取得《医疗机构执业许可证》或者诊所备案凭证（含《中医诊所备案证》）的非医疗机构，以及未办理核准登记或者备案的诊疗科目进行引流、推介的；④一年内发布两次以上（含两次）违法医疗广告，造成严重不良社会影响的；⑤其他应当认定为情节严重的。 ->点击阅读原文，解锁完整双语新闻 全球医疗情报领导者 解锁隐藏在数据中的商业潜力  关于 G B I ” 自从2002年成立以来，GBI始终以技术为驱动，为药企、器械及行业相关服务商提供贯穿生命周期的全球药品市场竞争数据、全球行业资讯、HCPs洞察、全国医疗器械数据等商业信息与洞察，助力企业在进行战略布局和决策时，脱颖而出。历经20余年的深耕细作GBI已成为95%以上跨国药企、国内头部药企、咨询与投资机构等医疗圈灯塔用户值得信赖的长期合作伙伴。 联系我们 投稿 | 发稿 | 媒体合作 ▶ olivia.xu@generalbiologic.com 数据库 | 咨询服务 | 资讯追踪 ▶ 点击左下“阅读原文”完成表单填写 点击阅读原文，解锁完整双语新闻