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Evofem Strengthens SOLOSEC Intellectual Property With New U.S. Patent From USPTO

Evofem Strengthens SOLOSEC Intellectual Property With New U.S. Patent From USPTO

Evofem通過美國專利商標局獲得新專利,加強了SOLOSEC的知識產權
PR Newswire ·  02/13 14:16

-- Allowed Patent Extends SOLOSEC IP to 2040 with Broad Claims that are Orange Book-listable --

-- 允許的專利將SOLOSEC的知識產權延伸至2040年,具有廣泛的索賠並可列入《橙皮書》 --

SAN DIEGO, Feb. 13, 2025 /PRNewswire/ -- Evofem Biosciences, Inc. (OTCQB: EVFM) today announced that the United States Patent and Trademark Office (USPTO) issued to the Company a Notice of Allowance for patent application 17/028,838, entitled "Method and Pharmaceutical Composition for Treating or Preventing Trichomoniasis and Uses Thereof." This Notice of Allowance is expected to result in the issuance of a U.S. patent once administrative processes are completed.

聖地亞哥,2025年2月13日/企業新聞/ -- Evofem Biosciences公司(OTCQB: EVFM)今天宣佈,美國專利商標局(USPTO)已向公司發出專利申請17/028,838的允許通知,該申請標題爲《治療或預防滴蟲病的方法及藥物組合物及其用途》。預計此允許通知將在管理程序完成後導致美國專利的發放。

"This new U.S. patent extends SOLOSEC's IP protection by a full five years, from 2035 to 2040," said Saundra Pelletier, Chief Executive Officer of Evofem. "This extension, for the treatment of trichomoniasis, significantly benefits prescribers, patients, and our investors with a longer opportunity to build the SOLOSEC brand with its single-dose regimen."

Evofem的首席執行官Saundra Pelletier表示:「這項新的美國專利將SOLOSEC的知識產權保護延長了整整五年,從2035年延長至2040年。這一延長對於治療滴蟲病,顯著有利於開處方的醫生、患者以及我們的投資者,提供了更長時間的機會來建立SOLOSEC品牌及其單劑量的治療方案。」

The allowed patent application is directed to treatment of Trichomonas vaginalis infections (trichomoniasis) with SOLOSEC (secnidazole) 2 g oral granules, with broad claims centered on pharmacokinetics and formulation features of Evofem's single-dose oral antimicrobial agent. Evofem expects the resulting patent will be Orange Book-listable.

該允許的專利申請針對使用SOLOSEC(secnidazole)2克口服顆粒治療陰道滴蟲感染(滴蟲病),廣泛的索賠集中在Evofem的單劑量口服抗菌劑的藥代動力學和配方特徵上。Evofem預計,由此產生的專利將可以列入《橙皮書》。

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.

滴蟲病是全球最常見的非病毒性性傳播感染。在美國,每年估計有690萬例新的T. vaginalis感染。未診斷的感染和對多日治療方案的依從性不足是關鍵的促成因素。所有感染滴蟲病的人應在同一時間用相同劑量進行治療,以防止再感染。SOLOSEC的設計旨在易於服用;一劑口服劑量包含完整的治療課程。

SOLOSEC is the first and only single-dose oral antibiotic FDA-approved to treat bacterial vaginosis (BV) in females 12 years of age and older as well as trichomoniasis in people 12 years of age and older. Evofem acquired global rights to the product in July 2024 and relaunched SOLOSEC in the U.S. in November 2024 with its women's health-focused commercial team.

SOLOSEC是FDA批准的首個也是唯一一個用於治療12歲及以上女性細菌性陰道炎(BV)和12歲及以上人群滴蟲病的單劑量口服抗生素。Evofem於2024年7月獲得該產品的全球權利,並在2024年11月重新在美國推出SOLOSEC,配備了專注於女性健康的商業團隊。

About Trichomoniasis
Trichomoniasis (or "Trich") is a sexually transmitted infection (STI) caused by infection with Trichomonas vaginalis, a protozoan parasite. It is the most common nonviral STI globally. Up to 70% of people infected with Trich are unaware that they are infected and may unwittingly pass the parasite to sexual partners. Untreated infections might last from months to years.

關於滴蟲病
滴蟲病(或稱爲「滴蟲」)是一種由陰道滴蟲(Trichomonas vaginalis)引起的性傳播感染(STI),是一種原生動物寄生蟲。它是全球最常見的非病毒性性傳播感染。多達70%的感染者並不知道自己感染了該病,可能會不知情地將寄生蟲傳播給性伴侶。未治療的感染可能持續數月到數年。

In women, Trich can cause a foul-smelling vaginal discharge, genital itching, and pain with urination or sex. Trich is also associated with an increased risk for cervical cancer, HIV acquisition, and, among women with HIV infection, pelvic inflammatory disease (PID). Pregnant women who have Trich may be at higher risk of delivering their babies prematurely.

在女性中,滴蟲病可能引起惡臭的陰道分泌物、陰部瘙癢以及排尿或性交時的疼痛。滴蟲病還與宮頸癌、HIV感染風險增加以及在HIV感染女性中與盆腔炎(PID)相關。懷孕的女性如果患有滴蟲病,可能面臨早產的更高風險。

Men who have Trich typically have no symptoms, however when men do have symptoms these may include itching or irritation inside the penis, burning with urination or after ejaculation, and discharge from the penis.2

患有滴蟲病的男性通常沒有症狀,但當男性出現症狀時,可能包括陰莖內部的瘙癢或刺激、排尿時或射精後有灼燒感,以及陰莖分泌物。

About Evofem Biosciences

關於Evofem Biosciences

Evofem is commercializing innovative products to address unmet needs in women's sexual and reproductive health. The Company's first FDA-approved product, PHEXXI (lactic acid, citric acid, and potassium bitartrate), is a 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.

Evofem正在商業化創新產品,以滿足女性性健康和生殖健康的未滿足需求。該公司的第一款FDA批准產品PHEXXI(乳酸、檸檬酸和酒石酸鉀)是一種無激素、按需處方避孕陰道凝膠。它裝在12個預填充的施藥器盒中,使用時在每次性交前0-60分鐘內施用。

In July 2024 Evofem broadened its commercial offering with the acquisition of SOLOSEC (secnidazole) 2g oral granules, 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.

2024年7月,Evofem通過收購SOLOSEC(希克納唑)2克口服顆粒,擴大了其商業產品,SOLOSEC是一種FDA批准的口服抗生素,治療兩種性健康疾病:細菌性陰道病(BV),一種常見的陰道感染,適用於12歲及以上女性,以及陰道滴蟲病,這是一種常見的性傳播感染(STI),適用於12歲及以上的人。SOLOSEC只需一劑即可提供完整療程。

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PHEXXI and SOLOSEC are registered trademarks of Evofem Biosciences, Inc.

PHEXXI和SOLOSEC是Evofem Biosciences, Inc.的註冊商標。

Forward-Looking Statements

前瞻性聲明

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. 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, 2023 filed with the SEC on March 27, 2024, Quarterly Report on Form 10-Q for the three months ended September 30, 2024 filed with the SEC on November 14, 2024, 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.

本新聞稿包含「前瞻性聲明」,其含義在1934年修訂的證券交易法第21E節及1995年私人證券訴訟改革法案提供的前瞻性聲明安全港內。請謹慎對待這些前瞻性聲明,因其僅在本新聞稿發佈之日有效。每項前瞻性聲明都涉及風險和不確定性。可能導致實際結果與前瞻性聲明中討論或暗示的內容顯著不同的重要因素是在公司向SEC提交的文件中披露的,包括截至2023年12月31日的年度報告(表格10-K),於2024年3月27日向SEC提交,以及截至2024年9月30日的季度報告(表格10-Q),於2024年11月14日提交SEC,以及任何後續提交。所有前瞻性聲明均明確完全受這些因素的限制。除非法律要求,否則公司不承擔更新任何前瞻性聲明的責任。

Contact

聯繫

Amy Raskopf, Chief Business Development Officer
Evofem Biosciences, Inc.
[email protected]
(917) 673-5775

艾米·拉斯科夫,首席業務發展官
Evofem Biosciences公司。
[email protected]
(917) 673-5775

Sources

來源

  1. 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.
  2. Mayo Clinic. Diseases & Conditions: Trichomoniasis. 17 May 2022. Accessed 5 Nov 2024 at .
  1. Kreisel KM等人。美國女性和男性中的性傳播感染:流行率和發病率估計,2018年。性傳播疾病。2021年4月1日;48(4):208-214。doi: 10.1097/OLQ.0000000000001355。PMID: 33492089;PMCID: PMC10245608。
  2. 梅奧診所。疾病與狀況:陰道滴蟲感染。2022年5月17日。2024年11月5日訪問。

SOURCE Evofem Biosciences, Inc.

來源:Evofem Biosciences, Inc.

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