Evofem Biosciences Announces Approval of Phexxi in Nigeria
Evofem Biosciences Announces Approval of Phexxi in Nigeria
-- First Regulatory Approval Outside the U.S. --
--美國境外的首次監管批准--
SAN DIEGO, Oct. 6, 2022 /PRNewswire/ -- Evofem Biosciences, Inc., (OTCQB: EVFM) today announced that its hormone-free contraceptive vaginal gel has been approved by the Nigerian Regulatory Agency NAFDAC (National Agency for Food and Drug Administration and Control).
聖地牙哥, 二零二二年十月六日 /通社/-- 艾芬生物科學股份有限公司(OTCQB: EVFM) 今天宣布，其無激素避孕陰道凝膠已被尼日利亞監管機構 NAFDAC 批准 (國家局食品和藥物管理局和控制).
This marks the Company's first approval outside the United States. Regulatory dossiers have also been submitted in Ghana, Ethiopia and Mexico. The product will be potentially marketed under the brand name Femidence™.
這標誌著公司在外部獲得首次批准 美國的。加納，埃塞俄比亞和墨西哥也提交了監管檔案。該產品將可能以品牌名稱 Femidence™ 進行銷售。
Nigeria is the most populous country in Africa and the seventh largest country in the world, with 45 million women of reproductive age. With nearly half of the population under the age of 18 years, a record number of young people will enter reproductive age in the next decade.
尼日利 是人口最多的國家 非洲 也是世界上第七大國家，擁有 4500 萬名生育年齡婦女。接近一半的人口在 18 歲以下，未來十年將有創紀錄的年輕人進入生殖年齡。
In October 2020, Adjuvant Capital made a $25 million strategic investment to expand global market access for Phexxi® (lactic acid, citric acid, potassium bitartrate) vaginal contraceptive gel and to support EVOGUARD, Evofem's registrational Phase 3 clinical trial evaluating Phexxi for the prevention of chlamydia and gonorrhea in women. Evofem is on track to report top-line data from this landmark trial in mid-October 2022. Positive study outcomes would enable regulatory submissions and potential U.S. approval for prevention of these sexually transmitted infections in 2023.
在 2020 年十月，輔助資本做了 二千五百萬 策略性投資以擴大 Pexxi®（乳酸，檸檬酸，酒石酸鉀）陰道避孕凝膠的全球市場准入並支持 喚起，Evofem 的註冊 3 期臨床試驗評估了 Pexxi 用於預防女性衣原體和淋病。Evofem 有望報告這個具有里程碑意義的審判中的頂線數據 2022 年十月中旬。積極的研究結果將使監管機構的意見書和潛在的美國批准預防這些性傳播感染 2023.
"We expect Nigeria will be one of many commercial markets around the world in which Evofem can generate shareholder returns while favorably impacting the lives of women," said Jenny Yip, Managing Partner at Adjuvant Capital and a Director of Evofem Biosciences. "Women everywhere are demanding more contraceptive choices to suit their needs, and they specifically want non-hormonal options, like Phexxi, that are free from common side effects like depression, mood swings and irritability."
「我們期待 尼日利 將成為全球眾多商業市場之一，Evofem 可以在這些市場中產生股東回報，同時對女性的生活有利影響。」 葉珍妮, 輔助資本的管理合夥人和 Evofem 生物科學的董事.「世界各地的婦女都要求更多的避孕選擇以滿足他們的需求，他們特別想要非激素的選擇，例如 Pexxi，沒有常見的副作用，如抑鬱症，情緒波動和煩躁。」
Evofem is grateful to DKT Nigeria, its distribution partner in Nigeria, for their support of this registration.
Evofem 感謝尼日利亞 DKT，它的分銷合作夥伴 尼日利，以表示他們對此註冊的支持。
About Evofem Biosciences
關於伊芙姆生物科學
Evofem Biosciences, Inc. is developing and 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. The Company expects to report top-line data in mid-October 2022 from its registrational Phase 3 clinical trial evaluating Phexxi for the prevention of chlamydia and prevention of gonorrhea in women. Learn more at phexxi.com and evofem.com.
Evofem Biosciences, Inc. 正在開發和商業化創新產品，以解決女性性和生殖健康中未滿足的需求。該公司首個 FDA 批准的產品 Pexxi®（乳酸，檸檬酸和酒石酸鉀），是一種無激素的按需處方避孕陰道凝膠。它裝在一盒 12 個預先填充的塗藥器中，並在每次性行為之前 0-60 分鐘應用。該公司預計將於 2022 年 10 月中旬報告其註冊第三期臨床試驗評估 Pexxi 用於預防衣原體和預防女性淋病的第三期臨床試驗數據。如需瞭解更多資訊，請前往相關網站和 Evofem.com。
Phexxi® is a registered trademark and Femidence™ is a trademark of Evofem Biosciences, Inc.
河南省 PHXI®是註冊商標和 Femidence™ 是 Evofem 生物科學公司的商標。
Forward-Looking Statements
前瞻性陳述
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. Various factors could cause actual results to differ materially from those discussed or implied in the forward-looking statements, including our ability to successfully commercialize Phexxi outside of the U.S. and general market and other conditions, and 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, or that could impair the value of Evofem Biosciences' assets and business, are disclosed in the Company's SEC filings, including its Annual Report on Form 10-K for the year ended December 31, 2021, its Quarterly Report on Form 10-Q for the quarter ended June 30, 2022, and 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.
本新聞稿包括《1934 年證券交易法》第 21E 條（經修訂的《1934 年證券交易法》第 21E 條）和 1995 年《私人證券訴訟改革法》所提供的安全港所指的「前瞻性陳述」。各種因素可能會導致實際結果與前瞻性聲明中討論或暗示的結果有很大不同，包括我們能夠在美國以外成功將 Pexxi 商業化以及一般市場以及其他條件，並且警告您不要對這些前瞻性聲明作出不當的依賴，這些陳述僅在本新聞稿發布日期為止。這些前瞻性陳述中的每一項都涉及風險和不確定性。可能導致實際業績與前瞻性聲明中討論或暗示的重要因素有重大差異，或可能損害 Evofem Biosciences 資產和業務價值的重要因素，在公司的 SEC 文件中披露，包括截至 2021 年 12 月 31 日，其截至 2022 年 6 月 30 日和隨後的 10-Q 表的年度報告，其截至 2021 年 12 月 31 日的 10-K 表年報。所有前瞻性陳述均通過這些因素明確完全符合條件。除法律要求外，本公司不承擔任何更新任何前瞻性聲明的責任。
Contacts
Investors:
Amy Raskopf
SVP, Investor Relations
Evofem Biosciences, Inc.
[email protected]
(917) 673-5775
联系人
投資者：
艾米·拉斯科夫
投資者關係資深副總裁
伊芬生物科學股份有限公司
[電子郵件保護]
(917) 673-5775
Media:
[email protected]
媒體:
[電子郵件保護]
SOURCE Evofem Biosciences, Inc.
來源伊芙姆生物科學有限公司
譯文內容由第三人軟體翻譯。