Evofem Announces Issuance Of U.S. Patent Covering Phexxi Composition Of Matter; Newly Issued Patent Expected To Provide Protection For Phexxi Into At Least 2033
Evofem Announces Issuance Of U.S. Patent Covering Phexxi Composition Of Matter; Newly Issued Patent Expected To Provide Protection For Phexxi Into At Least 2033
-- Issuance of U.S. Patent No. 11,439,610 Further Strengthens Evofem's Intellectual Patent Portfolio --
--美國第11,439,610號專利的頒發進一步加強Evofem的智力專利組合--
-- Newly Issued Patent Expected to Provide Protection for Phexxi into At Least 2033 --
--新頒發的專利預計至少在2033年之前為Phexxi提供保護--
SAN DIEGO, Sept. 23, 2022 /PRNewswire/ -- Evofem Biosciences (OTCPK: EVFM) today announced that the United States Patent and Trademark Office (USPTO) has issued U.S. Patent No. 11,439,610, which covers the composition of matter of Phexxi (lactic acid, citric acid, potassium bitartrate).
聖迭戈，9月Evofem Biosciences(OTCPK：EVFM)今天宣佈，美國專利商標局(USPTO)已經頒發了美國專利11,439,610號，該專利涵蓋Phexxi(乳酸、檸檬酸、酒石酸氫鉀)的物質組成。
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Phexxi is the first and only FDA-approved hormone-free, woman-controlled contraceptive gel that women use on demand. It works by maintaining vaginal pH in the optimal range of 3.5 to 4.5, which is inhospitable to sperm, as well as certain bacterial and viral pathogens including chlamydia and gonorrhea. Since Phexxi's initial launch in 2020, more than 100,000 women have been prescribed Phexxi by nearly 21,000 health care providers.
Phexxi是FDA批准的第一種也是唯一一種女性按需使用的無激素、女性控制的避孕凝膠。它的工作原理是將陰道pH值保持在3.5至4.5的最佳範圍內，這不利於精子以及某些細菌和病毒病原體，包括衣原體和淋病。自2020年首次推出Phexxi以來，已有近2.1萬名醫療保健提供者為10萬多名女性開了Phexxi的處方。
"We are extremely pleased with the continued development of the Phexxi patent portfolio, which comprises more than 40 patents. This newly issued patent expands the breadth and depth of our Phexxi intellectual property portfolio, adding composition of matter protection to our Orange Book-listed method of use patents and the further protection afforded by the QIDP designation granted by the FDA for the prevention of chlamydia and gonorrhea in women," said Saundra Pelletier, Chief Executive Officer of Evofem.
Evofem首席執行官Saundra Pelletier說：“我們對Phexxi專利組合的持續發展感到非常高興，該專利包括40多項專利。這項新發布的專利擴大了我們Phexxi知識產權組合的廣度和深度，為我們在橙皮書中列出的使用方法專利增加了物質保護成分，並通過FDA授予的預防女性衣原體和淋病的QIDP稱號提供了進一步的保護。”
Top-line data from EVOGUARD, Evofem's registrational Phase 3 clinical trial evaluating Phexxi for these two potential new indications, are expected in mid-October. Preliminary CDC data for 2021 show that infections with chlamydia and gonorrhea continued to increase during the second year of the COVID-19 pandemic, with no signs of slowing.
最重要的數據來自EVOGUARDEvofem的註冊第三階段臨床試驗評估Phexxi的這兩個潛在的新適應症，預計將於10月中旬進行。疾控中心2021年的初步數據顯示，在新冠肺炎大流行的第二年，衣原體和淋病感染繼續增加，沒有放緩的跡象。
At a medical conference this week, Leandro Mena, director of the CDC's Division of STD Prevention, said, "It is imperative that we... work to rebuild, innovate, and expand [STD] prevention in the U.S."
在本週的一次醫學會議上，美國疾病控制與預防中心性病預防部門的萊安德羅·梅納說，“當務之急是我們……努力在美國重建、創新和擴大[性病]預防工作。”
Positive outcomes of the EVOGUARD trial would enable regulatory submissions and potential approval of Phexxi for prevention of chlamydia and gonorrhea in 2023. There are currently no FDA-approved drug products to prevent these infections. Mena notes that a decrease in condom usage, particularly among young people, is fueling the rising rates.
取得的積極成果EVOGUARD試驗將使監管機構能夠提交並有可能在2023年批准Phexxi用於預防衣原體和淋病。目前還沒有FDA批准的藥物產品來預防這些感染。中東和北非地區指出，保險套使用量的減少，特別是年輕人中保險套使用量的減少，正在推動保險套使用率的上升。
Over 1.6 million cases of chlamydia were reported in 2021. Chlamydia usually has no signs or symptoms, and most cases are identified through preventive care visits. Therefore, CDC notes it is likely chlamydia was disproportionately affected by reduced screening during the Covid-19 pandemic, resulting in undiagnosed infections.
2021年報告的衣原體感染病例超過160萬例。衣原體通常沒有體徵或癥狀，大多數病例是通過預防性護理就診來確定的。因此，疾控中心指出，在新冠肺炎大流行期間，衣原體很可能受到篩查減少的不成比例的影響，導致未診斷的感染。
That same year reported cases of gonorrhea increased for the eighth consecutive year to 700,000.
同年，報告的淋病病例連續第八年增加，達到70萬例。
In 2020, about 50% of all gonorrhea infections were estimated to be resistant to at least one antibiotic.
2020年，據估計，大約50%的淋病感染對至少一種抗生素具有抗藥性。
The newly issued patent, entitled, "Compositions and Methods for Enhancing the Efficacy of Contraceptive Microbicides," is expected to provide protection into at least 2033. Evofem now has the sole right in the United States to make, have made, market, and sell for any commercial purpose the composition of matter that comprises Phexxi.
這項新發布的專利名為“增強避孕殺微生物劑效力的組合物和方法”，預計至少將提供到2033年的保護。Evofem現在擁有在美國制造、製造、銷售和銷售構成Phexxi的物質的任何商業目的的唯一權利。
譯文內容由第三人軟體翻譯。