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– Assigns PDUFA Ambition Date of May 25, 2020 –



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SAN DIEGO, Dec. 18, 2019 /PRNewswire/ — Evofem Biosciences, Inc. (NASDAQ: EVFM), a clinical-stage biopharmaceutical company, today appear that the U.S. Food and Drug Administration (FDA) accustomed cancellation of the New Drug Application (NDA) resubmission for Amphora®, a Multipurpose Vaginal pH Regulator (MVP-R™), for the blockage of pregnancy. Deemed a Class 2 resubmission by the FDA, the bureau has assigned a six-month analysis aeon and a Decree Drug User Fee Act (PDUFA) ambition date of May 25, 2020.

(PRNewsfoto/Evofem Biosciences, Inc.)



“Today’s accepting brings us one footfall afterpiece to carrying the aboriginal accurate contraceptive addition in decades,” said Saundra Pelletier, Evofem Biosciences’ Chief Executive Officer. “We attending advanced to continuing to assignment carefully with the FDA during the analysis action and to the abeyant to action women a new, non-hormonal decree contraceptive advantage that puts them in ascendancy of their animal health.”

The Amphora NDA resubmission includes abounding after-effects from the Phase 3 AMPOWER study, a acknowledging single-arm, open-label Phase 3 balloon that evaluated the adeptness and assurance of Amphora in about 1,400 advantageous women ages 18 to 35 years.



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The Aggregation is additionally evaluating the abeyant use of Amphora for the blockage of urogenital chlamydia and gonorrhea in women. Top-line after-effects from the Phase 2b AMPREVENCE trial, appear in December 2019, approved that the abstraction met both its primary and accessory endpoints, with a 50% about accident abridgement in chlamydia infection and a 78% about accident abridgement in gonorrhea infection compared to placebo.

About AmphoraAmphora® (L-lactic acid, citric acerbic and potassium bitartrate) is an investigational Multipurpose Vaginal pH Regulator (MVP-R™) advised to adapt vaginal pH aural the accustomed ambit of 3.5 to 4.5, alike in the attendance of semen, which commonly raises the vaginal pH to 7.0 to 8.0. This maintains an acerb ambiance that is brusque to sperm, as able-bodied as assertive viral and bacterial bacilli associated with sexually transmitted infections, but is basic to the adaptation of advantageous bacilli in the vagina.

About Evofem Biosciences                                                  Evofem Biosciences, Inc., (NASDAQ: EVFM) is a clinical-stage biopharmaceutical aggregation committed to developing and commercializing avant-garde articles to abode unmet needs in women’s animal and changeable health. Evofem Biosciences aims to beforehand the lives of women by developing avant-garde solutions, such as woman-controlled contraception and abeyant aegis from assertive sexually transmitted infections (STIs). The Company’s beforehand Multipurpose Vaginal pH Regulator (MVP-R™) artefact candidate, Amphora®, is in development for assorted abeyant indications: blockage of pregnancy, blockage of urogenital manual of Chlamydia trachomatis infection (chlamydia) in women, and blockage of urogenital manual of Neisseria gonorrhoeae infection (gonorrhea) in women. For added advice apropos Evofem, amuse appointment www.evofem.com.

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Amphora® is a registered brand and MVP-R™ is a brand of Evofem Biosciences, Inc.

Forward-Looking StatementsStatements in this columnist absolution about Evofem’s approaching expectations, affairs and prospects, as able-bodied as any added statements apropos affairs that are not absolute facts, may aggregate advanced statements aural the acceptation of The Private Securities Litigation Reform Act of 1995. These statements include, but are not bound to, statements apropos objectives, affairs and strategies that abode activities, contest or developments that the Aggregation intends, expects, projects, believes or anticipates will or may action in the future, including, after limitation, statements about the advancing timing and aftereffect of the re-submission of the NDA for Amphora for blockage of pregnancy. These statements are generally characterized by analogue such as “believes,” “hopes,” “may,” “anticipates,” “should,” “intends,” “plans,” “will,” “could,” “would,” “expects,” “estimates,” “projects,” “positioned,” “strategy” and agnate expressions and are based on assumptions and assessments fabricated in ablaze of management’s acquaintance and acumen of absolute trends, accepted conditions, accepted approaching developments and added factors believed to be appropriate. Advanced statements are not guarantees of approaching achievement and are accountable to risks and uncertainties, abounding of which are alfresco of the Company’s control. Important factors that could account absolute results, developments and business decisions to alter materially from advanced statements are declared in the sections blue-blooded “Risk Factors” in the Company’s filings with the Securities and Exchange Commission (SEC), including its best contempo Annual Report on Form 10-K and consecutive filings, and accommodate but are not bound to the following: whether the FDA approves Amphora as a contraceptive; the Company’s adeptness to accession the added funds all-important to commercialize Amphora as a contraceptive and/or to complete the development of Amphora to anticipate urogenital accretion of Chlamydia trachomatis and Neisseria gonorrhoeae in women; the Company’s assurance on third parties to conduct its analytic trials, analysis and development, and manufacturing; the availability of agreement from government authorities and bloom allowance companies for the Company’s products; the appulse of abeyant artefact accountability lawsuits; the access of all-encompassing and cher government regulation; the animation of the trading amount of the Company’s accepted stock, and the absorption of adeptness in its banal ownership. Advanced statements in this columnist absolution are fabricated as of the date of this columnist release, and the Aggregation undertakes no assignment to amend or alter any such statements, whether as a aftereffect of new information, approaching contest or otherwise. These advanced statements should not be relied aloft as apery Evofem’s angle as of any date consecutive to the date hereof.

Contact

Investor RelationsAmy RaskopfEvofem [email protected]: (858) 550-1900 x167M: (917) 673-5775

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MediaCara Miller Vice President, Public Affairs and Corporate Communications [email protected] Office: (858) 550-1900 x272

 

View aboriginal agreeable to download multimedia:http://www.prnewswire.com/news-releases/us-fda-acknowledges-receipt-of-evofem-biosciences-new-drug-application-resubmission-for-amphora-for-the-prevention-of-pregnancy-300976594.html

SOURCE Evofem Biosciences, Inc.

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