Evofem Announces Issuance of New U.S. Patent Covering Phexxi Composition of Matter

-- Issuance of U.S. Patent No. 11,992,472 Further Strengthens Evofem's Intellectual Patent Portfolio --

-- Newly issued patent is Evofem's fifth covering Hormone-Free "In the Moment" Contraceptive Phexxi in the United States --

SAN DIEGO, June 11, 2024 /PRNewswire/ -- Evofem Biosciences, Inc. (OTCQB:EVFM) today announced that the United States Patent and Trademark Office (USPTO) has issued U.S. Patent No. 11,992,472, which covers composition and methods for contraception with a composition that encompasses Phexxi^® (lactic acid, citric acid, and potassium bitartrate) vaginal gel. 

Phexxi is the first and only FDA-approved hormone-free, locally-acting contraceptive gel. It is applied zero-to-60 minutes before intercourse and works, without hormones, by maintaining the natural vaginal biome with a pH that is inhospitable to sperm as well as certain bacterial and viral pathogens. 

"We are extremely pleased with the continued development of the Phexxi patent portfolio, marked by the issuance of our fifth U.S. patent," said Saundra Pelletier, Chief Executive Officer of Evofem. "This Orange Book-listable patent attests to the innovation Phexxi brings to contraception and a woman's ability to protect herself from unintended pregnancy with no hormones."

Phexxi net sales have increased in each consecutive year since its U.S. commercial launch in 2020.  Key growth drivers for 2024 include increasing use of Phexxi for supplemental contraception among women of reproductive age who take oral birth control pills in conjunction with GLP-1 agonists like Mounjaro and Zepbound. GLP-1s may make oral contraceptives less effective at certain points in the dosing schedule - specifically for four weeks after initiation and for another four weeks after each dose escalation. Patients may be advised to switch to a non-oral contraceptive method or use a supplemental method to prevent unintended pregnancy during these times. ^1,2 A non-systemic, non-hormonal method, like Phexxi, is a logical choice for these women.

About Evofem Biosciences

Evofem Biosciences 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. Learn more at phexxi.com and evofem.com. 

In December 2023, Evofem into a Merger Agreement with Aditxt, Inc. (NASDAQ:ADTX) under which Aditxt intends to acquire Evofem. The parties reinstated and amended the Merger Agreement, as amended, in May 2024, and are working to close the contemplated transaction in the second half of 2024.

Phexxi® is a registered trademark of Evofem Biosciences, Inc.

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. 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 March 31, 2024 filed with the SEC on May 15, 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.

Sources

¹ Zepbound Prescribing Information. https://uspl.lilly.com/zepbound/zepbound.html#pi

² Zepbound Safety Summary with Warnings. https://zepbound.lilly.com/

Media Contact

[email protected]

Investor Contact

Amy Raskopf

Evofem Biosciences, Inc.

[email protected]

Mobile: (917) 673-5775

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SOURCE Evofem Biosciences, Inc.