Evofem Strengthens Phexxi Intellectual Property with New Composition of Matter Patent From USPTO

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Evofem Biosciences, Inc. strengthens Phexxi's intellectual property with a new composition of matter patent from the USPTO. The patent covers methods of contraception with Phexxi vaginal gel, making it the company's fifth patent in the United States. Phexxi is the first FDA-approved locally-acting contraceptive gel that works without hormones. The product has shown increased net sales since its launch in 2020, with key growth drivers for 2024 including expanded use in women taking oral contraceptives in conjunction with certain drugs.

Positive

• Phexxi's new patent enhances the company's intellectual property portfolio and solidifies its position in the contraceptive market.
• The patent covers broad method claims that are Orange Book-listable, indicating potential for market exclusivity and protection against generic competition.
• Phexxi is the first and only FDA-approved locally-acting contraceptive gel, offering a hormone-free option for women.
• The product has shown consistent growth in net sales since its launch in 2020, indicating a positive reception in the market.
• Expanded use of Phexxi in conjunction with specific drugs presents a significant growth opportunity for Evofem in 2024.
• The innovative approach of Phexxi in contraception highlights the company's commitment to providing women with effective and hormone-free birth control options.

Negative

• None.

-- Application allowed with broad method claims that are Orange Book-listable --

-- Once issued, this will be Evofem's fifth patent covering Hormone-Free "In the Moment" Contraceptive Phexxi in the United States --

SAN DIEGO, April 18, 2024 /PRNewswire/ -- Evofem Biosciences, Inc. (OTCQB: EVFM) announced today that the United States Patent and Trademark Office (USPTO) issued to the Company a Notice of Allowance for patent application 17/823,020 entitled, "Compositions and Methods for Enhancing the Efficacy of Contraceptive Microbicides." This Notice of Allowance is expected to result in the issuance of a U.S. patent once administrative processes are completed.

The allowed claims cover methods of contraception with a composition that encompasses Phexxi^® (lactic acid, citric acid, and potassium bitartrate) vaginal gel. Evofem expects the resulting patent will be Orange Book-listable. The patent, when issued, will be Evofem's fifth patent for Phexxi in the United States. 

"We are pleased that our U.S. continuation application from the 0001 L-lactic acid patent family has been allowed with broad method claims that are Orange Book-listable," said Saundra Pelletier, Chief Executive Officer of Evofem. "This patent allowance attests to the innovation Phexxi brings to contraception and a woman's ability to protect herself from unintended pregnancy with no hormones."

Phexxi is the first and only FDA-approved 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 naturally inhospitable to sperm.

Phexxi net sales have increased in each consecutive year since it was launched in 2020.  Key growth drivers for 2024 include expanded use of Phexxi in women of reproductive age who take oral contraceptives in conjunction with GLP-1 agonists like Mounjaro and Zepbound. These drugs may make oral birth control pills less effective at certain points in the dosing schedule. Patients are advised to 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. 

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, 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
media@evofem.com

Investor Contact
Amy Raskopf
Evofem Biosciences, Inc.
araskopf@evofem.com
Mobile: (917) 673-5775

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SOURCE Evofem Biosciences, Inc.

FAQ

What is the latest patent news from Evofem Biosciences, Inc.?

Evofem Biosciences, Inc. has strengthened Phexxi's intellectual property with a new composition of matter patent from the USPTO, covering methods of contraception with the vaginal gel.

How many patents does Evofem have for Phexxi in the United States?

Evofem will have five patents for Phexxi in the United States once the new patent is issued.

What is Phexxi and how does it work?

Phexxi is the first FDA-approved locally-acting contraceptive gel that works without hormones by maintaining the natural vaginal biome with a pH inhospitable to sperm.

What are the key growth drivers for Phexxi in 2024?

Key growth drivers for Phexxi in 2024 include expanded use in women taking oral contraceptives in conjunction with specific drugs that may reduce the effectiveness of birth control pills.

How has Phexxi's net sales performance been since its launch?

Phexxi has shown increased net sales in each consecutive year since its launch in 2020.