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

Rhea-AI Summary

Evofem Biosciences (OTCQB: EVFM) has announced the issuance of U.S. Patent No. 11,992,472 by the USPTO. This patent covers the composition and methods for using Phexxi, a hormone-free vaginal gel for contraception. Phexxi, which contains lactic acid, citric acid, and potassium bitartrate, is FDA-approved and works by maintaining a vaginal pH level inhospitable to sperm and certain pathogens. This is the fifth U.S. patent for Phexxi, further solidifying Evofem's intellectual property portfolio. CEO Saundra Pelletier highlighted the importance of this patent in demonstrating Phexxi's innovative approach to hormone-free contraception. Since its U.S. launch in 2020, Phexxi's net sales have consistently grown. Key growth drivers for 2024 include the increasing use of Phexxi for supplemental contraception among women taking GLP-1 agonists, which can reduce the efficacy of oral contraceptives.

Positive

• Issuance of a fifth U.S. patent strengthens Evofem's intellectual property portfolio.
• Phexxi is the first FDA-approved hormone-free, locally-acting contraceptive gel.
• Net sales of Phexxi have increased consecutively since its launch in 2020.
• Key growth drivers include the use of Phexxi as a supplemental contraceptive for women on GLP-1 agonists.

Negative

• Potential dependency on niche market segments like women using GLP-1 agonists for future growth.
• No specific financial figures or projections provided in the announcement.

Legal Expert

The issuance of U.S. Patent No. 11,992,472 enhances Evofem's intellectual property portfolio, which can be a strong competitive advantage in the pharmaceutical industry. By securing a fifth patent related to Phexxi, Evofem further solidifies its market position against competitors. This patent extends protection over the composition and methods of the contraceptive, deterring potential generic entrants and providing a legal moat around their product. Additionally, the inclusion of this patent in the FDA's Orange Book reinforces its legitimacy and can lead to additional market exclusivity benefits. However, investors should consider the typical time and financial effort involved in defending such patents, which can be substantial.

Market Research Analyst

Evofem's continued growth in net sales of Phexxi, driven by its unique position as a hormone-free contraceptive, is notable. The company's strategy to market Phexxi as a supplemental contraceptive for women using GLP-1 agonists like Mounjaro and Zepbound is particularly astute, given that these medications can reduce the efficacy of oral contraceptives. This niche market could provide a steady revenue stream. The emphasis on non-hormonal contraception aligns with a growing consumer preference for natural and hormone-free solutions, which could enhance long-term demand. However, the company's ability to maintain and grow market share will depend on effective marketing and education campaigns to increase awareness among both healthcare professionals and consumers.

-- 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
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 significance of Evofem's new U.S. patent for Phexxi?

The new U.S. patent strengthens Evofem's intellectual property portfolio, marking its fifth patent for Phexxi in the United States.

What makes Phexxi different from other contraceptives?

Phexxi is the first FDA-approved hormone-free, locally-acting contraceptive gel, working by maintaining a vaginal pH level inhospitable to sperm and certain pathogens.

How has Phexxi's market performance been since its launch?

Phexxi's net sales have increased consecutively each year since its U.S. commercial launch in 2020.

Why is Phexxi considered a logical choice for women on GLP-1 agonists?

GLP-1 agonists can make oral contraceptives less effective at certain points, making a non-hormonal method like Phexxi a logical supplemental choice.