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).
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.
“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.
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.
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.”
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.
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.
That same year reported cases of gonorrhea increased for the eighth consecutive year to 700,000.
In 2020, about 50% of all gonorrhea infections were estimated to be resistant to at least one antibiotic.
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.